FitBrain: Healing Hearts and Mending Minds in Older Adults Living With HIV

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02711878
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 115
• Locations: 3
• Arms: 2
• Duration (Months): 39.6
• Patients Per Site: 38.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to see if exercise is helpful for improving memory, concentration thinking abilities, physical function, and quality of life for adults aged 50 to 89 years living with HIV and who have two or more cardiovascular disease risk factors. The study will test two kinds of intervention exercises: one group will walk for exercise and the second group will stretch for exercise. Members of both interventions will be asked to participate in one-on-one interviews/assessments, measures of physical functioning, and some sessions with others who are also enrolled in the study.

Condition or Disease	Intervention/Treatment	Phase
HIV; Cardiovascular Disease; AIDS	Behavioral: Let's Move Program; Behavioral: Let's Flex Program; Behavioral: Group Motivational Interviewing	N/A

Detailed Description

This is a two arm, randomized controlled trial to test the longitudinal effects of the Let's Move Program (walking for exercise) compared to effects of the attention control Let's Flex Program (stretching for exercise) in participants aged 50 to 89 years living with HIV and who have two or more cardiovascular disease risk factors. Participants in both interventions will be asked to participate in one-on-one interviews/assessments, measures of physical functioning, and some sessions with others who are also enrolled in the study. Participants will participate in an in home exercise program for twelve weeks in which the study team will help identify maximum duration and intensity followed by a maintenance period for weeks 13-58.

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Healing Hearts and Mending Minds in Older Adults Living With HIV
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Dec 20, 2019
• Actual Study Completion Date: Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Let's Move Program Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks.	Behavioral: Let's Move Program; Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.; Behavioral: Group Motivational Interviewing; Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Active Comparator: Let's Flex Program Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks.	Behavioral: Let's Flex Program; Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.; Behavioral: Group Motivational Interviewing; Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.

Outcome Measures

Primary Outcome Measures

1. Stroop Color and Word Test Score [Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)]

   The Stroop Color and Word Test is a performance-based test of executive function and inhibitory responding. The participant is presented with a page with the words "red, blue, and green" printed 100 times in (20 words in 5 columns). Each word is printed in a different color of ink than the target word (e.g, the word "red" is printed in blue ink). Participants read the color of ink in which the word is printed as quickly are possible within a time limit. The correct number within the time limit is the score. Raw scores (unadjusted for age and education) range from 0-100.

2. Trail Making Test Score [Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)]

   The Trail Making Test is a performance based test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect circles as possible while still maintaining accuracy. Trails A subtest requires the connection in sequence of 25 circles labeled by numbers. Trails B requires the connection in sequence of 25 circles labeled by alternating numbers and letters (1-A-2-B-3-C). The score on the test is the time in seconds that it takes to complete. Higher scores (i.e., time) indicate poorer performance.

3. Letter Fluency Assessed by Change in FAS Test Score [Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)]

   The FAS test requires stating out loud as many words that begin with the assigned letter (F, A, and S) as possible within 60-seconds. Results represent total number of words stated for F,A & S combined.

4. Category Fluency Test Score [Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)]

   The category fluency test requires participants to state out load the names of as many animals as possible within 60-seconds. Results are total number of animals named.

5. Hopkins Verbal Learning Test (HVLT) - Revised Score [Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)]

   The HVLT-Revised is a list learning task requiring the respondent to recall as many words as possible from a list of 12 words provided orally by the examiner. There is a learning trial, a delayed recall trial, and a recognition trial. Results show HVLT Total recall (Total number if words recalled over 3 trials) and HVLT Delayed recall (Total number of words recalled after 25 minute delay).

6. Brief Visual Memory Test - Revised (BVMT-R) Score [Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)]

   The Brief Visual Memory Test is a performance based test that requires that participants reproduce simple visual images from memory (the images are displayed for 10 seconds then removed from view). The BVMT-R contains a learning trial, a recall trial, a recognition trial, and a copy trial. Each figure recalled is given 0,1, or 2 points based on accuracy and location recall. Results show BVMT Total recall (Total number if figures recalled over 3 trials: range 0 - 36) and BVMT delayed recall (total number of figures recalled after 25 min delay. Score range 0-12). Higher score correlate with better outcome.

7. Grooved Pegboard Test Score [Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)]

   The Grooved Pegboard Test requires the placing of grooved pegs into a same-shaped hole as quickly as possible, once with the dominant hand and once with the non-dominant hand.

