Assessment of Exercise Capacity in Single-ventricle Patients Undergoing Fontan Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Incremental shuttle walk test distance
研究概览
简要总结
In literature, it has been reported that exercise capacity decreases in single-ventricle patients undergoing Fontan Procedure due to various factors related to surgery and underlying cardiac anomaly. Cardiopulmonary exercise test (CPET) was generally used to evaluate exercise capacity in children and adults with fontan circulation. The fact that CPET requires a clinically expert team and equipment and is more expensive does not always make it possible to perform routine cardiopulmonary exercise testing. In some cases, field tests evaluating submaximal and maximal exercise capacity may be more practical than cardiopulmonary exercise testing. Therefore, in this study, it is aimed to evaluate the exercise capacity of Fontan patients with 6-minute walking test and incremental shuttle walk test and to compare vital signs during the tests.
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 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Incremental shuttle walk test distance
时间窗: 30-45 minutes
For the incremental shuttle walk test, it will be adjusted to a total of 10 meters with 2 cones placed at a distance of 9.0 meters from each other and a rotational margin of 0.5 meters. In this system, the patient will be asked to walk in a round-trip way by adapting to the increasing speed and the sound coming from outside. Walking/running distances of the patients in meters will be recorded.
6 minute walk test distance
时间窗: 15-20 minutes
The standard test protocol will be applied in a continuous 30 meter corridor. The patient wearing comfortable clothes and shoes will be given standard instructions and verbal guidance during the test. The distance the patient walked during the test will be recorded in meters.
Maximum isometric muscle strength of the quadriceps femoris
时间窗: 15-20 minutes
The maximum isometric muscle strength of the Quadriceps femoris muscle will be measured with a dynamometer (Lafayette Instrument Company, Lafayette, Indiana).
Body fat ratio
时间窗: 5-10 minutes
Body fat ratio will be evaluated by bioelectrical impedance analysis. Tanita Body Fat Analyzer (model TBF 300, Tokyo, Japan) will be used during the analysis.
Lean body weight
时间窗: 5-10 minutes
Lean body weight will be evaluated by bioelectrical impedance analysis. Tanita Body Fat Analyzer (model TBF 300, Tokyo, Japan) will be used during the analysis.
Right and left hand grip strength
时间窗: 15-20 minutes
Right and left hand grip strength will be measured using a hand grip strength hand dynamometer (Jamar, Sammons Preston, Rolyon, Bolingbrook, IL, USA). Measurements shall be made using standard procedures, right and left sides, with the arms at the side of the trunk, the elbow in a 90 degree flexion position, and the forearm and wrist in a neutral position. The highest of the three measurements will be considered as hand grip strength
Fat weight
时间窗: 5-10 minutes
Fat weight will be evaluated by bioelectrical impedance analysis. Tanita Body Fat Analyzer (model TBF 300, Tokyo, Japan) will be used during the analysis.
次要结局
未报告次要终点
研究者
Haluk TEKERLEK
Principal Investigator/Research Assistant
Hacettepe University