Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Mild to Moderate Chronicle Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Relation between plateau heart rate (bpm) from the first and last 3 minutes of the 6-minute stepper test and heart rate (bpm) from first ventilatory threshold from cardiopulmonary exercise testing.
研究概览
简要总结
The purpose of this study is to determine, if it exists, a relation between plateau heart rate from the last 3 minutes of the 6-minute stepper test and heart rate from first ventilatory threshold from cardiopulmonary exercise testing in order to individualise pulmonary rehabilitation in patients with mild to moderate chronicle obstructive pulmonary disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age > 18 ans ;
- •Chronicle obstructive pulmonary disease stage I/II (FEV1 ≥ 50%) ;
- •Chronicle obstructive pulmonary disease stage III/IV (FEV1 < 50%) from may 2019 (ethical approvement granted)
- •Weight ≤ 90kg ;
- •Eligible for pulmonary rehabilitation.
排除标准
- •Pregnant woman or likely to be ;
- •Patient under guardianship ;
- •Contraindication to cardiopulmonary exercise testing ;
- •Patient medically treated with heart rate modulator (excluding oral B2-agonist) ;
- •Patient treated with pacemaker or defibrillator ;
- •History of lower limb impairment (i.e. peripheral artery disease, orthopedic disorder etc.).
结局指标
主要结局
Relation between plateau heart rate (bpm) from the first and last 3 minutes of the 6-minute stepper test and heart rate (bpm) from first ventilatory threshold from cardiopulmonary exercise testing.
时间窗: Heart rate (bpm) will be assessed during cardiopulmonary exercise testing with electrocardiogram. During the 2 6-minute stepper test, heart will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum.
Outcome (heart rate) during different tests will be continuously recorded. Relation will be adjusted for age and step count.
次要结局
- Relation between minimal SpO2 (%)from the 6-minute stepper test and SpO2 (%) from first ventilatory threshold from cardiopulmonary exercise testing.(SpO2 will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum.)
- Steps during 6-minute stepper test using stepper device.(The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.)
- Blood pressure (mmHg) before and after every 6-minute stepper test using electrical blood pressure device.(The outcome will be assessed before and after every 6-minute stepper test. The 2 6-minute stepper test will be carried out the same day (minimum 20 minute of rest between each test) for a total time frame of 1 day.)