Effects of Inspiratory Muscle Training in Children After Fontan Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Assessment of the diaphragm muscle
研究概览
简要总结
This study will assess physical and respiratory capacity, diaphragmatic mobility and quality of life. Healthy children and children who have undergone Fontan surgery will participate. Some children in the late postoperative period of Fontan surgery will be randomized to a group of inspiratory muscle training that will last for 2 months. Children after Fontan surgery will be evaluated twice, once at the beginning and again after two months of follow-up.
详细描述
This study aims to evaluate physical capacity through cardiopulmonary testing, submaximal physical capacity testing by the 6-minute walk test, respiratory capacity by spirometry, respiratory muscle strength by manovacuometry, diaphragmatic mobility by ultrasound, quality of life by the AUQEI questionnaire. There are three groups, a healthy control group, a Fontan control group and a Fontan intervention group. The intervention will be done by respiratory muscle training using the Power Breath device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 8 to 12 years;
- •Both sexes;
- •No history of other heart disease;
- •No history of lung and musculoskeletal diseases;
- •>1 year post-operative Fontan Surgery;
- •Clinically stable;
- •Absence of serious arrhythmias;
- •Medical clearance to participate in the study; The legal guardian has agreed to participate in the research and the child has consented
排除标准
- •Musculoskeletal alterations;
- •Patients with neurological sequelae;
- •Patients with genetic syndromes associated with cognitive or psychiatric disorders;
- •History of perioperative arrhythmias;
- •Patients with uncontrolled heart failure;
- •Recent angina;
- •Severe arrhythmia;
- •Hemoptysis;
- •Pulmonary hypertension;
- •Diaphragmatic plication;
- •Moderate to severe asthma.
结局指标
主要结局
Assessment of the diaphragm muscle
时间窗: Baseline to 2 months
The mobility and thickness of the diaphragm muscle were assessed using ultrasound in M mode. Both variables were analyzed during spontaneous, relaxed breathing in terms of both tidal volume and deep breathing at vital capacity. Muscle mobility was examined along the right and left mid-axillary and parasternal lines with volunteers in both the supine and sitting positions. Muscle thickness was measured while the patients were in the supine position along the mid-axillary lines during both natural, relaxed and deep breathing. Measurements were taken in centimeters, with the largest value selected from at least three reproducible measurements.
次要结局
- Respiratory muscle strength(Baseline to 2 months)
- Lung function test(Baseline to 2 months)
- Six-minute walk test(Baseline to 2 months)
- Change in quality of life measurement(Baseline to 2 months)
- Improvement exercise tolerance and functional capacity (peak VO2)(Baseline to 2 months)