Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163891
First received: September 12, 2005
Last updated: October 3, 2006
Last verified: September 2005
  Purpose

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.


Condition Intervention
Lung Transplantation
Behavioral: Chest physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Prospective Randomised Two Month Trial Comparing Twho Chest Physiotherapy Protocols in Lung Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Patient adherence to the alternative protocols
  • Patient satisfaction with the alternative protocols.

Estimated Enrollment: 40
Study Start Date: September 2003
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:

  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.
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163891

Locations
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Investigators
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 Hospital
Principal Investigator: Brenda B Button, DPhysio PhD The Alfred Hospital
Principal Investigator: Samantha Ellis The Alfred Hospital
Principal Investigator: Greg I Snell, MBBS FRACP The Alfred Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163891     History of Changes
Other Study ID Numbers: 107/03, A10503
Study First Received: September 12, 2005
Last Updated: October 3, 2006
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:
Respiratory Therapy
Postoperative Care
Treatment Outcome

ClinicalTrials.gov processed this record on August 28, 2014