Ability of the 3-minute Step Test Protocol for Detecting Exercise Desaturation Episodes in Chronic Respiratory Insufficiency: Protocol STEPSAT: Three-min Step Test and Exercise Desaturation Detection in Chronic Respiratory Insufficiency Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Detection of exercise desaturation occurrence
研究概览
简要总结
The study project will aim at the evaluation of the occurrence of exercise desaturation phenomenon during two different modalities of exercise (walking and stepping condition). This study will allow determining the sensibility of the 3-minute step test to detect exercise desaturation, in comparison with the gold standard (6-minute walking test). The 3-minute step test could therefore appear as a complementary tool for the evaluation of oxygen desaturation in chronic respiratory disease.
详细描述
The 6-minute walking test is currently the gold standard for the evaluation of oxygen desaturation phenomenon during exercise and for the adjustment of O2 flow rate. But, due to spatial constraints, this test remains difficult to apply in ecological conditions and the 3-minute step test could be a complementary method to the walking test for the evaluation of chronic respiratory diseases. For this study, patients will perform, during 2 visits, a maximal graded test and two field tests (6-min walking test and 3-min step test) under identical conditions. During these tests, pulsed oxygen saturation and psycho-physiological adaptations to exercise will be monitored.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged by 18 and more ;
- •Patient with an chronic obstructive respiratory insufficiency, confirmed by clinical and functional criteria ;
- •Patient with exercise-induced oxygen desaturation ;
- •Patient clinical ly stable, with no exacerbation period within the last 2 months before inclusion ;
- •Consent form signed by the patient.
排除标准
- •Patient in exacerbation period at the inclusion time ;
- •Pregnant and breastfeeding women ;
- •Patient with orthopedic disorder that could limit the ability of stair climbing;
- •Any other disease that could influence exercise capacity of the patient or that could impair exercise test realization ;
- •Patient with law protection (guardianship or protection of vulnerable adults)
结局指标
主要结局
Detection of exercise desaturation occurrence
时间窗: At Visit 2: between Day 3 and Day 15 after Visit 1
Detection of exercise desaturation occurrence correspond to a fall of SpO2 rest value by at least 4 points during exercise, assessed with the measurement of pulsed oxygen saturation during the different tests.
次要结局
- Ventilatory output (VE)(At Visit 2: between Day 3 and Day 15 after Visit 1)
- CO2 production (VCO2)(At Visit 2: between Day 3 and Day 15 after Visit 1)
- Muscle deoxygenation (delta HHb)(At Visit 2: between Day 3 and Day 15 after Visit 1)
- Patient-perceived sensation of dyspnea(At Visit 2: between Day 3 and Day 15 after Visit 1)
- Patient-perceived sensation of lower extremity fatigue(At Visit 2: between Day 3 and Day 15 after Visit 1)
- Heart rate (HR)(At Visit 2: between Day 3 and Day 15 after Visit 1)
- Oxygen consumption (VO2)(At Visit 2: between Day 3 and Day 15 after Visit 1)