8. Finger Tapping Test Score [Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)]

   The finger tapping test a fine motor speed requires tapping a lever with the index finger as quickly as possible. Trials with the dominant and non-dominant hand are completed.

9. Coding Test Score [Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)]

   The coding test requires writing the corresponding symbol associated with a letter from a key provided. As many responses as possible are completed in the 120 second time limit. Results presented are the total number of correct responses (possible score range 0-135).

10. Digit Span Test Score [Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)]

    The digit span test is a performance based test that requires repeating an increasing span of digits that are provided verbally by the examiner. The test includes trials of repeating digits in the same order presented by the examiner, in the reverse order of that presented by the examiner, and in ascending sequence. Scores range from 0 to 48. Higher score correlates with better outcome.

11. Symbol Span Test Score [Baseline, 3 months, 6 months and 12 months Post Intervention]

    The subtest assesses visual working memory using novel visual stimuli. A series of abstract symbols on a page are shown briefly. Then the symbols are to be selected from an array of symbols in the same order they were presented on the previous page. This performance based test measures storage and manipulation of visual details in working memory. Score range from 0-36. Higher score correlates with better outcome.

12. Instrumental Activities of Daily Living (IADL) Test Score [Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)]

    The Instrumental Activities of Daily Living (IADL) Test is a self-report measure assessing the amount of assistance, if any, required to do day-to-day tasks necessary to live independently. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias). Higher scores indicate worse performance in instrumental activities activities of daily living.

13. NIH Toolbox [Baseline, Post Intervention (Up to 58 weeks)]

    Computerized cognitive tests developed and distributed by the NIH. Tests include Pattern Comparison Processing Speed Test, Picture Vocabulary Test, Reading Recognition Test, Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, List Sorting Working Memory Test, and Oral Symbol Digit Test

Secondary Outcome Measures

1. Change in Soluble Cluster of Differentiation 14 (sCD14) Level [Baseline, Post Intervention (Up to 58 weeks)]

   Soluble Cluster of Differentiation 14 (sCD14) is a marker of monocyte activation, is associated with neurocognitive impairment and HIV-associated neurocognitive disorders (HANDs) and higher mortality in persons living with HIV. Data not analyzed due to delays with Coronavirus Disease (COVID-19), loss of laboratory personnel and most recent, equipment required for analysis is in repair.

2. Change in Interleukin 6 (IL-6) Level [Baseline, Post Intervention (Up to 58 weeks)]

   IL-6 is a pro-inflammatory cytokine known to contribute to the pathogenesis of risk of cardiovascular disease (CVD) and cognitive impairment (CI) through inflammation and promotion of endothelial vascular dysfunction. IL-6 is measured by enzyme-linked immunosorbent assay (ELISA) and reported as in picograms per deciliter (pg/dL). Higher concentrations of IL-6 raise congenital heart defect risk. Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.

3. Change in Tumor Necrosis Factor Alpha (TNF-alpha) Level [Baseline, Post Intervention (Up to 58 weeks)]

   TNFR1 membrane bound receptors that have been shown to bind TNF alpha. Activation of TNFR1 mediates the proinflammatory properties of TNF alpha. Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.

4. Change in High Sensitivity C-Reactive Protein (hsCRP) Level [Baseline, Post Intervention (Up to 58 weeks)]

   CRP is an acute phase protein that is an inflammatory marker associated with cardiovascular disease (CVD) and insulin resistance and most recently associated with cognitive impairment.Levels of >3.0 mg/L are consistent with high relative risk for CVD. Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.

5. Change in Soluble Urokinase Plasminogen Activator Receptor (suPAR) Level [Baseline, Post Intervention (Up to 58 weeks)]

   Soluble urokinase Plasminogen Activator Receptor (suPAR) is an inflammatory biomarker is associated with higher risk for cardiovascular disease in persons with HIV. Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.

6. Change in Brain-derived Neurotrophic Factor (BDNF) Level [Baseline, Post Intervention (Up to 58 weeks)]

   BDNF is a protein that occurs naturally in the hippocampus, cortex, and basal forebrain-areas vital to learning, memory, and higher thinking; an increase in BDNF in animal models and humans is thought to enhance neurogenesis. BDNF is reported as in nanograms per milliliter (ng/mL). Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.

7. Change in Thiobarbituric Acid Reactive Substances (TBARS) Level [Baseline, Post Intervention (Up to 58 weeks)]

   Thiobarbituric acid reactive substances (TBARS) is associated with Vascular function and oxidative stress in persons with HIV. Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.

8. Flow-Mediated Dilatation (FMD) [Baseline, T2 (28-30 weeks post baseline)]

   Flow-mediated dilatation (FMD) is a measure of endothelial function; the measure of % FMD at 60 seconds reflects arterial relaxation time after cuff deflation.

9. Pulse Wave Velocity (PWV) [Baseline, Post Intervention (Up to 58 weeks)]

   Pulse wave velocity is the gold standard for measuring arterial stiffness and has strong predictive value for adverse cardiovascular and cerebrovascular events and is now a major target for vascular aging.

Other Outcome Measures

1. Pittsburgh Sleep Quality Index (PSQI) Score [Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)]

   The Pittsburgh Sleep Quality Index (PSQI) is a 19-item measure of the quality and patterns of sleep among adults. Scoring is based on a 0 to 3 Likert scale. The global score is 21; total possible score ranges from 0 to 21. The higher the score the worse the sleep quality.

2. Beck Depression Inventory-II (BDI-II) Score [Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)]

   BDI-II is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Each answer being scored on a scale value of 0 to 3. Scores range from 0-63. Interpretation: 0 through 9 indicate no or minimal depression; scores from 10 through 18 indicate mild to moderate depression; scores from 19 through 29 indicate moderate to severe depression; and scores from 30 through 63 indicate severe depression.

3. Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire [Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)]

   The 41-item Community Healthy Activities Model Program for Seniors evaluates weekly duration of various types of physical activity among older adults including light, moderate and vigorous intensity levels. The activity is assessed by hours per week using 6 categories less than 1 hour to 9 or more hours. The values presented below are hours participants indicated they spent in moderate intensity activity levels at the 3 time points over the past 4 weeks. Guidelines suggest 150 minutes (2.5 hours) per week in moderate intensity physical activity, below this number is considered sedentary. We measure change from baseline in time spent in moderate intensity exercise.

4. V02 Max Rate [Baseline]

   V02 max is the maximum rate of oxygen consumption as measured during incremental exercise using the Balke treadmill test. This is an exploratory outcome.

5. Six-minute Walk Test [Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)]

   Measure of functional capacity or submaximal exercise. Scores reflect distance walked in feet for 6 minutes duration. This is an exploratory outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HIV diagnosis

• English speaking

• Live independently within a 30-45 mile radius of Atlanta, Georgia

• Not involved in any structured exercise program or exercising 3 or more times per week for a minimum of 30 minutes

• Not involved in any weight loss program

• Not hospitalized within the last 60-days

• Clinically stable and on antiretroviral therapy (ART) 6 months before enrollment

• If taking statins, stable on medication for 3 months

• Score 3 or less on the verbal memory subtest of the Montreal Cognitive Assessment (MoCA)

• Less than 0.5 standard deviations (SD) below mean on the Oral Trail Making Test B

• Able to provide informed consent and pass a consent post-test

Exclusion Criteria:

• Non sedentary (defined as engaging in > 30 minutes of moderately strenuous exercise 3 times or more a week)

• Medical or physical condition that would preclude participation in the exercise component of the study (e.g., severe arthritis or mobility problems, lower extremity amputations, joint replacement(s), balance disorders, dizziness, dyspnea on exertion (DOE) with moderate exertion, difficulty walking one block, recent falls, obvious injury to lower extremity, uncontrolled hypertension or diabetes, renal failure, blindness, or a history of angina with activity)

• Ischemic changes or inappropriate BP changes on baseline exercise (modified Balke or Bruce) treadmill test

• On oral corticosteroids (nasal, optical and inhaler corticosteroids allowed without restriction) , experiencing acute inflammation at time of baseline or follow-up testing (this will result in rescheduling of testing if no other exclusion criteria apply after 2 weeks)

• Presence of current opportunistic infection

• Any terminal illness

• Regular use of anti-inflammatory medications such as non-steroidal anti-inflammatory agents excluding low dose aspirin

• On anti-psychotics

• On tricyclic antidepressants

• On anti-depressants equal to the equivalent of more than 1 mg of Clonazepam

• On Lithium

• Women who are pregnant

• Severe learning disabilities, intellectual disabilities, schizophrenia, bipolar, psychotic disorders to minimize confounding effects on neurocognitive data

