NCT05345041 · Rush University Medical Center
Church-based Intervention to Improve Physical Function
What this study is about
This is a 12-month multi-level behavioral cluster randomly assigned trial testing a church-based intervention to improve physical function (PF) in Americans with PF limitations.
View original scientific description
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.
Interventions
BEHAVIORAL
Keep it Movin'
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.
BEHAVIORAL
Go 4 Life Self Guided Education
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 outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 18, 2025 · Source of record for eligibility and locations