Improving Physical and Psychosocial Well-being of African American Older Adults

NCT ID: NCT03716037

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-22
• Study Completion Date: 2022-12-31

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.

Conditions

Physical Activity; Psychosocial Stressors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Physical Activity

Physical Activity for Life (PAL) is an 8-week exercise program, meeting three times per week for one hour sessions.

Group Type: EXPERIMENTAL

Physical Activity for Life (PAL)

Intervention Type: OTHER

The eight-week exercise program (The PAL Study) will incorporate balance, strength, endurance, and flexibility training. The duration of each exercise session, which will be offered three times a week, will be one hour. The supervised exercise session will include 30 minutes of moderate-intensity aerobic exercise, 15 minutes of resistance training, and 15 minutes of stretching and balance training

Contact Control

those in the attentional contact control group will receive a phone call from research personnel three times per week asking them about their physical exercise routines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical Activity for Life (PAL)

The eight-week exercise program (The PAL Study) will incorporate balance, strength, endurance, and flexibility training. The duration of each exercise session, which will be offered three times a week, will be one hour. The supervised exercise session will include 30 minutes of moderate-intensity aerobic exercise, 15 minutes of resistance training, and 15 minutes of stretching and balance training

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama, Tuscaloosa

OTHER

Sponsor Role: lead

Responsible Party

Mercy N. Mumba

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mercy N Mumba, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Uniontown Recreation Center

Uniontown, Alabama, United States

Countries

United States

Other Identifiers

18-010-ME

Identifier Type: -

Identifier Source: org_study_id