Ignite Creation Date:
2024-05-06 @ 12:24 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03757988
Status:
COMPLETED
Last Update Posted:
2020-09-21
First Post:
2018-11-27
Brief Title:
Targeting Physical Health in Schizophrenia Physical Activity Can Enhance Life
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
Status:
COMPLETED
Status Verified Date:
2020-07
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 develop and test the feasibility of an exercise intervention that combines group walking activity tracking and heart rate monitoring and determine the effectiveness of this intervention on the physical and mental health for individuals with schizophrenia spectrum disorders
Participants 14 individuals with schizophrenia spectrum disorders
Procedures methods During the baseline assessment subjects will be provided with a Fitbit wristband and instructed how to use it During the first group session subjects will be taught how to use their heart rate on the Fitbit to determine how fast subjects should walk to achieve the appropriate exercise dosage Information on proper care usage and how to determine the appropriate heart from the watch which will be used to guide the intensity of the walk will be provided to subjects and reviewed at each group session For all clinic based group sessions subjects will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the heart rate HR that corresponds with the intensity of that group session Next the group will go outside and walk for 30 minutes At the completion of 30 minutes everyone will go back into the clinic for water and review of the walk After the second group session of each week subjects will receive weekly progress reports of their steps and minutes spent walking the prior week obtained from Fitbit devices During this session subjects will also set individual goals for the upcoming week for both their intensity walks and total steps per day
Participants 14 individuals with schizophrenia spectrum disorders
Procedures methods During the baseline assessment subjects will be provided with a Fitbit wristband and instructed how to use it During the first group session subjects will be taught how to use their heart rate on the Fitbit to determine how fast subjects should walk to achieve the appropriate exercise dosage Information on proper care usage and how to determine the appropriate heart from the watch which will be used to guide the intensity of the walk will be provided to subjects and reviewed at each group session For all clinic based group sessions subjects will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the heart rate HR that corresponds with the intensity of that group session Next the group will go outside and walk for 30 minutes At the completion of 30 minutes everyone will go back into the clinic for water and review of the walk After the second group session of each week subjects will receive weekly progress reports of their steps and minutes spent walking the prior week obtained from Fitbit devices During this session subjects will also set individual goals for the upcoming week for both their intensity walks and total steps per day
Detailed Description:
Overview of Procedures PACE-life will be integrated into the Schizophrenia Treatment and Evaluation Program STEP outpatient clinics in Raleigh NC and Carrboro NC The group walks will occur in the surrounding area around the clinics on sidewalks bike trails and residential streets Goal setting groups and all assessments will take place in a conference room at the clinic Goal-setting will include setting goals for the upcoming week in terms of number of steps as well as how many intensity walks that individuals plan to complete
AssessmentsMeasures The exercise intervention PACE-Life will last for 24 weeks and includes both group walks and independent walks done at a location of the subjects choosing Participants will be asked to complete assessments at screening baseline mid-point post-test and 1-month follow-up approximately 28 weeks total
At Screening the following measures will be examined Demographics the Wechsler Abbreviated Scale of Intelligence WASI a licensed physician will complete a medical history and physical exam Physical Activity Readiness Questionnaire PAR-Q
At Baseline Mid-point Post-test and 1-Month Follow-up the following measures will be examined Demographics Minutes Spent Walking the Short Form International Physical Activity Questionnaire IPAQ Stepsday Cardiorespiratory fitness CRF- CRF will be measured using the 6-minute walk test 6MWT Self-determination Basic Needs the Basic Psychological Need Scale-in General the Basic Psychological Needs in Exercise Scale BPNES the Mini International Neuropsychiatric Interview MINI Baseline Only Resting 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 subjects regarding satisfaction and acceptability that will have both forced choice and open-ended questions
Intervention- Groups will occur twice per week for 30 minutes for the entire intervention without changes in frequency and duration The intensity however of both group walks and home-based walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF
Fitbits All participants will be provided a Fitbit that is labeled with a participant number All Fitbits are paired to a Fitbit account Data from Fitbit devices can be synced to the corresponding account and accessed through 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
AssessmentsMeasures The exercise intervention PACE-Life will last for 24 weeks and includes both group walks and independent walks done at a location of the subjects choosing Participants will be asked to complete assessments at screening baseline mid-point post-test and 1-month follow-up approximately 28 weeks total
At Screening the following measures will be examined Demographics the Wechsler Abbreviated Scale of Intelligence WASI a licensed physician will complete a medical history and physical exam Physical Activity Readiness Questionnaire PAR-Q
At Baseline Mid-point Post-test and 1-Month Follow-up the following measures will be examined Demographics Minutes Spent Walking the Short Form International Physical Activity Questionnaire IPAQ Stepsday Cardiorespiratory fitness CRF- CRF will be measured using the 6-minute walk test 6MWT Self-determination Basic Needs the Basic Psychological Need Scale-in General the Basic Psychological Needs in Exercise Scale BPNES the Mini International Neuropsychiatric Interview MINI Baseline Only Resting 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 subjects regarding satisfaction and acceptability that will have both forced choice and open-ended questions
Intervention- Groups will occur twice per week for 30 minutes for the entire intervention without changes in frequency and duration The intensity however of both group walks and home-based walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF
Fitbits All participants will be provided a Fitbit that is labeled with a participant number All Fitbits are paired to a Fitbit account Data from Fitbit devices can be synced to the corresponding account and accessed through 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
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 |