Church-based Intervention to Improve Physical Function
- Conditions
- Multiple Chronic ConditionsPhysical Function
- Interventions
- Behavioral: Go 4 Life Self Guided EducationBehavioral: Keep it Movin'
- Registration Number
- NCT05345041
- Lead Sponsor
- Rush University Medical Center
- Brief Summary
This is a 12-month multi-level behavioral cluster randomized trial testing a church-based intervention to improve physical function (PF) in Americans with PF limitations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 360
Churches (Community-level):
- Membership of 300 or more adults
- Located in Cook, Lake, Dupage, Will, McHenry, Kane, or Kendall counties
Participants (Individual-level):
- Age 40 or older
- Have mobility limitations (defined as SPPB score of ≤9)
- Ambulatory, defined as able to get out of a chair and walk without assistance without using a straight cane
- Able to speak and read English
- Attend recruitment church; and
- Safe to begin an exercise program, which will be determined using the Exercise Assessment and Screening for You (EASY) Tool.
Participants (Individual-level):
- Severe cognitive impairment, defined as five or more errors on the Short-Portable Mental Status Questionnaire
- Unable to consistently attend group classes at a scheduled time due to lack of reliable transportation, schedule conflicts, travel, plans to relocate, upcoming surgery, etc.
- Participating in a medically supervised rehabilitation program such as cardiac rehab
- Inpatient treatment for a psychiatric condition within the past 6 months, or currently receiving treatment for schizophrenia or other serious psychiatric illness
- Contraindications to exercise determined using the EASY/healthcare follow-up
- Congestive heart failure New York Health Association (NYHA) Class I or higher; unstable angina; heart attack or stroke within past 6 months
- Visual or hearing impairment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Go 4 Life Self Guided Education Go 4 Life Self Guided Education - Keep it Movin' Keep it Movin' -
- Primary Outcome Measures
Name Time Method Change in Physical Function Measured at baseline and 6 months and 12 months after start of the intervention Objective physical function will be measured using the Short Physical Performance Battery (SPPB) an instrument commonly used to measure physical performance within the aging population.
- Secondary Outcome Measures
Name Time Method Change in Self-Reported Physical Function Measured at baseline and 6 months and 12 months after start of the intervention Self-report of physical function will be evaluated by the Functional Status Questionnaire. The survey is a geriatric tool designed for participants to self-report capturing the participants' physical, psychological, social and role functions.
Change in Self-Reported Physical Activity Measured at baseline and 6 months and 12 months after start of the intervention Self reported physical activity will be evaluated using the Community Healthy Activities Model Program For Seniors (CHAMPS) questionnaire. The CHAMPS physical activity questionnaire is designed to promote physical activity in seniors. The CHAMPS tool is a 41-item questionnaire that asks about the length of time spent doing certain activities (less than an hour to 9 or more hours) in the past 4 weeks.
Change in Quality of Life Measured at baseline and 6 months and 12 months after start of the intervention Quality of life will be measured using EuroQual (EQ-5D-5L) questionnaire. The measure evaluates the participant's perception of their "health today" with respect to mobility, self-care, usual activities, pain/discomfort, and anxiety depression. the items are evaluated on a 5-point scale ranging from "no problem" in the area to "extreme problem" in the area.
Change in Physical Activity Measured at baseline and 6 months and 12 months after start of the intervention Objective physical activity (i.e., time spent in moderate and vigorous physical activity) will be collected via a wrist worn accelerometer (ActiGraph GT9X Link activity monitor) collected over 4-7 days. The ActiGraph GT9X Link provides physical activity data including raw acceleration, energy expenditure, steps taken, physical activity intensity, activity and sedentary bouts, and heart rate intervals.
Change in Social Support Measured at baseline and 6 months and 12 months after start of the intervention Social support for exercise will be measured using the Social Support \& Exercise Survey Self-efficacy questionnaire.
Change in Self-efficacy Measured at baseline and 6 months and 12 months after start of the intervention Self efficacy will be measured using The Self-Efficacy for Exercise Scale consisting of 9 hypothetical situations like weather, boredom that could impact a person's ability to exercise.
Trial Locations
- Locations (1)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States