Effects of Pulmonary Rehabilitation Associated With Respiratory Therapy vs Physiotherapy in Physical Capacity, Peripheral Muscle Strength and Quality of Life in Patients With Bronchiectasis: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Survival in months
研究概览
简要总结
The hypothesis of this study is that the group of patients who will carry out the rehabilitation program associated with respiratory therapy will have higher benefits in physical function, peripheral muscle strength and quality of life compared to the group that will only perform chest physiotherapy. Additionally, there will be a negative correlation between inflammatory mediators and measures of physical ability as well as the magnitude of improvement is lower after treatment in patients with higher baseline levels of inflammation. Furthermore, these patients will be reevaluated in 1 and 3 years, as a cohort, studying if exercise capacity may be a predictor of clinical and functional outcomes.
详细描述
All patients will have their dyspnea rated according to the Medical Research Council (MRC) scale. The Saint George Respiratory Questionnaire (SGRQ) and COPD Assessment test (CAT) will also be applied.
Spirometry will be performed according to recommendations of the American Thoracic Society/European Respiratory Society. The forced vital capacity and forced expiratory volume values in the first second will be compared with those predicted for the Brazilian population.
The maximal incremental cycle ergometer test will be carried out on an electromagnetically braked cycle ergometer with gas exchange and ventilatory variables analyzed breath-by-breath. After 2 min at rest and then 2 min pedaling in freewheel, the power (W) will continuously increase in a linear "ramp" pattern (1 to 20 W/min).
The incremental treadmill test will be performed to determine aerobic training load. The modified Balke protocol, according to the basal level of physical fitness (a total time increment between eight and 12 minutes).
The incremental shuttle walking test will be conducted according to the description of Singh et al.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical and / or CT of bronchiectasis without cystic fibrosis
- •Clinically stable (no change in symptoms of dyspnea, quantity and color of the secretion)
- •Greater than 18 and / or oxygen dependent at home
- •Medical Research Council MRC ≥ 1.
排除标准
- •Smokers or smoking history> 10 pack / years,
- •Cystic fibrosis (CF)
- •Chronic obstructive pulmonary disease (COPD)
- •Pulmonary fibrosis (PF)
- •Musculoskeletal limitations
结局指标
主要结局
Survival in months
时间窗: Up to 36 months
For the cohort follow up, the survival will be evaluated in months.
Pulmonary Function
时间窗: Up to 36 months
For the cohort follow up, forced expiratory volume in the first second will be primary outcome
The change in exercise capacity in patients with bronchiectasis
时间窗: Up to 36 months
Exercise capacity is measured by maximal cardiopulmonary exercise test on a cycle ergometer. The protocol will be used in ramp.
Exacerbations and Hospitalizations per year
时间窗: Up to 36 months
For the cohort follow up, the frequency of exacerbations and hospitalizations will be evaluated
次要结局
未报告次要终点
研究者
Anderson Alves de Camargo
Principal Investigator
University of Nove de Julho