Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000416695
Ethics application status
Approved
Date submitted
13/03/2014
Date registered
16/04/2014
Date last updated
9/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Community-based pulmonary rehabilitation in people with Chronic obstructive pulmonary disease (COPD) - economic benefit?
Scientific title
Community-based pulmonary rehabilitation in people with chronic obstructive pulmonary disease (COPD), the clinical and economic effects
Secondary ID [1] 284264 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 291386 0
Condition category
Condition code
Respiratory 291750 291750 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 weeks of twice weekly supervised training compared to usual care. The sessions will be supervised by an experienced physiotherapist in pulmonary rehaiblitation. The duration of sessions is 60 minutes. EAch sessions will consist of a combination of walking training, cycling and light upper and lower limb weights. The training is all conducted in a group setting.
Intervention code [1] 288971 0
Rehabilitation
Comparator / control treatment
Usual care (no exercise training or education), usual follow up with the GP and respiratory physician as required by the patient
Control group
Active

Outcomes
Primary outcome [1] 291687 0
QALYs Healthcare usage from Medicare Benefits Scheme and Pharmaceutical Benefits Scheme Hospitalisation rates
Timepoint [1] 291687 0
Baseline, 12 months
Secondary outcome [1] 307289 0
Incremental shuttle walk distance (ISWD) - exercise capacity
Timepoint [1] 307289 0
Baseline, 7 weeks, 6 months, 12 months
Secondary outcome [2] 307821 0
Hospital anxiety and depression scale - psychological symptoms
Timepoint [2] 307821 0
baseline, 7 weeks, 6 and 12months
Secondary outcome [3] 307822 0
St George's respiratory questionnaire - health related quality of life
Timepoint [3] 307822 0
Baseline, 7 weeks, 6 and 12 months

Eligibility
Key inclusion criteria
Diagnosis of COPD (Physician and FEV1/FVC < 70% predicted) with stage 2 to 4 and significant smoking history of a minimum of 10 pack years
Exertional dyspnoea of 2-4 according to MMRC
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Comorbidities limiting safety to exercise
Inability to understand English
Completion of pulmonary rehabilitation within previous 18 months
Acute exacerbation of COPD within last 4 weeks

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?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparison of groups using repeated measures ANOVA or Mann Whitney U tests with intention-to-treat analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/02/2001
Actual
13/03/2001
Date of last participant enrolment
Anticipated
30/12/2003
Actual
6/01/2004
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7866 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 288888 0
Charities/Societies/Foundations
Name [1] 288888 0
Victorian Tuberculosis and Lung Foundation - Edgar Tatnell Grant
Country [1] 288888 0
Australia
Primary sponsor type
Hospital
Name
Western Hospital
Address
Western Hospital
Gordon Street
Footscray 3011
Victoria
Country
Australia
Secondary sponsor category [1] 287585 0
None
Name [1] 287585 0
Address [1] 287585 0
Country [1] 287585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290717 0
Western Health Human Research Ethics committee
Ethics committee address [1] 290717 0
Ethics committee country [1] 290717 0
Australia
Date submitted for ethics approval [1] 290717 0
07/06/2000
Approval date [1] 290717 0
18/07/2000
Ethics approval number [1] 290717 0

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

Contacts
Principal investigator
Name 46942 0
Ms Kathy McCann
Address 46942 0
Ballarat Health Services 102 Ascot Street South Ballarat 3350 Victoria
Country 46942 0
Australia
Phone 46942 0
00 61 3 5320 3700
Fax 46942 0
Email 46942 0
[email protected]
Contact person for public queries
Name 46943 0
Annemarie Lee
Address 46943 0
Physiotherapy, The University of Melbourne 161 Barry St, Carlton 3010 Victoria
Country 46943 0
Australia
Phone 46943 0
00613 8344 6435
Fax 46943 0
Email 46943 0
[email protected]
Contact person for scientific queries
Name 46944 0
Annemarie Lee
Address 46944 0
Physiotherapy, The University of Melbourne 161 Barry St, Carlton 3010 Victoria
Country 46944 0
Australia
Phone 46944 0
00613 8344 6435
Fax 46944 0
Email 46944 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.