Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients
A Prospective Randomised Two Month Trial Comparing Twho Chest Physiotherapy Protocols in Lung Transplant Recipients
2 other identifiers
interventional
40
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedOctober 4, 2006
September 1, 2005
September 12, 2005
October 3, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Lung function
Chest radiographic score -Brasfield Score
Bronchoscopy score
Days in hospital due to chest infection
Antibiotic use
Quality of Life - SF-36 Health Survey
Functional exercise capacity - 6 minute walk test
Secondary Outcomes (2)
Patient adherence to the alternative protocols
Patient satisfaction with the alternative protocols.
Interventions
Eligibility Criteria
You may qualify if:
- All lung transplant recipients treated at The Alfred will be invited to participate in the study at three weeks following lung transplantation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayside Healthlead
Study Sites (1)
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bailey, M Stat PhD
Dept of Epidemiology & Preventative Medicine Monash University
- PRINCIPAL INVESTIGATOR
Prue E Munro, B Physio GradDip HealthMan
The Alfred
- PRINCIPAL INVESTIGATOR
Brenda B Button, DPhysio PhD
The Alfred
- PRINCIPAL INVESTIGATOR
Samantha Ellis
The Alfred
- PRINCIPAL INVESTIGATOR
Greg I Snell, MBBS FRACP
The Alfred
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
September 1, 2003
Last Updated
October 4, 2006
Record last verified: 2005-09