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, Amedro Pascal
Paediatric Cardiology and Pulmonology Department, M3C Regional Reference Centre, Montpellier University Hospital, Montpellier, France.
Paediatric Cardiology and Rehabilitation Centre, Institut-Saint-Pierre, Palavas-Les-Flots, France.
Int J Cardiol Heart Vasc. 2020 Mar 3;27:100489. doi: 10.1016/j.ijcha.2020.100489. eCollection 2020 Apr.
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.
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) 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 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.
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.
Clinicaltrials.gov (NCT03999320).
先天性心脏病（CHD）领域的最新进展显著改善了总体预后。现在，人们更加关注与健康相关的生活质量（HRQoL）以及身体活动的促进。无创放松疗法可能对担心运动诱发呼吸困难的心脏病患者有效。SOPHROCARE随机试验旨在评估凯西迪放松学对患有CHD的青少年和年轻人心肺健康的影响。
SOPHROCARE试验是一项针对13至25岁CHD患者的全国性、多中心、随机对照研究。患者将被随机分为两组（8次放松学组课程与无干预）。主要结局是基线至12个月随访期间预测最大摄氧量（VO2）百分比的变化。每组共需要94名患者，以80%的检验效能和5%的α风险观察VO2显著增加10%。次要结局包括：临床结局、心肺运动试验参数（VE/VCO2斜率、通气无氧阈值、氧脉搏、对高碳酸血症的呼吸反应）、与健康相关的生活质量评分（儿童生活质量量表）、身体和心理状况。
在关注CHD患者的生存之后，当前的研究正在转向二级预防和与患者相关的结局。我们试图在SOPHROCARE试验中评估，放松学计划是否可以改善患有CHD的年轻人的运动能力和生活质量。
Clinicaltrials.gov（NCT03999320）。
