Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000583448
Ethics application status
Approved
Date submitted
7/09/2007
Date registered
14/11/2007
Date last updated
2/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pulmonary rehabilitation or self management for Chronic Obstructive Pulmonary Disease: What is the best management approach?
Scientific title
Pumonary Rehabilitation or Chronic Disease Self Managment for Chronic Obstructive Pulmonary Disease to improve Disease Specific Health-Related Quality-of-Life
Universal Trial Number (UTN)
Trial acronym
PRSM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 2345 0
Condition category
Condition code
Respiratory 2449 2449 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pulmonary Rehabilitation: 8 weeks of upper and lower limb strengthening plus cardiovascular exercise under direct physiotherapist supervision for 2 x 1hour sessions per week, plus one 2 hour education session per week.

Chronic Disease Self Management (CDSM): Stanford CDSM: 17 hours of instruction once weekly over 7 weeks incorporating skills mastery, reinterpretation of symptoms, modeling, and social persuasion to enhance a sense of person efficacy.
Intervention code [1] 2065 0
Rehabilitation
Comparator / control treatment
Usual care through general medical practitioner
Control group
Active

Outcomes
Primary outcome [1] 3349 0
St George's Respiratory Questionnaire.
Timepoint [1] 3349 0
0, 3, 6, 9 and 12 months
Secondary outcome [1] 5564 0
Frenchay Activities Index
Timepoint [1] 5564 0
0.3.6.9 and 12 months
Secondary outcome [2] 5565 0
International Physical Activity Questionnaire
Timepoint [2] 5565 0
0.3.6.9 and 12 months
Secondary outcome [3] 5566 0
Hospital Anxiety and Depression Scale
Timepoint [3] 5566 0
0.3.6.9 and 12 months
Secondary outcome [4] 5567 0
Chronic Obstructive Pulmonary Disease Self-efficacy Scale
Timepoint [4] 5567 0
0.3.6.9 and 12 months

Eligibility
Key inclusion criteria
chronic obstructive pulmonary disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unstable cardiac disease
2. Recent (<3 months) neurological injury (eg. stroke)
3. Musculoskeletal conditions that prevent participation in exercise sessions
4. Limited written and verbal English language skills
5. Unstable psychiatric comorbidity precluding participation in group intervention sessions

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)
Concealed allocation via central randomization by phone or computer administered from an 'off-site' location
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
318
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 261 0
4000

Funding & Sponsors
Funding source category [1] 2601 0
Charities/Societies/Foundations
Name [1] 2601 0
MBF Foundation Ltd
Country [1] 2601 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland, Qld, 4072
Country
Australia
Secondary sponsor category [1] 2353 0
Charities/Societies/Foundations
Name [1] 2353 0
MBF Foundation Ltd
Address [1] 2353 0
MBF Foundation
Level 18, 50 Bridge Street
SYDNEY NSW 2000
Country [1] 2353 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4522 0
Medical Research Ethics Committee
Ethics committee address [1] 4522 0
Ethics Officer
The University of Queensland, 4072
Ethics committee country [1] 4522 0
Australia
Date submitted for ethics approval [1] 4522 0
27/08/2007
Approval date [1] 4522 0
Ethics approval number [1] 4522 0
2007001205
Ethics committee name [2] 4707 0
Ethics committee address [2] 4707 0
Ethics committee country [2] 4707 0
Date submitted for ethics approval [2] 4707 0
Approval date [2] 4707 0
31/10/2007
Ethics approval number [2] 4707 0
2007001205

Summary
Brief summary
This project will examine three approaches to the management of chronic obstructive pulmonary disease. It will evaluate whether any of the approaches are superior in terms of better outcomes and also which one is most economical relative to its benefits. The three approaches are a self-management approach, a structured respiratory rehabilitation program and standard general medical practice management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28038 0
Address 28038 0
Country 28038 0
Phone 28038 0
Fax 28038 0
Email 28038 0
Contact person for public queries
Name 11195 0
Prof Bill Vicenzino
Address 11195 0
Division of Physiotherapy
The University of Queensland
St Lucia Campus, 4072
Qld
Country 11195 0
Australia
Phone 11195 0
3365 2275
Fax 11195 0
3365 1622
Email 11195 0
[email protected]
Contact person for scientific queries
Name 2123 0
Prof Bill Vicenzino
Address 2123 0
Division of Physiotherapy
The University of Queensland
St Lucia Campus, 4072
Qld
Country 2123 0
Australia
Phone 2123 0
3365 2275
Fax 2123 0
3365 1622
Email 2123 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.