Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Maximum oxygen uptake (VO2 max)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 13 to 25 years old
- •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
排除标准
- •Medical contraindication to perform an exercise test.
- •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 .
结局指标
主要结局
Maximum oxygen uptake (VO2 max)
时间窗: Variation between Baseline (M0) and at 12 months (M12)
VO2max Variation
次要结局
- Quality of life score(Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12)
- Physical activity score(Variation between Baseline (M0) and at 12 months (M12))