Pulmonary Rehabilitation in Interstitial Lung Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by The Alfred.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
La Trobe University
Austin Hospital, Melbourne Australia
Victorian Tuberculosis and Lung Association
Information provided by:
The Alfred
ClinicalTrials.gov Identifier:
NCT00168285
First received: September 13, 2005
Last updated: April 4, 2007
Last verified: April 2007
  Purpose

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 Intervention
Interstitial Lung Disease
Behavioral: Pulmonary Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Pulmonary Rehabilitation in Interstitial Lung Disease - a Multi-Centre, Single-Blinded Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • Functional exercise capacity

Secondary Outcome Measures:
  • Maximal exercise capacity
  • Health-related quality of life
  • Dyspnoea

Estimated Enrollment: 56
Study Start Date: March 2005
Estimated Study Completion Date: May 2007
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).

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
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
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: NCT00168285

Locations
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
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

No publications provided by The Alfred

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00168285     History of Changes
Other Study ID Numbers: PRIDe
Study First Received: September 13, 2005
Last Updated: April 4, 2007
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by The Alfred:
Exercise
Pulmonary rehabilitation
Idiopathic pulmonary fibrosis
Connective tissue disorders

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014