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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Classical Cardiac Rehabilitation
Karate rehabilitation
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Corentin Celton
  • Groupe Hospitalier Paris Saint-Joseph

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Classical Cardiac Rehabilitation

Karate Rehabilitation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 20, 2019
Last Updated
September 11, 2023
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT03884855
Brief Title
Evaluation of the Benefit of Traditional Karate in Heart Failure for Cardiac Rehabilitation
Acronym
KAREAD
Official Title
Randomised Controlled Trial to Evaluate the Benefit of Traditional Karate in Heart Failure During Cardiac Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
September 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Classical Cardiac Rehabilitation
Arm Type
Active Comparator
Arm Description
Patients benefit from a classic cardiac rehabilitation cycle during 3 months.
Arm Title
Karate Rehabilitation
Arm Type
Experimental
Arm Description
Patients benefit from cardiac rehabilitation cycle with traditional karate during 3 months.
Intervention Type
Other
Intervention Name(s)
Classical Cardiac Rehabilitation
Intervention Description
Patients benefit from classical cardiac rehabilitation during 3 months.
Intervention Type
Other
Intervention Name(s)
Karate rehabilitation
Intervention Description
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 Measure Information:
Title
peak VO2
Description
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.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Description
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.
Time Frame
Day 1
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Description
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.
Time Frame
Month 3
Title
DASS 21 scale
Description
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.
Time Frame
Day 1
Title
DASS 21 scale
Description
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.
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe DUC, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Corentin Celton
City
Issy-les-Moulineaux
State/Province
Ile De France
ZIP/Postal Code
92130
Country
France
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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

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