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

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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