Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000372684
Ethics application status
Approved
Date submitted
5/09/2005
Date registered
13/09/2005
Date last updated
13/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early inpatient-outpatient hospital-based pulmonary rehabilitation following hospitalisation for acute exacerbations of COPD: a randomised controlled study
Scientific title
A randomised phase 3 study to evaluate the effects of early inpatient-outpatient hospital-based pulmonary rehabilitation following hospitalisation for acute exacerbations of COPD on acute healthcare utilisation, functional capacity and health-related quality of life.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 467 0
Condition category
Condition code
Respiratory 544 544 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 545 545 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early inpatient-outpatient hospital-based pulmonary rehabilitation.
Intervention code [1] 347 0
None
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 637 0
Acute healthcare utilisation
Timepoint [1] 637 0
Measured at 3 months
Secondary outcome [1] 1309 0
Six minute walk distance
Timepoint [1] 1309 0
Measured at 3 months.
Secondary outcome [2] 1310 0
Health-related quality of life
Timepoint [2] 1310 0
Measured at 3 months.

Eligibility
Key inclusion criteria
i) COPD as defined by BTS criteria (21)ii) Exertional dyspnoea interfering with daily activityiii) Ability to complete HRQL questionnaires.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Co-morbidities (eg. limiting angina or significant musculoskeletal disability) precluding ability to perform pulmonary rehabilitation. ii) Major cognitive dysfunction. iii) Overwhelming comorbidities (eg. significant neoplastic disease) such that pulmonary rehabilitation deemed futile.

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)
Central randomisation by phone/fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software/blocking
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 162 0
New Zealand
State/province [1] 162 0

Funding & Sponsors
Funding source category [1] 602 0
Charities/Societies/Foundations
Name [1] 602 0
Green Lane Research and Educational Fund
Country [1] 602 0
Canada
Primary sponsor type
Charities/Societies/Foundations
Name
Green Lane Research and Educational Fund
Address
Country
Canada
Secondary sponsor category [1] 491 0
Government body
Name [1] 491 0
Auckland District Health Board
Address [1] 491 0
Country [1] 491 0
New Zealand

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36218 0
Address 36218 0
Country 36218 0
Phone 36218 0
Fax 36218 0
Email 36218 0
Contact person for public queries
Name 9536 0
Dr Tam Eaton
Address 9536 0
Respiratory Services
Auckland City Hospital
Grafton Auckland 1003
Country 9536 0
New Zealand
Phone 9536 0
+64 9 3797440
Fax 9536 0
Email 9536 0
[email protected]
Contact person for scientific queries
Name 464 0
Dr Tam Eaton
Address 464 0
Respiratory Services
Auckland City Hospital
Grafton Auckland 1003
Country 464 0
New Zealand
Phone 464 0
+64 9 3797440
Fax 464 0
Email 464 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.