Brief Psychotic Disorder, Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorders, Unspecified Schizophrenia Spectrum and Other Psychotic Disorder
Conditions
Keywords
Walking, Exercise, Physical Health
Brief summary
Purpose: To test the effectiveness of an exercise intervention that combines group walking, activity tracking, and heart rate monitoring (i.e. Physical Activity can Enhance Life, PACE-Life) on the physical and mental health for individuals with schizophrenia spectrum disorder. Participants: 50 individuals with schizophrenia spectrum disorders. Procedures (methods): During the baseline assessment, which can be completed virtually and in-person (based on participant preference) all participants will be provided with a Fitbit wristband and instructed how to use it. During the first group session, participants will be taught how to use their heart rate (on the Fitbit) to determine how fast participants should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart rate from the watch, to guide the intensity of the walk, will be provided to participants and reviewed at each group session. Participants randomly assigned to the PACE Life virtual walking group sessions will meet the other group members and group leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that group session. Next, the group will exercise for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention. At the completion of the sessions, everyone will take a break for water and review the walk. After the second group session of each week, participants will receive weekly progress reports of their steps and minutes spent walking the prior week (obtained from Fitbit devices). During this session, participants will also set individual goals for the upcoming week for both their intensity walks and total steps per day. Participants randomly assigned to Fitbit Alone will be given a Fitbit and shown how to use it by study staff. Participants will also be given information on current recommended physical activity guidelines (150 min/week of moderate intensity exercise) and will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like participants are not wearing their Fitbit for a certain number of days (e.g. 3 consecutive days) or to troubleshoot any issues. If necessary, participants might be invited to meet with research staff to get assistance on any Fitibit or exercise-related issues.
Detailed description
Overview of Procedures: The PACE-Life Group will be integrated into the Schizophrenia Treatment and Evaluation Program (STEP) outpatient clinics in Raleigh, NC and Carrboro, NC. The group walks will occur on a secure online platform (Zoom). Goal-setting groups and all assessments will also take place on a secure online platform (Zoom). Goal-setting will include setting goals for the upcoming week in terms of number of steps as well as how many intensity walks individuals plan to complete. Clinic-based group sessions will also include if-then plans and problem solving any issues that interfere with home-based walks. The Fitbit Alone participants will be given a Fitbit and instructed on how to use them as well as information on current recommended physical activity guidelines. Participants will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like they are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. If necessary participants may be invited to meet with research staff to receive assistance on any Fitbit or exercise-related issues. Assessments/Measures: The exercise intervention, PACE-Life, will last for 16 weeks and includes both virtual group walks and independent walks. Participants will be asked to complete assessments (either virtually or in-person based on preference) at screening, baseline, mid-point, post-test, and 1-month follow-up. At Screening the following measures will be examined: Demographics, the Wide Range Achievement Test (WRAT), a licensed physician will complete a medical history and physical exam to provide medical clearance for participants, Physical Activity Readiness Questionnaire (PAR-Q) and the -the Mini-International Neuropsychiatric Interview (MINI) will be used to verify that participants have a schizophrenia spectrum diagnosis before they are enrolled in the study. At the 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), if in person, or compute CRF based on an equation by Jackson, A.S., et al (1990) that includes recent weight and height, for the calculation of BMI, gender, self-reported physical activity level, and age, Self-determination Basic Needs, the Basic Psychological Need Scale-in General, the Basic Psychological Needs in Exercise Scale (BPNES), the Positive and Negative Syndrome Scale (PANSS), 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 participants regarding satisfaction and acceptability that will include both Likert ratings and open-ended questions. Intervention- 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 the 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. Protocol Changes due to COVID-19 Pandemic: Protocol changes due to the COVID-19 pandemic have been formalized and made permanent as outlined above. Additionally, walking groups will take place virtually, on a secure online platform (Zoom). The Wide Range Achievement Test (WRAT) will be used instead of the Wechsler Abbreviated Scale of Intelligence (WASI) to measure a minimum reading level (4th grade) to participate in the study.
Interventions
BEHAVIORALPACE-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.
BEHAVIORALExercise 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.
Sponsors
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* DSM-V diagnosis of a 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 * Reading level \> 4th grade. Reading level will be measured by WRAT. * 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 * Willing and able to provide informed consent or has legal guardian present to provide informed consent.
Exclusion criteria
* Pregnant women will be excluded because pregnancy alters autonomic and immune responsiveness, increase weight gain, and can influence heart rate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Participant's Total Distance During 6-minute Walk | Baseline and the last study visit (Up to 20 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 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference Overall UCLA Loneliness Scale Score | Baseline and the last study visit (Up to 20 weeks) | 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). |
| Mean Difference in Body Mass Index (BMI) Change | Baseline and the last study visit (Up to 20 weeks) | 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). |
| Mean Difference in Body Weight Change | Baseline and the last study visit (Up to 20 weeks) | Mean difference in body weight change from baseline to last study visit (up to 20 weeks). |
| Mean Difference in Waist Circumference | Baseline and the last study visit (Up to 20 weeks) | Mean difference in waist circumference from baseline to last study visit (up to 20 weeks). Higher scores reflect worse outcomes. |
| Mean Difference in Systolic Blood Pressure Change | Baseline and the last study visit (Up to 20 weeks) | Mean difference in systolic blood pressure change from baseline to last study visit (up to 20 weeks). |
| Mean Difference in Diastolic Blood Pressure Change | Baseline and the last study visit (Up to 20 weeks) | Mean difference in diastolic blood pressure change from baseline to last study visit (up to 20 weeks). |
| Mean Difference in Resting Heart Rate Change | Baseline and the last study visit (Up to 20 weeks) | 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). |
| Mean Difference in Minutes Spent Walking | Baseline and the last study visit (up to 20 weeks) | 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. |
| Mean Difference in Daily Steps | Baseline and the last study visit (Up to 20 weeks) | 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. |
| Mean Difference Overall PANSS Score | Baseline and the last study visit (Up to 20 weeks) | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES) | Baseline and the last study visit (Up to 20 weeks) | Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores are averaged and range from 1-7. Higher scores reflect better outcomes (greater enjoyment of physical activity). |
| Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS) | Baseline and the last study visit (Up to 20 weeks) | Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from not at all true to very true. Possible scores on each subscale are averaged onto a scale of 1-7. Higher scores reflect better outcomes (better autonomy, competence, and relatedness). |
| Mean Difference in Composite Score on the Autonomy Support Scale | Baseline and the last study visit (Up to 20 weeks) | Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff. |
| End of Study Survey | Post treatment only (16 weeks) | Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores on each item range from 1-5. Higher scores reflect higher levels of satisfaction and enjoyment in the study. |
| Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2) | Baseline and the last study visit (Up to 20 weeks) | Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to not true for me and 4 corresponds to very true for me. Possible scores are averaged and range from 0-4. Higher scores reflect better outcomes (higher autonomous motivation to exercise). |
| Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES) | Baseline and the last study visit (Up to 20 weeks) | Mean difference in composite score from baseline to last study visit (up to 20 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 are averaged and range from 1-5. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 26 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | Fitbit Alone | Total | Walking Group |
|---|---|---|---|
| Age, Continuous | 39.89 years | 40.14 years | 40.38 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 45 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| MINI - Psychotic Disorders Current mood disorder w/ psychotic features | 0 Participants | 0 Participants | 0 Participants |
| MINI - Psychotic Disorders Current psychotic disorder | 13 Participants | 26 Participants | 13 Participants |
| MINI - Psychotic Disorders Lifetime mood disorder w/ psychotic features | 2 Participants | 4 Participants | 2 Participants |
| MINI - Psychotic Disorders Lifetime psychotic disorder | 25 Participants | 47 Participants | 22 Participants |
| Occupation Employed | 4 Participants | 11 Participants | 7 Participants |
| Occupation Student | 6 Participants | 6 Participants | 0 Participants |
| Occupation Unemployed/Disability | 16 Participants | 33 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 27 Participants | 11 Participants |
| Region of Enrollment United States | 26 Participants | 50 Participants | 24 Participants |
| Sex: Female, Male Female | 11 Participants | 25 Participants | 14 Participants |
| Sex: Female, Male Male | 15 Participants | 25 Participants | 10 Participants |
| WRAT 3 Word Reading Task (Raw Score) | 37.05 units on a scale STANDARD_DEVIATION 3.09 | 36.65 units on a scale STANDARD_DEVIATION 3.23 | 36.24 units on a scale STANDARD_DEVIATION 3.49 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 26 |
| other Total, other adverse events | 0 / 24 | 0 / 26 |
| serious Total, serious adverse events | 1 / 24 | 0 / 26 |
Outcome results
Primary
Difference in Participant's Total Distance During 6-minute Walk
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Group | Difference in Participant's Total Distance During 6-minute Walk | Baseline | 458.775 meters | Standard Deviation 91.467 |
| Walking Group | Difference in Participant's Total Distance During 6-minute Walk | Post-treatment | 452.355 meters | Standard Deviation 103.346 |
| Fitbit Alone | Difference in Participant's Total Distance During 6-minute Walk | Baseline | 467.209 meters | Standard Deviation 83.828 |
| Fitbit Alone | Difference in Participant's Total Distance During 6-minute Walk | Post-treatment | 448.711 meters | Standard Deviation 59.594 |
Comparison: Posttreatment - Baseline: 10 participants analyzed (had data at both time points)
Comparison: Posttreatment - Baseline: 9 participants analyzed (had data at both time points)
Secondary
Mean Difference in Body Mass Index (BMI) Change
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Group | Mean Difference in Body Mass Index (BMI) Change | Baseline | 36.026 kg/m^2 | Standard Deviation 8.296 |
| Walking Group | Mean Difference in Body Mass Index (BMI) Change | Post-treatment | 33.553 kg/m^2 | Standard Deviation 6.764 |
| Fitbit Alone | Mean Difference in Body Mass Index (BMI) Change | Baseline | 36.872 kg/m^2 | Standard Deviation 9.819 |
| Fitbit Alone | Mean Difference in Body Mass Index (BMI) Change | Post-treatment | 36.262 kg/m^2 | Standard Deviation 11.183 |
Comparison: Posttreatment - Baseline: 13 participants analyzed (had data at both time points)
Comparison: Posttreatment - Baseline: 15 participants analyzed (had data at both time points)
Secondary
Mean Difference in Body Weight Change
Mean difference in body weight change from baseline to last study visit (up to 20 weeks).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Group | Mean Difference in Body Weight Change | Baseline | 228.11 lbs | Standard Deviation 60.56 |
| Walking Group | Mean Difference in Body Weight Change | Post-treatment | 220.96 lbs | Standard Deviation 47.62 |
| Fitbit Alone | Mean Difference in Body Weight Change | Baseline | 240.88 lbs | Standard Deviation 66.43 |
| Fitbit Alone | Mean Difference in Body Weight Change | Post-treatment | 235.75 lbs | Standard Deviation 74.29 |
Comparison: Posttreatment - Baseline: 15 participants analyzed (had data at both time points)
Comparison: Posttreatment - Baseline: 15 participants analyzed (had data at both time points)
Secondary
Mean Difference in Daily Steps
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Group | Mean Difference in Daily Steps | Baseline | 4940.529 steps/day | Standard Deviation 4463.869 |
| Walking Group | Mean Difference in Daily Steps | Post-treatment | 4274.429 steps/day | Standard Deviation 3039.565 |
| Fitbit Alone | Mean Difference in Daily Steps | Baseline | 5010.667 steps/day | Standard Deviation 3487.757 |
| Fitbit Alone | Mean Difference in Daily Steps | Post-treatment | 4503.875 steps/day | Standard Deviation 3860.307 |
Comparison: Posttreatment - Baseline: 14 participants analyzed (had data at both time points)
Comparison: Posttreatment - Baseline: 15 participants analyzed (had data at both time points)
Secondary
Mean Difference in Diastolic Blood Pressure Change
Mean difference in diastolic blood pressure change from baseline to last study visit (up to 20 weeks).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Group | Mean Difference in Diastolic Blood Pressure Change | Baseline | 77.647 mmHg | Standard Deviation 8.746 |
| Walking Group | Mean Difference in Diastolic Blood Pressure Change | Post-treatment | 76.000 mmHg | Standard Deviation 9.921 |
| Fitbit Alone | Mean Difference in Diastolic Blood Pressure Change | Baseline | 81.111 mmHg | Standard Deviation 10.459 |
| Fitbit Alone | Mean Difference in Diastolic Blood Pressure Change | Post-treatment | 78.533 mmHg | Standard Deviation 13.174 |
Comparison: Posttreatment - Baseline: 14 participants analyzed (had data at both time points)
Comparison: Posttreatment - Baseline: 14 participants analyzed (had data at both time points)
Secondary
Mean Difference in Minutes Spent Walking
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Group | Mean Difference in Minutes Spent Walking | Baseline | 31.647 minutes/week | Standard Deviation 40.812 |
| Walking Group | Mean Difference in Minutes Spent Walking | Post-treatment | 55.866 minutes/week | Standard Deviation 83.874 |
| Fitbit Alone | Mean Difference in Minutes Spent Walking | Baseline | 44.278 minutes/week | Standard Deviation 88.842 |
| Fitbit Alone | Mean Difference in Minutes Spent Walking | Post-treatment | 58.188 minutes/week | Standard Deviation 149.56 |
Comparison: Posttreatment - Baseline: 15 participants analyzed (had data at both time points)
Comparison: Posttreatment - Baseline: 15 participants analyzed (had data at both time points)
Secondary
Mean Difference in Resting Heart Rate Change
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Group | Mean Difference in Resting Heart Rate Change | Baseline | 77.188 beats per minute | Standard Deviation 12.319 |
| Walking Group | Mean Difference in Resting Heart Rate Change | Post-treatment | 82.133 beats per minute | Standard Deviation 10.548 |
| Fitbit Alone | Mean Difference in Resting Heart Rate Change | Baseline | 77.313 beats per minute | Standard Deviation 13.459 |
| Fitbit Alone | Mean Difference in Resting Heart Rate Change | Post-treatment | 80.625 beats per minute | Standard Deviation 8.966 |
Comparison: Posttreatment - Baseline: 14 participants analyzed (had data at both time points)
Comparison: Posttreatment - Baseline: 14 participants analyzed (had data at both time points)
Secondary
Mean Difference in Systolic Blood Pressure Change
Mean difference in systolic blood pressure change from baseline to last study visit (up to 20 weeks).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Group | Mean Difference in Systolic Blood Pressure Change | Baseline | 125 mmHg | Standard Deviation 9.663 |
| Walking Group | Mean Difference in Systolic Blood Pressure Change | Post-treatment | 122 mmHg | Standard Deviation 9.878 |
| Fitbit Alone | Mean Difference in Systolic Blood Pressure Change | Baseline | 129.167 mmHg | Standard Deviation 8.333 |
| Fitbit Alone | Mean Difference in Systolic Blood Pressure Change | Post-treatment | 124.867 mmHg | Standard Deviation 12.047 |
Comparison: Posttreatment - Baseline: 15 participants analyzed (had data at both time points)
Comparison: Posttreatment - Baseline: 14 participants analyzed (had data at both time points)
Secondary
Mean Difference in Waist Circumference
Mean difference in waist circumference from baseline to last study visit (up to 20 weeks). Higher scores reflect worse outcomes.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Group | Mean Difference in Waist Circumference | Baseline | 109.88 cm | Standard Deviation 18.58 |
| Walking Group | Mean Difference in Waist Circumference | Post-treatment | 106.94 cm | Standard Deviation 17.54 |
| Fitbit Alone | Mean Difference in Waist Circumference | Baseline | 112.30 cm | Standard Deviation 20.82 |
| Fitbit Alone | Mean Difference in Waist Circumference | Post-treatment | 115.94 cm | Standard Deviation 27.36 |
Comparison: Posttreatment - Baseline: 11 participants analyzed (had data at both time points)
Comparison: Posttreatment - Baseline: 11 participants analyzed (had data at both time points)
Secondary
Mean Difference Overall PANSS Score
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Group | Mean Difference Overall PANSS Score | Baseline | 62.588 score on a scale | Standard Deviation 12.227 |
| Walking Group | Mean Difference Overall PANSS Score | Post-treatment | 55.467 score on a scale | Standard Deviation 9.211 |
| Fitbit Alone | Mean Difference Overall PANSS Score | Baseline | 60.700 score on a scale | Standard Deviation 9.183 |
| Fitbit Alone | Mean Difference Overall PANSS Score | Post-treatment | 61.062 score on a scale | Standard Deviation 14.289 |
Comparison: Posttreatment - Baseline: 15 participants analyzed (had data at both time points)
Comparison: Posttreatment - Baseline: 16 participants analyzed (had data at both time points)
Secondary
Mean Difference Overall UCLA Loneliness Scale Score
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Group | Mean Difference Overall UCLA Loneliness Scale Score | Baseline | 48.588 score on a scale | Standard Deviation 11.979 |
| Walking Group | Mean Difference Overall UCLA Loneliness Scale Score | Post-treatment | 50.133 score on a scale | Standard Deviation 10.37 |
| Fitbit Alone | Mean Difference Overall UCLA Loneliness Scale Score | Baseline | 46.450 score on a scale | Standard Deviation 11.353 |
| Fitbit Alone | Mean Difference Overall UCLA Loneliness Scale Score | Post-treatment | 47.812 score on a scale | Standard Deviation 11.485 |
Comparison: Posttreatment - Baseline: 15 participants analyzed (had data at both time points)
Comparison: Posttreatment - Baseline: 16 participants analyzed (had data at both time points)
Other Pre-specified
End of Study Survey
Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores on each item range from 1-5. Higher scores reflect higher levels of satisfaction and enjoyment in the study.
Time frame: Post treatment only (16 weeks)
Other Pre-specified
Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2)
Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to not true for me and 4 corresponds to very true for me. Possible scores are averaged and range from 0-4. Higher scores reflect better outcomes (higher autonomous motivation to exercise).
Time frame: Baseline and the last study visit (Up to 20 weeks)
Other Pre-specified
Mean Difference in Composite Score on the Autonomy Support Scale
Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff.
Time frame: Baseline and the last study visit (Up to 20 weeks)
Other Pre-specified
Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES)
Mean difference in composite score from baseline to last study visit (up to 20 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 are averaged and range from 1-5. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).
Time frame: Baseline and the last study visit (Up to 20 weeks)
Other Pre-specified
Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS)
Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from not at all true to very true. Possible scores on each subscale are averaged onto a scale of 1-7. Higher scores reflect better outcomes (better autonomy, competence, and relatedness).
Time frame: Baseline and the last study visit (Up to 20 weeks)
Other Pre-specified
Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES)
Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores are averaged and range from 1-7. Higher scores reflect better outcomes (greater enjoyment of physical activity).
Time frame: Baseline and the last study visit (Up to 20 weeks)