Active — Not RecruitingNot Applicable

Church-based Intervention to Improve Physical Function

United States360 participantsStarted 2023-09-21

Plain-language 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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Physical Function

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

Trial details

NCT IDNCT05345041

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-30

View on ClinicalTrials.gov More Physical Function trials

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.