Randomised Controlled Trial on the Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe COPD
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- meters as per walking test performance
研究概览
简要总结
This study will investigate if adding a domiciliary respiratory physiotherapy treatment to standard care in patients with chronic obstructive pulmonary disease (COPD) can improve physical function (walking test) and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe COPD (FEV1/FVC < 70% and FEV1 < 50% pred.) associated to hypoxaemic chronic respiratory insufficiency (PaO2 < 60mmHg) or
- •Very severe COPD (FEV1/FVC < 70% and FEV1 < 30% pred.)
- •With the following characteristics:
- •no signs of lung restriction (TLC≥80%)
- •clinically stable for at least the last four weeks
- •no participation to PR programmes in the last year
- •FEV1= Forced expiratory volume in the 1st second FVC= Forced vital capacity TLC= Total Lung Capacity PaO2= Partial pressure of arterial oxygen
排除标准
- •- Muscular-skeletal impairment that could limit the patient's participation to the exercise programme;
- •Cognitive impairment that could limit the patient's participation to the activities of education and exercise, as assessed by the Mini Mental State (MMS) test <26;
- •Malignancies
研究组 & 干预措施
Standard Care
Drugs for COPD (as prescribed), oxygen therapy if needed*, check-up by the general practitioner and/or respirologist as usual.
Educational leaflet regarding optimization of oxygen therapy and drugs; Benefits of physical activity and proposal of a programme of exercise training; Energy conservation techniques; Nutritional counselling; Activity of daily Living (ADL) diary; Prevention and management of acute exacerbation
Monthly phone call with the aim of verifying:
- the patients' clinical conditions;
- the patient's adherence to the pharmacological treatments prescribed
- the patient's compliance in filling out the clinical diary and the ADL diary
干预措施: Standard Care (Other)
domiciliary rehabilitation
Same as the standard care group plus 10 (ten) home-based visits supervised by a specifically trained respiratory therapist (education+exercise training) Autonomous home-based programme: The patients will be given instructions and training in order to continue the exercise training programme on the days the respiratory therapist is not visiting them.
Counselling addressed at the outdoor activities.
干预措施: domiciliary rehabilitation (Other)
结局指标
主要结局
meters as per walking test performance
时间窗: 8 weeks
次要结局
- services utilization(12 months)
- Quality of life(12 months)
- Bode index(12 months)
- dyspnea(12 months)
- relapses(12 months)
- meters as per walking test performance(12 months)
研究者
Marta Lazzeri
Dr
Associazione Riabilitatori Insufficienza Respiratoria