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Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis

U

University of Sao Paulo

Status

Unknown

Conditions

Bronchiectasis

Treatments

Other: Control
Other: Pulmonary Rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT02823587
USP 2016-1

Details and patient eligibility

About

The purpose of this study is to assess the effect of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis.

Full description

Bronchiectasis is characterized by pathological and irreversible dilation of bronchi caused by the inefficient removal of secretions and microorganisms and the perpetuation of inflammatory processes induced by chronic or recurrent infections, causing more damage to the airways that result in infections, and greater lesion airways and lung parenchyma. Pulmonary rehabilitation in people with bronchiectasis aims to improve exercise capacity, through effects on aerobic capacity and peripheral muscles, and to improve disease control and quality of life. The aim this study is to evaluate the effects of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis. In this study 60 volunteers, of both sexes, aged between 18-60 years, adequate the inclusion criteria, which will be assessed by lung function tests, the saccharin transport time, the inflammatory markers in the airways, the respiratory system resistance and quality of life scales. Volunteers will be randomly divided in pulmonary rehabilitation (PRG) and control groups (CG) that will be subdivided in bronchiectasis and healthy subgroups. In the PRG group they will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, while CG will be informed about the benefits of physical activities. All volunteers will be evaluated after 8 weeks of the baseline and at the end of the research. Data evolution will be collected from medical records and notes of the medical team and physical therapy that will follow the routine of these participants

Enrollment

60 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • clinically stable patients
  • both sexes
  • aged between 18-60 years
  • not due to cystic fibrosis bronchiectasis diagnosis
  • non smokers
  • no pulmonary disease

Exclusion criteria

  • asthma or other restrictive conditions
  • smokers assets
  • decompensated cardiovascular and metabolic diseases, neuromuscular or musculoskeletal that impede the realization of the Protocol.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 4 patient groups

Bronchiectasis Pulmonary Rehabilitation
Experimental group
Description:
The volunteers will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks.
Treatment:
Other: Pulmonary Rehabilitation
Healthy Pulmonary Rehabilitation
Experimental group
Description:
In this arm, the volunteers healthy will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks.
Treatment:
Other: Pulmonary Rehabilitation
Bronchiectasis Group Control
Sham Comparator group
Description:
The volunteers with bronchiectasis will be informed only about the benefits of physical activities
Treatment:
Other: Control
Healthy Group Control
Sham Comparator group
Description:
Volunteers healthy will be informed only about the benefits of physical activities
Treatment:
Other: Control

Trial contacts and locations

1

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Central trial contact

Ada C Gastaldi, PhD

Data sourced from clinicaltrials.gov

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