Trial Outcomes & Findings for Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial (NCT NCT04173572)

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 100ft). 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

50 participants

Primary outcome timeframe

Baseline and the last study visit (Up to 20 weeks)

Results posted on

2022-09-22

Participant Flow

Participants were randomly assigned to a group by an unblinded research assistant after they were screened as eligible and created a baseline appointment time with the research coordinator.

Participant milestones

Participant milestones
Measure	Walking Group Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Overall Study STARTED	24	26
Overall Study Cohort 1	7	6
Overall Study Cohort 2	8	12
Overall Study Cohort 3	9	8
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Walking Group Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Overall Study Withdrawal by Subject	1	5
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

This data was not collected during cohort 1 of the trial.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Walking Group n=24 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=26 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.	Total n=50 Participants Total of all reporting groups
Age, Continuous	40.38 years n=24 Participants	39.89 years n=26 Participants	40.14 years n=50 Participants
Sex: Female, Male Female	14 Participants n=24 Participants	11 Participants n=26 Participants	25 Participants n=50 Participants
Sex: Female, Male Male	10 Participants n=24 Participants	15 Participants n=26 Participants	25 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=24 Participants	1 Participants n=26 Participants	5 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=24 Participants	25 Participants n=26 Participants	45 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=26 Participants	0 Participants n=50 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants	0 Participants n=26 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Asian	3 Participants n=24 Participants	2 Participants n=26 Participants	5 Participants n=50 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants	0 Participants n=26 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Black or African American	7 Participants n=24 Participants	6 Participants n=26 Participants	13 Participants n=50 Participants
Race (NIH/OMB) White	11 Participants n=24 Participants	16 Participants n=26 Participants	27 Participants n=50 Participants
Race (NIH/OMB) More than one race	3 Participants n=24 Participants	2 Participants n=26 Participants	5 Participants n=50 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=26 Participants	0 Participants n=50 Participants
Region of Enrollment United States	24 Participants n=24 Participants	26 Participants n=26 Participants	50 Participants n=50 Participants
Occupation Employed	7 Participants n=24 Participants	4 Participants n=26 Participants	11 Participants n=50 Participants
Occupation Unemployed/Disability	17 Participants n=24 Participants	16 Participants n=26 Participants	33 Participants n=50 Participants
Occupation Student	0 Participants n=24 Participants	6 Participants n=26 Participants	6 Participants n=50 Participants
MINI - Psychotic Disorders Lifetime mood disorder w/ psychotic features	2 Participants n=24 Participants	2 Participants n=26 Participants	4 Participants n=50 Participants
MINI - Psychotic Disorders Current mood disorder w/ psychotic features	0 Participants n=24 Participants	0 Participants n=26 Participants	0 Participants n=50 Participants
MINI - Psychotic Disorders Lifetime psychotic disorder	22 Participants n=24 Participants	25 Participants n=26 Participants	47 Participants n=50 Participants
MINI - Psychotic Disorders Current psychotic disorder	13 Participants n=24 Participants	13 Participants n=26 Participants	26 Participants n=50 Participants
WRAT 3 Word Reading Task (Raw Score)	36.24 units on a scale STANDARD_DEVIATION 3.49 • n=17 Participants • This data was not collected during cohort 1 of the trial.	37.05 units on a scale STANDARD_DEVIATION 3.09 • n=20 Participants • This data was not collected during cohort 1 of the trial.	36.65 units on a scale STANDARD_DEVIATION 3.23 • n=37 Participants • This data was not collected during cohort 1 of the trial.

PRIMARY outcome

Timeframe: Baseline and the last study visit (Up to 20 weeks)

Population: Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes \& cancellation after 7 groups due to the onset of the COVID-19 pandemic). Participants who completed assessments from home were unable to provide data on this measure (n=5 in walking group, n=9 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=1 in walking group, n=2 in Fitbit alone).

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 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).

