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Physical Activity Program for Cardiac Health Among Older African American Populations

NCT ID: NCT04866732

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2022-07-30

Brief Summary

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Cardiovascular Diseases (CVD) are the leading cause of morbidity and mortality globally, and older African Americans (AAs) living in rural areas are disproportionately affected by this healthcare problem. The investigators propose conducting a mixed-methods study to gain information about CVD-related knowledge, perceptions regarding CVD-related healthcare needs, preferences and access barriers, and cultural aspects within this population. The information will be used in tailoring an existing intervention to meet those needs and preferences and evaluate its feasibility among older AAs living in rural Alabama. This study will lay a foundation for developing a federal grant application and a line of independent research by this early-stage investigator.

Detailed Description

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Cardiovascular diseases (CVD) are a leading cause of morbidity and mortality. Older populations are inherently more vulnerable to such conditions. Older African American (AA) populations living in rural areas are disproportionately affected by CVD, which has been shown to cause an increased risk for mortality in this population. Evidence suggests using lifestyle Physical activity programs to prevent CVD risk factors, which can decrease the morbidity and mortality rates associated with these health conditions. There are limited resources and healthcare services available to these populations, especially those living in Alabama's black belt. Therefore, this research project proposes conducting a phased mixed-methods study to collect data from rural AA older adults. These data are the critical first step towards developing a culturally sensitive, accessible, and acceptable intervention that addresses their needs and risk factors, incorporates their preferences, and mitigates identified barriers, which will be tested for feasibility and acceptability in this pilot study. The aims for this study are Aim 1: Through survey and interviews, assess: i) the knowledge and perceptions of AA older adults living in rural Alabama regarding CVD-related risk factors; ii) the needs/existing resources and access barriers for a community-based physical activity program; iii) the perceptions about a proposed intervention and its components, method of delivery, time/effort, and incentives; and iv) the cultural preferences regarding recruitment strategies, treatment strategies, and incentives. Aim2a: Based on the findings of Aim 1, develop a PA program for improving CVD-related risk factors among older AA populations living in rural Alabama. Aim2b: To examine the feasibility and acceptability of delivering a PA program (developed in Aim 2a) among the older AA populations living in rural Alabama. The enhanced program would enable AA older populations to prevent and manage CVD-related risk factors. It will also help in filling the gap of health disparity between AAs and other ethnicities.

Conditions

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Cardiovascular Disease

Keywords

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Cardiovascular African American Older Women Rural

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This project involves a mixed methods study with sequential design.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Needs assessment and feasibility group

Based on our target population's needs/preferences, an existing Physical Activity (PA) program will be modified and tailored to the needs of the target population. We anticipate that this PA program will include the following components: a) PA component - ( duration of walk) from baseline to the end of the study; b) weekly informational sessions on various topics related to CVD risk factors prevention; c) daily diary to record if they are facing any barriers in completing various components of the intervention; d) problem-solving sessions

Group Type EXPERIMENTAL

Physical Activity Cardiac Health Program

Intervention Type BEHAVIORAL

The investigators anticipate that the physical activity program will include the following components: a) physical activity component - the investigators propose an incremental physical activity component whereby participants will gradually increase their physical activity ( duration of walk) from baseline to the end of the study; b) weekly informational sessions on various topics related to Cardiovascular disease risk factors prevention; c) daily diary, which will be used to document record about any barriers for completing various components of the intervention; d) problem-solving sessions whereby participants will meet once a week with the investigators to talk about the barriers and facilitators of their weekly activity and any adherence issues.

Interventions

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Physical Activity Cardiac Health Program

The investigators anticipate that the physical activity program will include the following components: a) physical activity component - the investigators propose an incremental physical activity component whereby participants will gradually increase their physical activity ( duration of walk) from baseline to the end of the study; b) weekly informational sessions on various topics related to Cardiovascular disease risk factors prevention; c) daily diary, which will be used to document record about any barriers for completing various components of the intervention; d) problem-solving sessions whereby participants will meet once a week with the investigators to talk about the barriers and facilitators of their weekly activity and any adherence issues.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* AA women above 65 years of age
* residing in a community setting of rural Alabama
* diagnosis of CVD
* two or more CVD-related risk factors
* able to speak and understand English
* physically inactive (engaging in no structured ambulatory/walking based lifestyle physical activity),
* able to understand and participate in basic elements (informed consent, components of intervention) of the study.

