Clinical trial NCT04790214: Effect of a Cardiac Rehabilitation Program on Chronic Heart Failure Patients in Yaoundé, Cameroon
Official title: Effect of a Cardiac Rehabilitation Program on Chronic Heart Failure Patients in Yaoundé, Cameroon
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure (CHF)
Keywords: Cardiac rehabilitation
Chronic Heart failure
Physical function
Cameroon
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with stable CHF in stage II or III of the New York Heart Association.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of VO2 max
timeFrame: 8 weeks
Secondary outcomes:
measure: Variation in 6-minute walk test (6MWT) distance
timeFrame: 8 weeks
measure: Variation of duration of exercise and maximum load
timeFrame: 8 weeks
measure: Variation in level of anxiety and depression;
timeFrame: 8 weeks
measure: Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ)
timeFrame: 8 weeks
measure: Variation of time-domain heart rate variability (HRV) parameters
timeFrame: 8 weeks
measure: Variation of frequency-domain HRV parameters
timeFrame: 8 weeks
measure: Variation of index hypopnea-apnea index
timeFrame: 8 weeks
measure: Variation of sleep quality index
timeFrame: 8 weeks
measure: Variation of nocturnal saturation
timeFrame: 8 weeks
measure: Non adherence
timeFrame: 8weeks
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Dr Chris Nadège Nganou-Gnindjio
Study officials:
affiliation: Yaounde Central Hospital
name: Chris Nadège N Nganou-Gnindjio, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: