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

NCT00885521 — Phase 1, Completed, 39 participants, Bayside Health

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

RegistryNCT00885521
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment39 (Actual)
SponsorBayside Health (Other gov); collaborators: Austin Health, Sir Charles Gairdner Hospital, Curtin University
ConditionsBronchiectasis
InterventionsExercise (Other)
Datesstart 2009-02-01, primary completion 2013-02-01, completion 2013-02-01, first posted 2009-04-22, last updated 2014-03-11
Locations3 sites in Australia

Related Papers Related Patents Related Grants Related Experts
All trials for Bronchiectasis All trials of Exercise

-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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
ExerciseExperimentalOther: Exercise8 week, twice weekly exercise program with both endurance and upper and lower limb strength training
2No interventionNo exercise, twice weekly phone calls
  • Exercise (Other): 8 week, twice weekly exercise program with endurance and upper and lower limb strength training

+Outcome measures

Primary outcomes

  • Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire [July 2011]

Secondary outcomes

  • 6-Minute Walk Test [July 2011]

+Eligibility

Sex: All, ages: 20 Years to 80 Years

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

+Locations (3)

FacilityCityCountryStatus
The AlfredMelbourne, VictoriaAustralia
Austin HealthMelbourne, VictoriaAustralia
Sir Charles Gairdner HospitalPerth, Western AustraliaAustralia

+Publications

  • Results publication: Lee AL, Cecins N, Holland AE, Hill CJ, McDonald CF, Burge AT, Rautela L, Thompson PJ, Stirling RG, Jenkins S. Field Walking Tests Are Reliable and Responsive to Exercise Training in People With Non-Cystic Fibrosis Bronchiectasis. J Cardiopulm Rehabil Prev. 2015 Nov-Dec;35(6):439-45. doi: 10.1097/HCR.0000000000000130. PMID 26252343
  • Results publication: Lee AL, Hill CJ, Cecins N, Jenkins S, McDonald CF, Burge AT, Rautela L, Stirling RG, Thompson PJ, Holland AE. The short and long term effects of exercise training in non-cystic fibrosis bronchiectasis--a randomised controlled trial. Respir Res. 2014 Apr 15;15(1):44. doi: 10.1186/1465-9921-15-44. PMID 24731015
  • Results publication: Lee AL, Cecins N, Hill CJ, Holland AE, Rautela L, Stirling RG, Thompson PJ, McDonald CF, Jenkins S. The effects of pulmonary rehabilitation in patients with non-cystic fibrosis bronchiectasis: protocol for a randomised controlled trial. BMC Pulm Med. 2010 Feb 2;10:5. doi: 10.1186/1471-2466-10-5. PMID 20122281

+Investigators