Effectiveness and Tolerance of Respiratory Rehabilitation in Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Change in six-minute walk distance (6MWD)
研究概览
简要总结
Observational study summary The goal of this observational study is to determine whether an outpatient pulmonary rehabilitation (PR) program-already known to be effective and safe for chronic obstructive pulmonary disease (COPD)-is equally effective and well-tolerated when COPD is complicated by pulmonary hypertension (PH).
Main question In adults with COPD + PH, does outpatient PR improve six-minute walk distance (6MWD) and remain safe, to the same extent as in adults with COPD without PH?
How the study is conducted
Researchers retrospectively analyse medical records from the University Hospital of Poitiers covering a ten-year period. Eligible participants are adults with COPD who completed at least three weeks of supervised PR and underwent echocardiography to assess PH probability. Two cohorts are compared:
COPD + PH (intermediate or high echocardiographic suspicion) COPD without PH (no echocardiographic suspicion) Key data collected Change in 6MWD between the start and end of PR (primary endpoint) Proportion of participants achieving a clinically meaningful improvement in 6MWD Occurrence of severe exacerbations (hospital- or emergency-treated events) during the year after PR All-cause mortality within one year Adverse events or program interruptions indicating PR tolerance
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 18 years or older
- •Spirometry-confirmed chronic obstructive pulmonary disease with a post-bronchodilator FEV1 / FVC ratio below 0 .70
- •Completion of at least three consecutive weeks of outpatient pulmonary rehabilitation between January 2013 and December 2023 at the University - Hospital of Poitiers centre
- •Six-minute walk test performed within seven days before programme start and repeated during the final week
- •Transthoracic echocardiogram carried out within one year before or one year after programme start, used to grade pulmonary hypertension
排除标准
- •Pulmonary rehabilitation shorter than three weeks or missing six-minute walk test or echocardiogram data
- •Chronic lung disease other than chronic obstructive pulmonary disease or previous lung transplantation
- •,Hospital admission for an acute chronic obstructive pulmonary disease exacerbation in the four weeks preceding rehabilitation
- •Unstable cardiovascular disease that contraindicates exercise training
- •Active cancer with an expected survival under one year
- •Pregnancy at the time of rehabilitation
- •Documented refusal to allow medical data to be used for research
结局指标
主要结局
Change in six-minute walk distance (6MWD)
时间窗: Up to 3 weeks
Absolute difference (metres) between the 6-minute walk test performed at the start of the pulmonary-rehabilitation (PR) programme and the test repeated at the final session, following ATS/ACCP standards
次要结局
- Participants achieving the minimum clinically important difference (MCID) in 6MWD(Up to 3 weeks)
- Severe COPD exacerbations(Between 0 and 12 months after PR)
- All-cause mortality(Between 0 and 12 months after PR)
- Tolerance of PR(Day 1 and up to 3 weeks)