ClinicalTrials.gg
Active, not recruitingNCT05345041Updated Jul 27, 2026

Church-based Intervention to Improve Physical Function

An interventional study of Keep it Movin' and Go 4 Life Self Guided Education in Physical Function and Multiple Chronic Conditions, sponsored by Rush University Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Physical Function
  • Multiple Chronic Conditions
03

In context

Multiple Chronic Conditions

89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.

This study's planned enrollment of 360 is above the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.

Browse Multiple Chronic Conditions studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • to exercise determined using the EASY/healthcare follow-up
  • Congestive heart failure New York Health Association () Class I or higher; unstable angina; heart attack or stroke within past 6 months
  • Visual or hearing impairment.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
360 participants (estimated)

Study arms

  • Experimental
    Keep it Movin'

    Behavioral: Keep it Movin'

  • Active comparator
    Go 4 Life Self Guided Education

    Behavioral: Go 4 Life Self Guided Education

Interventions

  • BehavioralKeep 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.

  • BehavioralGo 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.

06

What researchers measure

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 intervention

Secondary 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 intervention

  2. 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 intervention

  3. 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 intervention

  4. 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 intervention

  5. Change in Quality of Life

    Quality of life will be measured using EuroQual (EQ-5D-5L) questionnaire. The measure evaluates the participant's perception of their "health today" with respect to mobility, self-care, usual activities, pain/discomfort, and anxiety depression. the items are evaluated on a 5-point scale ranging from "no problem" in the area to "extreme problem" in the area.

    Time frame: Measured at baseline and 6 months and 12 months after start of the intervention

  6. Change in Self-efficacy

    Self efficacy will be measured using The Self-Efficacy for Exercise Scale consisting of 9 hypothetical situations like weather, boredom that could impact a person's ability to exercise.

    Time frame: Measured at baseline and 6 months and 12 months after start of the intervention

07

Study locations

1 site
08

References and documents

Publications

  • Lange-Maia BS, Deckard A, Dugan SA, Cartwright Y, Epting SM, Jenkins L, Suzuki S, Press VG, Rothschild SK, Lynch EB. Keep it Movin': Design and methods of a church-based physical activity program to improve physical function among midlife and older black adults. Contemp Clin Trials. 2024 Dec;147:107742. doi: 10.1016/j.cct.2024.107742. Epub 2024 Nov 13. PubMed 39542132 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Aug 2026, 35 months after the start.

Of 59 non-industry interventional studies with no phase under Multiple Chronic Conditions, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's planned 35 months is above that.

Counting every sponsor, half of 59 studies reached it within 20 months; a quarter within 11 and three quarters within 37.

Multiple Chronic Conditions covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2022
First posted
Apr 25, 2022
StartActual
Sep 21, 2023
Primary completionEst.
Aug 30, 2026
CompletionEst.
Sep 1, 2026
Last update
Jul 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05345041
Responsible party
Elizabeth Lynch (Principal Investigator, Rush University Medical Center) — Principal investigator
First posted
Apr 25, 2022
Start date
Sep 21, 2023
Primary completion
Aug 30, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Jul 27, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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