Exercise Capacity in Bronchiectasis Resection

NCT01268475 | Unknown DMC

• 1 other identifier: CAPPesq 0671/10
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Bronchiectasis; Quality of Life; Respiratory Function Tests; Exercise Test

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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.

• 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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo Medical School - Heart Institute

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (1)

• Mariani AW, Vallilo CC, de Albuquerque ALP, Salge JM, Augusto MC, Suesada MM, Pego-Fernandes PM, Terra RM. Preoperative evaluation for lung resection in patients with bronchiectasis: should we rely on standard lung function evaluation? Eur J Cardiothorac Surg. 2021 Jun 14;59(6):1272-1278. doi: 10.1093/ejcts/ezaa454.

  PMID: 33491053 DERIVED

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Central Study Contacts

Ricardo Mingarini Terra, MD, PhD

CONTACT

55 11 3069597; rmterra@uol.com.br

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: December 30, 2010
• Study Start: March 1, 2009
• Last Updated: December 30, 2010

Record last verified: 2010-11

Locations

BR (1)