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 : January 13, 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 :||March 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%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716037
|Contact: Mercy N Mumba, PhDfirstname.lastname@example.org|
|Contact: Rebecca S Allen, PhD||+1 205 348 email@example.com|
|Principal Investigator:||Mercy N Mumba, PhD||University of Alabama at Birmingham|