NTR4398.
| Methods |
Study design: Randomised controlled trial Total duration of study: 12 weeks Details of any run‐in period: None stated Number of study centres and location: Not stated. The Netherlands Study setting: Not explicitly stated Withdrawals: Not stated Date of study: January 2014 to December 2016 |
| Participants |
Number recruited: Not stated (WHO ICTRP information only) Number completed: Not stated (WHO ICTRP information only) Mean (SD) age: Not stated (WHO ICTRP information only) Age range: Not stated (WHO ICTRP information only) Gender (M/F): Not stated (WHO ICTRP information only) Mean (SD) BMI: Not stated (WHO ICTRP information only) Severity of condition: Not stated (WHO ICTRP information only) Diagnostic criteria: Asthma diagnosis based on the presence of symptoms and bronchial hyperresponsiveness (provocative dose to achieve 20% reduction in FEV1% (PD20) metacholine < 1.76 mg) Baseline lung function: Not stated (WHO ICTRP information only) Smoking history: Not stated (WHO ICTRP information only) Asthma treatment: Not stated (WHO ICTRP information only) Inclusion criteria: Age > 18 and < 50 years. Acceptable operative risk. ACQ > 0.75 despite optimised medication use (long‐acting beta‐agonist and inhaled corticosteroid). BMI > 35 kg/m2 with a maximum weight of 150 kg. Ability to perform a reproducible lung function test. Ability to participate in pulmonary rehabilitation. Approval for 3‐, 6‐, and 12‐month follow‐up visits. Patient motivation to achieve the fullest benefit from pulmonary rehabilitation. Informed consent Exclusion criteria: Significant orthopaedic or neurologic problems that reduce mobility or co‐operation with physical training. COPD or other pulmonary pathology apart from asthma, except for adequately treated obstructive sleep apnoea with an apnoea‐hypopnoea index score < 5. Pregnancy. Asthma exacerbation in 6 weeks prior to screening requiring a course of oral steroids or antibiotics. Maintenance therapy with oral steroids. Current smoking (during pulmonary rehabilitation) or > 10 pack year history. Participation in pulmonary rehabilitation programme in 2 years before the study |
| Interventions |
Intervention: Pulmonary rehabilitation: training x 60 minutes x 3 times per week for 12 weeks under supervision of a physiotherapist, and with counselling of a psychologist and a dietician. Laparoscopic bariatric surgery: either a gastric sleeve gastrectomy or a Roux‐and‐Y gastric bypass surgery Comparison: Standard care Concomitant medications: Not stated Excluded medications: Maintenance therapy with oral steroids |
| Outcomes |
Primary outcomes: Symptom scores (ACQ), 3 months after bariatric surgery Secondary outcomes: BMI. Asthma‐related quality of life (AQLQ). Activity level (move‐monitor). Lung function (FEV1). Exercise capacity (6MWD). Postoperative complications. Cancelled surgeries. Inflammation (blood) Time points reported: After pulmonary rehabilitation and 3, 6, and 12 months after surgery |
| Notes |
Abbreviations: 6MWD: 6‐minute walk distance; ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AQLQ: Asthma Quality of Life Questionnaire; BMI: body mass index; COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in 1 second; FVC: forced vital capacity; GINA: Global Initiative for Asthma; SF‐36: 36‐item Short Form Health Survey; VAS: visual analogue scale; WHO ICTRP: World Health Organization International Clinical Trials Registry Platform.