Clinical trial NCT03884855: Evaluation of the Benefit of Traditional Karate in Heart Failure for Cardiac Rehabilitation
Official title: Randomised Controlled Trial to Evaluate the Benefit of Traditional Karate in Heart Failure During Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: peak VO2
timeFrame: Month 3
Secondary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: Day 1
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: Month 3
measure: DASS 21 scale
timeFrame: Day 1
measure: DASS 21 scale
timeFrame: Month 3
Other outcomes:
Locations:
city: Issy-les-Moulineaux
country: France
facility: Hôpital Corentin Celton
state: Ile De France
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Philippe DUC, MD
role: PRINCIPAL_INVESTIGATOR
References: