NCT03999320

Sophrology and Congenital Heart Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 13 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
OTHER	Sophrology sessions	8 sophrology sessions, approximately 60 minutes each, spread over 12 months
OTHER	usual care	usual care

Timeline

• Start date: 2019-07-19
• Primary completion: 2023-09-19
• Completion: 2023-09-19
• First posted: 2019-06-26
• Last updated: 2023-10-03

Locations

2 sites across 1 country: France