Clinical trial NCT00168285: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: Exercise
Pulmonary rehabilitation
Idiopathic pulmonary fibrosis
Connective tissue disorders
Lead sponsor: The Alfred
Sponsor class: OTHER
Collaborators: name: La Trobe University
name: Austin Hospital, Melbourne Australia
name: Victorian Tuberculosis and Lung Association
First posted: 2005-09-15
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Functional exercise capacity
Secondary outcomes:
measure: Maximal exercise capacity
measure: Health-related quality of life
measure: Dyspnoea
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Austin Hospital
state: Victoria
Study officials:
affiliation: Alfred Hospital and LaTrobe University
name: Anne E Holland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Alfred
name: Matthew Conron, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Alfred
name: Prue Munro, BAppSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Hospital, Melbourne Australia
name: Christine McDonald, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Hospital, Melbourne Australia
name: Catherine Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.