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Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods()()
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 pa...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7057190/ https://www.ncbi.nlm.nih.gov/pubmed/32154361 http://dx.doi.org/10.1016/j.ijcha.2020.100489 |
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author | Moreau, Johan Lavastre, Kathleen Romieu, Huguette Charbonnier, Françoise Guillaumont, Sophie Bredy, Charlene Abassi, Hamouda Werner, Oscar De La Villeon, Gregoire Requirand, Anne Auer, Annie Matecki, Stefan Karsenty, Clement Guitarte, Aitor Hadeed, Khaled Dulac, Yves Souletie, Nathalie Acar, Philippe Bajolle, Fanny Bonnet, Damien Negre-Pages, Laurence Mura, Thibault Mounier, Maria Seguela, Pierre-Emmanuel Thomas, Julie Iriart, Xavier Jean-Benoit-Thambo Amedro, Pascal |
author_facet | Moreau, Johan Lavastre, Kathleen Romieu, Huguette Charbonnier, Françoise Guillaumont, Sophie Bredy, Charlene Abassi, Hamouda Werner, Oscar De La Villeon, Gregoire Requirand, Anne Auer, Annie Matecki, Stefan Karsenty, Clement Guitarte, Aitor Hadeed, Khaled Dulac, Yves Souletie, Nathalie Acar, Philippe Bajolle, Fanny Bonnet, Damien Negre-Pages, Laurence Mura, Thibault Mounier, Maria Seguela, Pierre-Emmanuel Thomas, Julie Iriart, Xavier Jean-Benoit-Thambo Amedro, Pascal |
author_sort | Moreau, Johan |
collection | PubMed |
description | 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). |
format | Online Article Text |
id | pubmed-7057190 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-70571902020-03-09 Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods()() Moreau, Johan Lavastre, Kathleen Romieu, Huguette Charbonnier, Françoise Guillaumont, Sophie Bredy, Charlene Abassi, Hamouda Werner, Oscar De La Villeon, Gregoire Requirand, Anne Auer, Annie Matecki, Stefan Karsenty, Clement Guitarte, Aitor Hadeed, Khaled Dulac, Yves Souletie, Nathalie Acar, Philippe Bajolle, Fanny Bonnet, Damien Negre-Pages, Laurence Mura, Thibault Mounier, Maria Seguela, Pierre-Emmanuel Thomas, Julie Iriart, Xavier Jean-Benoit-Thambo Amedro, Pascal Int J Cardiol Heart Vasc Original Paper 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). Elsevier 2020-03-03 /pmc/articles/PMC7057190/ /pubmed/32154361 http://dx.doi.org/10.1016/j.ijcha.2020.100489 Text en © 2020 The Authors http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Original Paper Moreau, Johan Lavastre, Kathleen Romieu, Huguette Charbonnier, Françoise Guillaumont, Sophie Bredy, Charlene Abassi, Hamouda Werner, Oscar De La Villeon, Gregoire Requirand, Anne Auer, Annie Matecki, Stefan Karsenty, Clement Guitarte, Aitor Hadeed, Khaled Dulac, Yves Souletie, Nathalie Acar, Philippe Bajolle, Fanny Bonnet, Damien Negre-Pages, Laurence Mura, Thibault Mounier, Maria Seguela, Pierre-Emmanuel Thomas, Julie Iriart, Xavier Jean-Benoit-Thambo Amedro, Pascal Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods()() |
title | Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods()() |
title_full | Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods()() |
title_fullStr | Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods()() |
title_full_unstemmed | Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods()() |
title_short | Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods()() |
title_sort | impact of sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: the sophrocare study rationale, design and methods()() |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7057190/ https://www.ncbi.nlm.nih.gov/pubmed/32154361 http://dx.doi.org/10.1016/j.ijcha.2020.100489 |
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