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

NCT03884855 | Completed

• 1 other identifier: KAREAD
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  Day 1

• Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  Month 3

• DASS 21 scale

  Day 1

• DASS 21 scale

  Month 3

Study Arms (2)

Classical Cardiac Rehabilitation

ACTIVE COMPARATOR

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

Other: Classical Cardiac Rehabilitation

Karate Rehabilitation

EXPERIMENTAL

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

Other: Karate rehabilitation

Interventions

Classical Cardiac Rehabilitation OTHER

Patients benefit from classical cardiac rehabilitation during 3 months.

Classical Cardiac Rehabilitation

Karate rehabilitation 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.

Karate Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient under tutorship or curatorship
• Patient deprived of liberty
• Non-French speaking patient

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (2)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Hôpital Corentin Celton

Issy-les-Moulineaux, Île-de-France Region, 92130, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Philippe DUC, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 21, 2019
• Study Start: April 4, 2019
• Primary Completion: August 15, 2022
• Study Completion: September 11, 2023
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

FR (2)