Assessment of Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease: a Multicenter Validity Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Oxygen consumption
研究概览
简要总结
The aim of this study is to validate the six minute Stepper Test (6MST) and the 5-repetition chair lift test (5STS) as measures of exercise tolerance and muscle power, respectively, in patients with chronic respiratory disease.
As the reproducibility of the tests has been studied and validated in previous studies, the objective is to investigate the validity of the 6MST and 5STS in comparison with their respective gold standards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 and over
- •With a diagnosis of chronic obstructive pulmonary disease (GOLD II - IV) or pulmonary fibrosis (>6 months).
- •Able to understand and follow verbal instructions during tests
- •Affiliated with a social security scheme
- •Willing to participate in the study
排除标准
- •Have a neurological, cardiovascular or balance disorder that could impair test performance.
- •Having undergone respiratory rehabilitation within the last year.
- •With unstable disease (recent exacerbation < 4 weeks).
- •Pregnant and/or breast-feeding women
- •Patients under guardianship or curatorship
结局指标
主要结局
Oxygen consumption
时间窗: 19 days
Oxygen consumption will be measured using the Cortex Metamax 3B (MM3B) automated gas analysis system. Maximum oxygen consumption obtained at the end of six minutes step test (6MST) and compared with the maximum oxygen consumption obtained in the maximum cardiorespiratory exercise test performed on a cycloergometer (gold standard for measuring exercise tolerance). The 6MST aims at measuring the number of steps performed on a stepper in 6 minutes. A step is defined as a single complete movement of raising one foot and putting it down. The stepper is placed on the ground facing a wall to allow patients to maintain their balance by placing their fingers on the wall. The step height is set at 20 cm. Before starting the test, patients get accustomed to the stepper for 2 minutes. The protocol include a 3-minute rest period and a 6-minute stepping period.
Lower limb muscle power after Five Times Sit to Stand Test (5STS,) calculated by the ratio between STS mean velocity and STS mean force
时间窗: 19 days
The 5XSTS scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test.The Lower limb muscle power will be calculated by the ratio between STS mean velocity and STS mean force according to the following equation : Power 5STS = body mass x 0,9 x g x (Height x 0,5 - chair height)/(time 5STS x 0,1) \*g = 9,81 m/s, body mass in kg et Height in meters.
次要结局
- Respiratory rate after 6MST(19 days)
- Maximum effort test after 6MST(19 days)
- Oxygen saturation after 6MST(19 days)
- Lower limb muscle power after 5STS test(19 days)
- Heart rate after 6MST(19 days)
- Minute ventilation after 6MST(19 days)
- Leg fatigue after 6MST measured by the modified Borg scale(19 days)