ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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]

nil

Universal Trial Number (UTN)

U1111-1126-5665

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Fall risk

Condition category

Condition code

Musculoskeletal

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]

Not applicable

Comparator / control treatment

Compare baseline and data at the end of each season

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Postural Balance using a force platform (measuring medio-lateral sway range) and dynamic balance using the clinical four square step test

Timepoint [1]

Baseline, 3 months, 6 months, 9 months, 12 months

Secondary outcome [1]

Serum Vitamin D concentrations

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Clifford Craig Medical Research Trust

Address [1]

C/- Launceston General Hospital
Charles St
Launceston, 7250, TAS

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

The Physiotherapy Research Fund

Address [2]

Suite 2, 1175 Toorak Rd Camberwell, 3124, VIC

Country [2]

Australia

Funding source category [3]

University

Name [3]

The University of Tasmania

Address [3]

Research Office
Private Bag 1
Hobart, 7001, TAS

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee (Tasmania) Network

Ethics committee address [1]

Office of Research Services
University of Tasmania
Private Bag 1
Hobart TAS 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/04/2009

Approval date [1]

05/06/2009

Ethics approval number [1]

(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

Address

Country

Phone

Fax

Contact person for public queries

Name

Marie-Louise Bird

Address

The School of Human Life Sciences
The University of Tasmania
Locked Bag 1320
Launceston, TAS 7250

Country

Australia

Phone

+61 3 63243123

Fax

+61 3 63243995

birdm@utas.edu.au

Contact person for scientific queries

Name

Marie-Louise Bird

Address

The School of Human Life Sciences
The University of Tasmania
Locked Bag 1320
Launceston, TAS 7250

Country

Australia

Phone

+61 3 63243123

Fax

+61 3 63243995

birdm@utas.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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically