Home-based Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline number of steps (incremental step test) at 12 weeks
研究概览
简要总结
This project aims to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation (PR) program (reabilitAR) in patients with chronic obstructive pulmonary disease (COPD). It is also an aim to establish the minimal clinically important differences for PR in patients with COPD for a novel incremental step test (exercise capacity outcome measure).
Patients will be recruited at hospitals. Sociodemographic, anthropometric, and comorbidities; vital signs and peripheral oxygen saturation; symptoms (dyspnea, fatigue); lung function; functional capacity; exercise capacity; the impact of the disease, balance, and cognitive function will be collected before the reabilitAR program. Additionally, health care utilization will be registered. Then, patients will be entered into the reabilitAR program (12 weeks). The intervention consists in a strategic mixture of home visits and phone calls. The program includes exercise training and the self-management educational program Living Well with COPD. After 12 weeks all outcome measures will be reassessed.
It is expected that the home-based approach will express benefits and reflect the concerns to provide appropriate responses to the patient's needs by increasing access to PR.
详细描述
The World Health Organization (WHO) indicates that hundreds of millions of people worldwide are affected by chronic respiratory diseases (CRD), including chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) is an essential component in the management of CRD with the aim to improve patients' exercise and functional capacity and psychological condition with long-term adherence to health-enhancing behaviors, including exercise training and self-management skills.
However, despite the well-known evidence, this service is mostly underutilized due to poor accessibility, with only 1% of worldwide availability of PR services for COPD patients. Thus, is important to undertake actions that improve access to and delivery of PR services for suitable patients. One of the strategies in the international guidelines is the creation of new models of programs, where a home-based approach is indicated.
The aim of this project is to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation program (reabilitAR) in patients with COPD. It is also an aim to establish the minimal clinically important differences for PR in patients with COPD for a novel incremental step test (exercise capacity outcome measure).
The plan is to recruit the maximum of patients with COPD via clinicians at hospitals. This study will enroll adult patients with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Patients will be referred by pulmonologists, from medical consultation in hospitals and clinics in Portugal. With the referral, it is expected that the medical doctor explains the goal and benefits of PR. Eligible patients will be contacted by the reabilitAR team, for additional questions and to begin the integration process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD based on the GOLD criteria - postbronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <70%;
- •Electrocardiogram (ECG) record at rest;
- •Written informed consent form;
排除标准
- •Presence of any clinical condition that does not allow the participants to a home-based PR program, such as, significant cardiovascular (e.g. symptomatic ischaemic cardiac disease), neurological (e.g. neuromuscular dystrophy disease), or presence of musculoskeletal disease;
- •Signs of cognitive impairment (e.g. dementia).
结局指标
主要结局
Change from baseline number of steps (incremental step test) at 12 weeks
时间窗: At baseline and up to 12 weeks
The incremental step test will be used to assess exercise capacity
次要结局
- Number of exacerbations(Up to 12 weeks)
- Change from baseline score of fatigue at 12 weeks(At baseline and up to 12 weeks)
- Change from baseline score of London Chest Activities of Daily Living at 12 weeks(At baseline and up to 12 weeks)
- Change from baseline score of CAT at 12 weeks(At baseline and up to 12 weeks)
- Change from baseline score of dyspnea at 12 weeks(At baseline and up to 12 weeks)
- Change from baseline number of repetitions (1-minute sit-to-stand test) at 12 weeks(At baseline and up to 12 weeks)
- Change from baseline score of Hospital Anxiety and Depression Scale at 12 weeks(At baseline and up to 12 weeks)
- Change from baseline score of mMRC at 12 weeks(At baseline and up to 12 weeks)
研究者
Rui Vilarinho
Master
Polytechnic Institute of Porto