Long-term Evaluation of Activity and Health Status Pre and Post Pulmonary Rehabilitation - A Multi-Centred Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Quality of life score
研究概览
简要总结
This study has been designed to capture a large group of patients who undergo pulmonary rehabilitation and map their progression over a 5 year time-frame.
The outcome measures have been chosen to capture physiological, functional capacity, free-living activities plus admission and exacerbation rates thereby enhancing our understanding of the potential effects exercise and self management techniques may have on the disease progression.
Pulmonary rehabilitation has not been shown to reduce inflammation; therefore, unlike acute exacerbation's where a decrease in inflammation indicates recovery, the exact mechanisms responsible for improvement during pulmonary rehabilitation are as yet unknown.
详细描述
The benefits of pulmonary rehabilitation are well documented elsewhere, however, the exact mechanisms responsible for these significant improvements and alteration of the disease progression are unexplained. Also unexplained is the apparent lack of carry over of functional capacity into free-living activities as measured by activity monitors.
There are no reported effects on decreasing level of inflammatory cytokines or C-reactive protein (CRP) post rehabilitation, however, a training response to reactive oxidative stress (ROS) after a moderate intensity pulmonary rehabilitation programme has been reported. As oxidative stress is a catalyst to inflammation, a training response to exercise induced ROS in patients with COPD may also have a secondary effect of modifying inflammation in the stable COPD patient thereby improving patient outcomes.
No studies to-date have combined free-living activities, biomarkers and standard outcome measures in patient's pre and post pulmonary rehabilitation or follow-up patients over a five year period.
Subjects referred to pulmonary rehabilitation who fulfil the GOLD criteria for COPD will be recruited on a rolling basis and randomly allocated to one of two groups. Group 1 (Control), Group 2 (Intervention).
It is a multi-centred, randomised controlled trial using the above convenience sample of patients referred to pulmonary rehabilitation who meet the inclusion/exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of COPD based on the GOLD staging of the Disease
- •MMRC score of 3 or above
- •Ability to mobilize independently
- •Willing to comply with the home exercise and inspiratory muscle training programmes
- •Willing to wear the SenseWare Armband
- •Optimal medical management
- •No adverse effects to exercise testing
- •Patient's awaiting lung transplant
排除标准
- •Evidence of ischemic heart disease/acute changes on ECG
- •Uncontrolled hypertension
- •Insulin dependent diabetes mellitus
- •Uncontrolled CCF / idiopathic cardiomyopathy
- •Reversible Asthma
- •A diagnosis of lung cancer/TB/recent pneumothorax/PE or pneumonia
- •Any musculoskeletal/neurological condition which would render the patient incapable of completing the course
- •Exacerbation of COPD within 4 weeks of program
- •Poor cognitive status
- •Previous attendance at a pulmonary rehabilitation program
研究组 & 干预措施
Pulmonary Rehabilitation
Pulmonary rehabilitation classes based on the British Thoracic Society guidelines will be undertaken for two hours for 16 sessions within an eight week period.
干预措施: Pulmonary Rehabilitation (Other)
Pulmonary Rehabiliation
The control group will be assessed in the same time frame without participating in the rehabilitation class. They will avail of the next available class after the 12 month assessment.
结局指标
主要结局
Quality of life score
时间窗: One year
St George's quality of life score at the end of one year will be compared between those who underwent rehabilitaion and those who were in the control non intervention group.
次要结局
- Number of exacerbations of COPD.(over one year)
- Spiromtery(12 months)
研究者
Professor Richard Costello
consultant chest physician
Beaumont Hospital