The Effects of Combined Endurance and Strength Training on Quality of Life in Subjects With Moderate-severe Asthma: a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- asthma related Quality of Life
研究概览
简要总结
Emerging evidence suggests that regular exercise can complement medical treatment for asthma. Furthermore there are no specific recommendation on how plan exercise training. To the best of current knowledge, there isn't enough evidence of the effect of a strength training in subjects with asthma. Therefore the aim of this study is to evaluate the short and long term effects of a strength and endurance training compared with endurance training alone in subjects with asthma.
详细描述
To the best of current knowledge, there isn't enough evidence of the effect of a strength training in subjects with asthma. Aim of the study is evaluate the short (after pulmonary rehabilitation) and long term (after 12 months) effects of a strength and endurance training compared with endurance training alone in improving quality of life and disease control in subjects with asthma of Global Initiative for Asthma (GINA) stage from 4 to 5.This is a prospective randomized control trial. Subjects with diagnosis of asthma according to the GINA guidelines admitted to a reference centre for inpatient pulmonary rehabilitation will be randomly assigned to study or control group.
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
- 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
- •Diagnosis of asthma step 4 to 5 under optimal medical treatment for at least 6 months according to GINA guideline
- •Symptomatic despite being on treatment: Asthma Control Test (ACT) score ≥ 20 ≤24
- •Able to perform and complete with studies procedures (FeNO, CPET, Six Minute Walking Test (6MWT), MVS.
排除标准
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the Global initiative for Obstructive Lung Disease (GOLD) guidelines criteria
- •Smokers or ex-smokers with pack/years ≥10
- •Body Mass Index (BMI) ≥30
- •Change in asthma medications in the last 30 days
- •Cognitive impairment (Mini-Mental State Examination score <22)
- •History of oncological, neurological, cardiovascular diseases, musculoskeletal impairment and/or medical diseases precluding exercise testing and pulmonary rehabilitation
研究组 & 干预措施
Standard Program
twelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks.
干预措施: Standard Program + Endurance and Strength training (Procedure)
Standard Program
twelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks.
干预措施: Standard Program (Procedure)
Strength training
twelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks twelve 30-minute daily sessions of supervised peripheral limb muscle training, 2 set of 6-12 repetitions
干预措施: Standard Program + Endurance and Strength training (Procedure)
结局指标
主要结局
asthma related Quality of Life
时间窗: 1 year
Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)
次要结局
- Asthma control(1 year)
- Aerobic capacity(1 year)
- Eosinophilic airway inflammation(1 year)
- Quadriceps and biceps strength(1 year)
- Treatment satisfaction(1 year)
- Numbers of exacerbations(1 year)