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
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
Trial website
https://clinicaltrials.gov/study/NCT00885521
Trial related presentations / publications
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.
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.
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00885521