SOPHRO CARE: Sophrology and Congenital Heart Disease

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03999320
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site: 100
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease	Other: Sophrology sessions; Other: usual care	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial
• Actual Study Start Date: Jul 19, 2019
• Anticipated Primary Completion Date: Jul 19, 2023
• Anticipated Study Completion Date: Jul 19, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Maximum oxygen uptake (VO2 max) [Variation between Baseline (M0) and at 12 months (M12)]

   VO2max Variation

Secondary Outcome Measures

1. 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.

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Montpellier	Montpellier	Occitanie	France	34095
2	Institut Saint-Pierre	Palavas-les-Flots		France	34250

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Impact of Sophrology on cardiopulmonary fitness in teenagers and

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.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT03999320
• Other Study ID Numbers: RECHMPL18_0043; UF7590
• First Posted: Jun 26, 2019
• Last Update Posted: Dec 30, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital

Study Results

No Results Posted as of Dec 30, 2021