Effects of Pulmonary Rehabilitation on Secretion Transport, Inflammation and Respiratory System Strength and Quality of Life in Patients With Bronchiectasis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Sao Paulo
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Mucociliary transport in vivo
Study Overview
Brief Summary
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.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Bronchiectasis Pulmonary Rehabilitation
The volunteers will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks.
Intervention: Pulmonary Rehabilitation (Other)
Healthy Pulmonary Rehabilitation
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.
Intervention: Pulmonary Rehabilitation (Other)
Bronchiectasis Group Control
The volunteers with bronchiectasis will be informed only about the benefits of physical activities
Intervention: Control (Other)
Healthy Group Control
Volunteers healthy will be informed only about the benefits of physical activities
Intervention: Control (Other)
Outcomes
Primary Outcomes
Mucociliary transport in vivo
Time Frame: Through study completion, an average of 2 years.
This measurement it will be evaluated by the saccharine transport time, according to methodology (Stanley, 1984)
Secondary Outcomes
- Viscosity(Through study completion, an average of 2 years.)
- Exhaled breath condensate(Through study completion, an average of 2 years)
- Exhaled Nitric Oxide Fraction (FeNO)(Through study completion, an average of 2 years)
- Cytokine Analysis TNF-α(Through study completion, an average of 2 years)
- Cytokine Analysis IL-6(Through study completion, an average of 2 years)
- Maximal Static Respiratory Pressures(Through study completion, an average of 2 years.)
- Elasticity(Through study completion, an average of 2 years.)
- Cytokine Analysis IL-10(Through study completion, an average of 2 years)
- Mucociliary transport in vitro(Through study completion, an average of 2 years.)
- Six Minute Walking Test(Through study completion, an average of 2 years.)
- Quality of Life in Bronchiectasis(Through study completion, an average of 2 years.)
- Cough Impact Assessment(Through study completion, an average of 2 years.)
- Health-Related Quality of Life(Through study completion, an average of 2 years.)
- Impulse Oscillometry System (IOS)(Through study completion, an average of 2 years.)
- Pulmonary Function Test(Through study completion, an average of 2 years.)
Investigators
Ada Clarice Gastaldi
PhD
University of Sao Paulo