REACH: aeRobic Exercise and Cognitive Health

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT02384993
Collaborator
Alzheimer's Association (Other)
24
1
2
14.7
1.6

Study Details

Study Description

Brief Summary

The purpose of the aeRobic Exercise and Cognitive Health (REACH) study is to understand how an aerobic exercise intervention might help promote brain health and cognition, thereby delaying the onset of clinical symptoms of Alzheimer's disease.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Enhanced Physical Activity
N/A

Detailed Description

The prevalence and costs associated with Alzheimer's disease (AD) are projected to increase exponentially owing to the unprecedented expansion in the elderly segment of the United States' population. Given this looming specter, delaying the onset of AD symptoms and curbing the progression of the underlying disease process has become a national public health imperative. Delaying symptom onset by as little as 5 years could reduce the prevalence of AD by half. Unfortunately, currently available drug treatments for AD are not curative. Similarly, clinical trials testing novel disease-modifying therapeutics have been disappointing. The urgency of alternative approaches for halting the global crisis posed by AD cannot be overstated.

Animal studies have demonstrated that aerobic exercise (EXER) is a low-cost, low-risk intervention capable of altering the AD pathological process. Randomized controlled trials (RCTs) of EXER in older adults have also revealed its beneficial effects on AD-relevant measures such as brain glucose metabolism and memory/executive function. Importantly, a recent evidence review found that of 7 key modifiable risk factors for AD, physical activity had the highest impact on reducing the national prevalence of AD. However, there are presently no RCTs examining the effects of EXER in middle-aged, asymptomatic individuals at increased risk of AD. This is an important knowledge gap for several reasons. Interventions to halt the AD pathological cascade are more likely to be effective if implemented prior to pervasive neuronal damage. Secondly, persons with specific risk factors for developing AD (such as parental family history (FH)) represent a choice target population for any credible attempts at reducing the growing burden of AD. Lastly, a key limitation of prior EXER RCTs is the failure to adequately account for participants' physical activity levels outside of the intervention.

Accordingly, the main objective of this study is to pilot a 26-week trial of EXER among asymptomatic, middle-aged adults with and without family history (FH) of AD enrolled in the Wisconsin Registry for Alzheimer's Prevention (WRAP) or the Wisconsin Alzheimer's Disease Research Center (WADRC). The investigators' near-term goal is to assess the feasibility and acceptability of this structured intervention and preliminarily evaluate (i) its effect on AD-relevant outcomes such as glucose metabolism and (ii) the mechanism for such effects. The investigators' longer-term goal is to use the data gathered via this pilot to further refine the intervention, estimate effect sizes for key outcomes, and seek NIH funding for a longer and more definitive assessment of whether EXER can effectively curtail AD progression in midlife. The specific aims are:

AIM 1: Determine the feasibility and acceptability of a 26-week, 3-4 days per week, structured EXER regimen among middle-aged adults with FH of AD. Hypothesis: The investigators will successfully enroll the 30 participants (15 each in EXER and usual physical activity groups) targeted for this study. At least 90% of the participants within the EXER group, called the enhanced physical activity group, will complete ≥80% of scheduled training sessions.

AIM 2: Preliminarily characterize the effect of the EXER intervention on AD-related brain alteration. Hypothesis: Compared to participants randomized to the usual physical activity group, those randomized to the enhanced physical activity group will demonstrate preserved brain glucose metabolism. Similar effects will be seen in secondary outcomes including cerebral blood flow, hippocampal volume, vascular health, memory/executive function, and mood.

AIM 3: Preliminarily evaluate (i) the biological mechanisms by which EXER affects brain health and cognition, and (ii) the individual difference factors that potentially moderate EXER's effects. Hypotheses: (i) Persons in the enhanced physical activity group will exhibit significant increases in circulating neurotrophins and improved cardiorespiratory fitness, and (ii) the beneficial effects of EXER will be more pronounced for participants with decreased sedentary behaviors outside of the intervention (measured via accelerometry).

