Sophrology and Congenital Heart Disease

Study Overview
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Brief Summary
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The SOPHRO-CARE trial aims to measure the impact of sophrology on exercise capacity of adolescents and young adults with congenital heart disease. Investigator hypothesized that a series of group sessions of sophrology may improve the exercise capacity, in this population.

Detailed Description
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Adolescents and adults with congenital heart disease (CHD) have reduced exercise capacity compared to the general population. Our recent randomized trial in a population of children and adolescents with asthma showed that sophrology improve lung function (NCT02114398). Sophrology, from the Greek study of consciousness in harmony, is an adjuvant therapy, considered in healthcare as a relaxation technique, mainly based on breathing. Investigator assume that adolescents and young adults (13-25 y.o.) with CHD who participate in a program of sophrology with structured group sessions will improve their exercise capacity as measured by the maximum oxygen uptake (VO2max), in comparison with a control group.

Official Title
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Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Other: Sophrology sessions
* Other: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 13 to 25 years old With a congenital heart disease (CHD) as defined in the international anatomic and clinical classification (ACC) - CHD classification. Informed consent from adult patients or parents/legal guardians for minor patients Exclusion Criteria: Medical contraindication to perform an exercise test. Patient already included in a clinical trial. Cardiac surgery planned during the study Severe intellectual disability that does not allow practice of sophrology exercise or questionnaires to be completed .

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sophrology group<br>8 sophrology sessions, approximately 60 minutes each, spread over 12 months | Other: Sophrology sessions<br>* 8 sophrology sessions, approximately 60 minutes each, spread over 12 months<br>|
| Other: Control group<br>usual care | Other: usual care<br>* usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum oxygen uptake (VO2 max) | VO2max Variation | Variation between Baseline (M0) and at 12 months (M12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score | Quality of life score variation (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life. | Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12 | 
| Physical activity score | Score of physical activity (Ricci and Gagnon questionnaire, 9 items, total range score from 6 to 45, higher score indicating a higher level of physical activity) | Variation between Baseline (M0) and at 12 months (M12) |