Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000480381
Ethics application status
Approved
Date submitted
15/08/2008
Date registered
29/09/2008
Date last updated
17/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of free-living physical activity using a multi-sensor armband in people with chronic obstructive pulmonary disease (COPD) with and without co-morbid physical conditions
Scientific title
Assessment of free-living physical activity on total energy expenditure using a multi-sensor armband in people with chronic obstructive pulmonary disease (COPD) with and without co-morbid physical conditions
Secondary ID [1] 283230 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD (chronic obstructive pulmonary disease) 3565 0
Physical co-morbid medical condition 3566 0
Condition category
Condition code
Respiratory 3722 3722 0 0
Chronic obstructive pulmonary disease
Musculoskeletal 3723 3723 0 0
Osteoarthritis
Neurological 3724 3724 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Free-living physical activity over a seven day period. Free-living physical activity is the general activities of daily living generated by the subjects over the 24 hour day period including sleeping (excluding shower or water immersion)
Intervention code [1] 3280 0
Not applicable
Comparator / control treatment
COPD with no co-morbid physical condition will also undergo the free-living physical activity assessment over a seven day period
Control group
Active

Outcomes
Primary outcome [1] 4628 0
Total energy expenditure using the SenseWear Pro 3 Armband physical activity monitor which will be worn around the right triceps 24 hours a day (removed for shower or water immersion)
Timepoint [1] 4628 0
24 hours a day for seven continuous days (removed only for shower or water immersion)
Secondary outcome [1] 7823 0
Quality of life via SF-36 questionnaire and St George's Respiratory Questionnaire
Timepoint [1] 7823 0
Initial assessment only, i.e. at baseline
Secondary outcome [2] 7824 0
Functional performance via the Functional Performance Inventory questionnaire
Timepoint [2] 7824 0
Initial assessment only, i.e. at baseline

Eligibility
Key inclusion criteria
Confirmed COPD with and without physical co-morbidities (eg. orthopaedic or musculoskeletal conditions affecting the lower limbs of lumbar spine +/- affecting range of motion, neurological conditions with residual effects affecting the lower limbs, obesity)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to understand English
Completed a pulmonary rehabilitation program in the past 12 months
Cognitive decline

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/10/2008
Actual
13/02/2009
Date of last participant enrolment
Anticipated
Actual
19/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3745 0
Charities/Societies/Foundations
Name [1] 3745 0
Physiotherapy Research Foundation
Country [1] 3745 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Barker Street Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 3359 0
University
Name [1] 3359 0
University of Sydney
Address [1] 3359 0
East St Lidcombe NSW 2141
Country [1] 3359 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6003 0
Northern Hospital Network, South Eastern Sydney Illawarra Area Health Service
Ethics committee address [1] 6003 0
Edmund Blackett Building
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Ethics committee country [1] 6003 0
Australia
Date submitted for ethics approval [1] 6003 0
27/07/2007
Approval date [1] 6003 0
25/08/2008
Ethics approval number [1] 6003 0
07/267

Summary
Brief summary
Aim is to determine the overall level of activity generated in everyday living by patients with COPD and co-morbidities compared to a COPD population without co-morbidities. The hypothesis is that people with COPD and co-morbid conditions generate less physical activity in every day living compared to people living with COPD with no co-morbid conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28851 0
Mrs Renae McNamara
Address 28851 0
Physiotherapy, Prince of Wales Hospital, Barker Street Randwick NSW Australia 2031
Country 28851 0
Australia
Phone 28851 0
+61 02 9382 2851
Fax 28851 0
Email 28851 0
[email protected]
Contact person for public queries
Name 12008 0
Mrs Renae McNamara
Address 12008 0
Physiotherapy, Prince of Wales Hospital, Barker St Randwick NSW 2031
Country 12008 0
Australia
Phone 12008 0
0293822851
Fax 12008 0
0293822868
Email 12008 0
[email protected]
Contact person for scientific queries
Name 2936 0
Mrs Renae McNamara
Address 2936 0
Physiotherapy, Prince of Wales Hospital, Barker St Randwick NSW 2031
Country 2936 0
Australia
Phone 2936 0
0293822851
Fax 2936 0
0293822868
Email 2936 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.