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Physical Activity to Improve Physical Function in a Community-Based Health Ministry

Primary Purpose

Aging, Mobility Limitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring aging, physical function

Eligibility Criteria

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

Inclusion Criteria:

  1. Age 40 or older
  2. Not currently participating in another formal exercise program and perform less than 150 minutes per week of exercise
  3. Ambulatory, defined as able to get out of a chair and walk without assistance aside from using a straight cane.
  4. Have any difficulty: Walking ¼ mile, (about 2-3 blocks) OR Walking up 10 steps without resting
  5. Speak English
  6. Safe to begin an exercise program (determined using the Exercise Assessment and Screening for You (EASY) Tool. Physician clearance may be needed based upon EASY Screening recommendations

Exclusion Criteria:

  1. Severe cognitive impairment, defined as five or more errors on the Short-Portable Mental Status Questionnaire
  2. Plans to move out of the geographic area during the study period
  3. Plans to have major surgery within the study period Anticipate having major schedule changes that would interfere with ability to participate in the program.
  4. Inability to get to intervention location on a weekly basis
  5. Unwilling to commit to a weekly, approximately 90 minute program for 16 weeks.
  6. Contraindications to exercise determined using the EASY/healthcare follow-up.

  7. Self-reported

    • Heart disease
    • Uncontrolled diabetes mellitus
    • Pacemaker
    • Stroke within past 12 months
    • Severe chronic lung disease (emphysema or COPD)
    • Recent healing or unhealed fractures in the past 6 months
    • Heart failure
    • Chronic kidney disease

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Activity

Arm Description

16 week physical activity intervention

Outcomes

Primary Outcome Measures

Physical Function
Change in Short Physical Performance Battery score Scale ranges from 0-12 (integers only) with higher scores indicating better function.

Secondary Outcome Measures

Physical Activity (Objective)
Change in accelerometer measured physical activity (minutes of moderate/vigorous physical activity per day, and number of steps per day). Accelerometer will be worn for 1 full week at the hip but removed for sleep at night). Higher positive values of change indicate larger increases in physical activity.
Physical Activity (Self-Reported)
Change in physical activity as assessed by the Champs physical activity. questionnaire. Activity will be expressed as caloric expenditure/week in all exercise-related activities (in calories per week). Higher positive values of change indicate larger increases in physical activity.
Acceptability of intervention:
Acceptability questionnaire specific to intervention, attendance (% of sessions attended out of 16 total)

Full Information

First Posted
December 16, 2019
Last Updated
March 8, 2021
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04203030
Brief Title
Physical Activity to Improve Physical Function in a Community-Based Health Ministry
Official Title
Physical Activity to Improve Physical Function in a Community-Based Health Ministry in Chicago's West Side
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
September 4, 2020 (Actual)
Study Completion Date
September 4, 2020 (Actual)

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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being conducted to test if a program with physical activity and learning about movement (including goal setting, benefits of physical activity, and how to increase physical activity gradually) helps people to become more active and to move better. The physical activity program involves specific exercises done in a group setting, and the education part will involve learning about different ways to move to make everyday activities easier. The program will last 16 weeks. This program will take place in a large fellowship area of a partner church through an established community-based participatory research partnership in Chicago, IL.
Detailed Description
Limitations in physical function (PF) are related to decreased quality of life and are predictive of disability, nursing home admission, increased healthcare costs, and mortality in older adults. Structured physical activity has been shown to prevent mobility disability among those with physical function limitations, though community-based programs are needed, particularly in underserved communities. The purpose of this study is to pilot test a tailored physical activity intervention in churches in Chicago's West Side through an existing community-based participatory research partnership. The investigators previously found high rates of physical function limitations in these communities, and through qualitative research have identified intervention components that may aid in promoting physical activity among community members with physical function limitations. The primary aim is test the intervention in a 16 week, proof-of-concept study in 20 participants who are ambulatory but have PF limitations. The group-based physical activity intervention will take place in a large common area of a church. For feasibility the investigators will be testing the intervention in one church. The intervention will be delivered over 16 weeks, with assessments at baseline and 16 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Mobility Limitation
Keywords
aging, physical function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity
Arm Type
Experimental
Arm Description
16 week physical activity intervention
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
Participants will meet in a weekly group session to discuss a topic related to physical activity and physical function and participate in group-based physical activity. Participants will also have instructions to participate in physical activity outside of the weekly sessions, incrementally increasing their total physical activity over the intervention period.
Primary Outcome Measure Information:
Title
Physical Function
Description
Change in Short Physical Performance Battery score Scale ranges from 0-12 (integers only) with higher scores indicating better function.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Physical Activity (Objective)
Description
Change in accelerometer measured physical activity (minutes of moderate/vigorous physical activity per day, and number of steps per day). Accelerometer will be worn for 1 full week at the hip but removed for sleep at night). Higher positive values of change indicate larger increases in physical activity.
Time Frame
16 weeks
Title
Physical Activity (Self-Reported)
Description
Change in physical activity as assessed by the Champs physical activity. questionnaire. Activity will be expressed as caloric expenditure/week in all exercise-related activities (in calories per week). Higher positive values of change indicate larger increases in physical activity.
Time Frame
16 weeks
Title
Acceptability of intervention:
Description
Acceptability questionnaire specific to intervention, attendance (% of sessions attended out of 16 total)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 40 or older Not currently participating in another formal exercise program and perform less than 150 minutes per week of exercise Ambulatory, defined as able to get out of a chair and walk without assistance aside from using a straight cane. Have any difficulty: Walking ¼ mile, (about 2-3 blocks) OR Walking up 10 steps without resting Speak English Safe to begin an exercise program (determined using the Exercise Assessment and Screening for You (EASY) Tool. Physician clearance may be needed based upon EASY Screening recommendations Exclusion Criteria: Severe cognitive impairment, defined as five or more errors on the Short-Portable Mental Status Questionnaire Plans to move out of the geographic area during the study period Plans to have major surgery within the study period Anticipate having major schedule changes that would interfere with ability to participate in the program. Inability to get to intervention location on a weekly basis Unwilling to commit to a weekly, approximately 90 minute program for 16 weeks. Contraindications to exercise determined using the EASY/healthcare follow-up. Self-reported Heart disease Uncontrolled diabetes mellitus Pacemaker Stroke within past 12 months Severe chronic lung disease (emphysema or COPD) Recent healing or unhealed fractures in the past 6 months Heart failure Chronic kidney disease
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Physical Activity to Improve Physical Function in a Community-Based Health Ministry

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