Ignite Creation Date:
2024-05-06 @ 1:58 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04173572
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2019-11-20
Brief Title:
Targeting Physical Health in Schizophrenia Physical Activity Can Enhance Life Randomized Control Trial
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Targeting Physical Health in Schizophrenia Physical Activity Can Enhance Life Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACE-life
Brief Summary:
Purpose To test the effectiveness of an exercise intervention that combines group walking activity tracking and heart rate monitoring ie 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 minweek 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 eg 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
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 minweek 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 eg 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
AssessmentsMeasures 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 Stepsday 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 AS 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 SystolicDiastolic 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 Waisthip 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 Fitbitcom 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 stepsday 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
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
AssessmentsMeasures 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 Stepsday 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 AS 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 SystolicDiastolic 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 Waisthip 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 Fitbitcom 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 stepsday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R34MH111852-01A1 | NIH | None | httpsreporternihgovquickSearch1R34MH111852-01A1 |