Church-based Intervention to Improve Physical Function

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

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Function; Multiple Chronic Conditions
• Intervention / Treatment: Behavioral: Keep it Movin'; Behavioral: Go 4 Life Self Guided Education

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth M Lynch, PhD; Phone Number: 3125632254; Email: elizabeth_lynch@rush.edu
• Study Contact Backup: Name: Yolanda Cartwright, PhD, RD; Phone Number: 3129429697; Email: yolanda_cartwright@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60422
      • Recruiting
      • Rush University Medical Center
      • Contact: Elizabeth Lynch, PhD; Phone Number: 312-563-2254; Email: Elizabeth_Lynch@rush.edu
      • Contact: Yolanda Cartwright, PhD, RD; Phone Number: 312-942-9697; Email: yolanda_cartwright@rush.edu
      • Principal Investigator: Elizabeth Lynch, PhD
      • Principal Investigator: Steve Rothschild, MD
      • Sub-Investigator: Sheila Dugan, MD
      • Sub-Investigator: Brittany Lange-Maia, PhD
      • Sub-Investigator: Steve Epting, MA
      • Sub-Investigator: Sumihirio Suzuki, PhD
      • Sub-Investigator: Yolanda Cartwright, PhD, RD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Keep it Movin'	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.
Active Comparator: Go 4 Life Self Guided Education	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Multiple Chronic Conditions; Chronic Disease
• Other Study ID Numbers: 21061405

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No