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Pulmonary Rehabilitation in Interstitial Lung Disease

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ClinicalTrials.gov Identifier: NCT00168285
Recruitment Status : Unknown
Verified April 2007 by The Alfred.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : April 5, 2007
Sponsor:
Collaborators:
La Trobe University
Austin Hospital, Melbourne Australia
Victorian Tuberculosis and Lung Association
Information provided by:
The Alfred

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Behavioral: Pulmonary Rehabilitation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Pulmonary Rehabilitation in Interstitial Lung Disease - a Multi-Centre, Single-Blinded Randomised Controlled Trial
Study Start Date : March 2005
Estimated Study Completion Date : May 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Functional exercise capacity

Secondary Outcome Measures :
  1. Maximal exercise capacity
  2. Health-related quality of life
  3. Dyspnoea

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168285


Locations
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Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Austin Hospital
Melbourne, Victoria, Australia, 3084
Sponsors and Collaborators
The Alfred
La Trobe University
Austin Hospital, Melbourne Australia
Victorian Tuberculosis and Lung Association
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00168285    
Other Study ID Numbers: PRIDe
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 5, 2007
Last Verified: April 2007
Keywords provided by The Alfred:
Exercise
Pulmonary rehabilitation
Idiopathic pulmonary fibrosis
Connective tissue disorders
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases