Church-based Intervention to Improve Physical Function

NCT05345041 | Recruiting DMC

• 1 other identifier: 21061405
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Function; Multiple Chronic Conditions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Physical Activity

  Measured at baseline and 6 months and 12 months after start of the intervention

• Change in Self-Reported Physical Activity

  Measured at baseline and 6 months and 12 months after start of the intervention

• Change in Self-Reported Physical Function

  Measured at baseline and 6 months and 12 months after start of the intervention

• Change in Social Support

  Measured at baseline and 6 months and 12 months after start of the intervention

• Change in Quality of Life

  Measured at baseline and 6 months and 12 months after start of the intervention

Study Arms (2)

Keep it Movin'

EXPERIMENTAL

Behavioral: Keep it Movin'

Go 4 Life Self Guided Education

ACTIVE COMPARATOR

Behavioral: Go 4 Life Self Guided Education

Interventions

Keep it Movin' BEHAVIORAL

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.

Keep it Movin'

Go 4 Life Self Guided Education BEHAVIORAL

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.

Go 4 Life Self Guided Education

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60422, United States

RECRUITING

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elizabeth M Lynch, PhD

CONTACT

3125632254; elizabeth_lynch@rush.edu

Yolanda Cartwright, PhD, RD

CONTACT

3129429697; yolanda_cartwright@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The proposed study 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 (short physical performance battery \[SPPB\]\<10). Churches in both arms (12 in each) will receive a virtual church-wide walking program which will be open to all church members, providing support for physical activity (PA) at interpersonal and community-levels. Churches will be randomized to either the church-wide walking program plus Keep it Movin' (KIM) intervention (intervention arm) or the church-wide walking program plus education (control arm). Using an active comparator will allow the assessment of whether the KIM intervention is more effective than a church-wide walking program along with improving PA individuals with PF limitations. Individuals who meet study inclusion criteria, including limited PF and at least two chronic conditions will be recruited from churches in both arms.

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 25, 2022
• Study Start: September 21, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

US (1)