Improving Physical and Psychosocial Well-being of African American Older Adults
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|ClinicalTrials.gov Identifier: NCT03716037|
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : March 26, 2020
The proposed research effort will:
The purpose of this study is as follows:
- Test the feasibility and acceptability of an eight-week community-based exercise program among AA older adults living in rural areas.
- 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
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity Psychosocial Stressors||Other: Physical Activity for Life (PAL)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Improving Physical and Psychosocial Well-being of African American Older Adults Living in Rural Areas Through a Community-Based Exercise Program|
|Estimated Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Physical Activity
Physical Activity for Life (PAL) is an 8-week exercise program, meeting three times per week for one hour sessions.
Other: 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
No Intervention: 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.
- 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%
- physical activity as measured by Fitbit trackers [ Time Frame: 12 months ]Fitbit will track the daily steps
- psychosocial Well-being as measured by the Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health Measure-10 [ Time Frame: 12 months ]Primary psychosocial variables of interest, that is depression and anxiety will be measured using the PROMIS Global Health Measure-10, a 10-item questionnaire that examines physical, mental, and social health. The questions focus on the previous seven days. This tool is scored on a 5-point Likert scale. Internal consistency of the subscales ranges from Cronbach's alpha = 0.8-0.92. Scores range from 10-50. Higher values indicate higher functioning for all scales- physical, mental or social scales.
- Satisfaction Outcome as measured by the Client satisfaction Questionnaire [ Time Frame: 12 months ]Satisfaction with the intervention program will be assessed with the 8-item Client Satisfaction Questionnaire (CSQ-8; Attkisson, 2012), with established reliability, internal consistency, and validity across racial/ethnic groups. Summary scores range from 8-32 with higher scores indicating greater satisfaction. Study-specific satisfaction items will be assessed also using a 4-pt Likert scale . Higher scores mean increased participant satisfaction.
- Physical Function as measured by the senior fitness test [ Time Frame: 12 months ]all seven components of the senior fitness test will be examined. This is a validated tool for physical function in older adults.
- physical activity as measured by Fitbit trackers [ Time Frame: 12 months ]Fitbit will track number of minutes active every day.
- Feasibility of the community based exercise program as measured by randomization rate [ Time Frame: 12 months ]randomization rate which is the number of participants randomized divided by the number of participants consented and screened which should be ≥ 60%
- Feasibility of the community based exercise program as measured by retention rate [ Time Frame: 12 months ]retention rate which is the number of participants completing T2 divided by the number who were randomized should be ≥ 80%.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716037
|Contact: Mercy N Mumba, PhDemail@example.com|
|Contact: Rebecca S Allen, PhD||+1 205 348 firstname.lastname@example.org|
|Principal Investigator:||Mercy N Mumba, PhD||University of Alabama at Birmingham|