Trial Outcomes & Findings for Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life (NCT NCT03757988)

NCT ID: NCT03757988

Last Updated: 2020-09-21

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: Baseline, Post Treatment (24 weeks)
• Results posted on: 2020-09-21

Participant Flow

Participant milestones

Measure	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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

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. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life

Baseline characteristics by cohort

Measure	Single Arm Experimental Walking Group n=16 Participants 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	38.188 years STANDARD_DEVIATION 11.743 • n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	2 Participants n=93 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=93 Participants
Race/Ethnicity, Customized White	9 Participants n=93 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants
Region of Enrollment United States	16 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline, Post Treatment (24 weeks)

Population: Includes participants with data at Baseline and Post Treatment

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).

Outcome measures

Measure

Single Arm Experimental Walking Group n=15 Participants 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.

Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24

92.420 meters Standard Deviation 95.490

PRIMARY outcome

Timeframe: Post Treatment (24 weeks), Follow-Up (Up to 28 weeks)

Population: Includes participants with data at Post Treatment and Follow-Up

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).

Outcome measures

Measure

Single Arm Experimental Walking Group n=8 Participants 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.

Mean Difference in Participant's Total Distance During 6-Minute Walk From Post Treatment to Week 28

6.65 meters Standard Deviation 32.599

SECONDARY outcome

Timeframe: Up to 28 weeks

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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Mean Difference Overall UCLA Loneliness Scale Score Baseline to Post Treatment	0.133 score on a scale Standard Deviation 9.172
Mean Difference Overall UCLA Loneliness Scale Score Post Treatment to Follow-Up	-1.778 score on a scale Standard Deviation 8.511

SECONDARY outcome

Timeframe: Up to 28 weeks

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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Mean Difference Overall PANSS Score Baseline to Post Treatment	8.267 score on a scale Standard Deviation 12.151
Mean Difference Overall PANSS Score Post Treatment to Follow-Up	-2.778 score on a scale Standard Deviation 7.661

SECONDARY outcome

Timeframe: Up to 28 weeks

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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Mean Difference in Body Mass Index (BMI) Baseline to Post Treatment	0.280 kg/m^2 Standard Deviation 1.736
Mean Difference in Body Mass Index (BMI) Post Treatment to Follow-Up	0.022 kg/m^2 Standard Deviation 0.640

SECONDARY outcome

Timeframe: Up to 28 weeks

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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Mean Difference in Diastolic Blood Pressure Change Baseline to Post Treatment	5.667 mmHg Standard Deviation 12.675
Mean Difference in Diastolic Blood Pressure Change Post Treatment to Follow-Up	5.333 mmHg Standard Deviation 7.566

SECONDARY outcome

Timeframe: Up to 28 weeks

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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Mean Difference in Systolic Blood Pressure Change Baseline to Post Treatment	1.733 mmHg Standard Deviation 10.402
Mean Difference in Systolic Blood Pressure Change Post Treatment to Follow-Up	11.111 mmHg Standard Deviation 13.110

SECONDARY outcome

Timeframe: Up to 28 weeks

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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Mean Difference in Resting Heart Rate Change Baseline to Post Treatment	1.533 beats per minute Standard Deviation 19.460
Mean Difference in Resting Heart Rate Change Post Treatment to Follow-Up	2.667 beats per minute Standard Deviation 13.115

SECONDARY outcome

Timeframe: Up to 28 weeks

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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Mean Difference in Waist Circumference Baseline to Post Treatment	2.533 centimeters Standard Deviation 9.226
Mean Difference in Waist Circumference Post Treatment to Follow-Up	-0.667 centimeters Standard Deviation 2.411

SECONDARY outcome

Timeframe: Up to 28 weeks

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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Mean Difference in Weight Baseline to Post Treatment	0.887 kilograms Standard Deviation 4.659
Mean Difference in Weight Post Treatment to Follow-Up	0.556 kilograms Standard Deviation 1.384

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 weeks

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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Mean Difference in Weighted Average Motivation Score (Relative Autonomy Index) on the Behavioral Regulation Exercise Questionnaire (BREQ-2) Baseline to Post Treatment	-0.906 score on a scale Standard Deviation 5.476
Mean Difference in Weighted Average Motivation Score (Relative Autonomy Index) on the Behavioral Regulation Exercise Questionnaire (BREQ-2) Post Treatment to Follow-Up	0.157 score on a scale Standard Deviation 2.379

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 weeks

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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE) Autonomy scores from Baseline to Post Treatment	0.383 score on a scale Standard Deviation 0.944
Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE) Relatedness scores from Baseline to Post Treatment	0.978 score on a scale Standard Deviation 1.483
Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE) Competence scores from Baseline to Post Treatment	0.250 score on a scale Standard Deviation 1.225
Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE) Autonomy scores from Post Treatment to Follow-Up	-0.222 score on a scale Standard Deviation 0.491
Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE) Relatedness scores fromPost Treatment to Follow-Up	-0.333 score on a scale Standard Deviation 1.080
Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE) Competence scores from Post Treatment to Follow-Up	-0.194 score on a scale Standard Deviation 0.873

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 weeks

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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS) Autonomy scores from Baseline to Post Treatment	0.067 score on a scale Standard Deviation 1.132
Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS) Relatedness scores from Baseline to Post Treatment	0.017 score on a scale Standard Deviation 0.836
Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS) Competence scores from Baseline to Post Treatment	0.000 score on a scale Standard Deviation 0.970
Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS) Autonomy scores from Post Treatment to Follow-Up	0.079 score on a scale Standard Deviation 1.050
Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS) Relatedness scores fromPost Treatment to Follow-Up	-0.152 score on a scale Standard Deviation 0.335
Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS) Competence scores from Post Treatment to Follow-Up	-0.019 score on a scale Standard Deviation 0.709

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 weeks

Population: 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.

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Median Difference in Daily Steps From Fitbit Devices Week 1 to Post Treatment	-228 steps per day Interval -14752.0 to 3834.0
Median Difference in Daily Steps From Fitbit Devices Post Treatment to Follow-Up	-31.5 steps per day Interval -6223.0 to 4291.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 weeks

Population: 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

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).

Outcome measures

Measure	Single Arm Experimental Walking Group n=15 Participants 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.
Median Difference in Minutes Spent Walking From Fitbit Devices Week 1 to Post Treatment	-55.0 minutes per week Interval -1571.0 to 8.0
Median Difference in Minutes Spent Walking From Fitbit Devices Post Treatment to Follow-Up	27.5 minutes per week Interval -78.0 to 108.0

Adverse Events

Single Arm Experimental Walking Group

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single Arm Experimental Walking Group n=17 participants at risk 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.
Psychiatric disorders Psychiatric Hospitalization Due to Medication Non-Adherence	11.8% 2/17 • Number of events 2 • From the time of Informed Consent through follow-up, up to approximately 28 weeks
Psychiatric disorders Psychiatric Hospitalization	5.9% 1/17 • Number of events 1 • From the time of Informed Consent through follow-up, up to approximately 28 weeks
Psychiatric disorders Increased Psychiatric Symptoms	5.9% 1/17 • Number of events 1 • From the time of Informed Consent through follow-up, up to approximately 28 weeks

Other adverse events

Adverse event data not reported

Additional Information

Tonya Elliott

University of North Carolina at Chapel Hill

Phone: 919-966-3915

Email: tonya_elliott@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place