Overview

This trial is active, not recruiting.

Condition interstitial lung disease
Treatment pulmonary rehabilitation
Sponsor The Alfred
Collaborator La Trobe University
Start date March 2005
End date May 2007
Trial size 56 participants
Trial identifier NCT00168285, PRIDe

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
Functional exercise capacity
time frame:

Secondary Outcomes

Measure
Maximal exercise capacity
time frame:
Health-related quality of life
time frame:
Dyspnoea
time frame:

Eligibility Criteria

Male or female participants from 40 years up to 90 years old.

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

Additional Information

Official title Pulmonary Rehabilitation in Interstitial Lung Disease - a Multi-Centre, Single-Blinded Randomised Controlled Trial
Principal investigator Anne E Holland, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by The Alfred.