Physical FunctionNCT05345041
Church-based Intervention to Improve Physical Function
A study testing Keep it Movin' and Go 4 Life Self Guided Education in people with Physical Function and Multiple Chronic Conditions, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Function, Multiple Chronic Conditions
- What is being tested?
- Keep it Movin' and Go 4 Life Self Guided Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60422
About this study
Official title: Keep it Movin': A Church-based Intervention to Improve Physical Function
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.
- Conditions
- Physical Function, Multiple Chronic Conditions
- Being tested
- Keep it Movin', Go 4 Life Self Guided Education
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keep it Movin'Behavioural
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.
Go 4 Life Self Guided EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Keep it Movin' | Experimental | Not described Receives: Behavioral: Keep it Movin' |
| Go 4 Life Self Guided Education | Active comparator | Not described Receives: Behavioral: Go 4 Life Self Guided Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measured at baseline and 6 months and 12 months after start of the intervention
Secondary outcomes (6)
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.
Measured: Measured at baseline and 6 months and 12 months after start of the intervention
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.
Measured: Measured at baseline and 6 months and 12 months after start of the intervention
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.
Measured: Measured at baseline and 6 months and 12 months after start of the intervention
Change in Social Support
Social support for exercise will be measured using the Social Support \& Exercise Survey Self-efficacy questionnaire.
Measured: Measured at baseline and 6 months and 12 months after start of the intervention
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.
Measured: Measured at baseline and 6 months and 12 months after start of the intervention
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.
Measured: Measured at baseline and 6 months and 12 months after start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start21 Sep 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Lynch, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345041
- Sponsor's protocol ID
- 21061405
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keep it Movin': A Church-based Intervention to Improve Physical Function
- ClinicalTrials.gov ID
- NCT05345041
- Acronym / sponsor ID
- 21061405
- Conditions
- Physical Function, Multiple Chronic Conditions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Keep it Movin' | Experimental | Behavioral: Keep it Movin' |
| Go 4 Life Self Guided Education | Active comparator | Behavioral: Go 4 Life Self Guided Education |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
- Ambulatory, defined as able to get out of a chair and walk without assistance without using a straight cane
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Keep it Movin' |
| Go 4 Life Self Guided EducationIndividual 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. | Behavioural | Go 4 Life Self Guided Education |
Primary outcome
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.
6 secondary outcomes
Change in Physical Activity
Time frame: Measured at baseline and 6 months and 12 months after start of the intervention
Change in Self-Reported Physical Activity
Time frame: Measured at baseline and 6 months and 12 months after start of the intervention
Change in Self-Reported Physical Function
Time frame: Measured at baseline and 6 months and 12 months after start of the intervention
Change in Social Support
Time frame: Measured at baseline and 6 months and 12 months after start of the intervention
Change in Quality of Life
Time frame: Measured at baseline and 6 months and 12 months after start of the intervention
Change in Self-efficacy
Time frame: Measured at baseline and 6 months and 12 months after start of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Derived from this study: PubMed 39542132Lange-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keep it Movin' and Go 4 Life Self Guided Education in people with Physical Function and Multiple Chronic Conditions, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Function (time frame: Measured at baseline and 6 months and 12 months after start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05345041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.