• Confounding neuro-medical conditions (e.g., active central nervous system (CNS) opportunistic infections, seizure disorders, head injury with loss of consciousness greater than 30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae, and non-HIV-associated dementias)

• Meet criteria for any Substance Use Disorder or Major Depression within 6 months of evaluation

• Creatinine > 2.5 within the past 6 months

• Patient Health Questionnaire-2 (PHQ-2) score > 4

• Completed 8 years or less of school

• Failed to pass post-consent test after three attempts

• Two or more positive drug screen tests

• Alcohol breathalyzer test result > 0.03

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital Midtown	Atlanta	Georgia	United States	30308
2	Ponce De Leon Center	Atlanta	Georgia	United States	30308
3	Emory University Hospital	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Drenna Waldrop-Valverde, PhD, Emory University
• Principal Investigator: Rebecca Gary, PhD, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 15, 2018
• Informed Consent Form - Mar 14, 2018

More Information

Publications

None provided.

• Responsible Party: Drenna Waldrop-Valverde, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02711878
• Other Study ID Numbers: IRB00080302; 1R01NR014973-01
• First Posted: Mar 17, 2016
• Last Update Posted: Jul 1, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

Participant Flow

Recruitment Details	Participants were enrolled between September 2016 and December 2018.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Period Title: Overall Study
STARTED	76	39
Completed Visit T1 (13-15 Weeks Post Baseline)	69	33
Completed Visit T2 (28-30 Weeks Post Baseline)	68	33
Completed Visit T3 (56-58 Weeks Post Baseline)	72	31
COMPLETED	68	33
NOT COMPLETED	8	6

Baseline Characteristics

Arm/Group Title	Let's Move Program	Let's Flex Program	Total
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Total of all reporting groups
Overall Participants	76	39	115
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	73 96.1%	38 97.4%	111 96.5%
>=65 years	3 3.9%	1 2.6%	4 3.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.68 (5.2)	53.92 (5.2)	55.09 (5.2)
Sex: Female, Male (Count of Participants)
Female	26 34.2%	20 51.3%	46 40%
Male	50 65.8%	19 48.7%	69 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.3%	0 0%	1 0.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	63 82.9%	37 94.9%	100 87%
White	10 13.2%	2 5.1%	12 10.4%
More than one race	1 1.3%	0 0%	1 0.9%
Unknown or Not Reported	1 1.3%	0 0%	1 0.9%
Region of Enrollment (Count of Participants)
United States	76 100%	39 100%	115 100%

Outcome Measures

1. Primary Outcome

Title	Stroop Color and Word Test Score
Description	The Stroop Color and Word Test is a performance-based test of executive function and inhibitory responding. The participant is presented with a page with the words "red, blue, and green" printed 100 times in (20 words in 5 columns). Each word is printed in a different color of ink than the target word (e.g, the word "red" is printed in blue ink). Participants read the color of ink in which the word is printed as quickly are possible within a time limit. The correct number within the time limit is the score. Raw scores (unadjusted for age and education) range from 0-100.
Time Frame	Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Baseline	31.17 (8.13)	28.89 (7.59)
T1 (13-15 weeks post baseline)	32.87 (8.85)	30.69 (6.64)
T2 (28-30 weeks post baseline)	33.09 (8.72)	30.39 (9.5)
T3 ( 56-58 weeks post baseline)	33.44 (8.74)	31.77 (7.83)

2. Primary Outcome

Title	Trail Making Test Score
Description	The Trail Making Test is a performance based test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect circles as possible while still maintaining accuracy. Trails A subtest requires the connection in sequence of 25 circles labeled by numbers. Trails B requires the connection in sequence of 25 circles labeled by alternating numbers and letters (1-A-2-B-3-C). The score on the test is the time in seconds that it takes to complete. Higher scores (i.e., time) indicate poorer performance.
Time Frame	Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Part A - Baseline	35.84 (14.11)	37.74 (20.08)
Part A -T1 (13-15 weeks post baseline)	33.62 (12.39)	35.58 (16.51)
Part A - T2 (28-30 weeks post baseline)	34.73 (17.54)	39.03 (15.62)
Part A - T3 ( 56-58 weeks post baseline)	33.29 (12.49)	36.23 (12.92)
Part B - Baseline	113.7 (62.29)	137.95 (86.58)
Part B -T1 (13-15 weeks post baseline)	109.51 (58.68)	142.26 (93.74)
Part B - T2 (28-30 weeks post baseline)	117.91 (82.97)	164.58 (128.75)
Part B - T3 ( 56-58 weeks post baseline)	115.76 (94.08)	145.28 (115.38)

3. Primary Outcome

Title	Letter Fluency Assessed by Change in FAS Test Score
Description	The FAS test requires stating out loud as many words that begin with the assigned letter (F, A, and S) as possible within 60-seconds. Results represent total number of words stated for F,A & S combined.
Time Frame	Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Baseline	35.91 (10.67)	31.44 (8.64)
T1 ( 13-15 weeks post baseline)	38.51 (11.48)	31.28 (9.1)
T2 (28-30 weeks post baseline)	37.26 (11.18)	34.33 (11.01)
T3 ( 56-58 weeks post baseline)	38.24 (11.93)	35.4 (13.96)

4. Primary Outcome

Title	Category Fluency Test Score
Description	The category fluency test requires participants to state out load the names of as many animals as possible within 60-seconds. Results are total number of animals named.
Time Frame	Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Baseline	19.97 (4.96)	18.89 (6.03)
T1 (13-15 weeks post baseline)	19.87 (4.35)	17.63 (6.59)
T2 (28-30 weeks post baseline)	20.24 (4.38)	17.82 (6.26)
T3 (56-58 weeks post baseline)	19.22 (4.7)	17.13 (5.53)

5. Primary Outcome

Title	Hopkins Verbal Learning Test (HVLT) - Revised Score
Description	The HVLT-Revised is a list learning task requiring the respondent to recall as many words as possible from a list of 12 words provided orally by the examiner. There is a learning trial, a delayed recall trial, and a recognition trial. Results show HVLT Total recall (Total number if words recalled over 3 trials) and HVLT Delayed recall (Total number of words recalled after 25 minute delay).
Time Frame	Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	75	39
Total recall - Baseline	6.65 (2.57)	6.46 (2.4)
Total recall - T1 ( 13-15 weeks post baseline)	6.87 (2.37)	6.65 (2.17)
Total recall - T2 (28-30 weeks post baseline)	6.56 (2.68)	7 (2.25)
Total recall - T3 ( 56-58 weeks post baseline)	5.93 (2.6)	6.35 (2.68)
Delayed recall - Baseline	6.65 (2.57)	6.46 (2.4)
Delayed recall - T1 ( 13-15 weeks post baseline)	6.87 (2.37)	6.65 (2.17)
Delayed recall - T2 (28-30 weeks post baseline)	6.56 (2.68)	7 (2.25)
Delayed recall - T3 ( 56-58 weeks post baseline)	5.93 (2.6)	6.35 (2.68)

6. Primary Outcome

Title	Brief Visual Memory Test - Revised (BVMT-R) Score
Description	The Brief Visual Memory Test is a performance based test that requires that participants reproduce simple visual images from memory (the images are displayed for 10 seconds then removed from view). The BVMT-R contains a learning trial, a recall trial, a recognition trial, and a copy trial. Each figure recalled is given 0,1, or 2 points based on accuracy and location recall. Results show BVMT Total recall (Total number if figures recalled over 3 trials: range 0 - 36) and BVMT delayed recall (total number of figures recalled after 25 min delay. Score range 0-12). Higher score correlate with better outcome.
Time Frame	Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Total recall - Baseline	16.97 (7.02)	15.97 (4.2)
Total recall - T1 ( 13-15 weeks post baseline)	19.99 (5.96)	17.16 (4.59)
Total recall - T2 (28-30 weeks post baseline)	19.59 (6.78)	18.18 (5.69)
Total recall - T3 ( 56-58 weeks post baseline)	17.47 (7.17)	16.23 (7.36)
Delayed recall - Baseline	6.88 (2.84)	6.51 (2.58)
Delayed recall - T1 ( 13-15 weeks post baseline)	7.59 (2.42)	6.77 (2.03)
Delayed recall - T2 (28-30 weeks post baseline)	7.84 (2.81)	7.67 (2.79)
Delayed recall - T3 ( 56-58 weeks post baseline)	7.01 (2.88)	6.29 (3.25)

