4-10 Week Observational Study Comparing 3 Management Strategies for Obstructive Chronic BronchoPneumopathy (OCBP) in Common Clinical Practice
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in quality of life after 4 to 10 weeks of physical activity program
研究概览
简要总结
The management of patients with Obstructive Chronic BronchoPneumopathy (OCBP) is based on a progression of therapeutic options and on a sensitization to physical activity.
For these patients selected on OCBP stage 2, the treatment options include Long Acting Beta-Agonist Bronchodilator (LABA) or Long Acting Muscarinic Antagonist Anticholinergic (LAMA) or both (LAMA+LABA).
The purpose of this study is to observe in common clinical practice the benefit of physical activity on quality of life, dyspnoea and walking distance for these patients under treatment (LABA and/or LAMA) and to determine whether these 3 medical strategies (LABA/LAMA/LABA+LAMA) benefit from physical activity.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Obstructive Chronic BronchoPneumopathy stage ≥
- •Patients under treatment with LABA or LAMA or LABA+LAMA since at least 1 month.
- •VEMS/CVF<70%
- •VEMS<80%
- •Patients without regular physical activity and without physical activity program since 1 year.
排除标准
- •Patients under treatment with LABA + inhaled Corticoids.
- •Contraindication to physical activity.
- •Patients with previous history of respiratory exacerbations.
结局指标
主要结局
Change in quality of life after 4 to 10 weeks of physical activity program
时间窗: Visit 1 before physical activity program and Visit 2 after 4 to 10 weeks of physical activity program
Evaluation of quality of life by specific questionnaires (VQ11, RICCI Test) and by specific parameters such as: spirometry, dyspnea, Body Mass Index (BMI), 6 minute Stepper Test (TS6), Body mass index, airflow Obstruction, Dyspnea and Exercise tolerance (BODE), O2 maximal Volume (VO2max) or Electrocardiogram (ECG).
次要结局
- Medical Research Council dyspnea scale (grade degree 0 to 4)activity(Grade degree of dyspnea will be evaluated one time before and after the physical activity program an expected average of 10 weeks.)
- Actimetry by accelerometer (unit : number of body movement)(Accelerometer will be installed one time before and after the physical activity program an expected average of 10 weeks.)
- 6 Minute Walking Test (6MWT) (unit : meter)(6MWT will be realized one time before and after the physical activity program an expected average of 10 weeks.)