Outcome measures

Outcome measures
Measure	Walking Group n=12 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=11 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Difference in Participant's Total Distance During 6-minute Walk Baseline	458.775 meters Standard Deviation 91.467	467.209 meters Standard Deviation 83.828
Difference in Participant's Total Distance During 6-minute Walk Post-treatment	452.355 meters Standard Deviation 103.346	448.711 meters Standard Deviation 59.594

SECONDARY outcome

Timeframe: Baseline and the last study visit (up to 20 weeks)

Population: Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes \& cancellation after 7 groups due to the onset of the COVID-19 pandemic). Data was not available from all participants as it was dependent upon consistent daily wearing of Fitbit device. Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=2 in Fitbit alone).

Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 weeks). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.

Outcome measures

Outcome measures
Measure	Walking Group n=17 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=18 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Mean Difference in Minutes Spent Walking Baseline	31.647 minutes/week Standard Deviation 40.812	44.278 minutes/week Standard Deviation 88.842
Mean Difference in Minutes Spent Walking Post-treatment	55.866 minutes/week Standard Deviation 83.874	58.188 minutes/week Standard Deviation 149.560

SECONDARY outcome

Timeframe: Baseline and the last study visit (Up to 20 weeks)

Population: Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes \& cancellation after 7 groups due to the onset of the COVID-19 pandemic). Data was not available from all participants as it was dependent upon consistent daily wearing of Fitbit device. Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=3 in walking group, n=2 in Fitbit alone).

Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.

Outcome measures

Outcome measures
Measure	Walking Group n=17 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=18 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Mean Difference in Daily Steps Baseline	4940.529 steps/day Standard Deviation 4463.869	5010.667 steps/day Standard Deviation 3487.757
Mean Difference in Daily Steps Post-treatment	4274.429 steps/day Standard Deviation 3039.565	4503.875 steps/day Standard Deviation 3860.307

SECONDARY outcome

Timeframe: Baseline and the last study visit (Up to 20 weeks)

Population: Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes \& cancellation after 7 groups due to the onset of the COVID-19 pandemic). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=4 in Fitbit alone).

Mean difference in overall score from baseline to last study visit (up to 20 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

Outcome measures
Measure	Walking Group n=17 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=20 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Mean Difference Overall UCLA Loneliness Scale Score Baseline	48.588 score on a scale Standard Deviation 11.979	46.450 score on a scale Standard Deviation 11.353
Mean Difference Overall UCLA Loneliness Scale Score Post-treatment	50.133 score on a scale Standard Deviation 10.370	47.812 score on a scale Standard Deviation 11.485

SECONDARY outcome

Timeframe: Baseline and the last study visit (Up to 20 weeks)

Population: Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes \& cancellation after 7 groups due to the onset of the COVID-19 pandemic). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=4 in Fitbit alone).

Mean difference in the overall score from baseline to last study visit (up to 20 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

Outcome measures
Measure	Walking Group n=17 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=20 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Mean Difference Overall PANSS Score Baseline	62.588 score on a scale Standard Deviation 12.227	60.700 score on a scale Standard Deviation 9.183
Mean Difference Overall PANSS Score Post-treatment	55.467 score on a scale Standard Deviation 9.211	61.062 score on a scale Standard Deviation 14.289

SECONDARY outcome

Timeframe: Baseline and the last study visit (Up to 20 weeks)

Population: Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes \& cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=2 in walking group, n=2 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in Fitbit alone).

Mean difference in BMI from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e., greater body mass).

Outcome measures

Outcome measures
Measure	Walking Group n=15 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=18 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Mean Difference in Body Mass Index (BMI) Change Baseline	36.026 kg/m^2 Standard Deviation 8.296	36.872 kg/m^2 Standard Deviation 9.819
Mean Difference in Body Mass Index (BMI) Change Post-treatment	33.553 kg/m^2 Standard Deviation 6.764	36.262 kg/m^2 Standard Deviation 11.183

SECONDARY outcome

Timeframe: Baseline and the last study visit (Up to 20 weeks)

Population: Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes \& cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=2 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=3 in Fitbit alone).

Mean difference in body weight change from baseline to last study visit (up to 20 weeks).

Outcome measures

Outcome measures
Measure	Walking Group n=17 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=18 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Mean Difference in Body Weight Change Baseline	228.11 lbs Standard Deviation 60.56	240.88 lbs Standard Deviation 66.43
Mean Difference in Body Weight Change Post-treatment	220.96 lbs Standard Deviation 47.62	235.75 lbs Standard Deviation 74.29

SECONDARY outcome

Timeframe: Baseline and the last study visit (Up to 20 weeks)

Population: Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes \& cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=4 in walking group, n=7 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=1 in walking group, n=2 in Fitbit alone).

Mean difference in waist circumference from baseline to last study visit (up to 20 weeks). Higher scores reflect worse outcomes.

Outcome measures

Outcome measures
Measure	Walking Group n=13 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=13 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Mean Difference in Waist Circumference Baseline	109.88 cm Standard Deviation 18.58	112.30 cm Standard Deviation 20.82
Mean Difference in Waist Circumference Post-treatment	106.94 cm Standard Deviation 17.54	115.94 cm Standard Deviation 27.36

SECONDARY outcome

Timeframe: Baseline and the last study visit (Up to 20 weeks)

Population: Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes \& cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=2 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=3 in Fitbit alone).

Mean difference in systolic blood pressure change from baseline to last study visit (up to 20 weeks).

Outcome measures

Outcome measures
Measure	Walking Group n=17 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=18 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Mean Difference in Systolic Blood Pressure Change Baseline	125 mmHg Standard Deviation 9.663	129.167 mmHg Standard Deviation 8.333
Mean Difference in Systolic Blood Pressure Change Post-treatment	122 mmHg Standard Deviation 9.878	124.867 mmHg Standard Deviation 12.047

SECONDARY outcome

Timeframe: Baseline and the last study visit (Up to 20 weeks)

Population: Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes \& cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=2 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=3 in Fitbit alone).

Mean difference in diastolic blood pressure change from baseline to last study visit (up to 20 weeks).

Outcome measures

Outcome measures
Measure	Walking Group n=17 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=18 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Mean Difference in Diastolic Blood Pressure Change Post-treatment	76.000 mmHg Standard Deviation 9.921	78.533 mmHg Standard Deviation 13.174
Mean Difference in Diastolic Blood Pressure Change Baseline	77.647 mmHg Standard Deviation 8.746	81.111 mmHg Standard Deviation 10.459

SECONDARY outcome

Timeframe: Baseline and the last study visit (Up to 20 weeks)

Population: Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes \& cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=1 in walking group, n=4 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=1 in walking group).

Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).

Outcome measures

Outcome measures
Measure	Walking Group n=16 Participants Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=16 Participants Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Mean Difference in Resting Heart Rate Change Baseline	77.188 beats per minute Standard Deviation 12.319	77.313 beats per minute Standard Deviation 13.459
Mean Difference in Resting Heart Rate Change Post-treatment	82.133 beats per minute Standard Deviation 10.548	80.625 beats per minute Standard Deviation 8.966

Adverse Events

Walking Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Fitbit Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Walking Group n=24 participants at risk Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.	Fitbit Alone n=26 participants at risk Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view 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.
Psychiatric disorders Hospitalization unrelated to study	4.2% 1/24 • Number of events 1 • Adverse events were collected from the time of informed consent by each subject until they completed study procedures, for a duration of up to 20 weeks for each subject.	0.00% 0/26 • Adverse events were collected from the time of informed consent by each subject until they completed study procedures, for a duration of up to 20 weeks for each subject.

Other adverse events

Adverse event data not reported

Additional Information

Tonya Elliott

University of North Carolina at Chapel Hill

Phone: 919-966-3915

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place