Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12612000159853
Ethics application status
Approved
Date submitted
20/12/2011
Date registered
3/02/2012
Date last updated
3/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Seasonal Variation in Postural Balance in Community Dwelling Older Adults in Tasmania
Scientific title
Older adults (over 60 yrs.) longitudinal observational study over time with no intervention measuring physical fall risks and other determinants of balance that may vary seasonally
Secondary ID [1] 279634 0
nil
Universal Trial Number (UTN)
U1111-1126-5665
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fall risk 285434 0
Condition category
Condition code
Musculoskeletal 285615 285615 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Time over a one year period to determine effect of season on physical fall risk factors. Data collected from recruited community dwelling older older adults beween the end of spring 2009 and summer 2010, with participants attending for 5 data collection time points over the study period at approximately 3 monthly intervals (including retest of original season).
Intervention code [1] 283914 0
Not applicable
Comparator / control treatment
Compare baseline and data at the end of each season
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286177 0
Postural Balance using a force platform (measuring medio-lateral sway range) and dynamic balance using the clinical four square step test
Timepoint [1] 286177 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [1] 295311 0
Serum Vitamin D concentrations
Timepoint [1] 295311 0
Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Eligibility
Key inclusion criteria
Community dwelling adults over 60 years of age able to ambulate independently
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed kidney and liver disease, vitmain D supplementation over 800iu/day

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
81
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284412 0
Charities/Societies/Foundations
Name [1] 284412 0
Clifford Craig Medical Research Trust
Country [1] 284412 0
Australia
Funding source category [2] 284413 0
Charities/Societies/Foundations
Name [2] 284413 0
The Physiotherapy Research Fund
Country [2] 284413 0
Australia
Funding source category [3] 284414 0
University
Name [3] 284414 0
The University of Tasmania
Country [3] 284414 0
Australia
Primary sponsor type
University
Name
The University of Tasmania
Address
The School of Human Life Sciences
Locked Bag 1320
Launceston, 7250. TAS
Country
Australia
Secondary sponsor category [1] 283341 0
None
Name [1] 283341 0
Address [1] 283341 0
Country [1] 283341 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286366 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 286366 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart TAS 7001
Ethics committee country [1] 286366 0
Australia
Date submitted for ethics approval [1] 286366 0
02/04/2009
Approval date [1] 286366 0
05/06/2009
Ethics approval number [1] 286366 0
(H0010561).

Summary
Brief summary
Balance impairment is an important fall risk factor and increases in range in postural sway in the medio-lateral direction in older adults are associated with increased fall risk and rates. Multivariate analysis reveals serum vitamin D levels as an independent variable associated with postural sway. In individuals with suboptimal levels of vitamin D, postural sway improves after supplementation, independently of changes to fall rate or number of people falling. Both epidemiological and longitudinal studies have shown that vitamin D levels show seasonal variation. Lowest levels of serum vitamin D are recorded towards the end of winter, approximately four weeks after the shortest day of the year. Fall rates have been shown to decrease post supplementation with vitamin D in older adults with insufficient levels (between 22 and 49nmol/L) (RaR 0.72, 95% CI 0.55 to 0.95). As vitamin D varies seasonally, and is related to postural sway, this study investigates whether postural sway varies seasonally and is related to seasonal changes in vitamin D or fall rate.
Trial website
Trial related presentations / publications
Bird, ML and Hill, K and Robertson, I and Ball, MJ and Williams, AD, ‘Vitamin D status, ankle strength and activity show seasonal variation in older adults: relevance for winter falls in higher latitudes’ Age and Ageing (under review)


Conference Presentations
Bird, ML, Hill, KD, Robertson, IK, Ball, MJ, Pittaway, J & Williams, AD, Are seasonal variations in vitamin D and fall rate associated with changes in balance? Australian Physiotherapy Association Conference, 29 October to 1st November, Brisbane, Australia (2011)

Bird, ML, Hill, KD, Robertson, IK, Ball, MJ, Pittaway, J & Williams, AD Seasonal variation in vitamin D, activity and strength. 9th Asia/Oceania Regional Congress of Gerontology and Geriatrics 23-27th October, Melbourne, Australia (2011)
Public notes

Contacts
Principal investigator
Name 33556 0
Address 33556 0
Country 33556 0
Phone 33556 0
Fax 33556 0
Email 33556 0
Contact person for public queries
Name 16803 0
Marie-Louise Bird
Address 16803 0
The School of Human Life Sciences
The University of Tasmania
Locked Bag 1320
Launceston, TAS 7250
Country 16803 0
Australia
Phone 16803 0
+61 3 63243123
Fax 16803 0
+61 3 63243995
Email 16803 0
[email protected]
Contact person for scientific queries
Name 7731 0
Marie-Louise Bird
Address 7731 0
The School of Human Life Sciences
The University of Tasmania
Locked Bag 1320
Launceston, TAS 7250
Country 7731 0
Australia
Phone 7731 0
+61 3 63243123
Fax 7731 0
+61 3 63243995
Email 7731 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.