Sophrology and Congenital Heart Disease

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Other: usual care; Other: Sophrology sessions

• Registration Number: NCT03999320
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-26
• Study Start: 2019-07-19
• Primary Completion: 2023-09-19
• Study Completion: 2023-09-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	usual care	usual care
Sophrology group	Sophrology sessions	8 sophrology sessions, approximately 60 minutes each, spread over 12 months

Primary Outcome Measures

Name	Time	Method
Maximum oxygen uptake (VO2 max)	Variation between Baseline (M0) and at 12 months (M12)	VO2max Variation

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

CHU de Montpellier; 🇫🇷 Montpellier, Occitanie, France

Institut Saint-Pierre; 🇫🇷 Palavas-les-Flots, France