Effect of Physical Training in Functional Capacity, Metabolic Profile, Body Composition and Quality of Life in Patients With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Improvement exercise tolerance and functional capacity (peak VO2)
研究概览
简要总结
Previous Studies Indicate That a Substantial Proportion of the Congenital Heart Disease Patients Has Unhealthy Lifestyle Behaviors, Such as Smoking, Lack of Physical Activity, and Inadequate Dietary Patterns, Leading to the Development of Metabolic Disorders Such as Overweight/Obesity, Metabolic Syndrome, and Chronic Diseases Such as Cardiovascular Disease. Another Highly Prevalent Risk Factor in These Patients is Sedentary Behavior; These Patients Are Not Encouraged to Engage in Sports and Exercise During Childhood Due to Their Cardiac Condition, Leading to a Progressive Decrease in Physical Capacity. Studies Have Shown That Congenital Heart Disease Patients Are Not Active Enough and That a Substantial Amount of Patients is Overweight.This Study is a Randomized Controlled Trial That Investigates the Effects of the Home Based Program Physical Training, in the Exercise Capacity, Quality of Life and Body Composition.
详细描述
The objective of the study was to verify the effect of home physical training on improving physical capacity, body composition, quality of life, metabolic markers in patients with congenital heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Repaired congenital heart disease of all complexities
- •Age ≥ 18 years
- •New York Heart Association (NYHA) Class I or II
- •Able and willing to participate in a 12-week cardiac rehabilitation program
排除标准
- •Inability to give informed consent
- •Inability to participate in an exercise training program
- •Severe musculoskeletal disorders.
- •Patient heart failure
- •Patients who perform regular physical activities.
- •Patients with Univentricular Physiology,
- •Patients severe asthma,
- •Patients with a pacemaker.
- •Patients with atrial fibrillation;
- •Exercise-induced arrhythmia and/or ischemia
- •Cyanosis at rest
- •Severe intellectual disability
结局指标
主要结局
Improvement exercise tolerance and functional capacity (peak VO2)
时间窗: Baseline to 3 months
Change in functional capacity will be performed by cardiopulmonary exercise test and will be expressed by Peak VO2 and Predicted Peak VO2 (%). After the training program, an increase in the peak VO2(mL/kg/min) value between 10 to 15% is expected in relation to the baseline value.
次要结局
- Change in quality of life measurement(Baseline to 3 months)
- Improvement in peripheral blood flow post exercise training program(Baseline to 3 months)
- Change in body composition measurement(Baseline to 3 months)