Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001081909
Ethics application status
Approved
Date submitted
18/10/2011
Date registered
19/10/2011
Date last updated
8/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A short-term step training exergame intervention to improve parameters of fall-risk in independent living older people : A pilot randomized controlled study
Scientific title
A short-term step training exergame intervention vs no intervention to improve parameters of fall-risk in independent living older people
Secondary ID [1] 273182 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
accidental falls in older people 278932 0
cognitive function in older people 278933 0
physical function in older people 278934 0
Condition category
Condition code
Injuries and Accidents 279113 279113 0 0
Other injuries and accidents
Mental Health 279114 279114 0 0
Studies of normal psychology, cognitive function and behaviour
Physical Medicine / Rehabilitation 279115 279115 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will play an adapted open source active computer game (exergame) via their TV. A step pad and a computer unit will be provided to them.
While stepping on the step pad subjects interact with the computer. The game idea is to step as accurately as possible in terms of direction and timing. Arrows drift up the screen; when they reach a location on top of screen the subject's task is to step on the corresponding arrow of the step pad.
They will play this game to music but will not step in the rhythm to the music. In addition they will be distracted by other elements on the screen for which their task is not to step.
Participants will be asked to play as many times as they want with the recommended dose of 2-3 sessions per week for 15-20 minutes over a period of 8 weeks. The participants can play more often if they want to.
In addition subjects will be asked to do a choice stepping reaction time task once a week. In this game/test subjects step as quickly as they can in different step directions depending on arrows changing their color on the screen.
The intervention will be unsupervised. Participants will be instructed at the beginning of the study period in their homes when the system will be installed. To control for compliance people will be contacted by phone in week 1, 2, 3 and 6.
Intervention code [1] 269512 0
Prevention
Intervention code [2] 269560 0
Behaviour
Comparator / control treatment
None - during the study period, the control group will follow its usual activities
After this trial is finished the control group will receive the same intervention as the intervention group did.
Control group
Active

Outcomes
Primary outcome [1] 279756 0
Choice Stepping Reaction Time (CSRT) in milliseconds measured using a step pad
Timepoint [1] 279756 0
at baseline and 8-9 weeks after randomization
Secondary outcome [1] 294384 0
Physical/physiological fall-risk assessed by the Physiological Profile Assessment (PPA); this test battery involves 5 tests of different physiological functions involved in postural stability (contrast sensitivity, proprioception lower extremities, strength lower extremities, postural sway, hand reaction time). An overall score is generated from these 5 weighted sub-scores.
Timepoint [1] 294384 0
at baseline and 8-9 weeks after randomization
Secondary outcome [2] 294385 0
Fear of falling is measured by the short version of the Icon-FES, an iconographic questionnaire (10 items).
Timepoint [2] 294385 0
at baseline and 8-9 weeks after randomization
Secondary outcome [3] 294386 0
physical performance measured using the Timed up & go test (TUG), Sit to Stand 5 times (5STS), Alternate Step test (AST), 6m-walk
Timepoint [3] 294386 0
at baseline and 8-9 weeks after randomization
Secondary outcome [4] 294430 0
cognitive functions measured using pen- and paper-based neuropsychological tests as well as newly developed combined tests of stepping and cognition (Stroop test, Trailmaking Test A&B, Digit Symbol Substitution test)
Timepoint [4] 294430 0
at baseline and 8-9 weeks after randomization
Secondary outcome [5] 294492 0
physical activity measured using the Incidental and Planned Exercise Questionnaire (IPEQ)
Timepoint [5] 294492 0
at baseline and 8-9 weeks after randomization

Eligibility
Key inclusion criteria
age>65 years
independent living
ambulant with or without walking aid
able to step unassisted on the step pad
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
cognitive impairment (MMSE<24)
neurodegenerative diseases (e.g. Parkinson)
health problems that affect stepping ability (e.g. acute painful joint inflammation, mobility problems after stroke)
unstable health conditions

