Relationship Between the Severity of Bronchiectasis and Exercise Capacity in a Pilot Home Pulmonary Rehabilitation Program at the Virgen Macarena University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Exercise capacity of Non-cystic Fibrosis Bronchiectasis ( Non-CF bronchiectasis) after pulmonary rehabilitation home-based program (PRHP). Change in VO2 (oxygen consumption, ml/min)
研究概览
简要总结
A number of studies have described low exercise capacity and physical activity in patients with non-cystic fibrosis bronchiectasis (non-CF Bronchiectasis), although little research exists on using the cardiopulmonary exercise test (CPET) to evaluate exercise capacity and its most relevant changes after a pulmonary rehabilitation home-based program (PRHP). In addition, few studies have addressed tolerance to exercise and physical activity in severe cases of the disease.
Aims:
To evaluate the exercise capacity of non-CF BQ patients using CPET and physical activity after a pulmonary rehabilitation home-based program.
Methodology:
Our study describes a non-pharmacological clinical trial in non-CF BQ patients at the Virgen Macarena University Hospital (Seville, Spain). The patients were randomized into two groups: the control group (who were provided with training instructions) and the intervention group (who took part in a specific pulmonary rehabilitation home-based program).
详细描述
A signed informed consent form was provided prior to inclusion in the study. The data evaluated was obtained under strict confidentiality rules. All patients passed an initial assessment of the degree of physical activity by means of accelerometers, as well as pulmonary function tests and exercise tolerance (CPET) and 6MWT, stratification severity according to the E-FACED scales, quality of life using the saint george respiratory questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Certain diagnosis of non-CF bronchiectasis (chest HRCT)
- •Over 18 years old, clinically stable in the previous 6 weeks (no need for antibiotic therapy due to exacerbations) and a dyspnea score over 1 according to the modified Medical Research Council (mMRC) dyspnea scale
排除标准
- •Less of 18 years
- •Other airway disease ( Asthma or COPD)
- •Physical inability to perform a physical training program (neuromuscular pathology or residual injuries).
- •Smokers or former smokers of less than 6 months or with a history of consumption of 15 packs/year.
- •Cystic fibrosis.
- •Active infections (bronchopulmonary aspergillosis, pulmonary tuberculosis).
- •Active tuberculosis.
- •Medical illnesses that put the individual at risk of a decompensation due to the performance of any physical activity or cardiopulmonary stress test (unstable ischemic heart disease, acute myocardial infarction less than 1 month).
- •Pregnancy
- •Mental disorder that prevents the adequate interpretation of the indications or performance of the tests.
- •Attended pulmonary rehabilitation within 1 year.
结局指标
主要结局
Exercise capacity of Non-cystic Fibrosis Bronchiectasis ( Non-CF bronchiectasis) after pulmonary rehabilitation home-based program (PRHP). Change in VO2 (oxygen consumption, ml/min)
时间窗: Baseline and week 8
A measurement by cardiopulmonary exercise test (CPET) with oxygen consumption was performed at baseline and week 8 of the program.
次要结局
- Impact of quality of life before and after PRHP(Baseline and week 8)
- Level of physical activity (number of steps) of Non-CF bronchiectasis and its changes after PRHP(Baseline and week 8)
- Level of physical activity (METS) of Non-CF bronchiectasis and its changes after PRHP(Baseline and week 8)
- Dyspnoea(Baseline and week 8)
- Exacerbations(Baseline, week 4 and week8)