Effect of a Cardiac Rehabilitation Program on Chronic Heart Failure Patients in Yaoundé, Cameroon (CARECA-CHF)

March 4, 2021 updated by: CN NGANOU-GNINDJIO, MD, MSc, Yaounde Central Hospital
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
      • Yaoundé, Cameroon, BP: 35307 Bastos
        • Dr Chris Nadège Nganou-Gnindjio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stable CHF patients
Stable CHF patients on stage II/III based on the New York Heart Failure classification
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yaounde Central Hospital

Investigators

  • Principal Investigator: Chris Nadège N Nganou-Gnindjio, MD, MAS, Yaoundé Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARECA-CHF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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