Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis

NCT ID: NCT02823587

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-12-31

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

Conditions

Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pulmonary Rehabilitation

Intervention Type: OTHER

The exercise program will consist of an individual exercise prescription on the treadmill or bike, the initial intensity of 85% VO2max and active exercises or active-resistance for upper and lower limbs according to the capacity of each volunteer.

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.

Group Type: EXPERIMENTAL

Pulmonary Rehabilitation

Intervention Type: OTHER

The exercise program will consist of an individual exercise prescription on the treadmill or bike, the initial intensity of 85% VO2max and active exercises or active-resistance for upper and lower limbs according to the capacity of each volunteer.

Bronchiectasis Group Control

The volunteers with bronchiectasis will be informed only about the benefits of physical activities

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

No supervised exercise session, only will be informed at the beginning of the study to perform thirty minutes of physical activity of moderate intensity several days a week is associated with health benefits

Healthy Group Control

Volunteers healthy will be informed only about the benefits of physical activities

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

No supervised exercise session, only will be informed at the beginning of the study to perform thirty minutes of physical activity of moderate intensity several days a week is associated with health benefits

Interventions

Pulmonary Rehabilitation

The exercise program will consist of an individual exercise prescription on the treadmill or bike, the initial intensity of 85% VO2max and active exercises or active-resistance for upper and lower limbs according to the capacity of each volunteer.

Intervention Type: OTHER

Control

No supervised exercise session, only will be informed at the beginning of the study to perform thirty minutes of physical activity of moderate intensity several days a week is associated with health benefits

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ada Clarice Gastaldi

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ada C Gastaldi, PhD

Role: PRINCIPAL_INVESTIGATOR

Ribeirão Preto Medicine School - University of São Paulo

Locations

Ribeirão Preto Medical School

Ribeirão Preto, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Ada C Gastaldi, PhD

Role: CONTACT

ada@fmrp.usp.br

55 16 33150473

Facility Contacts

Ada C Gastaldi, Phd

Role: primary

ada@fmrp.usp.br

References

Chalmers JD, Goeminne P, Aliberti S, McDonnell MJ, Lonni S, Davidson J, Poppelwell L, Salih W, Pesci A, Dupont LJ, Fardon TC, De Soyza A, Hill AT. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014 Mar 1;189(5):576-85. doi: 10.1164/rccm.201309-1575OC.

Reference Type: BACKGROUND

PMID: 24328736 (View on PubMed)

Stanley P, MacWilliam L, Greenstone M, Mackay I, Cole P. Efficacy of a saccharin test for screening to detect abnormal mucociliary clearance. Br J Dis Chest. 1984 Jan;78(1):62-5.

Reference Type: BACKGROUND

PMID: 6691910 (View on PubMed)

Mandal P, Sidhu MK, Kope L, Pollock W, Stevenson LM, Pentland JL, Turnbull K, Mac Quarrie S, Hill AT. A pilot study of pulmonary rehabilitation and chest physiotherapy versus chest physiotherapy alone in bronchiectasis. Respir Med. 2012 Dec;106(12):1647-54. doi: 10.1016/j.rmed.2012.08.004. Epub 2012 Sep 1.

Reference Type: BACKGROUND

PMID: 22947443 (View on PubMed)

Trindade SH, de Mello JF Jr, Mion Ode G, Lorenzi-Filho G, Macchione M, Guimaraes ET, Saldiva PH. Methods for studying mucociliary transport. Braz J Otorhinolaryngol. 2007 Sep-Oct;73(5):704-12. doi: 10.1016/s1808-8694(15)30133-6.

Reference Type: BACKGROUND

PMID: 18094814 (View on PubMed)

Koczulla R, Dragonieri S, Schot R, Bals R, Gauw SA, Vogelmeier C, Rabe KF, Sterk PJ, Hiemstra PS. Comparison of exhaled breath condensate pH using two commercially available devices in healthy controls, asthma and COPD patients. Respir Res. 2009 Aug 24;10(1):78. doi: 10.1186/1465-9921-10-78.

Reference Type: BACKGROUND

PMID: 19703285 (View on PubMed)

Other Identifiers

USP 2016-1

Identifier Type: -

Identifier Source: org_study_id