Effect of a Cardiac Rehabilitation Program on Chronic Heart Failure Patients in Yaoundé, Cameroon

Study Overview
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Brief Summary
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CARECA-CHF study is a non-randomized, prospective, single-arm study, enrolled ambulatory patients with stable chronic heart failure [New York Heart Association (NYHA) class II/III]. Patients will be followed-up during a period of 06-08 weeks. The aim of this study is to assess the effect of a cardiac rehabilitation program on patients with stable chronic heart failure in Yaoundé, Cameroon.

Detailed Description
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CARECA-CHF study is a non-randomized, prospective, single-arm study, multicentric study. Patients with stable chronic heart failure [New York Heart Association (NYHA) class II/III] will be enrolled ambulatory. The program will take place during a period of 06-08 weeks. The aim of this study is to assess the effect of a cardiac rehabilitation program on patients with stable chronic heart failure in a resource-limited country.

Official Title
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Effect of a Cardiac Rehabilitation Program on Chronic Heart Failure Patients in Yaoundé, Cameroon

Conditions
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Chronic Heart Failure (CHF)

Intervention / Treatment
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* Other: CHF Patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stable chronic heart failure confirmed by a cardiac ultrasound and whose severity is rated stage II or III of NYHA followed at Yaoundé central hospital and Yaoundé general hospital; Stable under treatment; Whose cardiac ultrasound is less than six months old; Having given his free and informed consent. Exclusion Criteria: Poor adherence to the cardiac rehabilitation program activities; Patients lost insight the program; Withdrawal of informed consent.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with stable CHF in stage II or III of the New York Heart Association.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stable CHF patients<br>Stable CHF patients on stage II/III based on the New York Heart Failure classification | Other: CHF Patients<br>* Cardiac rehabilitation program on CHF patients on 06-08 weeks. Program will include: physical aerobic re-training, therapeutic education on CHF, psychological follow-up, nutritional education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of VO2 max | Variation of VO2 max at baseline and the end of the study | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in 6-minute walk test (6MWT) distance | Variation in 6MWT in meter distance from the baseline to week 6 or 8. By using pedometer | 8 weeks | 
| Variation of duration of exercise and maximum load | variation in duration of exercise and maximum load expressed by watt power | 8 weeks | 
| Variation in level of anxiety and depression; | Difference in level of anxiety and depression assessed by a questionnaire | 8 weeks | 
| Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ) | Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Minnesota Living With Heart Failure Questionnaire score at Week 8 adjusted for baseline | 8 weeks | 
| Variation of time-domain heart rate variability (HRV) parameters | Variation of time-domain heart rate variability parameters before and after the intervention | 8 weeks | 
| Variation of frequency-domain HRV parameters | variation of frequency-domain HRV parameters before and after the intervention. Variation of frequency-domain HRV parameters (HF, LF, LF/HF) before and after the intervention. | 8 weeks | 
| Variation of index hypopnea-apnea index | Variation of variation of index hypopnea-apnea after 6-8 weeks of aerobic training. | 8 weeks | 
| Variation of sleep quality index | variation of sleep quality index by Pittsburg questionnaire | 8 weeks | 
| Variation of nocturnal saturation | Variation of nocturnal saturation by oxymeter | 8 weeks | 
| Non adherence | evaluation of non adherence by questionnaire at the end of the study | 8weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cameroon, Cardiac rehabilitation, Chronic Heart failure, Physical function