Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000123842
Ethics application status
Approved
Date submitted
25/01/2012
Date registered
25/01/2012
Date last updated
27/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in bone structure, lean mass, and glucose metabolism after stroke: a prospective study
Scientific title
Changes in bone structure, lean mass, and glucose metabolism in people with stroke: a two year observation study
Secondary ID [1] 279784 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Stroke 4587 0
bone structure and density 4588 0
glucose metabolism 4589 0
Condition category
Condition code
Stroke 285843 285843 0 0
Ischaemic
Stroke 285844 285844 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a two year longitudinal, observation study of changes to bone density and structure, body composition and glucose metabolism after stroke
Intervention code [1] 4352 0
Not applicable
Comparator / control treatment
Observational study - not controlled (however, primary outcome results will be compared to 'normal' population age matched controls where possible)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5735 0
Bone structure and volumetric bone mineral density of paretic and non-paretic side radius and tibia, measured by high resolution peripheral quantitative computed tomography (pQCT)
Timepoint [1] 5735 0
Baseline (within 2 weeks of stroke), 6-, 12-,18- and 24 months
Primary outcome [2] 5736 0
Body composition: total body and regional bone mineral density and fat/ muscle mass measured by dual-energy xray absorptiometry (DXA)
Timepoint [2] 5736 0
Baseline, 1-, 3-, 6-, 12-, 18- and 24- months
Secondary outcome [1] 241680 0
Glucose tolerance measured by two hour oral glucose tolerance test
Timepoint [1] 241680 0
Baseline, 6-, 12-,18- and 24 months
Secondary outcome [2] 241681 0
Physical activity monitoring (PAL2 accelerometer)
Timepoint [2] 241681 0
Baseline, 1-, 3-, 6-, 12-, 18- and 24- months
Secondary outcome [3] 241682 0
Blood markers of bone resorption and formation, including osteocalcin, C-telopeptide (CTX), pro-collagen type 1 n-terminal propeptide (PINP)
Timepoint [3] 241682 0
Baseline, 1-, 3-, 6-, 12-, 18- and 24- months
Secondary outcome [4] 241683 0
Physical assessment of muscle strength (hand held dynamometry), muscle tone (modified ashworth scale, motor control (Chedoke McMaster Stroke Assessment ), arm use (Motor Activity Log), walking ability (Functional Ambulation Category)
Timepoint [4] 241683 0
Baseline, 1-, 3-, 6-, 12-, 18- and 24- months

Eligibility
Key inclusion criteria
The inclusion criteria are (1) a diagnosis of hemispheric stroke , (2) onset of stroke <1 week, (3) medically stable, (4) unable to ambulate within the first week after stroke, (5) able to understand simple verbal commands.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) brainstem or cerebellar stroke, (2) previous stroke in addition to the current admission, (3) known type 1 or type 2 diabetes (4) neurological conditions other than stroke (e.g. Parkinson’s disease) (5) significant musculoskeletal condition impacting on function (e.g. amputation, severe arthritis), (6) current or recent use of bone resorption inhibitors

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284569 0
Hospital
Name [1] 284569 0
Austin Health Medical Research Fund
Country [1] 284569 0
Australia
Funding source category [2] 284570 0
University
Name [2] 284570 0
LaTrobe University Faculty of Health Sciences
Country [2] 284570 0
Australia
Funding source category [3] 284571 0
Government body
Name [3] 284571 0
Australian Research Council
Country [3] 284571 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Florey Neuroscience Institutes
Address
Melbourne Brain Centre
245 Burgundy St
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 283489 0
University
Name [1] 283489 0
Melbourne University Department of Medicine
Address [1] 283489 0
Endocrince Centre of Excellence
Level 2 Centaur Building
Austin Health
Repatriation Campus
Waterdale Road
West Heidelberg, Victoria 3081
Country [1] 283489 0
Australia
Other collaborator category [1] 260475 0
University
Name [1] 260475 0
Hong Kong Polytechnic University
Address [1] 260475 0
Dept of Rehabilitation Sciences
Hong Kong Polytechnic University
Hung Hom
Kowloon
Country [1] 260475 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286556 0
Austin Health Human Ethics Committee
Ethics committee address [1] 286556 0
Ethics committee country [1] 286556 0
Australia
Date submitted for ethics approval [1] 286556 0
Approval date [1] 286556 0
01/04/2009
Ethics approval number [1] 286556 0
H2009/03428
Ethics committee name [2] 286557 0
LaTrobe University Human Ethics Committee
Ethics committee address [2] 286557 0
Ethics committee country [2] 286557 0
Australia
Date submitted for ethics approval [2] 286557 0
Approval date [2] 286557 0
21/12/2009
Ethics approval number [2] 286557 0

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

Contacts
Principal investigator
Name 29482 0
Address 29482 0
Country 29482 0
Phone 29482 0
Fax 29482 0
Email 29482 0
Contact person for public queries
Name 12729 0
Ms Karen Borschmann
Address 12729 0
Stroke Division
Florey Neuroscience Institutes
Melbourne Brain Centre
245 Burgundy St
Heidelberg 3084
Vic
Country 12729 0
Australia
Phone 12729 0
+61 3 9035 7073
Fax 12729 0
+61 3 9496 2251
Email 12729 0
[email protected]
Contact person for scientific queries
Name 3657 0
Prof Julie Bernhardt
Address 3657 0
Stroke Division
Florey Neuroscience Institutes
Melbourne Brain Centre
245 Burgundy St
Heidelberg 3084
Vic
Country 3657 0
Australia
Phone 3657 0
+61 3 9035 7073
Fax 3657 0
+61 3 9496 2251
Email 3657 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
SourceTitleYear of PublicationDOI
EmbaseChanges to volumetric bone mineral density and bone strength after stroke: A prospective study.2015https://dx.doi.org/10.1111/ijs.12228
EmbaseUpright activity and higher motor function may preserve bone mineral density within 6 months of stroke: a longitudinal study.2018https://dx.doi.org/10.1007/s11657-017-0414-4
EmbaseRecovery of upper limb function is greatest early after stroke but does continue to improve during the chronic phase: a two-year, observational study.2020https://dx.doi.org/10.1016/j.physio.2019.10.001
N.B. These documents automatically identified may not have been verified by the study sponsor.