Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2019-07-19
2023-09-19
Brief Summary
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Investigator hypothesized that a series of group sessions of sophrology may improve the exercise capacity, in this population.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Sophrology group
8 sophrology sessions, approximately 60 minutes each, spread over 12 months
Sophrology sessions
8 sophrology sessions, approximately 60 minutes each, spread over 12 months
Control group
usual care
usual care
usual care
Interventions
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Sophrology sessions
8 sophrology sessions, approximately 60 minutes each, spread over 12 months
usual care
usual care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 .
13 Years
25 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Pascal AMEDRO, MD
Role: PRINCIPAL_INVESTIGATOR
UH Montpellier
Sophie GUILLAUMONT, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Pierre Institut
Yves DULAC, MD
Role: PRINCIPAL_INVESTIGATOR
UH Toulouse
Damien BONNET, MD
Role: PRINCIPAL_INVESTIGATOR
APHP Necker
Alban Louen BARUTEAU, Professor
Role: PRINCIPAL_INVESTIGATOR
UH Nantes
Locations
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CHU de Montpellier
Montpellier, Occitanie, France
Institut Saint-Pierre
Palavas-les-Flots, , France
Countries
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References
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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.
Related Links
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Impact of Sophrology on cardiopulmonary fitness in teenagers and
Other Identifiers
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UF7590
Identifier Type: OTHER
Identifier Source: secondary_id
RECHMPL18_0043
Identifier Type: -
Identifier Source: org_study_id
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