Pulmonary Rehabilitation in Interstitial Lung Disease

April 4, 2007 updated by: The Alfred

Pulmonary Rehabilitation in Interstitial Lung Disease - a Multi-Centre, Single-Blinded Randomised Controlled Trial

Interstitial lung disease (ILD) is a highly disabling group of conditions including idiopathic pulmonary fibrosis (IPF), acute and chronic interstitial pneumonias, connective tissue diseases and sarcoidosis. People with ILD frequently experience breathlessness on exertion, which limits their ability to undertake daily activities. People with ILD report very poor quality of life due to low levels of physical functioning and vitality, and high levels of breathlessness and fatigue. There are few treatments for ILD and those that are available have limited impact on quality of life.

The aim of this study is to assess the effects of Pulmonary Rehabilitation, which consists of specialised exercise training for people with lung disease, on exercise capacity and quality of life in people with ILD. We hypothesis that exercise training will result in reduced dyspnoea, improved exercise tolerance and enhanced quality of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Interstitial lung disease (ILD) is a highly disabling group of conditions including idiopathic pulmonary fibrosis (IPF), acute and chronic interstitial pneumonias, connective tissue diseases and sarcoidosis. People with ILD frequently experience breathlessness on exertion, which limits their ability to undertake daily activities and reduces health-related quality of life.Available treatments for ILD have proved largely ineffective, offering no improvement in survival and demonstrating only limited impact on quality of life.

Aims of the Research

  1. Evaluate the effects of Pulmonary Rehabilitation on exercise capacity and quality of life in patients with ILD
  2. Determine the physiological response to Pulmonary Rehabilitation in patients with ILD
  3. Determine the relationship between the aetiology and severity of ILD and the effects of Pulmonary Rehabilitation.

Comparisons: 8 weeks exercise training compared to control group (maximal exercise capacity, functional exercise capacity, dyspnoea, quality of life).

Study Type

Interventional

Enrollment

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • Melbourne, Victoria, Australia, 3084
        • Austin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ambulant
  • Stable medical therapy
  • Dyspnoea on exertion following maximal treatment

Exclusion Criteria:

  • A history of syncope on exertion
  • Too unwell to attend the hospital for exercise training
  • Any other comorbidities which would prevent exercise training
  • Previous Pulmonary Rehabilitation in the last 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Functional exercise capacity

Secondary Outcome Measures

Outcome Measure
Health-related quality of life
Maximal exercise capacity
Dyspnoea

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Alfred

Collaborators

La Trobe University
Austin Hospital, Melbourne Australia
Victorian Tuberculosis and Lung Association

Investigators

  • Principal Investigator: Anne E Holland, PhD, Alfred Hospital and LaTrobe University
  • Principal Investigator: Matthew Conron, MBBS, The Alfred
  • Principal Investigator: Prue Munro, BAppSc, The Alfred
  • Principal Investigator: Christine McDonald, MBBS PhD, Austin Hospital, Melbourne Australia
  • Principal Investigator: Catherine Hill, PhD, Austin Hospital, Melbourne Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Anticipated)

May 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 5, 2007

Last Update Submitted That Met QC Criteria

April 4, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIDe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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