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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
8 sophrology sessions, approximately 60 minutes each, spread over 12 months
usual care
CHU de Montpellier
Montpellier, Occitanie, France
Institut Saint-Pierre
Palavas-les-Flots, France
Maximum oxygen uptake (VO2 max)
VO2max Variation
Time frame: Variation between Baseline (M0) and at 12 months (M12)
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.
Time frame: 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)
Time frame: Variation between Baseline (M0) and at 12 months (M12)
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