Sophrology and Congenital Heart Disease (SOPHRO CARE)

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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Other: usual care; Other: Sophrology sessions

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huguette ROMIEU; Email: huguette.romieu@wanadoo.fr

Study Locations

• France
  • Palavas-les-Flots, France, 34250
    • Institut Saint-Pierre
  • Occitanie
    • Montpellier, Occitanie, France, 34095
      • CHU de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sophrology group; 8 sophrology sessions, approximately 60 minutes each, spread over 12 months	Other: Sophrology sessions; 8 sophrology sessions, approximately 60 minutes each, spread over 12 months
Other: Control group; usual care	Other: usual care; usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum oxygen uptake (VO2 max)	VO2max Variation	Variation between Baseline (M0) and at 12 months (M12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	Variation between Baseline (M0) and at 12 months (M12)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Pascal AMEDRO, MD, UH Montpellier; Principal Investigator: Sophie GUILLAUMONT, MD, Saint Pierre Institut; Principal Investigator: Yves DULAC, MD, Uh Toulouse; Principal Investigator: Damien BONNET, MD, APHP Necker; Principal Investigator: Alban Louen BARUTEAU, Professor, UH Nantes

Publications and helpful links

General Publications

• 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.

Helpful Links

• Impact of Sophrology on cardiopulmonary fitness in teenagers and

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2019
• Primary Completion (Actual): September 19, 2023
• Study Completion (Actual): September 19, 2023

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: RECHMPL18_0043; UF7590 (Other Identifier: UH Montpellier)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No