PACE-life: Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT03757988
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 17
• Locations: 2
• Arm: 1
• Actual Duration (Months): 9.2
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Purpose: To develop and test the feasibility of an exercise intervention that combines group walking, activity tracking, and heart rate monitoring, and determine the effectiveness of this intervention on the physical and mental health for individuals with schizophrenia spectrum disorders.

Participants: 14 individuals with schizophrenia spectrum disorders.

Procedures (methods): During the baseline assessment, subjects will be provided with a Fitbit wristband and instructed how to use it. During the first group session, subjects will be taught how to use their heart rate (on the Fitbit) to determine how fast subjects should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart from the watch, which will be used to guide the intensity of the walk will be provided to subjects and reviewed at each group session. For all clinic based group sessions, subjects will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes. At the completion of 30 minutes, everyone will go back into the clinic for water and review of the walk. After the second group session of each week, subjects will receive weekly progress reports of their steps and minutes spent walking the prior week (obtained from Fitbit devices). During this session, subjects will also set individual goals for the upcoming week for both their "intensity walks" and total steps per day.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder; Brief Psychotic Disorder; Schizophreniform Disorder; Unspecified Schizophrenia Spectrum and Other Psychotic Disorder	Behavioral: Exercise Intervention- PACE-Life	N/A

Detailed Description

Overview of Procedures: PACE-life will be integrated into the Schizophrenia Treatment and Evaluation Program (STEP) outpatient clinics in Raleigh, NC and Carrboro, NC. The group walks will occur in the surrounding area around the clinics on sidewalks, bike trails, and residential streets. Goal setting groups and all assessments will take place in a conference room at the clinic. Goal-setting will include setting goals for the upcoming week in terms of number of steps as well as how many intensity walks that individuals plan to complete.

Assessments/Measures: The exercise intervention, PACE-Life, will last for 24 weeks and includes both group walks and independent walks (done at a location of the subject's choosing). Participants will be asked to complete assessments at screening, baseline, mid-point, post-test, and 1-month follow-up (approximately 28 weeks total).

At Screening the following measures will be examined: Demographics, the Wechsler Abbreviated Scale of Intelligence (WASI), a licensed physician will complete a medical history and physical exam, Physical Activity Readiness Questionnaire (PAR-Q).

At Baseline, Mid-point, Post-test, and 1-Month Follow-up the following measures will be examined: Demographics, Minutes Spent Walking, the Short Form International Physical Activity Questionnaire (IPAQ), Steps/day, Cardiorespiratory fitness (CRF)- CRF will be measured using the 6-minute walk test (6MWT), Self-determination Basic Needs, the Basic Psychological Need Scale-in General, the Basic Psychological Needs in Exercise Scale (BPNES), the Mini International Neuropsychiatric Interview (MINI) (Baseline Only), Resting Systolic/Diastolic Blood Pressure and resting heart rate (RHR), autonomous motivation will be measured with the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2), enjoyment of walking will be measured with the Physical Activity Enjoyment Scale (PACES), the UCLA Loneliness Scale, Weight, BMI, and Waist/hip Circumference.

At the conclusion of the open trial, the investigators will administer a brief questionnaire to the subjects regarding satisfaction and acceptability that will have both forced choice and open-ended questions.

Intervention- Groups will occur twice per week for 30 minutes for the entire intervention without changes in frequency and duration. The intensity, however, of both group walks and home-based walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.

Fitbits: All participants will be provided a Fitbit that is labeled with a participant number. All Fitbits are paired to a Fitbit account. Data from Fitbit devices can be synced to the corresponding account and accessed through Fitbit.com. Participants will be provided information about their accounts should participants want to look at the data but will be asked not to change any of the settings as the investigators will be using data for tracking steps/day and minutes spent walking.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life
• Actual Study Start Date: Dec 6, 2018
• Actual Primary Completion Date: Sep 11, 2019
• Actual Study Completion Date: Sep 11, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Single Arm Experimental Walking Group This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot.

Behavioral: Exercise Intervention- PACE-Life; Subjects will be provided with a Fitbit wristband and instructed how to use it. During the first group session, subjects will be taught how to use their heart rate (on the Fitbit) to determine how fast subjects should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart rate from the watch, which will be used to guide the intensity of the walk will be provided to subjects and reviewed at each group session. For all clinic based group sessions, subjects will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the HR that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes.