7. Primary Outcome

Title	Grooved Pegboard Test Score
Description	The Grooved Pegboard Test requires the placing of grooved pegs into a same-shaped hole as quickly as possible, once with the dominant hand and once with the non-dominant hand.
Time Frame	Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Dominant Hand - Baseline	100.26 (52.08)	103.46 (44.52)
Dominant Hand - T1 ( 13-15 weeks post baseline)	91.49 (26.16)	101.94 (30.38)
Dominant Hand -T2 (28-30 weeks post baseline)	90.81 (32.85)	101.78 (35.76)
Dominant Hand -T3 (56-58 weeks post baseline)	89.99 (34.03)	92.45 (29.37)
Nondominant Hand - Baseline	111.97 (48.88)	118.67 (56.29)
Nondominant Hand - T1 ( 13-15 weeks post baseline)	110.63 (43.35)	120.42 (37.18)
Nondominant Hand -T2 (28-30 weeks post baseline)	108.75 (50.43)	119.06 (43.12)
Nondominant Hand -T3 (56-58 weeks post baseline)	101.04 (46.31)	112.5 (41.98)

8. Primary Outcome

Title	Finger Tapping Test Score
Description	The finger tapping test a fine motor speed requires tapping a lever with the index finger as quickly as possible. Trials with the dominant and non-dominant hand are completed.
Time Frame	Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Dominant hand - Baseline	36.21 (8.13)	32.83 (9.89)
Dominant hand -T1 ( 13-15 weeks post baseline)	39.34 (10.47)	33.9 (11.37)
Dominant hand -T2 ( 28-30 weeks post baseline)	38.19 (8.98)	34.31 (8.72)
Dominant hand -T2 ( 56-58 weeks post baseline)	38.82 (9.57)	33.13 (6.92)
Nondominant hand - Baseline	34.85 (8.29)	33.29 (10.09)
Nondominant hand -T1 ( 13-15 weeks post baseline)	36.59 (8.32)	33.98 (9.51)
Nondominant hand -T2 ( 28-30 weeks post baseline)	35.94 (8.05)	34.53 (11.61)
Nondominant hand -T2 ( 56-58 weeks post baseline)	36.91 (8.36)	31.94 (7.39)

9. Primary Outcome

Title	Coding Test Score
Description	The coding test requires writing the corresponding symbol associated with a letter from a key provided. As many responses as possible are completed in the 120 second time limit. Results presented are the total number of correct responses (possible score range 0-135).
Time Frame	Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Baseline	46.07 (14.64)	45.69 (15.44)
T1 (13-15 weeks post baseline)	45.31 (16.14)	43.13 (14.58)
T2 (28-30 weeks post baseline)	47.89 (17.32)	42.84 (15.19)
T3 (56-58 weeks post baseline)	50.11 (16.41)	47.23 (14.93)

10. Primary Outcome

Title	Digit Span Test Score
Description	The digit span test is a performance based test that requires repeating an increasing span of digits that are provided verbally by the examiner. The test includes trials of repeating digits in the same order presented by the examiner, in the reverse order of that presented by the examiner, and in ascending sequence. Scores range from 0 to 48. Higher score correlates with better outcome.
Time Frame	Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	79	39
Baseline	23.19 (5.63)	21.67 (5.56)
T1 (13-15 weeks post baseline)	24.32 (5.16)	22.41 (4.72)
T2 (28-30 weeks post baseline)	23.86 (6.62)	21.76 (5.84)
T3 ( 56-58 weeks post baseline)	23.86 (6.32)	21.27 (5.56)

11. Primary Outcome

Title	Symbol Span Test Score
Description	The subtest assesses visual working memory using novel visual stimuli. A series of abstract symbols on a page are shown briefly. Then the symbols are to be selected from an array of symbols in the same order they were presented on the previous page. This performance based test measures storage and manipulation of visual details in working memory. Score range from 0-36. Higher score correlates with better outcome.
Time Frame	Baseline, 3 months, 6 months and 12 months Post Intervention

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Baseline	17.19 (6.11)	15.33 (5.89)
3 months post-intervention	19.56 (5.76)	16.78 (5.58)
6 months post-intervention	19.17 (7.16)	17.18 (6.38)
12 months post-intervention	19.56 (5.76)	16.78 (5.58)

12. Primary Outcome

Title	Instrumental Activities of Daily Living (IADL) Test Score
Description	The Instrumental Activities of Daily Living (IADL) Test is a self-report measure assessing the amount of assistance, if any, required to do day-to-day tasks necessary to live independently. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias). Higher scores indicate worse performance in instrumental activities activities of daily living.
Time Frame	Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	74	38
Baseline	7.95 (0.19)	7.86 (0.66)
T1 (13-15 weeks post baseline)	7.96 (0.24)	7.9 (0.30)
T2 (28-30 weeks post baseline)	7.83 (0.65)	7.93 (0.25)
T3 (56-58 weeks post baseline)	7.89 (0.44)	7.71 (0.76)