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)
A central randomisation by computer will be used. The central randomisation office is remote from participant recruitment centre and participant details will be provided by Email. The person performing the randomisation will not be involved in the clinical part of this study. Screening for eligibility and pre-assessment will be undertaken before randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use block-randomisation to form the allocation for the two comparison groups, using computer-generated random numbers. Couples (participants living in the same household) will be randomised into their own blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/10/2011
Actual
18/10/2011
Date of last participant enrolment
Anticipated
Actual
7/11/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270006 0
Government body
Name [1] 270006 0
NHMRC
Country [1] 270006 0
Australia
Primary sponsor type
Individual
Name
Prof Stephen R Lord
Address
Neuroscience Research Australia
Barker Street, Randwick, NSW 2031
Australia
Country
Australia
Secondary sponsor category [1] 268986 0
Individual
Name [1] 268986 0
Dr Stuart T Smith
Address [1] 268986 0
Neuroscience Research Australia
Barker Street, Randwick, NSW 2031
Australia
Country [1] 268986 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271968 0
Human Research Ethics Committee University of New South Wales
Ethics committee address [1] 271968 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 271968 0
Australia
Date submitted for ethics approval [1] 271968 0
26/05/2011
Approval date [1] 271968 0
03/06/2011
Ethics approval number [1] 271968 0
08351

Summary
Brief summary
One in three people 65 years and older fall each year with consequences for the individual and a high burden for society. Stepping is often the last protective option to prevent a fall. Studies have shown that impaired stepping is prevalent in older people and that impaired stepping is associated with high risk of falls. In this study a low-cost computer game device (dance pad) that enables a human-computer interaction via movements (exergame) will be used to as a home-based interactive step training in independent living older people. This randomised controlled pilot trial aims at improving parameters of fall-risk and physical function. Further aim is to investigate whether this step training to cognitive stimuli on a screen (TV) can improve parameters of cognitive function.
This study proposes to test the hypothesis that: a short-term volitional step training intervention using a dance pad can significantly improve risk factors for falls as well as measures of cognition in independent living older people.
The intervention will last 8 weeks and participants are asked to play a game of step co-ordination at least 2-3 times per week for 15 to 20 minutes and to do a choice stepping reaction time task once a week. People in the control group will maintain their usual activities.
Primary outcome measure will be the choice stepping reaction time (CSRT). Further outcomes are the Physiological Profile Assessment (PPA), tests of combined motor and cognitive function, tests of physical performance, tests of cognitive functions, and a iconographic measure of Fear of Falling.
Trial website
Trial related presentations / publications
Schoene D, Lord SR, Delbaere K, Severino C, Davies TA, Smith ST. A randomized controlled pilot study of home-based step training in older people using videogame technology. PLoS One. 2013;8(3):e57734. doi: 10.1371/journal.pone.0057734.
Public notes

Contacts
Principal investigator
Name 33252 0
Prof Stephen R Lord
Address 33252 0
Neuroscience Research Australia
Falls and Balance Research Group
Barker St
Randwick, NSW 2031
Country 33252 0
Australia
Phone 33252 0
+61 2 9399 1061
Fax 33252 0
Email 33252 0
s.lord@neura.edu.au
Contact person for public queries
Name 16499 0
Prof Stephen R Lord
Address 16499 0
Neuroscience Research Australia
Barker Street, Randwick, NSW 2031
Country 16499 0
Australia
Phone 16499 0
+61 2 9399 1061
Fax 16499 0
+61 2 9399 1204
Email 16499 0
s.lord@neura.edu.au
Contact person for scientific queries
Name 7427 0
Prof Stephen R Lord
Address 7427 0
Neuroscience Research Australia
Barker Street, Randwick, NSW 2031
Country 7427 0
Australia
Phone 7427 0
+61 2 9399 1061
Fax 7427 0
+61 2 9399 1204
Email 7427 0
s.lord@neura.edu.au

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