Status:

RECRUITING

Church-based Intervention to Improve Physical Function

Lead Sponsor:

Rush University Medical Center

Conditions:

Physical Function

Multiple Chronic Conditions

Eligibility:

All Genders

40+ years

Phase:

NA

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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 21 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

360 Patients enrolled

Trial Details

Trial ID

NCT05345041

Start Date

September 21 2023

End Date

September 1 2026

Last Update

April 18 2025

Active Locations (1)

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1

Rush University Medical Center

Chicago, Illinois, United States, 60422