A Pilot Study of Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in oxygen uptake at peak exercise (VO2max) in cardiopulmonary exercise test (Before and after Rehabilitation-at 3 and 6 months)
研究概览
简要总结
The effect of Pulmonary Rehabilitation in patients with bronchiectasis (BC) is not sufficiently studied. The aim of this study is to assess the clinical and biological response of a Pulmonary Rehabilitation Program (PRP) for 12 weeks in BC vs PRP plus hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate (HMB).
Methods: single center randomized controlled trial, parallel treatment design: Participants will be randomized assigned either will receive (n=14) PRP for 60 minutes, two supervised sessions per week in the hospital and one unsupervised session at home vs PRP (n=14) plus ONS (one can per day).
Outcome assessments will be performed at baseline, 12 weeks and 24 weeks:
1.- effort capacity –cardiopulmonary exercise test-, 2.- body composition (anthropometry, lean body mass by dual energy X-ray absorptiometry and bioimpedance, phase angle), 3.- peripheral muscle strength (dynamometry and respiratory -PEM (maximum expiratory pressure)and PIM (minimum expiratory pressure)-), 4.- spirometry, 5.- respiratory symptoms (bronchorrhea, dyspnoea, exacerbations),6.- level of physical activity (IPAQ questionnaire plus objective physical activity (WGT3X)), 7.- quality of life (QOL-B-Spain) , 8.-psychological symptoms (HASD) and 9.- biological markers of inflammation (leptin, adiponectin, interleukin-6, tumor necrosis factor-alpha, ultrasensitive C-reactive protein, GPR55 (G protein-coupled receptor 55) RNAm (messenger ribonucleic acid) expression in white blood cells) and oxidation (total antioxidant capacity, superoxide dismutase activity, 8-iso-prostaglandin F2a, Thiobarbituric acid reactive substances).
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
- 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
- •Patients ages from 18-80 (both included)
- •Patients with bronchiectasis, not cystic fibrosis bronchiectasis.
- •Bronchiectasis diagnosed by high resolution computed tomography (HRCT). of the chest
- •Patients followed in Bronchiectasis and Cystic Fibrosis Units in the Hospital.
- •BMI > 18.5 in patients under 65 years old, and > 20kg/m2 in patients over this age.
- •Ambulatory patients.
排除标准
- •Use of oral corticoids.
- •Respiratory exacerbation. If a patient had a respiratory exacerbation or a recent hospital admission, their participation will be postponed for at least 60 days til any acute disease is resolved.
- •Prior oral or parenteral supplements intake.
- •Traumatological, neurological or cardiovascular diseases that prevent patients from performing the training.
- •Life threatening hemoptysis in the past year.
- •Patients with cancer, major surgery in the previous three months, participating in another study, patients who are pregnant or may become pregnant, patients with acute intestinal disease, acute heart failure, severe hepatic failure or dialysis.
- •Gastrectomy, gastroparesis or other alterations of gastric emptying.
- •Enteral tube feeding, galactosemia, Fructosemia.
- •Allergy or known sensitivity to any ingredient of the enteral formula.
- •Cystic fibrosis.
- •Included in active list for transplantation.
- •Drug or alcohol abuse.
- •No informed consent signed.
研究组 & 干预措施
Pulmonary Rehabilitation (PRP)
Pulmonary Rehabilitation (PRP)
干预措施: Pulmonary Rehabilitation (Other)
Pulmonary Rehabilitation plus oral nutritional supplement
Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate (HMB)
干预措施: Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate (Dietary Supplement)
结局指标
主要结局
Change in oxygen uptake at peak exercise (VO2max) in cardiopulmonary exercise test (Before and after Rehabilitation-at 3 and 6 months)
时间窗: 3rd and 6th month visits
次要结局
- Body composition(3rd and 6th month visits)