Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Baseline cognitive function
研究概览
简要总结
Chronic obstructive pulmonary disease is a leading cause of mortality worldwide.
It is a systemic disease which includes pulmonary, cardiac, muscular, digestive and cognitive impairments.
Pulmonary rehabilitation is a symptomatic treatment to reduce dyspnea and functional incapacity. However, it effects on cognitive dysfunction are not well known.
The aim of this study is to assess the effects of a comprehensive pulmonary rehabilitation program on cognitive dysfunction in patients with severe to very severe chronic obstructive pulmonary disease using the Montreal Cognitive Assessment tool.
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 > 18years;
- •Chronic obstructive pulmonary disease stade III to IV;
- •Referred for pulmonary rehabilitation.
- •Non Inclusion Criteria:
- •Pregnancy or likely to be;
- •History of psychiatric, neuro-vascular, cognitive disease or cranial trauma;
- •Active alcoholism;
- •Guardianship;
- •Hospitalisation for acute exacerbation of chronic obstructive pulmonary disease in the previous 4 weeks;
排除标准
- •Interruption of the pulmonary rehabilitation program > 15 days;
- •Disruption of the training before the 18th session;
- •Less than 18 sessions in four month.
结局指标
主要结局
Baseline cognitive function
时间窗: Cognitive function is assessed at the beginning of the rehabilitation program : day 0
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Cognitive function after pulmonary rehabilitation
时间窗: Cognitive function is assessed at the end of the rehabilitation program : day 60
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Cognitive function : follow up
时间窗: Cognitive function is assessed 3 month after rehabilitation : day 150
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Change in cognitive function from baseline to the end of pulmonary rehabilitation
时间窗: Change in cognitive function from baseline to the end of pulmonary rehabilitation is assessed with end of pulmonary rehabilitation minus baseline values (day 60 - day 0)
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up
时间窗: Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up is assessed with the 3 month of follow minus the end of pulmonary rehabilitation values (day 150 - day 60)
Cognitive function is assessed with the Montreal Cognitive Assessement tool
次要结局
- Functional capacity (six-minute stepper test) : baseline(Functional capacity is assessed at the beginning of the rehabilitation program : day 0)
- Functional capacity (six-minute stepper test) : end of pulmonary rehabilitation(Functional capacity is assessed at the end of the rehabilitation program : day 60)
- Anxiety and depression : end of pulmonary rehabilitation(Anxiety and depression are assessed at the end of the rehabilitation program : day 60)
- Quality of life : end of pulmonary rehabilitation(Quality of life is assessed at the end of the rehabilitation program : day 60)
- Quality of life : follow-up(Quality of life is assessed 3 month after the end of the rehabilitation program : day 150)
- Anxiety and depression : baseline(Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0)
- Anxiety and depression : follow up(Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150)
- Quality of life : baseline(Quality of life is assessed at the beginning of the rehabilitation program : day 0)
- Functional capacity (six-minute walk test) : baseline(Functional capacity is assessed at the beginning of the rehabilitation program : day 0)
- Relation between the cognitive function and the respiratory function (forced expiratory volume in 1 second)(The relation is assessed between baseline demographic data at day 0)
- Adherence(Adherence is assessed at the end of the rehabilitation program : day 60)