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Church-based Intervention to Improve Physical Function in African Americans

Primary Purpose

Physical Function, Multiple Chronic Conditions

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Keep it Movin'

Go 4 Life Self Guided Education

About this trial

This is an interventional treatment trial for Physical Function

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Churches (Community-level):

Membership of 300 or more adults
Predominantly African American congregants
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)
Have ≥ 2 of the following conditions: heart disease, hypertension, stroke, diabetes, high cholesterol, arthritis, or BMI ≥ 30
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.

Sites / Locations

Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Keep it Movin'

Go 4 Life Self Guided Education

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Change in Social Support

Social support for exercise will be measured using the Social Support & Exercise Survey Self-efficacy questionnaire.

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.

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.

Full Information

NCT ID

NCT05345041

First Posted

April 15, 2022

Last Updated

October 11, 2023

Sponsor

Rush University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05345041

Brief Title

Church-based Intervention to Improve Physical Function in African Americans

Official Title

Keep it Movin': A Church-based Intervention to Improve Physical Function in African Americans

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 27, 2023 (Actual)

Primary Completion Date

September 1, 2025 (Anticipated)

Study Completion Date

September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a 12-month multi-level behavioral cluster randomized trial testing a church-based intervention to improve physical function (PF) in African Americans with PF limitations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Physical Function, Multiple Chronic Conditions

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

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 African 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

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Keep it Movin'

Arm Type

Experimental

Arm Title

Go 4 Life Self Guided Education

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Keep it Movin'

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Go 4 Life Self Guided Education

Intervention Description

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 Measure Information:

Title

Change in Physical Function

Description

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 Outcome Measure Information:

Title

Change in Physical Activity

Description

Time Frame

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

Title

Change in Self-Reported Physical Activity

Description

Time Frame

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

Title

Change in Self-Reported Physical Function

Description

Time Frame

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

Title

Change in Social Support

Description

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

Title

Change in Quality of Life

Description

Time Frame

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

Title

Change in Self-efficacy

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Churches (Community-level): Membership of 300 or more adults Predominantly African American congregants 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) Have ≥ 2 of the following conditions: heart disease, hypertension, stroke, diabetes, high cholesterol, arthritis, or BMI ≥ 30 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth M Lynch, PhD

Phone

3125632254

elizabeth_lynch@rush.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Yolanda Cartwright, PhD, RD

Phone

3129429697

yolanda_cartwright@rush.edu

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60422

Country

United States

Individual Site Status

Recruiting

Facility Contact: