Physical Activity Program for Cardiac Health Among Older African American Populations

Not Applicable

• Conditions: Cardiovascular; Disease
• Interventions: Behavioral: Physical Activity Cardiac Health Program

• Registration Number: NCT04866732
• Lead Sponsor: University of Alabama, Tuscaloosa

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-26
• Last Update Submitted: 2021-04-26
• Study First Posted: 2021-04-30
• Last Update Posted: 2021-04-30
• Study Start: 2021-07
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Needs assessment and feasibility group	Physical Activity Cardiac Health Program	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

Primary Outcome Measures

Name	Time	Method
Physical Activity	12 Weeks	The investigators will measure the leisure-time physical activity including walk. This will be measured by an accelerometer which gives more accurate information about the ambulation of a person. Scores can range between 0 and infinite.; The higher the score, the better is the outcome.