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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Secondary ID [2] 0 0
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

Study type
Description of intervention(s) / exposure
Behaviour - Chest physiotherapy

Behaviour: Chest physiotherapy

Intervention code [1] 0 0
Comparator / control treatment
Control group

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Bayside Health

Ethics approval
Ethics application status

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

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
Trial related presentations / publications
Public notes

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
Other publications