Physical Function Clinical Trial
Official title:
Keep it Movin': A Church-based Intervention to Improve Physical Function in African Americans
This is a 12-month multi-level behavioral cluster randomized trial testing a church-based intervention to improve physical function (PF) in African Americans with PF limitations.
Status | Recruiting |
Enrollment | 360 |
Est. completion date | September 1, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: Churches (Community-level): - Membership of 300 or more adults - Predominantly African American congregants - 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Physical Function | 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. | Measured at baseline and 6 months and 12 months after start of the intervention | |
Secondary | Change in Physical Activity | 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. | Measured at baseline and 6 months and 12 months after start of the intervention | |
Secondary | Change in Self-Reported Physical Activity | 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. | Measured at baseline and 6 months and 12 months after start of the intervention | |
Secondary | Change in Self-Reported Physical Function | 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. | Measured at baseline and 6 months and 12 months after start of the intervention | |
Secondary | Change in Social Support | Social support for exercise will be measured using the Social Support & Exercise Survey Self-efficacy questionnaire. | Measured at baseline and 6 months and 12 months after start of the intervention | |
Secondary | Change in Quality of Life | 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. | Measured at baseline and 6 months and 12 months after start of the intervention | |
Secondary | Change in Self-efficacy | 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. | Measured at baseline and 6 months and 12 months after start of the intervention |
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