Text Size

Exercise Training in Patients With Non-Cystic Fibrosis (CF) Bronchiectasis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Austin Health
Sir Charles Gairdner Hospital
Curtin University of Technology
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00885521
First received: April 21, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

The aim of this project is to examine the short and long term effects of an 8 week, twice weekly, outpatient exercise training program for people with bronchiectasis. Participants will be randomly allocated to undergo a supervised exercise training program at The Alfred, Austin Hospital or Sir Charles Gairdner Hospital.

The hypotheses of this study are:

  1. Patients with bronchiectasis who complete an exercise program will have a higher exercise capacity and better quality of life and these improvements will be sustained for up to 12 months after completion
  2. Exercise training will significantly reduce the incidence of pulmonary exacerbations, use of antibiotics and rate of hospitalisation

Condition Intervention Phase
Bronchiectasis
 Other: Exercise
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise Training in Patients With Non-CF Bronchiectasis - a Multi-Centre Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire [ Time Frame: July 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 6-Minute Walk Test [ Time Frame: July 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: February 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
8 week, twice weekly exercise program with both endurance and upper and lower limb strength training
 Other: Exercise
8 week, twice weekly exercise program with endurance and upper and lower limb strength training
No Intervention: 2
No exercise, twice weekly phone calls

Detailed Description:

Bronchiectasis not related to cystic fibrosis (non-CF bronchiectasis) is a chronic respiratory condition characterised by permanent dilatation of the airways arising from bronchial inflammation and infection. Predominant symptoms include daily productive cough, dyspnoea and generalised fatigue. This profile is associated with diminished health-related quality of life (HRQOL) and reduced exercise tolerance.

Available medical treatments for bronchiectasis include antibiotic and inhalation therapy. To date, there is no evidence that these treatments can reduce the exacerbation rate or modify the rate of disease progression. While international guidelines for pulmonary rehabilitation recommend the inclusion of patients with bronchiectasis, there is a deficiency in evidence supporting exercise training in this population. It is proposed that a standard exercise training program conducted according to Australian guidelines for pulmonary rehabilitation will improve both exercise capacity, quality of life and reduce the number of acute infections in both the short and long term in people with bronchiectasis.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of bronchiectasis (HRCT)
  • Stable medical status for last 4 weeks
  • History of 2 exacerbations in the last 2 years
  • Dysnpoea on exertion (Modified Medical Research Council score >1)

Exclusion Criteria:

  • Concurrent diagnosis of COPD (physician diagnosis and history of 10 pack year smoking)
  • Concurrent diagnosis of asthma (history of atopic disease and evidence of bronchodilator reversibility of 12% or 200ml in FEV1 or FVC)
  • Concurrent diagnosis of Interstitial lung disease
  • Concurrent diagnosis of Cystic Fibrosis
  • Medical condition which could place patient at risk during exercise training (angina, neurological or orthopaedic condition)
  • Prior completion of pulmonary rehabilitation within the last 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885521

Contacts
Contact: Annemarie L Lee, PhD 00613 9076 3450 Annemarie.Lee@alfred.org.au
Contact: Sue Jenkins, PhD 006189346 4408 S.Jenkins@curtin.edu.au

Locations
Australia, Victoria
The Alfred Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Annemarie L Lee, PhD     006139076 3450     Annemarie.Lee@alfred.org.au    
Contact: Anne E Holland, PhD     006139076 3450     a.holland@alfred.org.au    
Principal Investigator: Annemarie Lee, PhD            
Sub-Investigator: Anne Holland, PhD            
Sub-Investigator: Robert Stirling, FRACP            
Austin Health Recruiting
Melbourne, Victoria, Australia
Contact: Annemarie Lee, PhD     006139496 5461     Annemarie.Lee@austin.org.au    
Contact: Catherine J Hill, PhD     006139496 5461     Catherine.Hill@austin.org.au    
Principal Investigator: Annemarie Lee, PhD            
Sub-Investigator: Catherine Hill, PhD            
Sub-Investigator: Christine McDonald, PhD            
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Perth, Western Australia, Australia
Contact: Sue Jenkins, PhD     006189346 4408     S.Jenkins@curtin.edu.au    
Contact: Nola Cecins, Msc     0061893464408     N.Cecins@curtin.edu.au    
Principal Investigator: Sue Jenkins, PhD            
Sub-Investigator: Nola Cecins, MSc            
Sub-Investigator: Philip Thompson, FCCP            
Sponsors and Collaborators
Bayside Health
Austin Health
Sir Charles Gairdner Hospital
Curtin University of Technology
Investigators
Principal Investigator: Annemarie L Lee, PhD Bayside Health
  More Information

No publications provided by Bayside Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Annemarie Lee, Bayside Health
ClinicalTrials.gov Identifier: NCT00885521     History of Changes
Other Study ID Numbers: 348/08
Study First Received: April 21, 2009
Last Updated: April 21, 2009
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013