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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00163891




Registration number
NCT00163891
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
4/10/2006

Titles & IDs
Public title
Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients
Scientific title
A Prospective Randomised Two Month Trial Comparing Twho Chest Physiotherapy Protocols in Lung Transplant Recipients
Secondary ID [1] 0 0
A10503
Secondary ID [2] 0 0
107/03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lung function
Timepoint [1] 0 0
Primary outcome [2] 0 0
Chest radiographic score -Brasfield Score
Timepoint [2] 0 0
Primary outcome [3] 0 0
Bronchoscopy score
Timepoint [3] 0 0
Primary outcome [4] 0 0
Days in hospital due to chest infection
Timepoint [4] 0 0
Primary outcome [5] 0 0
Antibiotic use
Timepoint [5] 0 0
Primary outcome [6] 0 0
Quality of Life - SF-36 Health Survey
Timepoint [6] 0 0
Primary outcome [7] 0 0
Functional exercise capacity - 6 minute walk test
Timepoint [7] 0 0
Secondary outcome [1] 0 0
Patient adherence to the alternative protocols
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Patient satisfaction with the alternative protocols.
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
* All lung transplant recipients treated at The Alfred will be invited to participate in the study at three weeks following lung transplantation.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* ventilator dependent
* tracheostomy insitu
* pneumothorax
* major myopathy
* oxygen requirement of greater than 4 litres per minute
* or any condition that prevents them from performing PEP mask chest physiotherapy at the time of recruitment to the study.

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?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
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
1/09/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Chest infection is a common complication following lung transplant (LTx). Chest physiotherapy is widely accepted as an integral part of the management of chest infections, however there is no evidence available regarding the effectiveness of chest physiotherapy regimes for LTx recipients.

There is no consensus regarding whether LTx recipients should be instructed to perform regular daily chest physiotherapy routines regardless of the presence of lung secretions (ie prophylatically) because of the changes in mucus clearance bought about by lung transplant, or only when they have a chest infection. Some clinicians believe that a prophylactic regimen may be beneficial.

This research will compare two chest physiotherapy treatment regimens - our current practice of chest physiotherapy during chest infections only (Treatment A) with an independently performed daily chest physiotherapy regimen regardless of the presence of a chest infection (Treatment B). From this research, we aim to develop evidence-based treatment guidelines.
Trial website
https://clinicaltrials.gov/study/NCT00163891
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bailey, M Stat PhD
Address 0 0
Dept of Epidemiology & Preventative Medicine Monash University
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/NCT00163891