Congenital Heart Disease
Conditions
Brief summary
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
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.
Interventions
OTHERSophrology sessions
8 sophrology sessions, approximately 60 minutes each, spread over 12 months
OTHERusual care
usual care
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum oxygen uptake (VO2 max) | Variation between Baseline (M0) and at 12 months (M12) | VO2max Variation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score | Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12 | Quality of life score variation (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life. |
| Physical activity score | Variation between Baseline (M0) and at 12 months (M12) | 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) |
Countries
France
Outcome results
None listed