Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital

Study Overview
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Brief Summary
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This is a study to find out whether cardiac rehabilitation is feasible in Western Kenya. This study will test whether cardiac rehabilitation is feasible by measuring how many participants are able to follow and complete two different exercise protocols; one at home and one in hospital. It will also measure how the exercise intervention affects quality of living, depression and improvement in exercise tolerance.

Detailed Description
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Cardiovascular diseases are major drivers of global disease burden. Heart failure, has a 50% mortality at 5 years and is thought to be higher in resource limited settings. Cardiac rehabilitation (CR) is a multi-disciplinary intervention which has been demonstrated to improve functional status, quality of life, and reduce morbidity and mortality in patients with heart failure. In sub-Saharan Africa, despite a significant heart failure disease burden, CR is largely non-existent. There is a compelling need for urgent development of access to CR in the region. However, feasibility and potential utilization of CR is unknown. The investigators aim to conduct a mixed methods study to evaluate feasibility of home based and institution based CR. Participants will be voluntarily recruited from a convenience sample at the Moi Teaching and Referral Hospital (MTRH) outpatient cardiology clinic. Based on a reasonable estimate of expected subject recruitment over the time frame of study, 25 patients will be recruited into the institution based cardiac rehabilitation (IBCR) arm. In consideration of the potentially larger population and a wider geographical spread of home based cardiac rehabilitation (HBCR), 36 patients will be recruited to the HBCR arm and 40 patients will be recruited into an observational arm. While the study is not designed to make comparative outcome inferences between the HBCR and the IBCR groups, the sample size will be large enough to detect a clinically significant mean post intervention increase in 6 minute walk time distance in the HBCR arm of 50m. The participants will be involved in physical exercises, nutritional counseling and educational sessions. Upon completion of the rehabilitation protocols, patients from both study arms will also be invited to participate in focus group discussions. Data will be analyzed and numeric data will be expressed as number (percent), means (standard deviation) or median (interquartile range). Wilcoxon rank-sum and Fisher's exact tests for pre - post intervention comparisons of continuous and binary variables, respectively. Focus group discussions will be transcribed and analyzed to identify discussion themes.

Official Title
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Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: Cardiac rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New York Heart Association (NYHA) Class II and III heart failure Have had an echocardiographic study in the past 5 years Owns a mobile telephone Can participate in exercise Can read/ primary care giver can read in English or Kiswahili Can travel to hospital three times a week Exclusion Criteria: Recent acute illness requiring hospitalization or initiation of new medication in the preceding 4 weeks Limitation of activity because of factors other than fatigue or exertional dyspnea, such as arthritis, claudication in the legs, angina, advanced comorbidities Known arrhythmia Heart failure due to congenital heart disease Pregnant patients as may be confirmed by patient report or urine pregnancy tests Heart failure due to obstructive cardiomyopathy including mitral stenosis and aortic stenosis Presence of implanted pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Institutional based rehabilitation<br>Conduct cardiac rehabilitation exercise protocol within the hospital | Procedure: Cardiac rehabilitation<br>* Perform exercise prescription for 12 weeks<br>* Other names: exercise;|
| Active Comparator: Home based rehabilitation<br>Conduct cardiac rehabilitation exercise protocol at home | Procedure: Cardiac rehabilitation<br>* Perform exercise prescription for 12 weeks<br>* Other names: exercise;|
| Placebo Comparator: Observational arm<br>No prescribed exercises, followed up monthly | Procedure: Cardiac rehabilitation<br>* Perform exercise prescription for 12 weeks<br>* Other names: exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protocol adherence | Mean adherence of at least 25% to the exercise prescriptions | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6 minute walk time distance (in meters) | Measure of functional capacity | baseline, 12 weeks | 
| Change in Depression screen score using patient health questionnaire 9 (PHQ9) | Screen score based on patient health questionnaire 9 (PHQ9) | baseline, 12 weeks | 
| Change in Quality of life using short form health survey (SF 36) score | Quality of life based on short form health survey (SF 36) score | baseline, 12 weeks | 
| Qualitative assessment of perceptions towards cardiac rehabilitation from focus group discussions | Thematic analysis of barriers and incentives towards cardiac rehabilitation | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, exercise