Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Exercise Training in Patients With Non-CF Bronchiectasis - a Multi-centre Randomized Controlled Trial
Secondary ID [1] 0 0
348/08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire
Timepoint [1] 0 0
July 2011
Secondary outcome [1] 0 0
6-Minute Walk Test
Timepoint [1] 0 0
July 2011

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)
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
The Alfred - Melbourne
Recruitment hospital [2] 0 0
Austin Health - Melbourne
Recruitment hospital [3] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Austin Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Sir Charles Gairdner Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Curtin University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Annemarie L Lee, PhD
Address 0 0
Bayside Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00885521