Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000678695
Ethics application status
Approved
Date submitted
26/09/2005
Date registered
21/10/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Maintenance exercise following pulmonary rehabilitation: Is it necessary?
Scientific title
Does a maintenance exercise program following an eight week pulmonary rehabilitation program maintain functional exercise capacity and quality of life in patients with COPD
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 826 0
Condition category
Condition code
Respiratory 892 892 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 893 893 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised controlled trial:
2 groups. Intervention group- weekly supervised exercise training plus home program
Control group - unsupervised home program
Reasses 3, 6, 12 months
Intervention code [1] 679 0
Rehabilitation
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1156 0
Functional exercise capacity measured by 6 minute walk test, incremental shuttle walk test, endurance shuttle walk test
Timepoint [1] 1156 0
Measured at baseline (post an 8 week pulmonary rehabilitaion program) and at 3,6,12 months
Primary outcome [2] 1157 0
Quality of life measured by St George Respiratory Questionnaire
Timepoint [2] 1157 0
Measured at baseline (post an 8 week pulmonary rehabilitaion program) and at 3,6,12 months
Secondary outcome [1] 2121 0
Hospital anxiety and depression score
Timepoint [1] 2121 0
Measured at baseline, 3,6,12 months
Secondary outcome [2] 2122 0
Hospital admissions
Timepoint [2] 2122 0
Measured at baseline, 3,6,12 months

Eligibility
Key inclusion criteria
Diagnosed COPD ((FEV1/FVC < 70%)Completed an 8 week pulmonary rehabilitation program.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable angina, severe musculskeletal pain, unstable mental illness.

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)
the sequence was concealed in opaque envelopes until the interventions were assigned
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation in blocks using the website www.randomization.com which is recommended as the best freely available, internet-based randomisation services (BMC Medical research Methodology 2004,4:26)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/08/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 984 0
Self funded/Unfunded
Name [1] 984 0
Country [1] 984 0
Primary sponsor type
Hospital
Name
Physiotherapy Department, Royal Prince Alfred Hospital
Address
Country
Australia
Secondary sponsor category [1] 848 0
University
Name [1] 848 0
University of Sydney
Address [1] 848 0
Country [1] 848 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2293 0
Sydney South West Area Health Service (RPAH zone)
Ethics committee address [1] 2293 0
Ethics committee country [1] 2293 0
Australia
Date submitted for ethics approval [1] 2293 0
Approval date [1] 2293 0
Ethics approval number [1] 2293 0
Ethics committee name [2] 2294 0
University of Sydney
Ethics committee address [2] 2294 0
Ethics committee country [2] 2294 0
Australia
Date submitted for ethics approval [2] 2294 0
Approval date [2] 2294 0
Ethics approval number [2] 2294 0

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

Contacts
Principal investigator
Name 35132 0
Address 35132 0
Country 35132 0
Phone 35132 0
Fax 35132 0
Email 35132 0
Contact person for public queries
Name 9868 0
Mrs Lissa Spencer
Address 9868 0
Physiotherapy Department
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 9868 0
Australia
Phone 9868 0
+61 2 95159857
Fax 9868 0
+61 2 95159751
Email 9868 0
spencl@email.cs.nsw.gov.au
Contact person for scientific queries
Name 796 0
Dr Jennifer Alison
Address 796 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 796 0
Australia
Phone 796 0
+61 2 93519371
Fax 796 0
+61 2 93519601
Email 796 0
j.alison@fhs.usyd.edu.au

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.