Exclusion Criteria

* medical co-morbidity or any acute illness or frailty that would prevent their participation in the physical activity component,
* history of more than two falls in the last two months
* suicidal ideation
* scoring below 22 on Mini-Mental Status Examination Scale
* lack of transportation to the research sites
* concurrent participation in any other heart health or Physical activity intervention study.
* engaged in any kind of ambulatory/walking-based lifestyle physical activity
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

University of Alabama, Tuscaloosa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mudasir Andrabi, Ph D

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama

Robert Motl, Ph D

Role: STUDY_DIRECTOR

The University of Alabama at Birmingham

Karlene Ball, Ph D

Role: STUDY_DIRECTOR

The University of Alabama at Birmingham

Central Contacts

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Mudasir Andrabi, Ph D

Role: CONTACT

Phone: 4432045623

Email: [email protected]

Mercy Mumba, Ph D

Role: CONTACT

Phone: 2055305439

Email: [email protected]

References

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Abbott LS, Slate EH. Improving Cardiovascular Disease Knowledge among Rural Participants: The Results of a Cluster Randomized Trial. Healthcare (Basel). 2018 Jun 25;6(3):71. doi: 10.3390/healthcare6030071.

Reference Type RESULT
PMID: 29941776 (View on PubMed)

Abu Alhaija ES, Aldaikki A, Al-Omairi MK, Al-Khateeb SN. The relationship between personality traits, pain perception and attitude toward orthodontic treatment. Angle Orthod. 2010 Nov;80(6):1141-9. doi: 10.2319/012710-59.1.

Reference Type RESULT
PMID: 20677967 (View on PubMed)

Agrell B, Dehlin O. Comparison of six depression rating scales in geriatric stroke patients. Stroke. 1989 Sep;20(9):1190-4. doi: 10.1161/01.str.20.9.1190.

Reference Type RESULT
PMID: 2772980 (View on PubMed)

Andrawes WF, Bussy C, Belmin J. Prevention of cardiovascular events in elderly people. Drugs Aging. 2005;22(10):859-76. doi: 10.2165/00002512-200522100-00005.

Reference Type RESULT
PMID: 16245959 (View on PubMed)

Angermayr L, Melchart D, Linde K. Multifactorial lifestyle interventions in the primary and secondary prevention of cardiovascular disease and type 2 diabetes mellitus--a systematic review of randomized controlled trials. Ann Behav Med. 2010 Aug;40(1):49-64. doi: 10.1007/s12160-010-9206-4.

Reference Type RESULT
PMID: 20652464 (View on PubMed)

Bellet RN, Adams L, Morris NR. The 6-minute walk test in outpatient cardiac rehabilitation: validity, reliability and responsiveness--a systematic review. Physiotherapy. 2012 Dec;98(4):277-86. doi: 10.1016/j.physio.2011.11.003. Epub 2012 May 16.

Reference Type RESULT
PMID: 23122432 (View on PubMed)

Cho D, Nguyen NT, Strong LL, Wu IHC, John JC, Escoto KH, Wetter DW, McNeill LH. Multiple Health Behaviors Engagement in an African American Cohort: Clustering Patterns and Correlates. Health Educ Behav. 2019 Jun;46(3):506-516. doi: 10.1177/1090198119826207. Epub 2019 Feb 18.

Reference Type RESULT
PMID: 30776919 (View on PubMed)

Colantonio LD, Monda KL, Rosenson RS, Brown TM, Mues KE, Howard G, Safford MM, Yedigarova L, Farkouh ME, Muntner P. Characteristics and Cardiovascular Disease Event Rates among African Americans and Whites Who Meet the Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) Trial Inclusion Criteria. Cardiovasc Drugs Ther. 2019 Apr;33(2):189-199. doi: 10.1007/s10557-019-06864-2.

Reference Type RESULT
PMID: 30746585 (View on PubMed)

Der Ananian C, Winham DM, Thompson SV, Tisue ME. Perceptions of Heart-Healthy Behaviors among African American Adults: A Mixed Methods Study. Int J Environ Res Public Health. 2018 Nov 1;15(11):2433. doi: 10.3390/ijerph15112433.

Reference Type RESULT
PMID: 30388803 (View on PubMed)

Ferdinand DP, Nedunchezhian S, Ferdinand KC. Hypertension in African Americans: Advances in community outreach and public health approaches. Prog Cardiovasc Dis. 2020 Jan-Feb;63(1):40-45. doi: 10.1016/j.pcad.2019.12.005. Epub 2019 Dec 19.

Reference Type RESULT
PMID: 31863786 (View on PubMed)

Garatachea N, Torres Luque G, Gonzalez Gallego J. Physical activity and energy expenditure measurements using accelerometers in older adults. Nutr Hosp. 2010 Mar-Apr;25(2):224-30.

Reference Type RESULT
PMID: 20449530 (View on PubMed)

Other Identifiers

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000526161

Identifier Type: -

Identifier Source: org_study_id