Outcome Measures

Primary Outcome Measures

1. Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24 [Baseline, Post Treatment (24 weeks)]

   The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).

2. Mean Difference in Participant's Total Distance During 6-Minute Walk From Post Treatment to Week 28 [Post Treatment (24 weeks), Follow-Up (Up to 28 weeks)]

   The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).

Secondary Outcome Measures

1. Mean Difference Overall UCLA Loneliness Scale Score [Up to 28 weeks]

   Mean difference in overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).

2. Mean Difference Overall PANSS Score [Up to 28 weeks]

   Mean difference in the overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).

3. Mean Difference in Body Mass Index (BMI) [Up to 28 weeks]

   Mean difference in body mass index (BMI) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Higher scores reflect worse outcomes (i.e. greater body mass).

4. Mean Difference in Diastolic Blood Pressure Change [Up to 28 weeks]

   Mean difference in diastolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal diastolic blood pressure ranges from ≤ 70 to higher than 120 mmHg. Higher scores reflect worse outcomes (i.e., higher diastolic blood pressure).

5. Mean Difference in Systolic Blood Pressure Change [Up to 28 weeks]

   Mean difference in systolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal systolic blood pressure ranges from ≤120 to higher than 140 mmHg. Higher scores reflect worse outcomes (i.e., higher systolic blood pressure).

6. Mean Difference in Resting Heart Rate Change [Up to 28 weeks]

   Mean difference in resting heart rate change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal heart rate ranges from ≤ 60 to higher than 100. Higher scores reflect worse outcomes (poorer heart condition).

7. Mean Difference in Waist Circumference [Up to 28 weeks]

   Mean difference in waist circumference from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal waist circumference ranges ≤ than 94cm for males and < than 80 for females to higher than 102 cm for males and 88cm for females . Higher scores reflect worse outcomes (i.e. greater waist circumference = disease development risk).

8. Mean Difference in Weight [Up to 28 weeks]

   Mean difference in weight from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal weight ranges from 45 to 130 kilograms . Higher scores reflect worse outcomes (i.e., greater weight).

Other Outcome Measures

1. Mean Difference in Weighted Average Motivation Score (Relative Autonomy Index) on the Behavioral Regulation Exercise Questionnaire (BREQ-2) [Up to 28 weeks]

   Mean difference in weighted average motivation score (relative autonomy index) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. Zero corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from -24 to +20. Each subscale is calculated from averages (items scored 0-4) and then a weight is applied. Higher scores reflect better outcomes (higher autonomous motivation to exercise).

2. Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE) [Up to 28 weeks]

   Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores for each subscale range from 1 to 5. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).

3. Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS) [Up to 28 weeks]

   Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). 2. The BPNS is a 21-item self-report scale. Answers are on a 7 point Likert scale ranging from "Not at all true" to "Very true." Possible scores for each subscale range from 1 to 7. Higher scores reflect better outcomes (i.e more psychological needs being met).

4. Median Difference in Daily Steps From Fitbit Devices [Up to 28 weeks]

   Median difference in steps/day from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record steps taken. Higher scores reflect better outcomes (higher steps/day).

5. Median Difference in Minutes Spent Walking From Fitbit Devices [Up to 28 weeks]

   Median difference in weekly minutes spent walking from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record minutes spent walking in bouts of 15 minutes. Higher scores reflect better outcomes (higher weekly minutes spent walking).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) diagnosis of a Schizophrenia Spectrum Disorder (SSD) (Schizophrenia, Schizoaffective Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, and Unspecified Schizophrenia Spectrum and Other Psychotic Disorder)

• Between the ages of 18-65, both genders, and any ancestry;

• Intelligence Quotient (IQ) >70. IQ will be assessed using the WASI

• No hospitalizations for psychiatric reasons in the last 3 months

• Clinically stable (no psychiatric medication changes within the past month)

• Are not already engaging in consistent moderate-intensity exercise (cutoff = 60 min/week for the past 6 months);

• Present with no contra-indication to engage in regular moderate intensity exercise based on the American College of Sports Medicine guidelines. (If an individual answers yes to one item on the of the Physical Activity Readiness Questionnaire (PAR-Q), a questionnaire that assesses cardiovascular risk factors, she/he will be asked to get clearance from a physician prior to participating in the study)

• Willing and able to provide informed consent. (Note: The research assistant will read the consent form with the participant and ask the subject to repeat back the information after each section to determine whether he/she understands the information provided.)

Exclusion Criteria:

• Pregnant women will be excluded because pregnancy alters autonomic and immune responsiveness, increase weight gain, and can influence heart rate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
2	North Carolina Psychiatric Research Center	Raleigh	North Carolina	United States	27610

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: David Penn, PhD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol - Jun 4, 2020
• Statistical Analysis Plan - Jun 4, 2020

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03757988
• Other Study ID Numbers: 18-1296; 1R34MH111852-01A1
• First Posted: Nov 29, 2018
• Last Update Posted: Sep 21, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of North Carolina, Chapel Hill: Walking; Exercise; Physical Health
• Additional relevant MeSH terms: Disease; Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Results

Participant Flow

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Period Title: Overall Study
STARTED	17
COMPLETED	16
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Overall Participants	16
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.188 (11.743)
Sex: Female, Male (Count of Participants)
Female	6 37.5%
Male	10 62.5%
Race/Ethnicity, Customized (Count of Participants)
Asian/Pacific Islander	2 12.5%
Black or African American	3 18.8%
White	9 56.3%
Other	2 12.5%
Region of Enrollment (Count of Participants)
United States	16 100%

Outcome Measures

1. Primary Outcome

Title	Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24
Description	The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).
Time Frame	Baseline, Post Treatment (24 weeks)

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline and Post Treatment

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Mean (Standard Deviation) [meters]	92.420 (95.490)

2. Primary Outcome

Title	Mean Difference in Participant's Total Distance During 6-Minute Walk From Post Treatment to Week 28
Description	The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).
Time Frame	Post Treatment (24 weeks), Follow-Up (Up to 28 weeks)

Outcome Measure Data

Analysis Population Description

Includes participants with data at Post Treatment and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	8
Mean (Standard Deviation) [meters]	6.65 (32.599)

3. Secondary Outcome

Title	Mean Difference Overall UCLA Loneliness Scale Score
Description	Mean difference in overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Baseline to Post Treatment	0.133 (9.172)
Post Treatment to Follow-Up	-1.778 (8.511)

4. Secondary Outcome

Title	Mean Difference Overall PANSS Score
Description	Mean difference in the overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Baseline to Post Treatment	8.267 (12.151)
Post Treatment to Follow-Up	-2.778 (7.661)

5. Secondary Outcome

Title	Mean Difference in Body Mass Index (BMI)
Description	Mean difference in body mass index (BMI) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Higher scores reflect worse outcomes (i.e. greater body mass).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Baseline to Post Treatment	0.280 (1.736)
Post Treatment to Follow-Up	0.022 (0.640)

6. Secondary Outcome

Title	Mean Difference in Diastolic Blood Pressure Change
Description	Mean difference in diastolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal diastolic blood pressure ranges from ≤ 70 to higher than 120 mmHg. Higher scores reflect worse outcomes (i.e., higher diastolic blood pressure).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Baseline to Post Treatment	5.667 (12.675)
Post Treatment to Follow-Up	5.333 (7.566)

7. Secondary Outcome

Title	Mean Difference in Systolic Blood Pressure Change
Description	Mean difference in systolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal systolic blood pressure ranges from ≤120 to higher than 140 mmHg. Higher scores reflect worse outcomes (i.e., higher systolic blood pressure).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Baseline to Post Treatment	1.733 (10.402)
Post Treatment to Follow-Up	11.111 (13.110)

8. Secondary Outcome

Title	Mean Difference in Resting Heart Rate Change
Description	Mean difference in resting heart rate change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal heart rate ranges from ≤ 60 to higher than 100. Higher scores reflect worse outcomes (poorer heart condition).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Baseline to Post Treatment	1.533 (19.460)
Post Treatment to Follow-Up	2.667 (13.115)

9. Secondary Outcome

Title	Mean Difference in Waist Circumference
Description	Mean difference in waist circumference from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal waist circumference ranges ≤ than 94cm for males and < than 80 for females to higher than 102 cm for males and 88cm for females . Higher scores reflect worse outcomes (i.e. greater waist circumference = disease development risk).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Baseline to Post Treatment	2.533 (9.226)
Post Treatment to Follow-Up	-0.667 (2.411)

10. Secondary Outcome

Title	Mean Difference in Weight
Description	Mean difference in weight from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal weight ranges from 45 to 130 kilograms . Higher scores reflect worse outcomes (i.e., greater weight).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Baseline to Post Treatment	0.887 (4.659)
Post Treatment to Follow-Up	0.556 (1.384)

11. Other Pre-specified Outcome

Title	Mean Difference in Weighted Average Motivation Score (Relative Autonomy Index) on the Behavioral Regulation Exercise Questionnaire (BREQ-2)
Description	Mean difference in weighted average motivation score (relative autonomy index) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. Zero corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from -24 to +20. Each subscale is calculated from averages (items scored 0-4) and then a weight is applied. Higher scores reflect better outcomes (higher autonomous motivation to exercise).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Baseline to Post Treatment	-0.906 (5.476)
Post Treatment to Follow-Up	0.157 (2.379)

12. Other Pre-specified Outcome

Title	Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE)
Description	Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores for each subscale range from 1 to 5. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Autonomy scores from Baseline to Post Treatment	0.383 (0.944)
Relatedness scores from Baseline to Post Treatment	0.978 (1.483)
Competence scores from Baseline to Post Treatment	0.250 (1.225)
Autonomy scores from Post Treatment to Follow-Up	-0.222 (0.491)
Relatedness scores fromPost Treatment to Follow-Up	-0.333 (1.080)
Competence scores from Post Treatment to Follow-Up	-0.194 (0.873)

13. Other Pre-specified Outcome

Title	Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS)
Description	Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). 2. The BPNS is a 21-item self-report scale. Answers are on a 7 point Likert scale ranging from "Not at all true" to "Very true." Possible scores for each subscale range from 1 to 7. Higher scores reflect better outcomes (i.e more psychological needs being met).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Autonomy scores from Baseline to Post Treatment	0.067 (1.132)
Relatedness scores from Baseline to Post Treatment	0.017 (0.836)
Competence scores from Baseline to Post Treatment	0.000 (0.970)
Autonomy scores from Post Treatment to Follow-Up	0.079 (1.050)
Relatedness scores fromPost Treatment to Follow-Up	-0.152 (0.335)
Competence scores from Post Treatment to Follow-Up	-0.019 (0.709)

14. Other Pre-specified Outcome

Title	Median Difference in Daily Steps From Fitbit Devices
Description	Median difference in steps/day from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record steps taken. Higher scores reflect better outcomes (higher steps/day).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up. If estimate is missing for baseline or posttest, the closest point within three weeks was used as an estimate.

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Week 1 to Post Treatment	-228
Post Treatment to Follow-Up	-31.5

15. Other Pre-specified Outcome

Title	Median Difference in Minutes Spent Walking From Fitbit Devices
Description	Median difference in weekly minutes spent walking from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record minutes spent walking in bouts of 15 minutes. Higher scores reflect better outcomes (higher weekly minutes spent walking).
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Includes participants with data at Baseline, Post Treatment, and Follow-Up. If estimate is missing for baseline or posttest, the closest point within three weeks was used as an estimate

Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Measure Participants	15
Week 1 to Post Treatment	-55.0
Post Treatment to Follow-Up	27.5

Adverse Events

Time Frame	From the time of Informed Consent through follow-up, up to approximately 28 weeks
Arm/Group Title	Single Arm Experimental Walking Group
Arm/Group Description	This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
All Cause Mortality
	Single Arm Experimental Walking Group
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Serious Adverse Events
	Single Arm Experimental Walking Group
	Affected / at Risk (%)	# Events
Total	3/17 (17.6%)
Psychiatric disorders
Psychiatric Hospitalization Due to Medication Non-Adherence	2/17 (11.8%)	2
Psychiatric Hospitalization	1/17 (5.9%)	1
Increased Psychiatric Symptoms	1/17 (5.9%)	1
Other (Not Including Serious) Adverse Events
	Single Arm Experimental Walking Group
	Affected / at Risk (%)	# Events
Total	0/17 (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.