Clinical trial NCT03999320: Sophrology and Congenital Heart Disease
Official title: Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Maximum oxygen uptake (VO2 max)
timeFrame: Variation between Baseline (M0) and at 12 months (M12)
Secondary outcomes:
measure: Quality of life score
timeFrame: Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12
measure: Physical activity score
timeFrame: Variation between Baseline (M0) and at 12 months (M12)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
state: Occitanie
city: Palavas-les-Flots
country: France
facility: Institut Saint-Pierre
Study officials:
affiliation: UH Montpellier
name: Pascal AMEDRO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Pierre Institut
name: Sophie GUILLAUMONT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Toulouse
name: Yves DULAC, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP Necker
name: Damien BONNET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Nantes
name: Alban Louen BARUTEAU, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moreau J, Lavastre K, Romieu H, Charbonnier F, Guillaumont S, Bredy C, Abassi H, Werner O, De La Villeon G, Requirand A, Auer A, Matecki S, Karsenty C, Guitarte A, Hadeed K, Dulac Y, Souletie N, Acar P, Bajolle F, Bonnet D, Negre-Pages L, Mura T, Mounier M, Seguela PE, Thomas J, Iriart X, Jean-Benoit-Thambo, Amedro P. Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods. Int J Cardiol Heart Vasc. 2020 Mar 3;27:100489. doi: 10.1016/j.ijcha.2020.100489. eCollection 2020 Apr.