The Effects of Maintenance Schedules Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ).
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD), a preventable and treatable condition, is a major healthcare problem with huge human and economic costs. It affects 3 million people, results in 1.4 million consultations, causes 30,000 deaths, and costs £800M per year in the UK. Considerable research expenditure is devoted to finding new and expensive interventions. However pulmonary rehabilitation (PR) is an available therapeutic option with good evidence of benefit for patients in terms of quality of life and daily functioning.
The primary objective of the study is to evaluate the effectiveness and cost effectiveness of the addition of a maintenance programme following pulmonary rehabilitation in patients with COPD when compared to standard care.
The secondary objective is to identify baseline characteristics that will predict improvement in pulmonary rehabilitation programmes and adherence to maintenance strategies. By measuring a series of demographic, clinical, physiological, psychological and biochemical parameters the researchers hope to be able to predict those patients who are likely to receive the greatest benefit from pulmonary rehabilitation.
An additional objective will be to prepare a detailed maintenance programme manual. This will be available to other centres providing pulmonary rehabilitation at the conclusion of the study
详细描述
This will be a randomised, controlled, parallel study of a maintenance pulmonary rehabilitation (PR) programme in patients with chronic obstructive pulmonary disease (COPD). Following successful completion of a PR programme in Norwich(see below) patients will be randomised to receive maintenance PR or standard medical care.
Prior to enrolment in the PR programme, patients will undergo standard baseline assessments, after providing informed consent. These will include a medical examination, demographic details, past medical history, spirometry, an incremental shuttle walk test (ISWT) to determine a predicted maximum oxygen consumption, an endurance shuttle walk test (ESWT) at 85% of predicted maximum oxygen consumption (V02), chronic respiratory questionnaire (CRQ), EuroQol (EQ5D), hospital anxiety and depression score (HADS), serum interleukin(IL)-6 and C-reactive protein (CRP), body mass index (BMI), skinfold thickness and muscle strength.
At the end of PR and twelve months following PR patients will undergo medical examination, ESWT at 85% of predicted maximum VO2, CRQ, EQ5D, HADS, serum interleukin(IL)-6 and CRP, BMI, skinfold thickness and muscle strength and an assessment of activity in the preceding month.
At 3 months, 6 months and 9 months following PR patients will complete the CRQ and a questionnaire to assess activity in the preceding month. These will be undertaken by postal questionnaire.
Baseline socioeconomic and costs questionnaire will be completed at entry to the PR and follow-up cost questionnaires will be completed following PR and after 3, 6, 9 and 12 months. Patients will be given a diary card on which to record NHS contacts, prescriptions etc at all visits.
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
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged more than 35 years
- •Physician labelled diagnosis of COPD, emphysema or chronic bronchitis
- •Ex or current smoker of more than 20 pack years
- •FEV1 less than 80% of predicted
- •Patients may be taking long or short acting bronchodilators and/or inhaled or oral corticosteroids and/or theophyllines.
- •Patients having attended at least 60% of the exercise sessions in the initial PR(22)* * This is an inclusion criterion for randomisation to receive maintenance PR or standard medical care but not entry into the study
排除标准
- •Significant cardiac or pulmonary disease other than COPD such that COPD is the minor contribution to the patients' symptoms.
- •Myocardial infarction within the previous 6 months or unstable angina
- •Respiratory infection defined as cough, antibiotic use or purulent sputum within 4 weeks prior to randomisation.
- •Severe or uncontrolled co-morbid disease, which is likely to affect the outcome of the study.
- •Abnormalities in cognitive functioning that would limit the patient's ability to undertake the procedures required in the study.
- •Unable to give written informed consent.
结局指标
主要结局
The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ).
时间窗: 14 Months
次要结局
- Hospital anxiety and depression score (HADS)(14 Months)
- Quality Adjusted Life Years (QALY) gained (estimated from EQ-5D data)(14 Months)
- Changes in medication and NHS Resource Utilisation including hospitalisations, health professional contact, medication and adverse events(14 Months)
- Change in peripheral blood C-reactive protein, Tumour Necrosis Factor (TNF) alpha, Interleukin (IL) 6(14 Months)
- Endurance shuttle walk test(14 months)
- Fat free mass(14 Months)
- Body mass index(14 Months)