Exercise Capacity Muscle Oxygenation and Arterial Stiffness in Children With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Upper extremity exercise capacity
研究概览
简要总结
The primary aim is to evaluate pulmonary function, respiratory muscle strength, upper and lower extremity exercise capacity, muscle oxygenation, dyspnea, peripheral muscle strength, arterial stiffness, physical activity level and balance in children with pulmonary arterial hypertension and compare with age- and sex-matched healthy controls.
The second aim is to investigate the relationship between upper extremity exercise capacity, arterial stiffness, respiratory and peripheral muscle strength
详细描述
Pulmonary arterial hypertension (PAH) is defined as higher than 25 mmHg in mean pulmonary arterial pressure at rest. Pulmonary arterial hypertension is chronic and progressive disease.
Symptoms such as dyspnea, fatigue, exercise intolerance, cyanosis and syncope are shown in children with PAH. Most common symptom is dyspnea during exertion. Dyspnea at rest could occur while the severity of disease is progressed. All these symptoms have been associated with decreased cardiac output and mismatch oxygen transport.
This study is planned as a cross-sectional study. At least 13 children with PAH and at least 13 age- and sex- matched healthy controls will be included in this study. Individuals' pulmonary function (spirometer), respiratory muscle strength (mouth pressure device), upper extremity exercise capacity (the six minute Peg Board Ring Test), lower extremity exercise capacity (six minute walk test), muscle oxygenation ('Moxy' monitor device), dyspnea (modified Borg Scale), peripheral muscle strength (hand-held dynamometer), arterial stiffness (arteriograph device), physical activity level (multi-sensor activity monitor) and static balance (balance system with computed) will evaluated in children with PAH and healthy controls. All assessments will be completed in two days.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 6-18
- •Diagnosed with pulmonary arterial hypertension
- •Stability of clinical condition and receiving standard medical treatment
- •Healthy controls:
- •Between the ages of 6-18
- •Willing to participate in the study
排除标准
- •Having any acute infection, orthopedic, neurological, cooperation, vision or hearing problems that may prevent during the measurements
- •Participated in a planned exercise program in a last three months
- •Healthy controls:
- •Having any acute or chronic illness
- •Active or ex-smoker
结局指标
主要结局
Upper extremity exercise capacity
时间窗: First day
Six minutes PegBoard and Ring Test (6-PBRT) will be applied to evaluate upper extremity exercise capacity. There are a total of 20 rings and 2 wooden bars at above and 2 wooden bars at below. Patients will be asked to move the each two rings from upper bars to lower bars and than from lower bars to upper bars with hands as fast as. The total number of rings moved during the test will be recorded at the end of test.
Muscle oxygenation
时间窗: First day
Muscle oxygenation will be evaluated with the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA) as a non-invasive. The device will be attached with soft tape on the participants' skin surface. The device will be placed on the 1/3 lower motor point of the deltoid muscle group of the dominant arm during the the six minutes PegBoard and Ring Test and placed on the 1/3 lower motor point of the quadriceps muscle of dominant leg during the six minutes walk test. At rest and during the test, skeletal muscle oxygenation (StO2) and total hemoglobin (THb) values will be recorded.
次要结局
- Respiratory muscle strength(First day)
- Peripheral muscle strength(Second day)
- Physical activity (Total energy expenditure)(Second day)
- Dyspnea(Second day)
- Lower extremity exercise capacity(Second day)
- Physical activity (Average metabolic equivalent)(Second day)
- Physical activity (Active energy expenditure)(Second day)
- Physical activity (Number of steps)(Second day)
- Physical activity (Lying down duration)(Second day)
- Physical activity (Physical activity duration)(Second day)
- Physical activity (Sleep duration)(Second day)
- Pulmonary function (Forced expiratory volume in the first second (FEV1))(First day)
- Pulmonary function (Forced vital capacity (FVC))(First day)
- Pulmonary function (FEV1 / FVC)(First day)
- Pulmonary function (Peak flow rate (PEF))(First day)
- Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))(First day)
- Balance(Second day)
- Arterial Stiffness(Second day)
研究者
Meral Boşnak Güçlü
Prof. Dr.
Gazi University