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

Not Applicable

• Conditions: Chronic Heart Failure (CHF)
• Interventions: Other: CHF Patients

• Registration Number: NCT04790214
• Lead Sponsor: Yaounde Central Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-02-25
• Status Verified: 2021-03
• Study Start: 2021-03-01
• Study First Submitted QC: 2021-03-04
• Last Update Submitted: 2021-03-04
• Study First Posted: 2021-03-10
• Last Update Posted: 2021-03-10
• Primary Completion: 2021-06-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stable CHF patients	CHF Patients	Stable CHF patients on stage II/III based on the New York Heart Failure classification

Primary Outcome Measures

Name	Time	Method
Change of VO2 max	8 weeks	Variation of VO2 max at baseline and the end of the study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dr Chris Nadège Nganou-Gnindjio; 🇨🇲 Yaoundé, Cameroon