Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis

NCT02823587 | Unknown DMC

• 1 other identifier: USP 2016-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Bronchiectasis; Mucociliary clearance; Exercise; Inflammation

Outcome Measures

Primary Outcomes (1)

• Mucociliary transport in vivo

  This measurement it will be evaluated by the saccharine transport time, according to methodology (Stanley, 1984)

  Through study completion, an average of 2 years.

Secondary Outcomes (15)

• Mucociliary transport in vitro

  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.

Study Arms (4)

Bronchiectasis Pulmonary Rehabilitation

EXPERIMENTAL

The volunteers will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks.

Other: Pulmonary Rehabilitation

Healthy Pulmonary Rehabilitation

EXPERIMENTAL

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.

Other: Pulmonary Rehabilitation

Bronchiectasis Group Control

SHAM COMPARATOR

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

Other: Control

Healthy Group Control

SHAM COMPARATOR

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

Other: Control

Interventions

Pulmonary Rehabilitation 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 Pulmonary Rehabilitation; Healthy Pulmonary Rehabilitation

Control 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

Bronchiectasis Group Control; Healthy Group Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Ribeirão Preto Medical School

Ribeirão Preto, São Paulo, 14049-900, Brazil

RECRUITING

Related Publications (5)

• 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.

  PMID: 24328736 BACKGROUND

• 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.

  PMID: 6691910 BACKGROUND

• 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.

  PMID: 22947443 BACKGROUND

• 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.

  PMID: 18094814 BACKGROUND

• 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.

  PMID: 19703285 BACKGROUND

MeSH Terms

Conditions

Bronchiectasis; Motor Activity; Inflammation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ada C Gastaldi, PhD

  Ribeirão Preto Medicine School - University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ada C Gastaldi, PhD

CONTACT

55 16 33150473; ada@fmrp.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2019
• Last Updated: August 21, 2017

Record last verified: 2016-12

Locations

BR (1)