Pulmonary Rehabilitation in Interstitial Lung Disease
Primary Purpose
Interstitial Lung Disease
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Lung Disease focused on measuring Exercise, Pulmonary rehabilitation, Idiopathic pulmonary fibrosis, Connective tissue disorders
Eligibility 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
Sites / Locations
- Alfred Hospital
- Austin Hospital
Outcomes
Primary Outcome Measures
Functional exercise capacity
Secondary Outcome Measures
Maximal exercise capacity
Health-related quality of life
Dyspnoea
Full Information
NCT ID
NCT00168285
First Posted
September 13, 2005
Last Updated
April 4, 2007
Sponsor
The Alfred
Collaborators
La Trobe University, Austin Hospital, Melbourne Australia, Victorian Tuberculosis and Lung Association
1. Study Identification
Unique Protocol Identification Number
NCT00168285
Brief Title
Pulmonary Rehabilitation in Interstitial Lung Disease
Official Title
Pulmonary Rehabilitation in Interstitial Lung Disease - a Multi-Centre, Single-Blinded Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The Alfred
Collaborators
La Trobe University, Austin Hospital, Melbourne Australia, Victorian Tuberculosis and Lung Association
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
Exercise, Pulmonary rehabilitation, Idiopathic pulmonary fibrosis, Connective tissue disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
56 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary Rehabilitation
Primary Outcome Measure Information:
Title
Functional exercise capacity
Secondary Outcome Measure Information:
Title
Maximal exercise capacity
Title
Health-related quality of life
Title
Dyspnoea
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne E Holland, PhD
Organizational Affiliation
Alfred Hospital and LaTrobe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Conron, MBBS
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prue Munro, BAppSc
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine McDonald, MBBS PhD
Organizational Affiliation
Austin Hospital, Melbourne Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Hill, PhD
Organizational Affiliation
Austin Hospital, Melbourne Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Austin Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
18245143
Citation
Holland AE, Hill CJ, Conron M, Munro P, McDonald CF. Short term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease. Thorax. 2008 Jun;63(6):549-54. doi: 10.1136/thx.2007.088070. Epub 2008 Feb 1.
Results Reference
derived
Learn more about this trial
Pulmonary Rehabilitation in Interstitial Lung Disease
We'll reach out to this number within 24 hrs