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Active, Not Recruiting

NCT Number: NCT05345041

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Physical Function Chronic Disease Disease Attributes Multiple Chronic Conditions Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60422, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Physical Function

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

    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.

Secondary outcomes

  1. Change in Physical Activity

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

    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.

  2. Change in Self-Reported Physical Activity

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

    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.

  3. Change in Self-Reported Physical Function

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

    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.

  4. Change in Social Support

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

    Social support for exercise will be measured using the Social Support & Exercise Survey Self-efficacy questionnaire.

  5. Change in Quality of Life

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

    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.

  6. Change in Self-efficacy

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

    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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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