Evaluation of the Benefit of Traditional Karate in Heart Failure for Cardiac Rehabilitation

Study Overview
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Brief Summary
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Cardiac rehabilitation is based on physical activity which, usually, associates combination of a cycle ergometer or treadmill completed by gymnastics. Some studies have been done with complementary physical activities such as tai chi or yoga integrated into the strategy of non-drug therapies. The tai chi study showed a tendency to improve the peak of VO2 in the tai chi group but which was not significant but also a significant improvement on secondary objectives such as quality of life, the increase in the 6-minute walk test and a decrease in the level of natriuretic peptides. A study of the effects of yoga after coronary artery bypass surgery showed at one year an improvement of the ejection fraction, the lipid profile and the state of anxiety of the patients. This study showed that the addition of yoga to conventional cardiac rehabilitation could improve cardiovascular risk factors especially in patients with abnormalities such as low HDL. The physical activities offered in rehabilitation to improve physical performance are currently limited to cycling, treadmill or gymnastics. Many patients do not like cycling or treadmill, which limits their adherence to a cardiac rehabilitation program. Moreover, one of the main problems of rehabilitation is that after the rehabilitation cycle, a minority of patients continue the physical activity. Strategies for implementing home exercises have been tested to increase the level of physical activity after rehabilitation. Cardiac rehabilitation has several components: correction of risk factors, optimization of treatment, physical activity to improve the physical abilities to exertion that are directly correlated to mortality. Our hypothesis is that the implementation of a program of physical activity based on traditional karate would improve the physical abilities to effort and the quality of life of patients, to give a better psychological confidence to patients who, after a cardiovascular event such as acute coronary syndrome, bypass surgery or valvular surgery, have marked anxiety or depression. Rehabilitation, and especially physical activity, is one of the therapeutic means proposed. The interest of this study would be to be able to offer an additional activity for rehabilitation centers, to offer patients an activity in post-rehabilitation. In addition, interaction between patients could increase adherence to rehabilitation.

Official Title
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Randomised Controlled Trial to Evaluate the Benefit of Traditional Karate in Heart Failure During Cardiac Rehabilitation

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Classical Cardiac Rehabilitation
* Other: Karate rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female ≥ 18 years Patient with heart failure Patient with impaired ejection fraction with Left ventricular ejection fraction ≤ 40% Patient affiliated with a health insurance plan Patient giving free, informed and express consent Exclusion Criteria: Patient under tutorship or curatorship Patient deprived of liberty Non-French speaking patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Classical Cardiac Rehabilitation<br>Patients benefit from a classic cardiac rehabilitation cycle during 3 months. | Other: Classical Cardiac Rehabilitation<br>* Patients benefit from classical cardiac rehabilitation during 3 months.<br>|
| Experimental: Karate Rehabilitation<br>Patients benefit from cardiac rehabilitation cycle with traditional karate during 3 months. | Other: Karate rehabilitation<br>* Patients benefit from cardiac rehabilitation with traditional karate during 3 months. Patients will have four 60-minute group sessions four times a week, during which they will have 45-minute individual exercises and 15-minute pairs of exercises. The course of the sessions has been protocolised.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak VO2 | The peak VO 2 will be measured during cardiac stress test at 3 month, at the end of cardiac rehabilitation.This peak VO2 measurement will be compared to peak VO2 at the Day 1, before cardiac rehabilitation. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | The following questions refer to patient's heart failure and how it may affect his life. This questionnaire quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | Day 1 | 
| Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | The following questions refer to patient's heart failure and how it may affect his life. The score will be compared to the responses to the questionnaire at Day 1. This questionnaire quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | Month 3 | 
| DASS 21 scale | The DASS is a quantitative measure of distress along the 3 axes of depression, anxiety and stress. The scale will be completed at day 1. Each item is scored on a 4-point scale (0 = Did not apply to me at all, to 3 = Applied to me very much or most of the time). Sum the score of each item to get a total score. Higher scores indicate greater levels of distress. | Day 1 | 
| DASS 21 scale | The DASS is a quantitative measure of distress along the 3 axes of depression, anxiety and stress. The scale will be completed at month 3, at the end of cardiac rehabilitation. Each item is scored on a 4-point scale (0 = Did not apply to me at all, to 3 = Applied to me very much or most of the time). Sum the score of each item to get a total score. Higher scores indicate greater levels of distress. | Month 3 |