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Clinical Trials/NCT03716037
NCT03716037
Completed
N/A

Improving Physical and Psychosocial Well-being of African American Older Adults Living in Rural Areas Through a Community-Based Exercise Program

University of Alabama, Tuscaloosa1 site in 1 country41 target enrollmentSeptember 22, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Physical Activity
Sponsor
University of Alabama, Tuscaloosa
Enrollment
41
Locations
1
Primary Endpoint
Feasibility of the community based exercise program as measured by enrollment rate
Status
Completed
Last Updated
last year

Overview

Brief Summary

The proposed research effort will:

The purpose of this study is as follows:

  1. Test the feasibility and acceptability of an eight-week community-based exercise program among AA older adults living in rural areas.
  2. Determine whether participation in physical exercise through a community-based exercise program in comparison with an attentional control group: a) improves physical well-being b) improves psychosocial well-being

Detailed Description

Among the aging population, African Americans (AA) experience depression and other chronic diseases such as diabetes, hypertension, and cardiovascular disease at a higher rate compared to non-minorities; moreover, those living in rural areas are less likely to seek treatment due to various factors including lack of accessibility, affordability, and acceptability of health care services. Fortunately, non-pharmacologic and cost-effective interventions such as physical activity can yield physical, psychosocial, and cognitive benefits for older adults. The purpose of the proposed research effort is to test the feasibility of, and effect of a community-based physical exercise program among community-dwelling older adults living in rural areas on the physical and psychosocial well-being. The research effort will be a randomized controlled trial. Fifty African American older adults will be recruited from community centers. A total of 50 participants will be recruited. These adults will be randomly assigned to either the intervention or control group, with each group containing 25 participants. The intervention will occur over a period of eight week. The exercise program will be offered three times a week, with each session lasting one hour. Study measures will be collected prior to the start of the exercise program, after the fourth session, after the last session, and at one-month follow-up. The primary outcome measures for the feasibility study will include enrollment rate, randomization rate, retention rate, and data completion rate. Additionally, the investigators will examine whether there is improvement I both physical and psychosocial measures. All statistical analyses will be conducted using Statistical Package for the Social Sciences (SPSS) version 22.

Registry
clinicaltrials.gov
Start Date
September 22, 2021
End Date
December 31, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Alabama, Tuscaloosa
Responsible Party
Principal Investigator
Principal Investigator

Mercy N. Mumba

Assistant Professor

University of Alabama, Tuscaloosa

Eligibility Criteria

Inclusion Criteria

  • At least 65 years of age
  • Identifying as AA
  • community dwelling and living in a rural community.
  • Sedentary life style (engaging in less than two hours of structured physical exercises whether independently or in a group setting every week)
  • Identify as having altered psychosocial health by scoring at least a 10 on the Patient Health Questionnaire (PHQ-9), which is indicative of moderate depressive symptoms (Kroenke, Spitzer, \& Williams, 2001).

Exclusion Criteria

  • cognitive impairment as defined by the St. Louis University Mental Status Exam

Outcomes

Primary Outcomes

Feasibility of the community based exercise program as measured by enrollment rate

Time Frame: 12 months

enrollment rate which is the number of participants who sign the informed consent form divided by the number who are approached should be ≥ 60%

Secondary Outcomes

  • Satisfaction Outcome as measured by the Client satisfaction Questionnaire(12 months)
  • psychosocial Well-being as measured by the Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health Measure-10(12 months)
  • Feasibility of the community based exercise program as measured by randomization rate(12 months)
  • physical activity as measured by Fitbit trackers(12 months)
  • Feasibility of the community based exercise program as measured by retention rate(12 months)
  • Physical Function as measured by the senior fitness test(12 months)

Study Sites (1)

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