Determination of the Minimal Clinically Significant Difference (MCID) of Multidimensional Dyspnea Profile (MDP) Scores in Chronic Obstructive Pulmonary Disease (COPD) Patients During Pulmonary Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- sensory Borg scale
研究概览
简要总结
This study is designed to determine the individual threshold of minimal clinical change (MCID) for each component of the Multidimensional Dyspnea Profile (MDP) questionnaire in COPD patients undergoing pulmonary rehabilitation.
详细描述
The aim of the research is to determine the minimal clinically significant difference (MCID) in MDP scores in COPD patients after a respiratory rehabilitation course using the anchoring method :
- The A1 score will be compared with the Borg Affective Dyspnea (BorgA) scale.
- The sensory score will be compared with the Borg Sensory Dyspnea Scale (BorgS).
- The 5 sensory items will be compared with the Borg Sensory Dyspnea scale.
- The emotional score will be compared with the Borg Emotional Dyspnea Scale.
- The 5 emotional items will be compared with the Borg affective dyspnea scale. The various questionnaires will be administered to patients at inclusion, after a constant work-rate cycling exercise test, and at isotime during the same cycling exercise test at the end of the pulmonary rehabilitation course.
The sensitivity study will be conducted using the visual analog dyspnea scale instead of the Borg score. Finally, we will also determine the MCID using the distribution method. The MCID score will be correlated with various quality of life and physical performance scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gold B or D COPD patient
- •Moderate to severe obstructive ventilatory disorder (FEV1<80%)
- •Admitted for a pulmonary rehabilitation
- •Having given free, informed and written consent
排除标准
- •Lack of French language skills, preventing completion of questionnaires
- •Cognitive impairment preventing completion of questionnaires
- •Patient under guardianship
- •Patient not affiliated to the social security system
- •Chronic ethylism
结局指标
主要结局
sensory Borg scale
时间窗: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
The two Borg scales will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.
multidimensional (MDP) questionnaire
时间窗: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
The multidimensional questionnaire measuring the sensory component of dyspnea (intensity of the 5 respiratory descriptors) and the affective component of dyspnea (immediate discomfort and intensity of emotional responses). The MDP will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.
affective Borg scale
时间窗: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
The two Borg scales will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.
次要结局
- Hospital Anxiety and Depression scale (HADS)(at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course))
- Saint George Respiratory Questionnaire (SGRQ)(at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course))
- VQ11(at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course))
- lung function tests(at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course))
- 6 minutes walk test(at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course))
- mMRC (Modified Medical Research Council) dyspnea score(at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course))
- Dyspnoea 12(at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course))
- Affective and Sensory dyspnea visual analog scale (VAS)(at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course))
- COPD Assessment Test (CAT) score(at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course))
- rise chair test (optional)(at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course))