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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00168285
Registration number
NCT00168285
Ethics application status
Date submitted
13/09/2005
Date registered
15/09/2005
Date last updated
5/04/2007
Titles & IDs
Public title
Pulmonary Rehabilitation in Interstitial Lung Disease
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Scientific title
Pulmonary Rehabilitation in Interstitial Lung Disease - a Multi-Centre, Single-Blinded Randomised Controlled Trial
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Secondary ID [1]
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PRIDe
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung Disease
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Pulmonary Rehabilitation
Behaviour: Pulmonary Rehabilitation
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Functional exercise capacity
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Maximal exercise capacity
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Health-related quality of life
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Dyspnoea
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Assessment method [3]
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Timepoint [3]
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Eligibility
Key inclusion criteria
- Ambulant
- Stable medical therapy
- Dyspnoea on exertion following maximal treatment
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Minimum age
40
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2007
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Hospital - Melbourne
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Recruitment hospital [2]
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Austin Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment postcode(s) [2]
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3084 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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La Trobe University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Austin Hospital, Melbourne Australia
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Victorian Tuberculosis and Lung Association
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00168285
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Anne E Holland, PhD
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Address
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Alfred Hospital and LaTrobe University
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00168285
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