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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Pulmonary Rehabilitation in Interstitial Lung Disease - a Multi-Centre, Single-Blinded Randomised Controlled Trial
Secondary ID [1] 0 0
PRIDe
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Functional exercise capacity
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Maximal exercise capacity
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Health-related quality of life
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Dyspnoea
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
* Ambulant
* Stable medical therapy
* Dyspnoea on exertion following maximal treatment
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2007
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
La Trobe University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Austin Hospital, Melbourne Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Victorian Tuberculosis and Lung Association
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00168285
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Anne E Holland, PhD
Address 0 0
Alfred Hospital and LaTrobe University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00168285