Pulmonary Rehabilitation in Interstitial Lung Disease

Sponsor

The Alfred (Other)

Overall Status

Unknown status

CT.gov ID

NCT00168285

Collaborator

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

Enrollment

Locations

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Evaluate the effects of Pulmonary Rehabilitation on exercise capacity and quality of life in patients with ILD
Determine the physiological response to Pulmonary Rehabilitation in patients with ILD
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

Study Type:

Interventional

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 :

Mar 1, 2005

Anticipated Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Functional exercise capacity []

Secondary Outcome Measures

Maximal exercise capacity []
Health-related quality of life []
Dyspnoea []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Alfred Hospital	Melbourne	Victoria	Australia	3004
2	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