Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients

Lung Transplantation Clinical Trial

Official title:

A Prospective Randomised Two Month Trial Comparing Twho Chest Physiotherapy Protocols in Lung Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163891
• Other study ID #: 107/03
• Secondary ID: A10503
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: October 3, 2006
• Start date: September 2003

Study information

• Verified date: September 2005
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical 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.

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.

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:

1. 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

2. There will be no difference in patient adherence to the alternative protocols.

3. There will be no difference in patient satisfaction with the alternative protocols.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• All lung transplant recipients treated at The Alfred will be invited to participate in the study at three weeks following lung transplantation.

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Behavioral:
• Chest physiotherapy

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function
Primary	Chest radiographic score -Brasfield Score
Primary	Bronchoscopy score
Primary	Days in hospital due to chest infection
Primary	Antibiotic use
Primary	Quality of Life – SF-36 Health Survey
Primary	Functional exercise capacity - 6 minute walk test
Secondary	Patient adherence to the alternative protocols
Secondary	Patient satisfaction with the alternative protocols.