Church-based Intervention to Improve Physical Function in African Americans

Physical Function Clinical Trial

Official title:

Keep it Movin': A Church-based Intervention to Improve Physical Function in African Americans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345041
• Other study ID #: 21061405
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: October 2023
• Source: Rush University Medical Center
• Contact: Elizabeth M Lynch, PhD
• Phone: 3125632254
• Email: elizabeth_lynch[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2025
• 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)
• Have = 2 of the following conditions: heart disease, hypertension, stroke, diabetes, high cholesterol, arthritis, or BMI = 30
• 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.

Related Conditions & MeSH terms

• Chronic Disease
• Multiple Chronic Conditions
• Physical Function

Intervention

Behavioral:
• Keep it Movin'
Individual participants in churches randomized to the intervention arm will participate in the Keep it Movin' multi-component PA education program, as well as be encouraged by their church and study interventionist to participate in the church-wide walking program. Individuals enrolled in Keep It Movin' will attend weekly 90-minute sessions for 24 weeks. All sessions will include the structured physical activity component from the LIFE study intervention, with the following components, which were added to address needs of the target community: functional education, social support and problem-solving. To increase the functional gains seen in the LIFE pilot study and add content addressing self-management and PA with multiple chronic conditions (MCCs), the number of sessions in the proposed trial has been increased from 16 to 24 weeks.
• Go 4 Life Self Guided Education
Individual participants in churches randomized to the comparator arm will receive the church-wide walking program and the Go4Life Your Everyday Guide to Exercise and Physical Activity which was developed by the National Institutes of Health National Institute on Aging to promote physical activity in older adults. This includes an evidence-based exercise guide and motivational tips to help older adults start and sustain an exercise program. The Go4Life guide will add individual level education and encouragement to the interpersonal and community levels of intervention provided by the church-wide walking program.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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