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

Chronic Heart Failure (CHF) Clinical Trial

— CARECA-CHF  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04790214
• Other study ID #: CARECA-CHF
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2021
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: September 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure (CHF)
• Heart Failure

Intervention

Other:
• CHF Patients
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

Locations

Country	Name	City	State
Cameroon	Dr Chris Nadège Nganou-Gnindjio	Yaoundé

Sponsors (1)

Lead Sponsor	Collaborator
Yaounde Central Hospital

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of VO2 max	Variation of VO2 max at baseline and the end of the study	8 weeks
Secondary	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
Secondary	Variation of duration of exercise and maximum load	variation in duration of exercise and maximum load expressed by watt power	8 weeks
Secondary	Variation in level of anxiety and depression;	Difference in level of anxiety and depression assessed by a questionnaire	8 weeks
Secondary	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
Secondary	Variation of time-domain heart rate variability (HRV) parameters	Variation of time-domain heart rate variability parameters before and after the intervention	8 weeks
Secondary	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
Secondary	Variation of index hypopnea-apnea index	Variation of variation of index hypopnea-apnea after 6-8 weeks of aerobic training.	8 weeks
Secondary	Variation of sleep quality index	variation of sleep quality index by Pittsburg questionnaire	8 weeks
Secondary	Variation of nocturnal saturation	Variation of nocturnal saturation by oxymeter	8 weeks
Secondary	Non adherence	evaluation of non adherence by questionnaire at the end of the study	8weeks