Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Distance in meters covered over a time of 6 minutes 2
研究概览
简要总结
The study aims to develop and test the effectiveness of a new home-based pulmonary rehabilitation program comprising two distinct phases, the first in which an 8-week respiratory rehabilitation program is carried out the second in which a maintenance pulmonary rehabilitation program is carried out.
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)
盲法说明
The outcome evaluation will be performed by a cardiopulmonary technician that has no information about the patient group
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
- •COPD diagnose with B or E characterization according to GOLD criteria;
- •Residence in the area covered by the institution where the study is carried out
排除标准
- •Frequency of a PR programme in the previous six months
- •COPD exacerbation for less than one week;
- •Presence of unstable comorbidities (List of predetermined diagnoses that constitute absolute exclusion criteria);
- •Presence of comorbidities that constitute relative exclusion criteria through a medical evaluation.
- •Score of the Clinical Frailty Scale 2.0 above six or above five in case of not having a responsible caregiver and living alone
- •SpO2 below 85% in the 6-minute walk test
结局指标
主要结局
Distance in meters covered over a time of 6 minutes 2
时间窗: 7 months
Distance in meters covered over a time of 6 minutes 2 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Distance in meters covered over a time of 6 minutes 1
时间窗: 8 weeks
Distance in meters covered over a time of 6 minutes 1 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Distance in meters covered over a time of 6 minutes 0
时间窗: Baseline
Distance in meters covered over a time of 6 minutes 0 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Distance in meters covered over a time of 6 minutes 3
时间窗: 12 months
Distance in meters covered over a time of 6 minutes 3 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
次要结局
- Dyspnoea 0(Baseline)
- Health-Related Quality of Life 1(8 weeks)
- Number of emergency department visits due to COPD exacerbation 3(12 months)
- COPD symptom control 0(Baseline)
- Anxiety and Depression 1(8 weeks)
- Anxiety and Depression 2(7 months)
- Health-Related Quality of Life 2(7 months)
- Dyspnoea 2(7 months)
- Dyspnoea 3(12 months)
- Health-Related Quality of Life 0(Baseline)
- Number of emergency department visits due to COPD exacerbation 0(Baseline)
- Dyspnoea 1(8 weeks)
- Number of emergency department visits due to COPD exacerbation 2(7 months)
- COPD symptom control 3(12 months)
- Functional capacity 0(Baseline)
- Health-Related Quality of Life 3(12 months)
- Anxiety and Depression 0(Baseline)
- Anxiety and Depression 3(12 months)
- Physical activity 0(Baseline)
- Physical activity 2(7 months)
- Number of emergency department visits due to COPD exacerbation 1(8 weeks)
- COPD symptom control 1(8 weeks)
- COPD symptom control 2(7 months)
- Physical activity 1(8 weeks)
- Physical activity 3(12 months)
- Functional capacity 1(8 weeks)
- Functional capacity 3(12 months)
- Functional capacity 2(7 months)
研究者
Liliana Silva
RN
Unidade Local de Saúde de Matosinhos, EPE