Pulmonary Rehabilitation in Interstitial Lung Disease

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00168285
• Other study ID #: PRIDe
• Status: Active, not recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: April 4, 2007
• Start date: March 2005
• Est. completion date: May 2007

Study information

• Verified date: April 2007
• Source: The Alfred
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Behavioral:
• Pulmonary Rehabilitation

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Austin Hospital	Melbourne	Victoria

Sponsors (4)

Lead Sponsor	Collaborator
The Alfred	Austin Hospital, Melbourne Australia, La Trobe University, Victorian Tuberculosis and Lung Association

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional exercise capacity
Secondary	Maximal exercise capacity
Secondary	Health-related quality of life
Secondary	Dyspnoea