Impact of Cardiovascular Rehabilitation on the Quality of Life of Adolescents and Young Adults With Congenital Heart Disease: A Randomized Controlled Multicentre Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 32
- 主要终点
- Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life.
研究概览
简要总结
The investigators aim to measure the impact of a rehabilitation program in congenital cardiology in terms of health related quality of life. The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer.
详细描述
Adolescents and adults with congenital heart disease (CHD) have reduced exercise capacity compared to the general population, even for "simple" heart disease.
Regular physical activity is known to reduce the risk of acquired heart disease.
Cardiac rehabilitation programs have been largely developed to manage adult coronary and heart failure patients, which is not yet the case routinely in patients, adults and children, carriers of DC.
The investigators assume that patients who participate in this program will improve their quality of life compared to controls.
The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 included
- •With a congenital heart diseases (CHD) as defined in the international CHD classification.
- •Recent (< 3 months) cardio-pulmonary exercise test (CPET)with maximum oxygen uptake (VO2max) <80% of theoretical values and/or first ventilatory anaerovic threshold (VAT) <55% of VO2max.
- •Consent of the adult patient or the parents or legal guardians of the minor patient.
- •Beneficiary of the social security scheme.
排除标准
- •Uncontrolled arrhythmia.
- •Cardiac surgery planned during the rehabilitation program.
- •Severe musculoskeletal disorders.
- •Severe intellectual disability that does not allow the quality of life questionnaire to be completed.
- •Pregnancy.
- •Patient who already underwent cardiac rehabilitation in the last 24 months.
- •All medical contraindications to perform a cardiorespiratory stress test.
- •Uncontrolled heart failure (NYHA IV)
- •Obesity (BMI > 30)
结局指标
主要结局
Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life.
时间窗: follow up of patients over 12 months
Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12
次要结局
- ventilatory anaerobic threshold (VAT, ml/kg/min)(Month 0 and Month 12)
- cardiac events(Month 0 and Month 12)
- Peak oxygen uptake (VO2max, ml/kg/min)(Month 0 and Month 12)
- physical activity scoring(Month 0 and Month 12)
- Cardiac output during exercise(Month 0 and Month12)
- functional NYHA class(Month 0 and Month 12)
- knowledge of the disease(Month 0 and Month 12)