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Trial registered on ANZCTR


Registration number
ACTRN12613000671763
Ethics application status
Approved
Date submitted
13/06/2013
Date registered
20/06/2013
Date last updated
20/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
SureStep – An inter-active step training program to improve physical and cognitive functioning in independent living older people
Scientific title
An interactive step training intervention vs no intervention to improve physical and cognitive functioning, in independent living older people: A randomized controlled trial
Secondary ID [1] 282416 0
Nil
Universal Trial Number (UTN)
Trial acronym
SureStep
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical function
289000 0
cognitive function
289001 0
falls 289002 0
Condition category
Condition code
Other 289346 289346 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Mental Health 289347 289347 0 0
Studies of normal psychology, cognitive function and behaviour
Injuries and Accidents 289348 289348 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A step training system will be provided to participants. This will consist of a computer unit, a dongle and a step pad. The participant’s TV will be used for the display screen. The dongle will be plugged into the computer and link with the step pad. In addition, a USB modem will be provided to enable the upload of data to a central server via the internet.

Intervention participants will play the exergames (exercise + video games) by giving step responses on the pad. Several games will be played: a modified version of Tetris (rotation of down-drifting objects), a choice stepping reaction time task (rapid stepping), Dance Dance Revolution (step coordination including go/no-go tasks and tasks of divided attention), and a Trail-Stepping task (set-shifting). In all games, participants are required to step after or while solving cognitive tasks thus combining balance training and cognitive exercises. They will receive feedback about their performance.

Participants will be asked to play as many times as they want with the recommended dose of 3 or more sessions per week for 20 minutes for a period of 3 months.

The intervention will be unsupervised and participants will exercise in their own homes. Instructions will be provided at the beginning of the study period when the system is installed. To encourage adherence, participants will be contacted by phone after weeks 1, 4, 8, 12 or if data upload shows non-adherence in between (non-use of the system for 5 days). In addition participants will be provided with a phone number to call if they have questions or problems related to system.
Intervention code [1] 287051 0
Prevention
Comparator / control treatment
Participants in the control group will be provided with written health advice at the beginning of the trial and asked to maintain their usual activities. Participants will be provided with a phone number which they can call if they have questions or problems related to content of the educational material.
Control group
Active

Outcomes
Primary outcome [1] 289457 0
Physical/physiological fall-risk assessed by the Physiological Profile Assessment (PPA); this assessment involves tests of contrast sensitivity, lower limb proprioception, knee extension strength, postural sway and simple reaction time. An overall score is generated from these 5 sub-scores with higher scores indicate a higher fall risk.
Timepoint [1] 289457 0
3 months (end of intervention)
Primary outcome [2] 289479 0
The Stroop Stepping Test (SST) will be used as a measure of combined stepping and executive functioning. In the centre of a display screen an arrow appears pointing in one of four directions (front, right, back, left). Inside this arrow is a written word indicating a different direction. Participants are required to step by the word and ignore the orientaion of the arrow.
Timepoint [2] 289479 0
after 3 months
Secondary outcome [1] 302532 0
Concern about falling will be assessed with the Icon-FES. Using an iconographic questionnaire, pictures are presented and participants are required to rate their concern of having a fall while doing particular activities on a 4 point Likert scale. Higher scores indicate higher concern.
Timepoint [1] 302532 0
after 3 months
Secondary outcome [2] 302570 0
Depressive symptoms will be measured using the 9 item Patient Health Questionnaire (PHQ-9). Different cutpoints for different levels of depressive symptoms/clinical depression have been established. Higher scores indicate an increased likelihood of depression.
Timepoint [2] 302570 0
after 3 months
Secondary outcome [3] 302571 0
Specific cognitive functions will be assessed using a range of neuropsychological tests.
The Trailmaking Test will be used to assess attention and executive functioning (set-shifting). Participants are required to connect numbers (A) or alternating numbers and letters (B) in ascending order. The difference score (Trails B minus Trails A) will also be taken to provide a measure of executive functioning removing the motor speed component.
The digit symbol test assesses processing speed and working memory. Participants are required to match symbols to numbers as quickly as possible.
The attentional network test will be used to measure three independent networks of attention (orienting, alerting and executive function). During this reaction time test paradigm, participants respond with button presses to arrow directions. Different stimuli (simple arrows, sets of five arrows, flanker tasks) and cueing (no cueing, spatial cueing, timed cueing) are used.
The Stroop task measures selective attention and response inhibition using the interference of different colour-word presentations.
To measure visuo-spatial performance, a mental rotation task will be used. Participants are required to determine whether shapes that are rotated clockwise/anti-clockwise are the same or different shapes.
A dual task will be used to assess divided attention. The Timed up and go test (see below) will be administered with a concurrent cognitive task.
Timepoint [3] 302571 0
after 3 months
Secondary outcome [4] 302572 0
Functional mobility will be assessed using the Timed up and go test (TUG) and Sit-to-stand test. The TUG requires participants to stand up from a normal height armed chair, walk three meters at a self-selected comfortable walking speed, turn, walk back and sit down again. The time to complete the test is recorded. The Sit-to-Stand test requires participants to stand up and sit down five times as fast as possible from a normal height chair with their arms crossed over the chest.
Timepoint [4] 302572 0
after 3 months
Secondary outcome [5] 302573 0
Choice Stepping Reaction Time (CSRT) will be assessed using the same step pad as used in the intervention. Participants step as quickly as they can in different step directions indicated by arrows changing their color on the screen.
Timepoint [5] 302573 0
after 3 months
Secondary outcome [6] 302574 0
To test reactive stepping responses the Push and Release test will be used. Participants are required to lean backwards and push against the hands of the assessor. The assessor suddenly releases his hands and observes the stepping response of participants to recover balance. Recovery is rated on a scale from 0 (one sufficiently large step to recover balance) to 4 (no step response).
Timepoint [6] 302574 0
after 3 months
Secondary outcome [7] 302687 0
Falls data will be acquired using falls calendars and the ProFaNE definiton for falls.
Timepoint [7] 302687 0
monthly falls calendars (with follow-up telephone calls as required) for 6 months from randomisation

