A Pragmatic, Randomised, Controlled, Trial of the Effect of a Tailored Pulmonary Rehabilitation Package in Uncontrolled Asthma Associated With Elevated Body Mass Index
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- AQLQ- Asthma quality of life questionnaire
研究概览
简要总结
Aim to evaluate the impact of a pulmonary rehabilitation (rehab) programme tailored and delivered to overweight and obese patients with difficult asthma on:
- Asthma related quality of life (primary outcome) and asthma control (secondary outcome)
- Treatment burden and healthcare usage (secondary outcomes)
- Physical activity level, exercise tolerance, lung function and inflammation (secondary outcome)
- Anxiety and depression (secondary outcome)
详细描述
Eligible individuals will be identified through Difficult Asthma Clinics or ward admissions. Those wishing to participate will receive an information sheet and be invited to provide written informed consent prior to commencing the study.
Baseline Visit
Measurements taken at the baseline visit will include:
Demographics - age, gender, smoking history (current, ex, none, years since stopped, pack years), age at asthma diagnosis, duration of asthma, atopy, co-morbidities (allergic/perennial rhinitis, nasal polyps, nasal surgery, eczema, gastro-oesophageal reflux disease (GORD), diabetes, hypertension, cardiac disease, osteopenia/osteoporosis etc), medications (inhaled/nebulised short acting beta2-agonists (SABA), inhaled and oral corticosteroids (OCS) etc), healthcare usage (oral corticosteroid boosts, unscheduled general practice (GP) or accident and emergency (A+E) attendances, hospital and intensive care unit (ICU) admissions in preceding year), weight, height and body mass index (BMI).
Questionnaires - Medical Research Council (MRC) dyspnoea scale, Asthma Control Questionnaire (ACQ6), Asthma Quality of Life Questionnaire (AQLQ), and Hospital Anxiety and Depression Scale (HAD).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 year (smokers, ex-smokers and non-smokers)
- •Confirmed asthma as per Global Initiative for Asthma (GINA) guidelines 2015[4] with characteristic symptoms and at least one of the following:
- •Airflow limitation - FEV1/FVC < 70% (at any time in the past) and 12% and 200ml increase in FEV1 in the preceding 5 years either:
- •i. After inhaled/nebulised bronchodilator or 4+ weeks of anti- inflammatory treatment ii. Between visits
- •Positive bronchial challenge in the preceding 5 years:
- •I. Histamine or methacholine provocation concentration causing a 20% drop in FEV1 (PC20) <8mg/ml ii. Provoking dose of mannitol required to cause a drop in FEV1 of 15% (PD15) mannitol <635mg
- •Difficult asthma defined as per Scottish Intercollegiate Guidelines Network(SIGN)/British Thoracic Society(BTS) guideline 2014 as persistent symptoms and/or frequent asthma attacks despite treatment at step 4 or step 5 with either:
- •ACQ6>1.5
- •≥2 systemic corticosteroid boosts in previous year
- •≥1 hospitalization in previous year
- •BMI≥25 kg/m2
- •MRC dyspnoea scale ≥3/5
排除标准
- •ICU admission +/- mechanical ventilation in the previous year for asthma exacerbation
- •Respiratory tract infection requiring antibiotics or asthma exacerbation requiring corticosteroid boost in preceding 4 weeks
- •Significant respiratory or other co-morbidity likely to influence the conduct of the study
- •Pregnancy and breast feeding
- •Severe and/or unstable cardiac disease
- •Impaired mobility that impacts on ability to participate in physical training
- •Recent (within the preceding 6 months) commencement of antifungal, biologic (omalizumab, lebrikizumab, mepolizumab) or Airsonett device; eligible if on treatment for >6months or discontinued >6 months ago.
结局指标
主要结局
AQLQ- Asthma quality of life questionnaire
时间窗: 8 weeks
change from week 0 to week 8 for pulmonary rehab vs usual care control group. AQLQ consists of 32 questions related to quality of life scored out of 7, and then averaged. Total score is out of 7 with 1 being the worst and 7 the best. There is also a score between 1 and 7 for 4 subscales which cover areas of symptoms, activity limitation, emotional function and environmental stimuli. These subscales are also averaged over a number of questions with 1 being worst and 7 best.
次要结局
- Inflammation(48/56 weeks)
- Change in healthcare usage(48/56 weeks)
- Lung function(48/56 weeks)
- Change in treatment burden(48 or 56 weeks)
- Hospital anxiety and depression scale(48/56 weeks)
- AQLQ- asthma quality of life questionnaire(8 weeks)
- ACQ6- asthma control questionnaire 6(48 (or 56) weeks depending on group)
- Body mass index(48/56 weeks)
- Exercise tolerance(48/56 weeks)
- AQLQ(48 (or 56) weeks depending on group)
- Medical Research Council (MRC) dyspnoea score(48/56 weeks)
- Physical activity(48/56 weeks)