Effect of Combined Inspiratory Muscle Training and Aerobic Exercises on Ventilatory Function in Adults With Repaired Tetralogy of Fallot
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- "Change from Baseline in Ventilatory function : Forced vital capacity (FVC) , Forced expiratory volume in 1 second (FEV1), expiratory vital capacity (EVC) and inspiratory vital capacity (IVC).
研究概览
简要总结
The goal of this clinical trial is to learn if combined inspiratory muscle training and aerobic exercise can improve ventilatory function in adults with repaired Tetralogy of Fallot (TOF). It will also learn if exercises work to raise functional capacity and Quality of life (QoL) . The main questions it aims to answer is:
- Dose combined inspiratory muscle training and aerobic exercise (study group) improve ventilatory function in adults with repaired (TOF) more than aerobic exercise only (control group)?
- Can combine inspiratory muscle training and aerobic exercise (study group) raise functional capacity and (QoL) in adults with repaired (TOF) more than aerobic exercise only (control group)?
Researchers will compare between combination of inspiratory muscle training and aerobic exercise on one group and the aerobic exercise only on other group, on ventilatory function, functional capacity and (QoL) on adults with repaired TOF.
Participants will:
On study group , participants will perform respiratory muscle training in addition to moderate intensity aerobic exercise for 6 weeks. 3 times/week
On controlled group , participants will perform moderate intensity aerobic exercise for 6 weeks. 3 times/week.
all participants will test ventilatory function , functional capacity and will answer a survey questions about their quality of life before and after training
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with TOF.
- •Have surgical correction of the abnormality.
- •Class II-III according to New York Heart Association (NYHA)
- •Ejection fracture > 40
- •Vitally stable during the study period
排除标准
- •Resent cardiopulmonary surgery or intervention "less than 6 months"
- •Presence of pulmonary disease which is not a complication of TOF (eg:
- •bronchial asthma, lung fibrosis…..)
- •Neuromuscular or musculoskeletal disease and severe scoliosis affecting pulmonary function or physical exercise.
- •Mental or physical limitations
- •active infection or systemic illness.
- •Hemodynamic instability
- •Mouth burn, injury, or deformities
- •Implanted pacemaker
结局指标
主要结局
"Change from Baseline in Ventilatory function : Forced vital capacity (FVC) , Forced expiratory volume in 1 second (FEV1), expiratory vital capacity (EVC) and inspiratory vital capacity (IVC).
时间窗: At Baseline and after 6 weeks of training
次要结局
- Change from Baseline in Six-minute walk test (6MWT)(At Baseline and after 6 weeks of training)
- changes from baseline in 36-Item Short Form Health Survey (SF-36)(at Baseline and after 6 weeks of training)
研究者
Omnia Ahmed Khalaf Ismail
Physical Therapist
Cairo University