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| ID | Type | Description | Link |
|---|---|---|---|
| UF7590 | Other Identifier | UH Montpellier |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sophrology group | Experimental | 8 sophrology sessions, approximately 60 minutes each, spread over 12 months |
|
| Control group | Other | usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sophrology sessions | Other | 8 sophrology sessions, approximately 60 minutes each, spread over 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum oxygen uptake (VO2 max) | VO2max Variation | Variation between Baseline (M0) and at 12 months (M12) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Montpellier | Occitanie | 34095 | France | ||
| Institut Saint-Pierre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32154361 | Background | 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. | |
| 42052946 |
| Label | URL |
|---|---|
| Impact of Sophrology on cardiopulmonary fitness in teenagers and | View source |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| usual care | Other | usual care |
|
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) |
| Palavas-les-Flots |
| 34250 |
| France |
| Derived |
| Moreau J, Neyraud C, Huguet H, Andrianoely M, Romieu H, Charbonnier F, Guillaumont S, De La Villeon G, Vincenti M, Requirand A, Auer A, Dulac Y, Guitarte A, Acar P, Bajolle F, Bonnet D, Chabaneix J, Iriart X, Thambo JB, Le Gloan L, Hauet Q, Venna A, Cadene A, Picot MC, Duflos C, Amedro P. Remote Sophrology in Congenital Heart Disease: The SOPHROCARE Randomized Controlled Trial. Eur J Cardiovasc Nurs. 2026 Apr 29:zvag115. doi: 10.1093/eurjcn/zvag115. Online ahead of print. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |