Church-based Intervention to Improve Physical Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorRush University Medical Center
About this trial
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
This trial accepts healthy volunteersQualifiers
Membership of 300 or more adults
Located in Cook, Lake, Dupage, Will, McHenry, Kane, or Kendall counties
Age 40 or older
Have mobility limitations (defined as SPPB score of ≤9)
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Keep it Movin'
BehavioralIndividual 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.
Go 4 Life Self Guided Education
BehavioralIndividual 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.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Keep it Movin'Experimental treatment 1 intervention
Group B: Go 4 Life Self Guided EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Physical Function
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.
Time frame
Measured at baseline and 6 months and 12 months after start of the interventionSecondary outcomes
1
Change in Physical Activity
Objective physical activity (i.e., time spent in moderate and vigorous physical activity) will be collected via a wrist worn accelerometer (ActiGraph GT9X Link activity monitor) collected over 4-7 days. The ActiGraph GT9X Link provides physical activity data including raw acceleration, energy expenditure, steps taken, physical activity intensity, activity and sedentary bouts, and heart rate intervals.
Time frame
Measured at baseline and 6 months and 12 months after start of the intervention2
Change in Self-Reported Physical Activity
Self reported physical activity will be evaluated using the Community Healthy Activities Model Program For Seniors (CHAMPS) questionnaire. The CHAMPS physical activity questionnaire is designed to promote physical activity in seniors. The CHAMPS tool is a 41-item questionnaire that asks about the length of time spent doing certain activities (less than an hour to 9 or more hours) in the past 4 weeks.
Time frame
Measured at baseline and 6 months and 12 months after start of the intervention3
Change in Self-Reported Physical Function
Self-report of physical function will be evaluated by the Functional Status Questionnaire. The survey is a geriatric tool designed for participants to self-report capturing the participants' physical, psychological, social and role functions.
Time frame
Measured at baseline and 6 months and 12 months after start of the intervention4
Change in Social Support
Social support for exercise will be measured using the Social Support \& Exercise Survey Self-efficacy questionnaire.
Time frame
Measured at baseline and 6 months and 12 months after start of the interventionSponsors and contacts
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Source ClinicalTrials.gov