AIM 4: Preliminarily determine whether EXER improves vascular health. Hypothesis: Individuals in the enhanced physical activity group will exhibit comparatively increased cerebral blood flow, and improved endothelial function.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Aerobic Exercise for Alzheimer's Disease Prevention in At-Risk Middle-Aged Adults
Actual Study Start Date :
Apr 28, 2015
Actual Primary Completion Date :
Jul 19, 2016
Actual Study Completion Date :
Jul 19, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Enhanced Physical Activity

Those assigned to the enhanced physical activity group will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training, and maintaining this level of exercise for the remainder of the 26-week intervention. A gradual increase in exercise intensity and duration will be used throughout this twenty-six week exercise intervention, with the initial speed and duration calibrated to each participant's baseline aerobic capacity. Training will occur in individual sessions supervised by exercise specialists with the appropriate education and experience. Each training session will begin with an appropriate warm-up, slowly build up, and end with an appropriate cool down period.

Behavioral: Enhanced Physical Activity
This is a 26-week aerobic exercise intervention. The primary mode of training is treadmill walking, with the initial speed and duration calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining 150+ minutes of exercise per week by the seventh week. Exercise will be set between 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be approximately 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period.
Other Names:
  • Aerobic Exercise (EXER)
  • No Intervention: Usual Physical Activity

    All study participants randomized to the usual physical activity group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program.

    Outcome Measures

    Primary Outcome Measures

    1. Acceptability: Percentage of Sessions Completed by Enhanced Physical Activity Group [up to 26 weeks]

      This intervention will be considered acceptable if participants who complete the Enhanced Physical Activity intervention, complete ≥80% of scheduled training sessions.

    2. Feasibility: Percentage of Participants Who Completed the Study [up to 3 years]

      Feasibility is in part defined as at least 90% of enrolled participants completed the study.

    3. Cerebral Glucose Metabolism as Measured by FDG PET Scanning [over 26 weeks (assessed at baseline visit and at week-26 visit)]

      Changes in cerebral glucose metabolism will be assessed using fluorodeoxyglucose (FDG) positron emission tomography (PET) scanning. This method measures the brain's use of blood sugar while in a resting state. Measurements were taken in the posterior cingulate cortex (PCC). An increase in this measure indicates an increase in the brain's uptake and usage of blood sugar.

    Secondary Outcome Measures

    1. Ultrasound-Measured Cerebral Blood Flow - Mean Flow Velocity [over 26 weeks (assessed at baseline visit and at week-26 visit)]

      Cerebral blood flow velocity changes in the middle cerebral artery will be measured using Transcranial Doppler ultrasound imaging.

    2. California Verbal Learning Test-II Total Score [over 26 weeks (assessed at baseline visit and at week-26 visit)]

      The California Verbal Learning Test-II assesses cognitive function. Higher scores indicate more words recalled. Scores range from 0 to 100.

    3. Delis-Kaplan Executive Function System Color Word Interference (D-KEFS CWI) Score [up to 26 weeks (measured at baseline and 26 weeks)]

      The D-KEFS CWI will be used to measure executive function. Lower times indicate improved executive function. Scores range from 0 to 90.

    4. Mini Mental State Examination (MMSE) Score [up to 26 weeks (assessed at baseline and 26 weeks)]

      The Mini Mental State Examination (MMSE) measures global cognitive function. Scores range from 0 to 30. Higher scores indicate better cognitive function.

    5. California Verbal Learning Test-II Long Delay Score [over 26 weeks (assessed at baseline visit and at week-26 visit)]

      The California Verbal Learning Test-II assesses cognitive function. Long delay is a test where there is a 20 minute time period between initial word list presented and recall. Higher scores indicate more words recalled. Scores range from 0 to 20.

    6. Profile of Mood States (POMS) Score [up to 26 weeks (assessed at baseline and 26 weeks)]

      The Profile of Mood States was used to assess mood. POMS is divided into six subscales including tension-anxiety (9 items, score range: 0-36), depression (15 items, range: 0-60), anger-hostility (12 items, range: 0-48), vigor-activity (8 items, range: 0-32), fatigue (7 items, range: 0-28), and confusion-bewilderment (7 items, range: 0-28). Total mood disturbance is calculated by adding five of the six subscales (Tension, Depression, Anger, Fatigue, and Confusion) and subtracting Vigor (Scores range from -32 to 200). Lower scores typically indicate more steady mood profiles. Higher scores indicate more mood disturbance.

    7. Change in Hippocampal Volume [up to 26 weeks (assessed at baseline and 26 weeks)]

      Hippocampal volume will be assessed using T1-weighted 3T MRI images.

    Other Outcome Measures

    1. Ancillary Neuroimaging Measures [over 26 weeks (assessed at baseline visit and at week-26 visit)]

      Ancillary neuroimaging measures include MRI brain scans of blood flow and brain structure.

    2. Cardiorespiratory Fitness Measured by Peak Oxygen Consumption (VO2peak) [over 26 weeks (assessed at baseline visit and at week-26 visit)]

      The investigators will examine Cardiorespiratory Fitness by measuring VO2peak on a graded treadmill test - after participants fasted for 12-hours.

    3. Brain Derived Neurotrophic Factor [over 26 weeks (assessed at baseline visit and at week-26 visit)]

      The investigators will examine levels of Brain Derived Neurotrophic Factor to assess changes in blood neurotrophic levels.

    4. Vascular Endothelial Growth Factor [over 26 weeks (assessed at baseline visit and at week-26 visit]

      Levels of Vascular Endothelial Growth Factor will be assessed to identify changes in vascular health.

    5. Arterial Plaque Presence [over 26 weeks (assessed at baseline visit and at week-26 visit)]

      Changes in plaque presence will be measured using Comprehensive Carotid Ultrasound.

    6. Subclinical Atherosclerosis Burden [over 26 weeks (assessed at baseline visit and at week-26 visit)]

      Changes in subclinical atherosclerosis burden will be measured using Carotid Intima-Media Thickness Ultrasound.

    7. Endothelial Function [over 26 weeks (assessed at baseline visit and at week-26 visit)]

      Endothelial function changes will be assessed via ultrasound using Brachial Artery Reactivity Testing.

    8. Sedentary Behavior Measured Via Accelerometer [up to 26 weeks (measured at baseline and 26 weeks)]

      Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living PA and sedentary behavior before and after the intervention.

    9. Moderate to Vigorous Physical Activity (MVPA) [up to 26 weeks (assessed at baseline and 26 weeks)]

      Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living physical activity before and after the intervention.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age between 45 and 80 at baseline visit.

    • Must be currently physically inactive (i.e. not meeting national guidelines of 150+ minutes per week of moderate exercise).

    • Participant is not pregnant at the time of the positron emission tomography (PET) and magnetic resonance (MR) imaging exams.

    • Willing and able to complete all assessments and exercise intervention faithfully.

    • Fluent and proficient in English language and capable of completing neuropsychological testing in English.

    • Participant must have physician clearance to participate in this study.

    Exclusion Criteria:
    • Any significant neurologic disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma (10 min or more of loss of consciousness) followed by persistent neurologic deficits or known structural brain abnormalities.

    • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, body. X-ray may be used to establish suitability for MRI.

    • Inability to complete exercise test due to medical restrictions such as hip surgery, knee surgery, arthritis, or other orthopedic concerns that prevent being able to walk on a treadmill, type I or II diabetes mellitus, and documented vascular disease such as coronary artery disease.

    • Clinically significant findings from the exercise test that prohibit participation in moderate intensity exercise (i.e. 3rd degree heart block).

    • Current Axis I DSM-IV disorder including but not limited to major depression within the past two years, history of bipolar I disorder, history of schizophrenia spectrum disorders (DSM IV criteria).

    • History of alcohol or substance abuse or dependence (DSM IV criteria).

    • Any significant systemic illness or unstable medical condition that could affect cognition, CBF or BOLD, or cause difficulty complying with the exam. History of chemotherapy, thyroid disease, or renal insufficiency are excluded.

    • Severe untreated hypertension (>200/100mmHG).

    • Participants who do not have the cognitive competence and legal capacity to make informed medical decisions are excluded at entry. If a participant experiences significant cognitive decline during the study such that they no longer have medical decision making capacity the investigators will enact procedures that have been approved locally by the IRB and legal counsel at the University of Wisconsin-Madison:

    1. use their initial expressed and written consent as an indicator of willingness to continue to participate in the study; AND B) require that they provide assent at the time of follow-up visits witnessed and counter signed by their caregiver; AND C) signed consent from the patient's legally authorized representative.
    • Current use of antipsychotic medications such as non-SSRI antidepressants, neuroleptics, chronic anxiolytics, or sedative hypnotics, as well as some cardiac glycosides such as Digoxin.

    • Investigational agents are prohibited.

    • Exceptions to these criteria will be rare but may be considered on a case-by-case basis at the discretion of the investigators in consultation with study physicians.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wisconsin School of Medicine and Public Health Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • University of Wisconsin, Madison
    • Alzheimer's Association

    Investigators

    • Principal Investigator: Ozioma C. Okonkwo, PhD, University of Wisconsin, Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT02384993
    Other Study ID Numbers:
    • 2014-1434
    • 2014-NIRGD-305257
    • A534255
    • SMPH\MEDICINE\GER-AD DEV
    First Posted:
    Mar 10, 2015
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Wisconsin, Madison
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Period Title: Overall Study
    STARTED 12 12
    COMPLETED 12 11
    NOT COMPLETED 0 1

    Baseline Characteristics

    Arm/Group Title Usual Physical Activity Enhanced Physical Activity Total
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists. Total of all reporting groups
    Overall Participants 12 12 24
    Age, Customized (Count of Participants)
    50-59 years
    4
    33.3%
    1
    8.3%
    5
    20.8%
    60-69 years
    7
    58.3%
    9
    75%
    16
    66.7%
    70-79 years
    1
    8.3%
    2
    16.7%
    3
    12.5%
    Sex: Female, Male (Count of Participants)
    Female
    6
    50%
    5
    41.7%
    11
    45.8%
    Male
    6
    50%
    7
    58.3%
    13
    54.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    12
    100%
    12
    100%
    24
    100%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    12
    100%
    12
    100%
    24
    100%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Years of Education (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    16.67
    (2.57)
    16.58
    (2.47)
    16.62
    (2.46)
    Number of Participants with APOE e4 positive (Count of Participants)
    Count of Participants [Participants]
    5
    41.7%
    4
    33.3%
    9
    37.5%
    BMI (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    29.38
    (5.96)
    29.37
    (4.93)
    29.37
    (5.35)
    Systolic blood pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    128.50
    (19.65)
    121.88
    (18.39)
    125.19
    (18.92)
    Diastolic blood pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    79.92
    (9.47)
    75.33
    (10.20)
    77.63
    (9.90)
    Number of Participants with Parental History of Alzheimer's Disease (Count of Participants)
    Count of Participants [Participants]
    12
    100%
    12
    100%
    24
    100%
    MMSE (scores on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [scores on a scale]
    29.67
    (0.49)
    29.58
    (0.67)
    29.62
    (0.58)

    Outcome Measures

    1. Primary Outcome
    Title Acceptability: Percentage of Sessions Completed by Enhanced Physical Activity Group
    Description This intervention will be considered acceptable if participants who complete the Enhanced Physical Activity intervention, complete ≥80% of scheduled training sessions.
    Time Frame up to 26 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Enhanced Physical Activity
    Arm/Group Description Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 11
    Mean (Standard Deviation) [Percentage of Sessions]
    99.2
    (2.7)
    2. Primary Outcome
    Title Feasibility: Percentage of Participants Who Completed the Study
    Description Feasibility is in part defined as at least 90% of enrolled participants completed the study.
    Time Frame up to 3 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 12 12
    Count of Participants [Participants]
    12
    100%
    11
    91.7%
    3. Primary Outcome
    Title Cerebral Glucose Metabolism as Measured by FDG PET Scanning
    Description Changes in cerebral glucose metabolism will be assessed using fluorodeoxyglucose (FDG) positron emission tomography (PET) scanning. This method measures the brain's use of blood sugar while in a resting state. Measurements were taken in the posterior cingulate cortex (PCC). An increase in this measure indicates an increase in the brain's uptake and usage of blood sugar.
    Time Frame over 26 weeks (assessed at baseline visit and at week-26 visit)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 12 11
    baseline
    1.49
    (0.04)
    1.50
    (0.03)
    26 weeks
    1.52
    (0.04)
    1.54
    (0.04)
    4. Secondary Outcome
    Title Ultrasound-Measured Cerebral Blood Flow - Mean Flow Velocity
    Description Cerebral blood flow velocity changes in the middle cerebral artery will be measured using Transcranial Doppler ultrasound imaging.
    Time Frame over 26 weeks (assessed at baseline visit and at week-26 visit)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 11 9
    Baseline
    45.05
    41.13
    26 Weeks
    49.47
    45.85
    5. Secondary Outcome
    Title California Verbal Learning Test-II Total Score
    Description The California Verbal Learning Test-II assesses cognitive function. Higher scores indicate more words recalled. Scores range from 0 to 100.
    Time Frame over 26 weeks (assessed at baseline visit and at week-26 visit)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 12 11
    baseline
    49.58
    (11.06)
    53.18
    (7.99)
    26 weeks
    53.33
    (9.18)
    60.64
    (9.04)
    6. Secondary Outcome
    Title Delis-Kaplan Executive Function System Color Word Interference (D-KEFS CWI) Score
    Description The D-KEFS CWI will be used to measure executive function. Lower times indicate improved executive function. Scores range from 0 to 90.
    Time Frame up to 26 weeks (measured at baseline and 26 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 12 11
    baseline
    60.00
    (11.71)
    64.82
    (15.11)
    26 weeks
    60.00
    (11.99)
    57.64
    (11.96)
    7. Secondary Outcome
    Title Mini Mental State Examination (MMSE) Score
    Description The Mini Mental State Examination (MMSE) measures global cognitive function. Scores range from 0 to 30. Higher scores indicate better cognitive function.
    Time Frame up to 26 weeks (assessed at baseline and 26 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 12 11
    baseline
    29.67
    (0.49)
    29.55
    (0.69)
    26 weeks
    29.08
    (1.24)
    29.55
    (0.52)
    8. Secondary Outcome
    Title California Verbal Learning Test-II Long Delay Score
    Description The California Verbal Learning Test-II assesses cognitive function. Long delay is a test where there is a 20 minute time period between initial word list presented and recall. Higher scores indicate more words recalled. Scores range from 0 to 20.
    Time Frame over 26 weeks (assessed at baseline visit and at week-26 visit)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 12 11
    baseline
    10.83
    (2.83)
    12.00
    (2.72)
    26 weeks
    11.42
    (3.26)
    14.00
    (1.73)
    9. Secondary Outcome
    Title Profile of Mood States (POMS) Score
    Description The Profile of Mood States was used to assess mood. POMS is divided into six subscales including tension-anxiety (9 items, score range: 0-36), depression (15 items, range: 0-60), anger-hostility (12 items, range: 0-48), vigor-activity (8 items, range: 0-32), fatigue (7 items, range: 0-28), and confusion-bewilderment (7 items, range: 0-28). Total mood disturbance is calculated by adding five of the six subscales (Tension, Depression, Anger, Fatigue, and Confusion) and subtracting Vigor (Scores range from -32 to 200). Lower scores typically indicate more steady mood profiles. Higher scores indicate more mood disturbance.
    Time Frame up to 26 weeks (assessed at baseline and 26 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 12 11
    Baseline Tension
    8.00
    (2.92)
    7.67
    (3.11)
    Post-intervention Tension
    8.64
    (3.41)
    6.00
    (3.82)
    Baseline Depression
    5.17
    (6.60)
    4.83
    (6.64)
    Post-intervention Depression
    5.36
    (5.52)
    3.27
    (5.53)
    Baseline Anger
    3.17
    (4.49)
    5.50
    (4.98)
    Post-intervention Anger
    4.27
    (3.41)
    3.82
    (5.10)
    Baseline Vigor
    16.83
    (6.31)
    16.25
    (6.86)
    Post-intervention Vigor
    16.25
    (6.86)
    15.36
    (4.74)
    Baseline Fatigue
    4.92
    (3.55)
    6.58
    (5.25)
    Post-intervention Fatigue
    7.64
    (4.15)
    5.91
    (4.70)
    Baseline Confusion
    5.17
    (2.95)
    6.83
    (2.52)
    Post-intervention Confusion
    5.55
    (3.05)
    5.45
    (3.17)
    Baseline Total Mood Disturbance
    9.58
    (19.71)
    15.17
    (19.94)
    Post-intervention Total Mood Disturbance
    16.09
    (15.64)
    7.55
    (20.47)
    10. Secondary Outcome
    Title Change in Hippocampal Volume
    Description Hippocampal volume will be assessed using T1-weighted 3T MRI images.
    Time Frame up to 26 weeks (assessed at baseline and 26 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    11. Other Pre-specified Outcome
    Title Ancillary Neuroimaging Measures
    Description Ancillary neuroimaging measures include MRI brain scans of blood flow and brain structure.
    Time Frame over 26 weeks (assessed at baseline visit and at week-26 visit)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    12. Other Pre-specified Outcome
    Title Cardiorespiratory Fitness Measured by Peak Oxygen Consumption (VO2peak)
    Description The investigators will examine Cardiorespiratory Fitness by measuring VO2peak on a graded treadmill test - after participants fasted for 12-hours.
    Time Frame over 26 weeks (assessed at baseline visit and at week-26 visit)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 12 11
    baseline
    25.74
    (6.58)
    23.57
    (4.97)
    26 weeks
    27.18
    (6.05)
    27.46
    (4.71)
    13. Other Pre-specified Outcome
    Title Brain Derived Neurotrophic Factor
    Description The investigators will examine levels of Brain Derived Neurotrophic Factor to assess changes in blood neurotrophic levels.
    Time Frame over 26 weeks (assessed at baseline visit and at week-26 visit)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    14. Other Pre-specified Outcome
    Title Vascular Endothelial Growth Factor
    Description Levels of Vascular Endothelial Growth Factor will be assessed to identify changes in vascular health.
    Time Frame over 26 weeks (assessed at baseline visit and at week-26 visit