13. Primary Outcome

Title	NIH Toolbox
Description	Computerized cognitive tests developed and distributed by the NIH. Tests include Pattern Comparison Processing Speed Test, Picture Vocabulary Test, Reading Recognition Test, Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, List Sorting Working Memory Test, and Oral Symbol Digit Test
Time Frame	Baseline, Post Intervention (Up to 58 weeks)

Outcome Measure Data

Analysis Population Description

In order to reduce participant burden, the NIH toolbox neurocognitive tests were not administered because was redundant with the outcomes measured by the other cognitive tests.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	0	0

14. Secondary Outcome

Title	Change in Soluble Cluster of Differentiation 14 (sCD14) Level
Description	Soluble Cluster of Differentiation 14 (sCD14) is a marker of monocyte activation, is associated with neurocognitive impairment and HIV-associated neurocognitive disorders (HANDs) and higher mortality in persons living with HIV. Data not analyzed due to delays with Coronavirus Disease (COVID-19), loss of laboratory personnel and most recent, equipment required for analysis is in repair.
Time Frame	Baseline, Post Intervention (Up to 58 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Secondary Outcome

Title	Change in Interleukin 6 (IL-6) Level
Description	IL-6 is a pro-inflammatory cytokine known to contribute to the pathogenesis of risk of cardiovascular disease (CVD) and cognitive impairment (CI) through inflammation and promotion of endothelial vascular dysfunction. IL-6 is measured by enzyme-linked immunosorbent assay (ELISA) and reported as in picograms per deciliter (pg/dL). Higher concentrations of IL-6 raise congenital heart defect risk. Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.
Time Frame	Baseline, Post Intervention (Up to 58 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Secondary Outcome

Title	Change in Tumor Necrosis Factor Alpha (TNF-alpha) Level
Description	TNFR1 membrane bound receptors that have been shown to bind TNF alpha. Activation of TNFR1 mediates the proinflammatory properties of TNF alpha. Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.
Time Frame	Baseline, Post Intervention (Up to 58 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

17. Secondary Outcome

Title	Change in High Sensitivity C-Reactive Protein (hsCRP) Level
Description	CRP is an acute phase protein that is an inflammatory marker associated with cardiovascular disease (CVD) and insulin resistance and most recently associated with cognitive impairment.Levels of >3.0 mg/L are consistent with high relative risk for CVD. Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.
Time Frame	Baseline, Post Intervention (Up to 58 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

18. Secondary Outcome

Title	Change in Soluble Urokinase Plasminogen Activator Receptor (suPAR) Level
Description	Soluble urokinase Plasminogen Activator Receptor (suPAR) is an inflammatory biomarker is associated with higher risk for cardiovascular disease in persons with HIV. Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.
Time Frame	Baseline, Post Intervention (Up to 58 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

19. Secondary Outcome

Title	Change in Brain-derived Neurotrophic Factor (BDNF) Level
Description	BDNF is a protein that occurs naturally in the hippocampus, cortex, and basal forebrain-areas vital to learning, memory, and higher thinking; an increase in BDNF in animal models and humans is thought to enhance neurogenesis. BDNF is reported as in nanograms per milliliter (ng/mL). Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.
Time Frame	Baseline, Post Intervention (Up to 58 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

20. Secondary Outcome

Title	Change in Thiobarbituric Acid Reactive Substances (TBARS) Level
Description	Thiobarbituric acid reactive substances (TBARS) is associated with Vascular function and oxidative stress in persons with HIV. Data not analyzed due to delays with COVID-19, loss of laboratory personnel and most recent, equipment required for analysis is in repair.
Time Frame	Baseline, Post Intervention (Up to 58 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

21. Secondary Outcome

Title	Flow-Mediated Dilatation (FMD)
Description	Flow-mediated dilatation (FMD) is a measure of endothelial function; the measure of % FMD at 60 seconds reflects arterial relaxation time after cuff deflation.
Time Frame	Baseline, T2 (28-30 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move	Let's Flex
Arm/Group Description	Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress. After the twelve-week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress. After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Baseline	4.62 (3.2)	5.64 (3.8)
T2 (28-30 weeks post baseline)	4.31 (2.1)	5.48 (2.6)

