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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00885521
Registration number
NCT00885521
Ethics application status
Date submitted
21/04/2009
Date registered
22/04/2009
Date last updated
11/03/2014
Titles & IDs
Public title
Exercise Training in Patients With Non-cystic Fibrosis (CF) Bronchiectasis
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Scientific title
Exercise Training in Patients With Non-CF Bronchiectasis - a Multi-centre Randomized Controlled Trial
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Secondary ID [1]
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348/08
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Exercise
Experimental: Exercise - 8 week, twice weekly exercise program with both endurance and upper and lower limb strength training
No Intervention: 2 - No exercise, twice weekly phone calls
Other interventions: Exercise
8 week, twice weekly exercise program with endurance and upper and lower limb strength training
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire
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Assessment method [1]
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Timepoint [1]
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July 2011
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Secondary outcome [1]
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6-Minute Walk Test
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Assessment method [1]
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Timepoint [1]
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July 2011
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Eligibility
Key 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)
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Minimum age
20
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2013
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Sample size
Target
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Accrual to date
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Final
39
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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The Alfred - Melbourne
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Recruitment hospital [2]
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Austin Health - Melbourne
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Recruitment hospital [3]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment postcode(s) [3]
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- Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Austin Health
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Sir Charles Gairdner Hospital
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Curtin University
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00885521
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Annemarie L Lee, PhD
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Address
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Bayside Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00885521
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