Clinical trial NCT03716037: Improving Physical and Psychosocial Well-being of African American Older Adults
Official title: Improving Physical and Psychosocial Well-being of African American Older Adults Living in Rural Areas Through a Community-Based Exercise Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Psychosocial Stressors
Keywords: physical activity
exercise
depression
anxiety
stress
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 41
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. At least 65 years of age
2. Identifying as AA
3. community dwelling and living in a rural community.
4. Sedentary life style (engaging in less than two hours of structured physical exercises whether independently or in a group setting every week)
5. 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:

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

Primary outcomes:
measure: Feasibility of the community based exercise program as measured by enrollment rate
timeFrame: 12 months
Secondary outcomes:
measure: physical activity as measured by Fitbit trackers
timeFrame: 12 months
measure: psychosocial Well-being as measured by the Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health Measure-10
timeFrame: 12 months
measure: Satisfaction Outcome as measured by the Client satisfaction Questionnaire
timeFrame: 12 months
measure: Physical Function as measured by the senior fitness test
timeFrame: 12 months
measure: physical activity as measured by Fitbit trackers
timeFrame: 12 months
measure: Feasibility of the community based exercise program as measured by randomization rate
timeFrame: 12 months
measure: Feasibility of the community based exercise program as measured by retention rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Uniontown
country: United States
facility: Uniontown Recreation Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Mercy N Mumba, PhD
role: PRINCIPAL_INVESTIGATOR
References: