Exercise Capacity in Bronchiectasis Resection

Bronchiectasis Clinical Trial

Official title:

Impact of Pulmonary Resection on Exercise Capacity in Patients With Bronchiectasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01268475
• Other study ID #: CAPPesq 0671/10
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2010
• Last updated: December 29, 2010
• Start date: March 2009

Study information

• Verified date: November 2010
• Source: University of Sao Paulo
• Contact: Ricardo Mingarini Terra, MD, PhD
• Phone: 55 11 3069597
• Email: rmterra[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiectasis

Locations

Country	Name	City	State
Brazil	University of Sao Paulo Medical School - Heart Institute	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of Pulmonary Resection on Exercise Capacity	Exercise Capacity will be assessed using Cardiopulmonary Exercise Test.	Change from Baseline in Exercise Capacity at 3 months and Change from Baseline in Exercise Capacity at 9 months	No
Secondary	Impact of Pulmonary Resection on Quality of Life.	Quality of life will be assessed using WHOQOL-Bref and SF-36 questionnaries.	Change from Baseline in Quality of Life at 3 months and Change from Baseline in Quality of Life at 9 months.	No
Secondary	Impact of Pulmonary Resection on Lung Function.	Lung Function will be assessed using Spirometry Test.	Change from Baseline in Lung Function at 3 months and Change from Baseline in Lung Function at 9 months.	No