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Church-based Intervention to Improve Physical Function

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Rush

Status

Enrolling

Conditions

Physical Function
Multiple Chronic Conditions

Treatments

Behavioral: Keep it Movin'
Behavioral: Go 4 Life Self Guided Education

Study type

Interventional

Funder types

Other

Identifiers

NCT05345041
21061405

Details and patient eligibility

About

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.

Enrollment

360 estimated patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

360 participants in 2 patient groups

Keep it Movin'
Experimental group
Treatment:
Behavioral: Keep it Movin'
Go 4 Life Self Guided Education
Active Comparator group
Treatment:
Behavioral: Go 4 Life Self Guided Education

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Elizabeth M Lynch, PhD; Yolanda Cartwright, PhD, RD

Data sourced from clinicaltrials.gov

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