22. Secondary Outcome

Title	Pulse Wave Velocity (PWV)
Description	Pulse wave velocity is the gold standard for measuring arterial stiffness and has strong predictive value for adverse cardiovascular and cerebrovascular events and is now a major target for vascular aging.
Time Frame	Baseline, Post Intervention (Up to 58 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

23. Other Pre-specified Outcome

Title	Pittsburgh Sleep Quality Index (PSQI) Score
Description	The Pittsburgh Sleep Quality Index (PSQI) is a 19-item measure of the quality and patterns of sleep among adults. Scoring is based on a 0 to 3 Likert scale. The global score is 21; total possible score ranges from 0 to 21. The higher the score the worse the sleep quality.
Time Frame	Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move	Let's Flex
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period up to 58 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress. After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Baseline	7.97 (8.0)	7.46 (6.0)
T2 (28-30 weeks post baseline)	7.38 (3.87)	8.13 (3.87)
T3 (56-58 weeks post baseline)	7.32 (4.45)	8.55 (4.45)

24. Other Pre-specified Outcome

Title	Beck Depression Inventory-II (BDI-II) Score
Description	BDI-II is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Each answer being scored on a scale value of 0 to 3. Scores range from 0-63. Interpretation: 0 through 9 indicate no or minimal depression; scores from 10 through 18 indicate mild to moderate depression; scores from 19 through 29 indicate moderate to severe depression; and scores from 30 through 63 indicate severe depression.
Time Frame	Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move	Let's Flex
Arm/Group Description	Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.	Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress. After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Baseline	6.95 (5.0)	8.64 (6.0)
T2 (28-30 weeks post baseline)	8.28 (7.0)	10.79 (4.0)
T3 (56-58 weeks post baseline)	7.17 (4.45)	11.13 (4.45)

25. Other Pre-specified Outcome

Title	Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
Description	The 41-item Community Healthy Activities Model Program for Seniors evaluates weekly duration of various types of physical activity among older adults including light, moderate and vigorous intensity levels. The activity is assessed by hours per week using 6 categories less than 1 hour to 9 or more hours. The values presented below are hours participants indicated they spent in moderate intensity activity levels at the 3 time points over the past 4 weeks. Guidelines suggest 150 minutes (2.5 hours) per week in moderate intensity physical activity, below this number is considered sedentary. We measure change from baseline in time spent in moderate intensity exercise.
Time Frame	Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move	Let's Flex
Arm/Group Description	Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.	Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress. After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Baseline	9.85 (10.4)	12.13 (10.4)
T2 (28-30 weeks post baseline)	12.1 (7.56)	8.59 (7.56)
T3 (56-58 weeks post baseline)	9.72 (4.45)	8.96 (4.45)

26. Other Pre-specified Outcome

Title	V02 Max Rate
Description	V02 max is the maximum rate of oxygen consumption as measured during incremental exercise using the Balke treadmill test. This is an exploratory outcome.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Number analyzed includes participants that completed the baseline visit.

Arm/Group Title	Let's Move Program	Let's Flex Program
Arm/Group Description	Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress. After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Mean (Standard Deviation) [mL/kg/min]	20.48 (19.5)	20.67 (20.3)

27. Other Pre-specified Outcome

Title	Six-minute Walk Test
Description	Measure of functional capacity or submaximal exercise. Scores reflect distance walked in feet for 6 minutes duration. This is an exploratory outcome.
Time Frame	Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)

Outcome Measure Data

Analysis Population Description

The number analyzed includes participants who were able to complete each study visit.

Arm/Group Title	Let's Move	Let's Flex
Arm/Group Description	Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress. After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.	Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress. After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Measure Participants	76	39
Baseline	1465.58 (63.58)	1475.07 (63.58)
T2 (28-30 weeks post baseline)	1469.3 (261.75)	1478.11 (261.75)
T3 (56-58 weeks post baseline)	1497.68 (243.54)	1475.35 (243.54)

Adverse Events

Time Frame	Patients were followed for the duration of the study (up to 58 weeks post intervention).
Arm/Group Title	Let's Move Program		Let's Flex Program
Arm/Group Description	Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks. Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.		Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks. Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen. Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
All Cause Mortality
	Let's Move Program		Let's Flex Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/39 (0%)
Serious Adverse Events
	Let's Move Program		Let's Flex Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Let's Move Program		Let's Flex Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.