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

NCT ID: NCT03884855

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-04
• Study Completion Date: 2023-09-11

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Classical Cardiac Rehabilitation

Patients benefit from a classic cardiac rehabilitation cycle during 3 months.

Group Type: ACTIVE_COMPARATOR

Classical Cardiac Rehabilitation

Intervention Type: OTHER

Patients benefit from classical cardiac rehabilitation during 3 months.

Karate Rehabilitation

Patients benefit from cardiac rehabilitation cycle with traditional karate during 3 months.

Group Type: EXPERIMENTAL

Karate rehabilitation

Intervention Type: OTHER

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.

Interventions

Classical Cardiac Rehabilitation

Patients benefit from classical cardiac rehabilitation during 3 months.

Intervention Type: OTHER

Karate rehabilitation

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe DUC, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

Groupe Hospitalier Paris Saint-Joseph

Paris, , France

Hôpital Corentin Celton

Issy-les-Moulineaux, Île-de-France Region, France

Countries

France

Other Identifiers

KAREAD

Identifier Type: -

Identifier Source: org_study_id