Effect of pre-surgical pulmonary rehabilitation on outcomes of bariatric surgery in morbidly obese patients with asthma

Completed

• Conditions: 10003018; 10006436; Bronchial asthma; overweight

• Registration Number: NL-OMON40508
• Lead Sponsor: Sint Franciscus Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-07-22
• Results First Posted: 2018-01-19
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

-Age > 18 and <55 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
<p>Symptom scores (asthma control questionnaire (ACQ)), 3 months after bariatric<br /><br>surgery.</p><br>

Secondary Outcome Measures

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