Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods
Year: 2020
Type: article
Study design: Study Protocol
Abstract: Background Recent advances in the field of congenital heart disease (CHD) have significantly improved the overall prognosis. Now more attention is being given to health-related quality of life (HRQoL) and promotion of physical activity. Non-invasive relaxation therapy may be effective in cardiac patients concerned with exercise-induced dyspnoea. The SOPHROCARE randomised trial aims to assess the impact of Caycedian Sophrology on cardiopulmonary fitness in adolescents and young adults with CHD. Methods The SOPHROCARE trial is a nationwide, multicentre, randomised, controlled study in CHD patients aged from 13 to 25 years old. Patients will be randomised into 2 groups (8 Sophrology group sessions vs. no intervention). The primary outcome is the change in percent predicted maximum oxygen uptake (VO2 max ) between baseline and 12-month follow-up. A total of 94 patients in each group is required to observe a significant increase of 10% in VO2 max with a power of 80% and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, cardiopulmonary exercise test parameters (VE/VCO2 slope, ventilatory anaerobic threshold, oxygen pulse, respiratory response to hypercapnia), health-related quality of life score (PedsQL), physical and psychological status. Conclusion After focusing on the survival in CHD, current research is opening on secondary prevention and patient-related outcomes. We sought to assess in the SOPHROCARE trial, if a Sophrology program, could improve exercise capacity and quality of life in youth with CHD. Trial registration Clinicaltrials.gov (NCT03999320).
Source: IJC Heart & Vasculature
Authors: Johan Moreau, Kathleen Lavastre, Huguette Romieu, Françoise Charbonnier, Sophie Guillaumont, Charlene Bredy, Hamouda Abassi, Oscar Werner, Gregoire De La Villeon, Anne Requirand, Annie Auer, Stefan Matecki, Clement Karsenty, Aitor Guitarte, Khaled Hadeed, Yves Dulac, Nathalie Souletie, Philippe Acar, Fanny Bajolle, Damien Bonnet, Laurence Negre-Pages, Thibault Mura, Maria Mounier, Pierre-Emmanuel Seguela, Julie Thomas, Xavier Iriart, Jean-Benoit-Thambo, Pascal Amedro
Institutions: Inserm, Physiologie et Médecine Expérimentale du Coeur et des Muscles, Centre Hospitalier Universitaire de Montpellier, Hôpital Arnaud de Villeneuve, Université de Montpellier, Institut Saint-Pierre, Aix-Marseille Université, Centre National de la Recherche Scientifique, Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan, Hôpital des Enfants, Hôpital Paule de Viguier, Hôpital de La Grave, Université Toulouse III - Paul Sabatier, Hôpital Necker-Enfants Malades, Université Paris Cité, Sorbonne Paris Cité, Assistance Publique – Hôpitaux de Paris, Université Paris Descartes, Neuropsychiatrie : Recherche Epidemiologique et Clinique, Centre Hospitalier Universitaire de Bordeaux
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,809
OpenAlex ID: W3010442782