SAMBA Trial: Towards a Paradigm Shift in Severe Asthma Management: Deep Analysis of the Effect of suBmaximal Aerobic Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Asthma Quality of Life Questionnaire (AQLQ)
研究概览
简要总结
The effects of regular exercise on asthma control has not yet been well demonstrated.
The aim of this study is to investigate the impact of submaximal aerobic training on exercise tolerance (VO2max - primary outcome) and a set of secondary outcomes: quality of life, asthma symptoms control, bronchial and systemic inflammatory markers, lung function, bronchial hyperresponsiveness, anxiety and depression and body composition in patients with persistant asthma.
详细描述
While it is well known that intense physical exercise can generate bronchospasm and limit exercise performance, it recently appeared that regular physical exercise practiced aerobically could improve the clinical status of asthmatic patients.
The investigators are planning a 12-week randomized controlled study to assess the effect of regular aerobic exercise on exercise tolerance (VO2max), quality of life, asthma control, lung function, bronchial hyperresponsiveness, anxiety and depression, and bronchial and systemic inflammation in patients with persistent asthma.
The hypothesis is that regular physical exercise increases exercise tolerance, symptoms control, lung function and quality of life and reduces inflammation, anxiety and depression and bronchial hyperresponsiveness compared to simple physiotherapy sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •asthmatic patient
- •aged 18- 65 years
- •ACQ > 1.5
- •stable background treatment comprising at least one inhaled corticosteroid or an anti-leukotriene
排除标准
- •IMC > 35
- •severe osteoarthritis of the knees and hips
- •unstable angor
- •Severe uncontrolled hypertension
研究组 & 干预措施
control group
No intervention - collection of data at baseline and 3 months without any intervention in between.
respiratory physiotherapy
Exercises to improve the way of breathing. The breathing exercise sessions will last 30 minutes and be supervised by a physiotherapist 3 times per week.
干预措施: Respiratory physiotherapy (Other)
Aerobic exercise training
Arm Description: The aerobic training program will be performed indoor three times a week for 12 weeks, under the direct supervision of a chest physician and a physiotherapist. Each aerobic training session will last 75 minutes and will be divided in 5 min of warm-up, 60 min of aerobic training (including 20 minutes on three different ergometers: bicycle, treadmill and rower/elliptical trainers) and 10 min of cool-down. Training intensity is determined by the maximal aerobic power (MAP) previously measured during an initial cardiopulmonary exercise test. Progressive increase in training load during the first three weeks (3x20 minutes at 50% of MAP), followed by 3x20 min at 60% of MAP from weeks 4 to 6, then 3x20 min at 70% of MAP from week 7 to week 9. Finally trainings from week 10 to week 12 include one session of interval training and two sessions of continuous training.
干预措施: Aerobic exercise training (Other)
结局指标
主要结局
Asthma Quality of Life Questionnaire (AQLQ)
时间窗: 3 months
A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease 32 items with 2-week recall, 4 different domains : Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items) 7-point Likert scale (7 = not impaired at all - 1 = severely impaired) Scores range 1-7, with higher scores indicating better quality of life. Change from Baseline AQLQ at 3 months
Asthma Control Questionnaire (ACQ)
时间窗: 3 months
A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. 7 items; 1 week recall (for items on symptoms and rescue inhaler use) ACQ has a multidimensional construct assessing symptoms (5 items--self-administered) and rescue bronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%) Scores range between 0 (totally controlled) and 6 (severely uncontrolled). Change from Baseline ACQ at 3 months
fall in FEV1 during ergospirometric measurement
时间窗: 3 months
Change from Baseline fall in FEV1 during ergospirometric measurement
FeNo (fractional exhaled nitric oxide)
时间窗: 3 months
change from baseline FENO at 3 months
Hospital Anxiety and depression scale (HAD)
时间窗: 3 months
The questionnaire comprises seven questions for anxiety and seven questions for depression For each item, 4 response modes coded from 0 to 3. The anxiety and depression items are alternating. In addition, an alteration in the order of the ratings was carried out to avoid biases linked to their repetition. An overall score is calculated by adding the 14 items but also 2 subtotals corresponding to the 2 subscales. The higher the scores, the higher the symptomatology. From 0 to 7 : absence of anxiety disorders and depressive disorders From 8 to 10 : anxiety and depressive disorders suspected From 11 to 21 : severe anxiety and depressive disorders
FEV1 (Forced Expiratory volume in 1 second)
时间窗: 3 months
Change from Baseline FEV1 at 3 months
Amount of eosinophils and neutrophils in sputum
时间窗: 3 months
Change from baseline in amount of eosinophils and neutrophils in sputum
PC20M (measures the concentration of metacholine necessary to bring down the FEV1 by 20% compared to its base value)
时间窗: 3 months
Change from baseline PC20M at 3 months
Vo2max (maximum oxygen consumption)
时间窗: 3 months
change from baseline Vo2Max at 3 months
PMA (Maximum aerobic power)
时间窗: 3 months
change from baseline PMA at 3 months
sputum cell counts
时间窗: 3 months
change from baseline
Asthma control test (ACT)
时间窗: 3 months
change from baseline A questionnaire to determine if patient's asthma symptoms are well controlled. A score varying between 1 and 5 is assigned to each question. A score varying between 1 and 5 is assigned to each question. The higher the total score, the better the asthma is controlled From 1 to 14 : Uncontrolled asthma From 15 to 19 : Partially Controlled Asthma From 20 to 25 : Well controlled asthma
DLCO (Diffusing Capacity of the Lung for Carbon Monoxide)
时间窗: 3 months
Measures the efficiency of the gas transfer characteristics of the lungs change from baseline DLCO at 3 months
KCO (transfer coefficient of the lung for carbon monoxide)
时间窗: 3 months
change from baseline KCO at 3 months
FRC (Functional Residual Capacity)
时间窗: 3 months
The volume of air present in the lungs at the end of passive expiration Change from baseline FRC at 3 months
FVC (Forced Vital Capacity)
时间窗: 3 months
FVC is the greatest total amount of air the patient can forcefully breathe out after breathing in as deeply as possible Change from Baseline FVC1 at 3 months
TLC (Total Lung Capacity)
时间窗: 3 months
It is the total volume of air in the lungs after a maximal inspiration change from baseline TLC at 3 months
RV (Residual Volume)
时间窗: 3 months
It is the amount of air remaining in the lungs after a maximal expiration Change from baseline RV at 3 months
sGaw (Specific airway conductance)
时间窗: 3 months
Change from baseline sGaw at 3 months
maximal inspiratory power
时间窗: 3 months
Measured in KPa Change from baseline
maximum isometric force of the quadriceps
时间窗: 3 months
measured using a dynamometer Change from baseline
VOCs
时间窗: 3 months
volatils organics compounds change form baseline
maximal expiratory power
时间窗: 3 months
Measured in KPa Change from baseline
isometric force of long finger grasp
时间窗: 3 months
measured using a Jamar dynamometer change from baseline
次要结局
- Asthma Quality of Life Questionnaire (AQLQ)(3 months)
- FEV1 (Forced Expiratory volume in 1 second)(3 months)
- Asthma control test (ACT)(3 months)
- Hospital Anxiety and depression scale (HAD)(3 months)
- sputum cell counts(3 months)
- FeNo (fractional exhaled nitric oxide)(3 months)
- FVC (Forced Vital Capacity)(3 months)
- Amount of eosinophils and neutrophils in sputum(3 months)
- Asthma Control Questionnaire (ACQ)(3 months)
- PMA (Maximum aerobic power)(3 months)
研究者
Renaud Louis
Professor Doctor
University of Liege