Lung TransplantationNCT00163891
Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients
A study testing Chest physiotherapy in people with Lung Transplantation, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Chest physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2003to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All lung transplant recipients treated at The Alfred will be invited to participate in the study at three weeks following lung transplantation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomised Two Month Trial Comparing Twho Chest Physiotherapy Protocols in Lung Transplant Recipients
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.
Read the detailed description
Very little is known about the effectiveness of chest physiotherapy protocols in lung transplant recipients. Clinical practice is based upon the experiences of individual clinicians and generalisations from other patient populations.
There is anecdotal evidence (from discussion with physiotherapists at the European Cystic Fibrosis Conference, 2001) that some lung transplant centres are advising their patients to undertake daily (prophylactic) chest physiotherapy as part of their usual routine. They believe that this may compensate for the reduced stimulus to cough caused by the lack of vagal nerve supply to the transplanted lung/s.There is no evidence that this time consuming intervention is of any benefit to the patient in the short or longer term.
Some patients have bronchial anastomotic complications and dynamic airway collapse that may further impair secretion removal. The mechanical effects of Positive Expiratory Pressure (PEP) mask Physiotherapy, particularly its ability to splint open airways, provides a theoretical basis for why this technique may be beneficial to lung transplant recipients. We have also noted a clinical benefit in a small number of patients who have been treated with PEP.
This study aims to evaluate two chest physiotherapy protocols using a variety of outcome measures and act as a starting point for future/ongoing research in this important clinical area.
This study is a prospective randomised two month trail comparing two chest physiotherapy protocols in lung transplant recipients.
The protocols are:
Treatment A - Positive expiratory pressure (PEP) mask physiotherapy in upright sitting carried out only during chest infections
Treatment B - Positive expiratory pressure (PEP) mask physiotherapy in upright sitting performed twice daily as a prophylactic routine
The null hypotheses are:
- Comparing Treatment A \& B, there will be no difference in:
- Lung function
- Chest X ray (Brasfield scores)
- Airway status (Bronchoscopy scores)
- Days in hospital due to chest infection
- Days on antibiotics
- Exercise capacity (6 minute walk test)
- Quality of life
- There will be no difference in patient adherence to the alternative protocols.
- There will be no difference in patient satisfaction with the alternative protocols.
- Conditions
- Lung Transplantation
- Being tested
- Chest physiotherapy
- Keywords
- Respiratory Therapy, Postoperative Care, Treatment Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest physiotherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Investigators
- Michael Bailey, M Stat PhD, Principal investigator, Dept of Epidemiology & Preventative Medicine Monash UniversityPrue E Munro, B Physio GradDip HealthMan, Principal investigator, The AlfredBrenda B Button, DPhysio PhD, Principal investigator, The AlfredSamantha Ellis, Principal investigator, The AlfredGreg I Snell, MBBS FRACP, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163891
- Sponsor's protocol ID
- 107/03
- Other IDs
- A10503
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 4 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Two Month Trial Comparing Twho Chest Physiotherapy Protocols in Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT00163891
- Acronym / sponsor ID
- 107/03
- Conditions
- Lung Transplantation
- Keywords
- Respiratory Therapy, Postoperative Care, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Bayside HealthOther government
- Study start
- Sep 2003
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Very little is known about the effectiveness of chest physiotherapy protocols in lung transplant recipients. Clinical practice is based upon the experiences of individual clinicians and generalisations from other patient populations.
There is anecdotal evidence (from discussion with physiotherapists at the European Cystic Fibrosis Conference, 2001) that some lung transplant centres are advising their patients to undertake daily (prophylactic) chest physiotherapy as part of their usual routine. They believe that this may compensate for the reduced stimulus to cough caused by the lack of vagal nerve supply to the transplanted lung/s.There is no evidence that this time consuming intervention is of any benefit to the patient in the short or longer term.
Some patients have bronchial anastomotic complications and dynamic airway collapse that may further impair secretion removal. The mechanical effects of Positive Expiratory Pressure (PEP) mask Physiotherapy, particularly its ability to splint open airways, provides a theoretical basis for why this technique may be beneficial to lung transplant recipients. We have also noted a clinical benefit in a small number of patients who have been treated with PEP.
This study aims to evaluate two chest physiotherapy protocols using a variety of outcome measures and act as a starting point for future/ongoing research in this important clinical area.
This study is a prospective randomised two month trail comparing two chest physiotherapy protocols in lung transplant recipients.
The protocols are:
Treatment A - Positive expiratory pressure (PEP) mask physiotherapy in upright sitting carried out only during chest infections
Treatment B - Positive expiratory pressure (PEP) mask physiotherapy in upright sitting performed twice daily as a prophylactic routine
The null hypotheses are:
- Comparing Treatment A \& B, there will be no difference in:
- Lung function
- Chest X ray (Brasfield scores)
- Airway status (Bronchoscopy scores)
- Days in hospital due to chest infection
- Days on antibiotics
- Exercise capacity (6 minute walk test)
- Quality of life
- There will be no difference in patient adherence to the alternative protocols.
- There will be no difference in patient satisfaction with the alternative protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All lung transplant recipients treated at The Alfred will be invited to participate in the study at three weeks following lung transplantation.
Key exclusion criteria (6 listed)
- ventilator dependent
- tracheostomy insitu
- pneumothorax
- major myopathy
- oxygen requirement of greater than 4 litres per minute
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest physiotherapy | Behavioural | – |
Primary outcome
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
2 secondary outcomes
Patient adherence to the alternative protocols
Patient satisfaction with the alternative protocols.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bailey, M Stat PhD principal investigator
Dept of Epidemiology & Preventative Medicine Monash University
Prue E Munro, B Physio GradDip HealthMan principal investigator
The Alfred
Brenda B Button, DPhysio PhD principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest physiotherapy in people with Lung Transplantation, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2006.