Brief Title
Exercise Training in Patients With Non-cystic Fibrosis (CF) Bronchiectasis
Official Title
Exercise Training in Patients With Non-CF Bronchiectasis - a Multi-centre Randomized Controlled Trial
Brief Summary
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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire
Secondary Outcome
6-Minute Walk Test
Condition
Bronchiectasis
Intervention
Exercise
Study Arms / Comparison Groups
Exercise
Description: 8 week, twice weekly exercise program with both endurance and upper and lower limb strength training
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
39
Start Date
February 2009
Completion Date
February 2013
Primary Completion Date
February 2013
Eligibility 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
Gender
All
Ages
20 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Annemarie L Lee, PhD, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00885521
Organization ID
348/08
Responsible Party
Sponsor
Study Sponsor
Bayside Health
Collaborators
Austin Health
Study Sponsor
Annemarie L Lee, PhD, Principal Investigator, Bayside Health
Verification Date
March 2014