Effects of a Home-based Versus a Hospital-based Outpatient Pulmonary Rehabilitation Program in Patients With COPD: a Multicenter, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 20
- 主要终点
- The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable.
研究概览
简要总结
Short term efficacy of pulmonary rehabilitation for improving functional capacity and quality of life of chronic obstructive respiratory disease (COPD) patient is well known. However, there is an important gap between the scientific knowledge and the clinical use of pulmonary rehabilitation since a a very small number of patients benefit from this therapeutic intervention. We estimate that less than 1% of the 750 000 canadians suffering from COPD have access to a pulmonary rehabilitation program. We want to study the efficacy of a home-based rehabilitation program as a way to facilitate the access to rehabilitation.
详细描述
This article on the main outcome is available. Maltais F, Bourbeau J, Shapiro S, Lacasse Y, Perrault H, Baltzan M, Hernandez P, Rouleau M, Julien M, Parenteau S, Paradis B, Levy RD, Camp P, Lecours R, Audet R, Hutton B, Penrod JR, Picard D, Bernard S. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Int Med 2008;149:869-878.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to ambulate. Defined as a 6MWD greater than 110 meters.
- •Subject is diagnosed with COPD.
- •40 years-old and older
- •Currently or previously smoking with a smoking history of at least 10 pack-years.
- •Forced expiratory volume on one second (FEV1) after the use of a bronchodilator between 25 an 70% of the predicted value, and FEV1 to forced vital capacity ratio less than 70%.
- •No previous diagnosis of asthma, left heart congestive heart failure (either radiographic evidence of pulmonary congestion, echocardiographic or ventriculographic evidence of a reduced ventricular ejection fraction), terminal disease, dementia or uncontrolled psychiatric illness.
- •Never participated to a respiratory rehabilitation program and not staying or planning to stay in a long term care facility.
- •Subject understands and is able to read and write French or English.
- •MRC dyspnea scale of at least 2.
排除标准
- •The need for supplemental oxygen at rest or during exercise will not be an exclusion criterion.
结局指标
主要结局
The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable.
时间窗: The data collection was terminated in January 2007 and publication was done December 2008
Maltais F, Bourbeau J, Shapiro S, Lacasse Y, Perrault H, Baltzan M, Hernandez P, Rouleau M, Julien M, Parenteau S, Paradis B, Levy RD, Camp P, Lecours R, Audet R, Hutton B, Penrod JR, Picard D, Bernard S. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Int Med 2008;149:869-878.
次要结局
- 2-CRQ total score and specific domains, exercise tolerance (6MWD and submaximal exercise test) and ADL at 4 months.(The data collection was terminated in January 2007.)
- 3-Health service utilization (physician and emergency department visits, hospitalizations) over the 1-year study period.(The data collection was terminated in January 2007.)
- 4 Intervention cost.(The data collection was terminated in January 2007.)