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    15. Other Pre-specified Outcome
    Title Arterial Plaque Presence
    Description Changes in plaque presence will be measured using Comprehensive Carotid Ultrasound.
    Time Frame over 26 weeks (assessed at baseline visit and at week-26 visit)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    16. Other Pre-specified Outcome
    Title Subclinical Atherosclerosis Burden
    Description Changes in subclinical atherosclerosis burden will be measured using Carotid Intima-Media Thickness Ultrasound.
    Time Frame over 26 weeks (assessed at baseline visit and at week-26 visit)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    17. Other Pre-specified Outcome
    Title Endothelial Function
    Description Endothelial function changes will be assessed via ultrasound using Brachial Artery Reactivity Testing.
    Time Frame over 26 weeks (assessed at baseline visit and at week-26 visit)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 12 9
    Baseline
    2.22
    (1.78)
    1.86
    (0.93)
    26 Weeks
    2.71
    (1.69)
    2.33
    (1.71)
    18. Other Pre-specified Outcome
    Title Sedentary Behavior Measured Via Accelerometer
    Description Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living PA and sedentary behavior before and after the intervention.
    Time Frame up to 26 weeks (measured at baseline and 26 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 12 11
    Baseline
    670.73
    (27.2)
    726.0
    (22.9)
    26 weeks
    690.1
    (26.7)
    698.6
    (27.1)
    19. Other Pre-specified Outcome
    Title Moderate to Vigorous Physical Activity (MVPA)
    Description Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living physical activity before and after the intervention.
    Time Frame up to 26 weeks (assessed at baseline and 26 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Usual Physical Activity Enhanced Physical Activity
    Arm/Group Description Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
    Measure Participants 12 11
    baseline
    78.97
    (10.19)
    60.58
    (7.08)
    26 weeks
    69.3
    (8.37)
    89.05
    (15.48)

    Adverse Events

    Time Frame up to 26 weeks
    Adverse Event Reporting Description
    Arm/Group Title Enhanced Physical Activity Usual Physical Activity
    Arm/Group Description Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists. Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program.
    All Cause Mortality
    Enhanced Physical Activity Usual Physical Activity
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/12 (0%) 0/12 (0%)
    Serious Adverse Events
    Enhanced Physical Activity Usual Physical Activity
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/12 (0%) 0/12 (0%)
    Other (Not Including Serious) Adverse Events
    Enhanced Physical Activity Usual Physical Activity
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/12 (8.3%) 0/12 (0%)
    Musculoskeletal and connective tissue disorders
    Hip Surgery 1/12 (8.3%) 1 0/12 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE 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.

    Results Point of Contact

    Name/Title Ozioma C. Okonkwo
    Organization University of Wisconsin - Madison
    Phone (608) 265-4479
    Email ozioma@medicine.wisc.edu
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT02384993
    Other Study ID Numbers:
    • 2014-1434
    • 2014-NIRGD-305257
    • A534255
    • SMPH\MEDICINE\GER-AD DEV
    First Posted:
    Mar 10, 2015
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022