Physical ActivityNCT03716037
Improving Physical and Psychosocial Well-being of African American Older Adults
A study testing Physical Activity for Life (PAL) in people with Physical Activity and Psychosocial Stressors, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Psychosocial Stressors
- What is being tested?
- Physical Activity for Life (PAL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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).
Who cannot join
- 1. cognitive impairment as defined by the St. Louis University Mental Status Exam
Trial locations and contacts
1 site in 1 country.
United States1 site
Uniontown Recreation Center
Uniontown, Alabama, 36786
About this study
Official title: Improving Physical and Psychosocial Well-being of African American Older Adults Living in Rural Areas Through a Community-Based Exercise Program
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
Read the 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
- Being tested
- Physical Activity for Life (PAL)
- Keywords
- physical activity, exercise, depression, anxiety, stress
- Medical subject headings
- Motor Activity, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity for Life (PAL)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
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | Physical Activity for Life (PAL) is an 8-week exercise program, meeting three times per week for one hour sessions. Receives: Other: Physical Activity for Life (PAL) |
| Contact Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the community based exercise program as measured by enrollment rate
enrollment rate which is the number of participants who sign the informed consent form divided by the number who are approached should be ≥ 60%
Measured: 12 months
Secondary outcomes (7)
physical activity as measured by Fitbit trackers
Fitbit will track the daily steps
Measured: 12 months
psychosocial Well-being as measured by the Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health Measure-10
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.
Measured: 12 months
Satisfaction Outcome as measured by the Client satisfaction Questionnaire
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.
Measured: 12 months
Physical Function as measured by the senior fitness test
all seven components of the senior fitness test will be examined. This is a validated tool for physical function in older adults.
Measured: 12 months
physical activity as measured by Fitbit trackers
Fitbit will track number of minutes active every day.
Measured: 12 months
Feasibility of the community based exercise program as measured by randomization rate
randomization rate which is the number of participants randomized divided by the number of participants consented and screened which should be ≥ 60%
Measured: 12 months
Feasibility of the community based exercise program as measured by retention rate
retention rate which is the number of participants completing T2 divided by the number who were randomized should be ≥ 80%.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start22 Sep 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mercy N. Mumba, University of Alabama, Tuscaloosa
- Investigators
- Mercy N Mumba, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716037
- Sponsor's protocol ID
- 18-010-ME
- Status last verified
- May 2024
- First submitted
- 11 Oct 2018
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical and Psychosocial Well-being of African American Older Adults Living in Rural Areas Through a Community-Based Exercise Program
- ClinicalTrials.gov ID
- NCT03716037
- Acronym / sponsor ID
- 18-010-ME
- Conditions
- Physical Activity, Psychosocial Stressors
- Keywords
- physical activity, exercise, depression, anxiety, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Other: Physical Activity for Life (PAL)Physical Activity for Life (PAL) is an 8-week exercise program, meeting three times per week for one hour sessions. |
| Contact Control | No intervention | –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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- 1. cognitive impairment as defined by the St. Louis University Mental Status Exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Physical Activity |
Primary outcome
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%
7 secondary outcomes
physical activity as measured by Fitbit trackers
Time frame: 12 months
psychosocial Well-being as measured by the Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health Measure-10
Time frame: 12 months
Satisfaction Outcome as measured by the Client satisfaction Questionnaire
Time frame: 12 months
Physical Function as measured by the senior fitness test
Time frame: 12 months
physical activity as measured by Fitbit trackers
Time frame: 12 months
Feasibility of the community based exercise program as measured by randomization rate
Time frame: 12 months
Feasibility of the community based exercise program as measured by retention rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mercy N Mumba, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity for Life (PAL) in people with Physical Activity and Psychosocial Stressors, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the community based exercise program as measured by enrollment rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.