Sophrology and Congenital Heart Disease (SOPHRO CARE)

University Hospital Center (CHU)

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Other: usual care; Other: Sophrology sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT03999320

RECHMPL18_0043

UF7590 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 13 to 25 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Sophrology group

Experimental group

Description:

8 sophrology sessions, approximately 60 minutes each, spread over 12 months

Treatment:

Other: Sophrology sessions

Control group

Other group

Description:

usual care

Treatment:

Other: usual care