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Completed

NCT Number: NCT00885521

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

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

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Austin Health, Melbourne, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

8 week, twice weekly exercise program with endurance and upper and lower limb strength training

Primary outcomes

  1. Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire

    Time frame: July 2011

Secondary outcomes

  1. 6-Minute Walk Test

    Time frame: July 2011

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Collaborators

  • Austin Health
  • Curtin University
  • Sir Charles Gairdner Hospital

Registry information

Official study title

Exercise Training in Patients With Non-CF Bronchiectasis - a Multi-centre Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 22, 2009
Registry last updated
Mar 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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