Clinical trial NCT05345041: Church-based Intervention to Improve Physical Function
Official title: Keep it Movin': A Church-based Intervention to Improve Physical Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Function
Multiple Chronic Conditions
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 360
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

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 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.

Primary outcomes:
measure: Change in Physical Function
timeFrame: Measured at baseline and 6 months and 12 months after start of the intervention
Secondary outcomes:
measure: Change in Physical Activity
timeFrame: Measured at baseline and 6 months and 12 months after start of the intervention
measure: Change in Self-Reported Physical Activity
timeFrame: Measured at baseline and 6 months and 12 months after start of the intervention
measure: Change in Self-Reported Physical Function
timeFrame: Measured at baseline and 6 months and 12 months after start of the intervention
measure: Change in Social Support
timeFrame: Measured at baseline and 6 months and 12 months after start of the intervention
measure: Change in Quality of Life
timeFrame: Measured at baseline and 6 months and 12 months after start of the intervention
measure: Change in Self-efficacy
timeFrame: Measured at baseline and 6 months and 12 months after start of the intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: