Pulmonary Determinants of Cardiorespiratory Fitness in Patients With Fontan Procedure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- FEV1/FVC
研究概览
简要总结
This study will examine and record the patient's medical information and medical records (patient files, computer records, etc.). Physical examination, echocardiographic, electrocardiographic, laboratory, radiological, etc. evaluations are made during the routine controls of the patients. Within the scope of this study, no attempt will be made on the patients, no additional tests will be performed, or treatment changes will not be made in the patients because they are included in this study. After these records, KPET will be performed by a specialist doctor and physiotherapist for the patients who are directed to the Faculty of Physical Therapy and Rehabilitation Cardiopulmonary Rehabilitation Unit. Pulmonary function tests and respiratory muscle strength measurements will be performed on patients who have adequate rest after CPET.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fontan Group Inclusion Criteria:
- •Be between 8-55 years old
- •Having undergone a Fontan operation
- •Clinical stability of the patients (preserved ventricular function)
- •No change in ongoing drug therapy that adversely affects clinical stability
- •At least 1 year after the operation
- •Fontan Group
排除标准
- •Neurological and/or genetic musculoskeletal disease
- •Having orthopedic and cognitive problems that prevent testing
- •The patient's and/or family's unwillingness to participate in the study
- •Control Group Inclusion Criteria:
- •Not have cardiovascular, neurological, and/or genetic musculoskeletal disease
- •Not having orthopedic and cognitive problems that prevent testing
- •The patient's and/or family's willingness to participate in the study
研究组 & 干预措施
Fontan group
Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
干预措施: Cardiopulmonary exercise test (Other)
Fontan group
Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
干预措施: Pulmonary function test (Other)
Fontan group
Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
干预措施: Respiratory muscle strength test (Other)
Control Group
Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
干预措施: Cardiopulmonary exercise test (Other)
Control Group
Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
干预措施: Pulmonary function test (Other)
Control Group
Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
干预措施: Respiratory muscle strength test (Other)
结局指标
主要结局
FEV1/FVC
时间窗: 15-20 minutes
Maximal inspiratory pressure
时间窗: 15-20 minutes
Ratio curve of minute ventilation to carbon dioxide production (VE/VCO2) slope
时间窗: 30-45 minutes
Ratio of minute ventilation to carbon dioxide production (VE/VCO2)
时间窗: 30-45 minutes
Oxygen uptake efficiency slope (OUES)
时间窗: 30-45 minutes
Maximal oxygen consumption
时间窗: 30-45 minutes
Forced vital capacity (FVC)
时间窗: 15-20 minutes
Forced expiratory volume in 1 second (FEV1)
时间窗: 15-20 minutes
Maximal expiratory pressure
时间窗: 15-20 minutes
Minute ventilation (VE)
时间窗: 30-45 minutes
End tidal carbon dioxide pressure (PetCO2)
时间窗: 30-45 minutes
End tidal oxygen pressure (PetO2)
时间窗: 30-45 minutes
次要结局
未报告次要终点
研究者
Haluk TEKERLEK
Research assistant
Hacettepe University