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Trial registered on ANZCTR


Registration number
ACTRN12615000916549
Ethics application status
Approved
Date submitted
21/08/2015
Date registered
2/09/2015
Date last updated
2/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the effects of daily fatigue on balance and other fall risk factors in older people.
Scientific title
Investigating the effects of daily fatigue on balance and other fall risk factors in older people.
Secondary ID [1] 287182 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental falls 295750 0
Balance control 296029 0
Fatigue 296030 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296027 296027 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 296305 296305 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to attend the falls and balance laboratory at NeuRA before and after a planned busy day and planned restful day, presented in a random order, at least one week apart.
For the busy day, participants will be asked to schedule several daily activities (based on their estimates of the busiest days they have) into the one day, between 10am and 4pm.
For the relaxing day, participants will be asked to schedule few daily activities (based on their most relaxing days), between 10am and 4pm.
Participants will be asked to wear an activity monitor on each of the busy day and the restful day, to quantify the amount of time sitting, standing and moving.
Intervention code [1] 292454 0
Behaviour
Intervention code [2] 292699 0
Lifestyle
Intervention code [3] 292700 0
Prevention
Comparator / control treatment
no treatment (restful day)
Control group
Active

Outcomes
Primary outcome [1] 295696 0
Composite falls risk score measured using the Physiological Profile Assessment which includes measures of: vision, knee extensor strength, lower limb proprioception (joint matching task), simple reaction time (finger press) and postural sway when standing on a compliant surface.
Timepoint [1] 295696 0
Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
Primary outcome [2] 295697 0
Perceived fatigue levels using the Visual Analogue Scale for Fatigue.
Timepoint [2] 295697 0
Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
Primary outcome [3] 295731 0
Coordinated stability – a measure of dynamic balance while standing
Timepoint [3] 295731 0
Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
Secondary outcome [1] 316247 0
Executive function (visuomotor tracking, divided attention) measured using the Trail making tests A and B: difference in execution time (to remove the motor/speed component)
Timepoint [1] 316247 0
Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
Secondary outcome [2] 316248 0
Upper body strength measured using a grip strength dynamometer
Timepoint [2] 316248 0
Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
Secondary outcome [3] 316249 0
Gait velocity measured using an electronic walkway
Timepoint [3] 316249 0
Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
Secondary outcome [4] 316250 0
Mobility measured with the Timed up and Go test.
Timepoint [4] 316250 0
Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
Secondary outcome [5] 316347 0
Choice Stepping Reaction Time Performance using a computerised stepping mat
Timepoint [5] 316347 0
Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
Secondary outcome [6] 316348 0
Digit symbol test of executive function
Timepoint [6] 316348 0
Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.

Eligibility
Key inclusion criteria
People will be eligible if they are 65 years or older and do
not have acute or chronic disorders that affect either their stepping or their cognitive performance.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to stand unassisted, have a significant visual, cognitive or neurological impairment (including Dementia, Alzheimer's Disease, Parkinson's Disease or Multiple Sclerosis) or have insufficient English language skills to understand the assessment procedure.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
50 older adult participants will be recruited. This sample size is consistent with previously published experimental
studies of fatigue in older people [1,2], including our own work, which found significant reduction in leg strength
(10%) associated with differences in gait control between pre and post fatigue assessments [3].
1. U. Granacher, I. Wolf, A. Wehrle, S. Brindenbaugh, R. Kressig. Effects of muscle fatigue on gait
characteristics under single and dual-task conditions in young and older adults, Journal of
NeuroEngineering and Rehabilitation, 2010;7(56).
2. J. Helbostad, S. Leirfall, R. Moe-Nilssen, O. Sletvold. Physical fatigue affects gait characteristics in older
persons. Journals of Gerontology. Series A, Biological Sciences and Medical Sciences, 2007;62A(9):
1010–1015.
3. Hatton AL, Menant JC, Lord SR, Lo JC, Sturnieks DL The effect of lower limb muscle fatigue on obstacle
negotiation during walking in older adults. Gait Posture. 2013;37(4):506-10.

Continuously scored measures will be analysed using repeated measures analysis of variance models with time (pre versus post) and interventions (rest versus active day) as the within-subject factors.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2015
Actual
11/05/2015
Date of last participant enrolment
Anticipated
31/10/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291827 0
Government body
Name [1] 291827 0
NHMRC Program Grant APP1055084. Gandevia S, Lord S, Herbert R, Taylor J. Motor impairment: basic and applied
human neurophysiology. 2014-2018.
Country [1] 291827 0
Australia
Primary sponsor type
Individual
Name
Dr Daina Sturnieks
Address
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031

Country
Australia
Secondary sponsor category [1] 290490 0
Individual
Name [1] 290490 0
Professor Stephen Lord
Address [1] 290490 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031

Country [1] 290490 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293351 0
University of New South Wales Ethics Committee
Ethics committee address [1] 293351 0
Ethics committee country [1] 293351 0
Australia
Date submitted for ethics approval [1] 293351 0
29/10/2014
Approval date [1] 293351 0
16/12/2014
Ethics approval number [1] 293351 0
HC14340

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

Contacts
Principal investigator
Name 59170 0
Dr Daina L Sturnieks
Address 59170 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country 59170 0
Australia
Phone 59170 0
+61293991062
Fax 59170 0
Email 59170 0
d.sturnieks@neura.edu.au
Contact person for public queries
Name 59171 0
Daina L Sturnieks
Address 59171 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country 59171 0
Australia
Phone 59171 0
+61293991062
Fax 59171 0
Email 59171 0
d.sturnieks@neura.edu.au
Contact person for scientific queries
Name 59172 0
Daina L Sturnieks
Address 59172 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country 59172 0
Australia
Phone 59172 0
+61293991062
Fax 59172 0
Email 59172 0
d.sturnieks@neura.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
SourceTitleYear of PublicationDOI
EmbaseA busy day has minimal effect on factors associated with falls in older people: An ecological randomised crossover trial.2018https://dx.doi.org/10.1016/j.exger.2018.03.009
N.B. These documents automatically identified may not have been verified by the study sponsor.