Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 261
- 试验地点
- 2
- 主要终点
- Change in Mood and Anxiety
研究概览
简要总结
The purpose of this project is to investigate whether a 12-week, fulltime pulmonary rehabilitation program can enhance cognitive functioning, mood, anxiety, and quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Referral to the Extensive Pulmonary Rehabilitation Program
排除标准
- •Unfinished primary school
- •Referral to the Compact Pulmonary Rehabilitation Program
结局指标
主要结局
Change in Mood and Anxiety
时间窗: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
Hospital Anxiety and Depression Scale (HADS) Symptom Checklist 90 - Revised (SCL-90-R), subscales Anxiety, Depression, Agoraphobia
Change in Quality of Life
时间窗: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
Saint George Respiratory Questionnaire (SGRQ) SF-36 Health Survey
Change in 6 Minute Walking distance Test(6-MWT)
时间窗: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
6 Minute Walking distance Test (6-MWT)
Change in Objective Cognitive functioning
时间窗: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
CNS-Vital Signs, computerized neuropsychological assessment WMS - Verbal Paired Associates Direct Recall Word fluency-category (GIT): animals \& profession Letter fluency: D-A-T Purdue Pegboard
Change in Subjective Cognitive Functioning
时间窗: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
Cognitive Failures Questionnaire (CFQ)
次要结局
- Dropout from pulmonary rehabilitation(From the moment of randomization untill the moment of dropout from pulmonary rehabilitation, assessed up to 1 year after randomization.)
- Adherence to pulmonary rehabilitation(These data are collected during the total period of pulmonary rehabilitation, which has a time frame of 12 weeks.)
- Change in Fatigue(In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.)
研究者
Margriet M. Sitskoorn
Professor, PhD
Tilburg University