Eligibility
Key inclusion criteria
age greater than or equal to 70 years
ambulant with or without walking aids
able to step unassisted (no assistive devices or personal support) on step pad
no major cognitive impairment (Mini-Cog >=3)
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
unable to understand instructions (non-english speaking background)
health problems that affect stepping ability (e.g. acute painful joint inflammation, mobility problems after stroke)
unstable health conditions
neurodegenerative disease
blind or colour-blind
no HDMI source on TV

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 sites and participant details will be provided by Email. The person performing the randomisation will not be involved in any other aspects 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)
Permuted block-randomisation using computer-generated random numbers will be used. Couples (participants living in the same household) will be randomised into their own blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
between-group:

Differences at baseline will be explored using Chi square (discrete variables) and Student t-tests (continuous variables).
Analysis of Covariance (ANCOVA) will be used to analyse group differences for all continuous outcome variables adjusting for baseline performance. Negative binomial regression will be used to test for differences in fall rates between groups.

The Alpha level will be set to 5%.

within-group:

Paired t-tests and repeated measures ANOVA will be used to analyse changes within groups and to explore subgroups (e.g. different doses) in the intervention group.

The estimated sample size is based on the effects of a pilot study for the Stroop Stepping Test as outcome measure (effect size f=0.3443374, ANCOVA, Alpha 5%, Power 80%, Numerator df 1, Number of groups 2, Number of covariates 1 (same variable at baseline, 20% drop out).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
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)
NSW

Funding & Sponsors
Funding source category [1] 287190 0
Government body
Name [1] 287190 0
National Health and Medical Research Council
Address [1] 287190 0
GHD Building Level 1, 16 Marcus Clarke St
Canberra ACT 2601
Country [1] 287190 0
Australia
Primary sponsor type
Individual
Name
Stephen R Lord
Address
Neuroscience Research Australia
Barker Street, Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 285951 0
Individual
Name [1] 285951 0
Stuart T Smith
Address [1] 285951 0
Neuroscience Research Australia
Barker Street, Randwick, NSW 2031
Country [1] 285951 0
Australia
Secondary sponsor category [2] 285952 0
Individual
Name [2] 285952 0
Daniel Schoene
Address [2] 285952 0
Neuroscience Research Australia
Barker Street, Randwick, NSW 2031
Country [2] 285952 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289184 0
Human Research Ethics Committee University of New South Wales
Ethics committee address [1] 289184 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] 289184 0
Australia
Date submitted for ethics approval [1] 289184 0
26/05/2011
Approval date [1] 289184 0
03/06/2011
Ethics approval number [1] 289184 0
08351

Summary
Brief summary
With advanced ageing, physical and cognitive functions decline and these age-related changes increase the risk of falls. Above the age of 65 years, about one third of individuals experience at least one fall every year with about half of those who fall in this period do so multiple times.

As stepping and specific cognitive functions are risk factors for falls in older people, this study aims at improving these functions to reduce risk.

In this randomised controlled trial, participants will use low-cost computer game technology to play a range of games that combine stepping and specific cognitive functions. Earlier studies have shown that this intervention type and mode of delivery is feasible and safe. In this phase III trial, participants will be recommended to perform the exergames three or more times per week for 20 minutes for a period of three months.

At the end of the trial, physical and cognitive functions associated with fall risk will be assessed. Falls will also be recorded over a period of six months. Using this novel approach of delivery, we hypothesize that playing exergames can improve both physical and cognitive functioning and reduce the risk of falls.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39650 0
Prof Stephen R Lord
Address 39650 0
Neuroscience Research Australia
Falls and Balance Research Group
Barker St
Randwick, NSW 2031
Country 39650 0
Australia
Phone 39650 0
+61 2 9399 1061
Fax 39650 0
Email 39650 0
s.lord@neura.edu.au
Contact person for public queries
Name 39651 0
Prof Stephen R Lord
Address 39651 0
Neuroscience Research Australia
Falls and Balance Research Group
Barker St
Randwick, NSW 2031
Country 39651 0
Australia
Phone 39651 0
+61 2 9399 1061
Fax 39651 0
Email 39651 0
s.lord@neura.edu.au
Contact person for scientific queries
Name 39652 0
Prof Stephen R Lord
Address 39652 0
Neuroscience Research Australia
Falls and Balance Research Group
Barker St
Randwick, NSW 2031
Country 39652 0
Australia
Phone 39652 0
+61 2 9399 1061
Fax 39652 0
Email 39652 0
s.lord@neura.edu.au

No information has been provided regarding IPD availability
Summary results
No Results