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

November 18, 2010
December 29, 2010
March 2009
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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.
Same as current
Complete list of historical versions of study NCT01268475 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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Exercise Capacity in Bronchiectasis Resection
Impact of Pulmonary Resection on Exercise Capacity in Patients With Bronchiectasis

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

Bronchiectasis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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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.
Both
18 Years to 90 Years
No
Contact: Ricardo Mingarini Terra, MD, PhD 55 11 3069597 rmterra@uol.com.br
Brazil
 
NCT01268475
CAPPesq 0671/10
Yes
Instituto do Coração HCFMUSP (Dr. Ricardo Mingarini Terra, MD, PhD), Instituto do Coração HCFMUSP
University of Sao Paulo
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University of Sao Paulo
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP