Sophrology and Congenital Heart Disease

Congenital Heart Disease Clinical Trial

— SOPHRO CARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999320
• Other study ID #: RECHMPL18_0043
• Secondary ID: UF7590
• Status: Completed
• Phase: N/A
• Start date: July 19, 2019
• Est. completion date: September 19, 2023

Study information

• Verified date: October 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 19, 2023
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Sophrology sessions
8 sophrology sessions, approximately 60 minutes each, spread over 12 months
• usual care
usual care

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier	Occitanie
France	Institut Saint-Pierre	Palavas-les-Flots

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum oxygen uptake (VO2 max)	VO2max Variation	Variation between Baseline (M0) and at 12 months (M12)
Secondary	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
Secondary	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)

External Links

•   Impact of Sophrology on cardiopulmonary fitness in teenagers and