NCT03630432.

Study name	Pulmonary rehabilitation for uncontrolled asthma associated with elevated BMI
Methods	Study design: Randomised controlled trial Total duration of study: 8 weeks intervention and follow‐up 40 weeks later Details of any run‐in period: None stated Number of study centres and location: Single site. Scotland Study setting: Hospital Withdrawals: No report of results found.
Participants	Number recruited: No report of results found. Number completed: No report of results found. Mean (SD) age: No report of results found. Age range: No report of results found. Gender (M/F): No report of results found. Mean (SD) BMI: No report of results found. Severity of condition: Severe asthma Diagnostic criteria: Diagnosed as per GINA Guidelines 2015 with characteristic symptoms and at least 1 of the following. Airflow limitation: FEV1/FVC < 70% (at any time in the past) and 12% and 200 mL increase in FEV1 in the preceding 5 years either: after inhaled/nebulised bronchodilator or 4+ weeks of anti‐inflammatory treatment; OR between visits.  Positive bronchial challenge in the preceding 5 years Baseline lung function: No report of results found. Smoking history: No report of results found. Asthma treatment: Not stated Inclusion criteria: Adults aged 18 to 80 years (smokers, ex‐smokers, and non‐smokers). Confirmed asthma as per GINA Guidelines 2015. Difficult asthma defined as per SIGN/BTS Guideline 201. BMI ≥ 25 kg/m2. MRCD score ≥ 3/5 Exclusion criteria: ITU 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 comorbidity likely to influence the conduct of the study. Pregnancy and breastfeeding. Severe and/or unstable cardiac disease. Impaired mobility that impacts upon ability to participate in physical training. Commenced antifungal, biologic (omalizumab, lebrikizumab, mepolizumab), or Airsonett device within the preceding 6 months
Interventions	Intervention: 8‐week rolling PRP. Once‐weekly 1‐hour session of supervised exercise (aerobic, resistance, and flexibility training) and once‐weekly 0.5‐hour education session (topics including what is asthma, treatments and inhaler technique, self‐management, importance of exercise and health promotion) Comparison: Usual care for 8 weeks, then enter PRP Concomitant medications: Not stated Excluded medications: Commencement within the preceding 6 months of antifungal, biologic (omalizumab, lebrikizumab, mepolizumab), or Airsonett device; eligible if on treatment for > 6 months or discontinued > 6 months ago
Outcomes	Primary outcomes: Quality of life (AQLQ) Secondary outcomes: Asthma control (ACQ). Change in treatment burden (asthma medication use treatment chart). Change in healthcare usage (number of episodes of unscheduled care). MRCD score. BMI. Inflammation (changes in blood eosinophils and FeNO). Lung function (changes in FEV1 and FVC, lowest oxygen saturation). Exercise tolerance (change in 6MWD). Physical activity (change in actigraphy data). Hospital Anxiety and Depression Scale score Time points reported: Baseline, 8 weeks, 40 weeks
Starting date	May 2017
Contact information	Douglas C Cowan: douglas.cowan@ggc.scot.nhs.uk Clare Ricketts: clare.ricketts@nhs.net
Notes	Funding: None stated Notable conflicts of interest: None stated Other: Trial commenced May 2017 based on trial registry data. Emailed authors to determine whether any results available (without reply)

Abbreviations: 6MWD: 6‐minute walk distance; ACQ: Asthma Control Questionnaire; AQLQ: Asthma Quality of Life Questionnaire; BMI: body mass index; BTS: British Thoracic Society; FeNO: fractional exhaled nitric oxide; FEV₁: forced expiratory volume in 1 second; FVC: forced vital capacity; GINA: Global Initiative for Asthma; ITU: intensive therapy unit; MRCD: MEdical Research Council Dyspnea Scale; PRP: pulmonary rehabilitation programme; SIGN: Scottish Intercollegiate Guidelines Network.