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Exercise Capacity in Bronchiectasis Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01268475
First received: November 18, 2010
Last updated: December 29, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition
Bronchiectasis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Pulmonary Resection on Exercise Capacity in Patients With Bronchiectasis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Impact of Pulmonary Resection on Exercise Capacity [ Time Frame: Change from Baseline in Exercise Capacity at 3 months and Change from Baseline in Exercise Capacity at 9 months ] [ Designated as safety issue: No ]
    Exercise Capacity will be assessed using Cardiopulmonary Exercise Test.


Secondary Outcome Measures:
  • Impact of Pulmonary Resection on Quality of Life. [ Time Frame: Change from Baseline in Quality of Life at 3 months and Change from Baseline in Quality of Life at 9 months. ] [ Designated as safety issue: No ]
    Quality of life will be assessed using WHOQOL-Bref and SF-36 questionnaries.

  • Impact of Pulmonary Resection on Lung Function. [ Time Frame: Change from Baseline in Lung Function at 3 months and Change from Baseline in Lung Function at 9 months. ] [ Designated as safety issue: No ]
    Lung Function will be assessed using Spirometry Test.


Estimated Enrollment: 30
Study Start Date: March 2009
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with clinical and radiological diagnosis of bronchiectasis recruited on Pulmonary Suppurative Disease Clinic of Thoracic Surgery Department

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268475

Contacts
Contact: Ricardo Mingarini Terra, MD, PhD 55 11 3069597 rmterra@uol.com.br

Locations
Brazil
University of Sao Paulo Medical School - Heart Institute Recruiting
São Paulo, Brazil, 05403-000
Contact: Ricardo Mingarini Terra, MD, PhD     55 11 30695197     rmterra@uol.com.br    
Principal Investigator: Ricardo M Terra, MD, PhD            
Sub-Investigator: Jader J Junqueira, MD            
Sub-Investigator: André Albuquerque, MD            
Sub-Investigator: Fabio B Jatene, MD, PhD            
Sub-Investigator: Milena M Suesada, PT            
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

Responsible Party: Instituto do Coração HCFMUSP (Dr. Ricardo Mingarini Terra, MD, PhD), Instituto do Coração HCFMUSP
ClinicalTrials.gov Identifier: NCT01268475     History of Changes
Other Study ID Numbers: CAPPesq 0671/10
Study First Received: November 18, 2010
Last Updated: December 29, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Bronchiectasis
Quality of Life
Respiratory Function Tests
Exercise Test

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013