Obesity and asthma: effect of training on top of surgery

Recruiting

• Conditions: AsthmaObesityPulmonary rehabilitationbariatric surgeryLife style

• Registration Number: NL-OMON21509
• Lead Sponsor: Sint Franciscus GasthuisLUMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

Age > 18 and <50 years
-Acceptable operative risk
-ACQ > 0.75 despite optimized medication use (LABA and ICS)
-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 months follow-up visits, and patient motivation to achieve the fullest benefit from pulmonary rehabilitation.
-Informed consent

Exclusion Criteria

-Significant orthopedic or neurologic problems that reduce mobility or cooperation with physical training.
-COPD or other pulmonary pathology apart from asthma, except for adequate treated OSAS with a AHI < 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 PY in history
-Participation in Pulmonary Rehabilition program in last 2 year before the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom scores (asthma control questionnaire (ACQ)), 3 months after bariatric surgery.

Secondary Outcome Measures

Name	Time	Method
BMI, Asthma-related quality of life (AQLQ), activity level (move-monitor), lung function (FEV1), exercise capacity (6MWD), postoperative complications, cancelled surgeries, inflammation (blood). Tertiary endpoint are symptoms scores, patient utilities (EQ5D5L), postoperative complications, cancelled surgeries and the incremental cost-effectiveness of pulmonary rehabilitation + laparoscopic bariatric surgery as compared to laparoscopic bariatric surgery alone.