Exercise Capacity in Bronchiectasis Resection

• Conditions: Bronchiectasis

• Registration Number: NCT01268475
• Lead Sponsor: University of Sao Paulo

Brief Summary

Bronchiectasis can be defined as an abnormal and irreversible dilatation of the bronchial tree due to repeated cycles of inflammation and infection, resulting in progressive loss of lung function. The surgical treatment by pulmonary resection or even lung transplantation is indicated in cases of bronchiectasis primary nonresponsive to appropriate medical treatment, or when associated with serious complications. There are few literature data on the influence of bronchiectasis in exercise capacity, quality of life and functional capacity, and the impact of lung resection in patients with this diagnosis. The primary objective of this study is to evaluate prospectively the impact of lung resection on exercise capacity in patients with clinical and radiological diagnosis of bronchiectasis. The secondary objective of this study is to evaluate the impact of lung resection on quality of life and lung function and to analyze the the presence of predictors of postoperative functional deterioration and the occurrence of complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Status Verified: 2010-11
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-12-29
• Last Update Submitted: 2010-12-29
• Study First Posted: 2010-12-30
• Last Update Posted: 2010-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Clinical and radiographic diagnosis of bronchiectasis;
• Lack of adequate response to clinical treatment after 1 year of follow-up and / or presence of disease complications;
• Agreement to participate of the study by signing of the Informed Consent Term

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Exclusion Criteria

• Comorbidities that prevent the patient to undergo general anesthesia;
• Musculoskeletal and/or psychomotor disability to perform pulmonary function tests and cardiopulmonary exercise tests;
• Inability to understand the quality of life questionnaires;
• Age over 90 years or less 18 years.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of Pulmonary Resection on Exercise Capacity	Change from Baseline in Exercise Capacity at 3 months and Change from Baseline in Exercise Capacity at 9 months	Exercise Capacity will be assessed using Cardiopulmonary Exercise Test.

Secondary Outcome Measures

Name	Time	Method
Impact of Pulmonary Resection on Quality of Life.	Change from Baseline in Quality of Life at 3 months and Change from Baseline in Quality of Life at 9 months.	Quality of life will be assessed using WHOQOL-Bref and SF-36 questionnaries.
Impact of Pulmonary Resection on Lung Function.	Change from Baseline in Lung Function at 3 months and Change from Baseline in Lung Function at 9 months.	Lung Function will be assessed using Spirometry Test.

Trial Locations

Locations (1)

University of Sao Paulo Medical School - Heart Institute; 🇧🇷 São Paulo, Brazil