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

Primary Purpose

Chronic Heart Failure (CHF)

Status
Unknown status
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
CHF Patients
Sponsored by
Yaounde Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Heart Failure (CHF) focused on measuring Cardiac rehabilitation, Chronic Heart failure, Physical function, Cameroon

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr Chris Nadège Nganou-Gnindjio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stable CHF patients

Arm Description

Stable CHF patients on stage II/III based on the New York Heart Failure classification

Outcomes

Primary Outcome Measures

Change of VO2 max
Variation of VO2 max at baseline and the end of the study

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2021
Last Updated
March 4, 2021
Sponsor
Yaounde Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04790214
Brief Title
Effect of a Cardiac Rehabilitation Program on Chronic Heart Failure Patients in Yaoundé, Cameroon
Acronym
CARECA-CHF
Official Title
Effect of a Cardiac Rehabilitation Program on Chronic Heart Failure Patients in Yaoundé, Cameroon
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yaounde Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure (CHF)
Keywords
Cardiac rehabilitation, Chronic Heart failure, Physical function, Cameroon

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with stable CHF in stage II or III of the New York Heart Association.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stable CHF patients
Arm Type
Experimental
Arm Description
Stable CHF patients on stage II/III based on the New York Heart Failure classification
Intervention Type
Other
Intervention Name(s)
CHF Patients
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of VO2 max
Description
Variation of VO2 max at baseline and the end of the study
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Variation in 6-minute walk test (6MWT) distance
Description
Variation in 6MWT in meter distance from the baseline to week 6 or 8. By using pedometer
Time Frame
8 weeks
Title
Variation of duration of exercise and maximum load
Description
variation in duration of exercise and maximum load expressed by watt power
Time Frame
8 weeks
Title
Variation in level of anxiety and depression;
Description
Difference in level of anxiety and depression assessed by a questionnaire
Time Frame
8 weeks
Title
Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ)
Description
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
Time Frame
8 weeks
Title
Variation of time-domain heart rate variability (HRV) parameters
Description
Variation of time-domain heart rate variability parameters before and after the intervention
Time Frame
8 weeks
Title
Variation of frequency-domain HRV parameters
Description
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.
Time Frame
8 weeks
Title
Variation of index hypopnea-apnea index
Description
Variation of variation of index hypopnea-apnea after 6-8 weeks of aerobic training.
Time Frame
8 weeks
Title
Variation of sleep quality index
Description
variation of sleep quality index by Pittsburg questionnaire
Time Frame
8 weeks
Title
Variation of nocturnal saturation
Description
Variation of nocturnal saturation by oxymeter
Time Frame
8 weeks
Title
Non adherence
Description
evaluation of non adherence by questionnaire at the end of the study
Time Frame
8weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Nadège N Nganou-Gnindjio, MD, MAS
Organizational Affiliation
Yaounde Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Chris Nadège Nganou-Gnindjio
City
Yaoundé
ZIP/Postal Code
BP: 35307 Bastos
Country
Cameroon

12. IPD Sharing Statement

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

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