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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.
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Scientific title
Investigating the effects of daily fatigue on balance and other fall risk factors in older people.
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Secondary ID [1]
287182
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Accidental falls
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Balance control
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Fatigue
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Condition category
Condition code
Physical Medicine / Rehabilitation
296027
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0
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Other physical medicine / rehabilitation
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Injuries and Accidents
296305
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Behaviour
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Intervention code [2]
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Lifestyle
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Intervention code [3]
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Prevention
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Comparator / control treatment
no treatment (restful day)
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
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Primary outcome [2]
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Perceived fatigue levels using the Visual Analogue Scale for Fatigue.
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Assessment method [2]
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Timepoint [2]
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Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
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Primary outcome [3]
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Coordinated stability – a measure of dynamic balance while standing
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Assessment method [3]
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Timepoint [3]
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Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
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Secondary outcome [1]
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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)
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Assessment method [1]
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Timepoint [1]
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Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
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Secondary outcome [2]
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Upper body strength measured using a grip strength dynamometer
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Assessment method [2]
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Timepoint [2]
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Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
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Secondary outcome [3]
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Gait velocity measured using an electronic walkway
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Assessment method [3]
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Timepoint [3]
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Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
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Secondary outcome [4]
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Mobility measured with the Timed up and Go test.
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Assessment method [4]
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Timepoint [4]
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Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
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Secondary outcome [5]
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Choice Stepping Reaction Time Performance using a computerised stepping mat
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Assessment method [5]
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Timepoint [5]
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Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
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Secondary outcome [6]
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Digit symbol test of executive function
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Assessment method [6]
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Timepoint [6]
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Start (9am) and end (4pm) of both the busy (intervention) and restful (control) days.
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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.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/05/2015
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Actual
11/05/2015
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Date of last participant enrolment
Anticipated
31/10/2015
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NHMRC Program Grant APP1055084. Gandevia S, Lord S, Herbert R, Taylor J. Motor impairment: basic and applied human neurophysiology. 2014-2018.
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Address [1]
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National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Dr Daina Sturnieks
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Address
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Professor Stephen Lord
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Address [1]
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Neuroscience Research Australia Margarete Ainsworth Building Barker Street Randwick NSW 2031
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of New South Wales Ethics Committee
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Ethics committee address [1]
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UNSW Research Ethics & Compliance Support Level 3, Rupert Myers Building (South) The University of New South Wales Sydney NSW 2052
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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29/10/2014
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Approval date [1]
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16/12/2014
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Ethics approval number [1]
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HC14340
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Summary
Brief summary
Fatigue can impair standing balance and functional task performance in older people. We have recently found that general fatigue (induced by repeated sit-to-stand movements as fast as possibly until exhaustion) impaired movement control and foot positioning before and after negotiation of low-level obstacles in older people while walking. However, it is not known whether more ecological aspects of general fatigue may similarly impair balance and mobility and increase the risk of falling in older people. This study will determine whether a busy day of physical activity ("real world" fatigue) impacts balance and mobility measures in older people, compared to a more restful day.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Daina L Sturnieks
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Address
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Neuroscience Research Australia Margarete Ainsworth Building Barker Street Randwick NSW 2031
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Country
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Australia
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Phone
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+61293991062
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Fax
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Email
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d.sturnieks@neura.edu.au
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Contact person for public queries
Name
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Daina L Sturnieks
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Address
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Neuroscience Research Australia Margarete Ainsworth Building Barker Street Randwick NSW 2031
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Country
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Australia
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Phone
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+61293991062
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Fax
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Email
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d.sturnieks@neura.edu.au
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Contact person for scientific queries
Name
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Daina L Sturnieks
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Address
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Neuroscience Research Australia Margarete Ainsworth Building Barker Street Randwick NSW 2031
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Country
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Australia
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Phone
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+61293991062
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Fax
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Email
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d.sturnieks@neura.edu.au
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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
Source
Title
Year of Publication
DOI
Embase
A busy day has minimal effect on factors associated with falls in older people: An ecological randomised crossover trial.
2018
https://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.
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