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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884855
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

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.


Condition or disease Intervention/treatment Phase
Heart Failure Other: Classical Cardiac Rehabilitation Other: Karate rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomised Controlled Trial to Evaluate the Benefit of Traditional Karate in Heart Failure During Cardiac Rehabilitation
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Classical Cardiac Rehabilitation
Patients benefit from a classic cardiac rehabilitation cycle during 3 months.
Other: Classical Cardiac Rehabilitation
Patients benefit from classical cardiac rehabilitation during 3 months.

Experimental: Karate Rehabilitation
Patients benefit from cardiac rehabilitation cycle with traditional karate during 3 months.
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.




Primary Outcome Measures :
  1. peak VO2 [ Time Frame: Month 3 ]
    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.


Secondary Outcome Measures :
  1. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [ Time Frame: Day 1 ]
    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.

  2. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [ Time Frame: Month 3 ]
    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.

  3. DASS 21 scale [ Time Frame: Day 1 ]
    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.

  4. DASS 21 scale [ Time Frame: Month 3 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884855


Contacts
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Contact: Philippe DUC, MD 0144127038 ext +33 pduc@hpsj.fr

Locations
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France
Hôpital Corentin Celton Recruiting
Issy-les-Moulineaux, Ile De France, France, 92130
Contact: Marie-Christine Iliou, MD       marie-christine.iliou@ccl.aphp.fr   
Principal Investigator: Marie-Christine Iliou, MD         
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Philippe DUC, MD       pduc@hpsj.fr   
Contact: Helene BEAUSSIER, PharmD, PhD    0144127038 ext +33    crc@hpsj.fr   
Principal Investigator: Philippe DUC, MD         
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Philippe DUC, MD Groupe Hospitalier Paris Saint Joseph
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03884855    
Other Study ID Numbers: KAREAD
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases