Church-based Intervention to Improve Physical Function

NCT ID: NCT05345041

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2026-09-01

Brief Summary

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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

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Conditions

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Physical Function Multiple Chronic Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Keep it Movin'

Group Type EXPERIMENTAL

Keep it Movin'

Intervention Type 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.

Go 4 Life Self Guided Education

Group Type ACTIVE_COMPARATOR

Go 4 Life Self Guided Education

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Lynch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elizabeth M Lynch, PhD

Role: CONTACT

3125632254

Yolanda Cartwright, PhD, RD

Role: CONTACT

3129429697

Facility Contacts

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Elizabeth Lynch, PhD

Role: primary

312-563-2254

Yolanda Cartwright, PhD, RD

Role: backup

312-942-9697

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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21061405

Identifier Type: -

Identifier Source: org_study_id

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