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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04790214
Recruitment Status : Enrolling by invitation
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
CN NGANOU-GNINDJIO, MD, MSc, Yaounde Central Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure (CHF) Other: CHF Patients Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with stable CHF in stage II or III of the New York Heart Association.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of a Cardiac Rehabilitation Program on Chronic Heart Failure Patients in Yaoundé, Cameroon
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change of VO2 max [ Time Frame: 8 weeks ]
    Variation of VO2 max at baseline and the end of the study


Secondary Outcome Measures :
  1. 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

  2. Variation of duration of exercise and maximum load [ Time Frame: 8 weeks ]
    variation in duration of exercise and maximum load expressed by watt power

  3. Variation in level of anxiety and depression; [ Time Frame: 8 weeks ]
    Difference in level of anxiety and depression assessed by a questionnaire

  4. 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

  5. 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

  6. 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.

  7. 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. Variation of sleep quality index [ Time Frame: 8 weeks ]
    variation of sleep quality index by Pittsburg questionnaire

  9. Variation of nocturnal saturation [ Time Frame: 8 weeks ]
    Variation of nocturnal saturation by oxymeter

  10. Non adherence [ Time Frame: 8weeks ]
    evaluation of non adherence by questionnaire at the end of the study


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790214


Locations
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Cameroon
Dr Chris Nadège Nganou-Gnindjio
Yaoundé, Cameroon, BP: 35307 Bastos
Sponsors and Collaborators
Yaounde Central Hospital
Investigators
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Principal Investigator: Chris Nadège N Nganou-Gnindjio, MD, MAS Yaounde Central Hospital
More Information
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Responsible Party: CN NGANOU-GNINDJIO, MD, MSc, Dr, Principal investigator, Yaounde Central Hospital
ClinicalTrials.gov Identifier: NCT04790214    
Other Study ID Numbers: CARECA-CHF
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CN NGANOU-GNINDJIO, MD, MSc, Yaounde Central Hospital:
Cardiac rehabilitation
Chronic Heart failure
Physical function
Cameroon
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases