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Trial registered on ANZCTR


Registration number
ACTRN12616001325493
Ethics application status
Approved
Date submitted
12/09/2016
Date registered
22/09/2016
Date last updated
27/06/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of cognitive and cognitive-motor training on falls in older people
Scientific title
A randomised controlled trial on the effect of cognitive-only and cognitive-motor training on falls in older people: understanding physical, neuropsychological and neural mechanisms
Secondary ID [1] 290112 0
NHMRC 1086804
Universal Trial Number (UTN)
Trial acronym
smart+/-step
Linked study record

Health condition
Health condition(s) or problem(s) studied:
accidental falls 299126 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299144 299144 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 299145 299145 0 0
Other injuries and accidents
Public Health 299146 299146 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves home-based cognitive or motor+cognitive training in community dwelling older people. Participants will be randomised to one of 3 arms for a 12-month intervention duration. Arm 1 involves cognitive training (seated computer games) for 120 minutes per week . Arm 2 involves cognitive-motor training (playing computer games with the feet while standing and stepping) for 120 minutes per week. Arm 3 is the no-intervention control.

The training interventions (arms 1 and 2) involve home-based training with a custom built system of software (user interface and games), operating on a supplied personal computer and response device (touch pad for arm 1 or stepping mat for arm 2). Following a 1-hour session of instruction and safety check with a trained research assistant, participants will be asked to undertake training unsupervised in their home. Participants will receive a follow-up home visit at 4 weeks (~1 hour) to ensure safe use and progression of training and discuss any issues related to using the program (with the exception of those participants who were deemed safe at the first visit, are fully compliant in the first 4 weeks and report that they do not require a second visit, for whom a telephone call will replace the 4 week home visit).


Upon trial commencement, arm 1 and 2 participants will be instructed to gradually increase their training dose from 40 min per week (week 1,2), to 60 min (week 3,4), 80 min (week 5,6), 100 min (week 7, 8) and 120 min from week 9 onwards.

The training will be recommended to be split over 3 or 4 sessions during the week and compliance will be monitored via data transfer to a web application. Participants not engaging in the minimum weekly training dose (80 mins) for 2 consecutive weeks will be contacted by telephone to discuss any issues and to encourage adherence.

Intensity and progression of intensity of training will be adjusted as performance improves and the participant moves through the inbuilt game levels. Support will be provided by telephone and additional home visits from the research staff may be requested for those experiencing difficulty.

Intervention group participants will also receive a custom-designed 10-page booklet containing health-related information relevant to older adults (e.g. healthy eating, exercise, hydration, mental health, bone and joint health).
Intervention code [1] 295029 0
Prevention
Intervention code [2] 295897 0
Treatment: Devices
Comparator / control treatment
Control group participants will receive a custom-designed 10-page booklet containing health-related information relevant to older adults (e.g. healthy eating, exercise, hydration, mental health, bone and joint health). The control group will receive telephone calls instead of home visits.
Control group
Active

Outcomes
Primary outcome [1] 298631 0
The rate of falling in each group: Falls will be monitored with supplied monthly fall diaries returned via mail.
Timepoint [1] 298631 0
monthly from baseline to 12 months after baseline assessment
Secondary outcome [1] 324809 0
Standing balance (postural sway) will be measured in a random subsample of 300 participants (100 per group), while standing on on a foam rubber mat, using a swaymeter that records displacements of the body at the level of the pelvis for 30 seconds,
Timepoint [1] 324809 0
6 months after baseline assessment
Secondary outcome [2] 324810 0
Stepping performance (speed and errors) using the choice stepping reaction time test with and without additional cognitive tasks of inhibition (go/no-go) and conflict resolution (stroop), in a random subsample of 300 participants (100 per group).
Timepoint [2] 324810 0
6 months after baseline assessment
Secondary outcome [3] 324811 0
Gait velocity will be measured in a random subsample of 300 participants (100 per group), with a GAITRite mat (CIR Systems Inc. Clifton, NJ) under single- and dual-task conditions.
Timepoint [3] 324811 0
6 months after baseline assessment
Secondary outcome [4] 324812 0
The Timed Up & Go test of mobility in a random subsample of 300 participants (100 per group).
Timepoint [4] 324812 0
6 months after baseline assessment
Secondary outcome [5] 324813 0
Simple hand reaction time will be measured in a random subsample of 300 participants (100 per group), seated using a light as the stimulus and a finger-press as the response.
Timepoint [5] 324813 0
6 months after baseline assessment
Secondary outcome [6] 324814 0
Leaning balance will be measured in a random subsample of 300 participants (100 per group), using the maximal balance range and coordinated stability test
Timepoint [6] 324814 0
6 months after baseline assessment
Secondary outcome [7] 324957 0
Trail Making Test of executive function in a random subsample of 300 participants (100 per group).
Timepoint [7] 324957 0
6 months after baseline assessment
Secondary outcome [8] 324958 0
Stroop test, a composite measure of attention and response inhibition, will be assessed in a random subsample of 300 participants (100 per group).
Timepoint [8] 324958 0
6 months after baseline assessment
Secondary outcome [9] 324959 0
Controlled Oral Word Association Test of semantic/verbal fluency in a random subsample of 300 participants (100 per group).
Timepoint [9] 324959 0
6 months after baseline assessment
Secondary outcome [10] 324960 0
Digit Span test of working memory in a random subsample of 300 participants (100 per group).
Timepoint [10] 324960 0
6 months after baseline assessment
Secondary outcome [11] 324961 0
The Wisconsin Card Sorting Test of set shifting will be undertaken in a random subsample of 300 participants (100 per group).
Timepoint [11] 324961 0
6 months after baseline assessment
Secondary outcome [12] 324962 0
The Addenbrooke's Cognitive Examination Revised test of global cognition in a random subsample of 300 participants (100 per group).
Timepoint [12] 324962 0
6 months after baseline assessment
Secondary outcome [13] 324963 0
Brain structural plasticity assessed via structural MRI in a subsample of 105 participants (35 per group).
Timepoint [13] 324963 0
6 months after baseline assessment
Secondary outcome [14] 324964 0
White matter plasticity determined with Diffusion Tractography Imaging in a subsample of 105 participants (35 per group).
Timepoint [14] 324964 0
6 months after baseline assessment
Secondary outcome [15] 324965 0
Brain functional network plasticity assessed using resting state fMRI in a subsample of 105 participants (35 per group).
Timepoint [15] 324965 0
6 months after baseline assessment
Secondary outcome [16] 324966 0
Brain neurometabolic changes assessed with 1H-Magnetic Resonance Spectroscopy in a subsample of 105 participants (35 per group).
Timepoint [16] 324966 0
6 months after baseline assessment
Secondary outcome [17] 324968 0
Concern about falling will be assessed with the icon-FES mobile application
Timepoint [17] 324968 0
6 months after baseline assessment
Secondary outcome [18] 327663 0
Pattern separation memory test in a random subsample of 105 participants (35 per group).
Timepoint [18] 327663 0
6 months after baseline assessment
Secondary outcome [19] 327664 0
Quality of life assessed using the EuroQol EQ-5D
Timepoint [19] 327664 0
6 and 12 months after baseline assessment
Secondary outcome [20] 327665 0
Cost-effectiveness of the intervention measured by intervention and medical costs
Timepoint [20] 327665 0
12 months after baseline assessment
Secondary outcome [21] 327692 0
Gait variability will be measured in a random subsample of 300 participants (100 per group), with a GAITRite mat (CIR Systems Inc. Clifton, NJ) under single- and dual-task conditions in a random subsample of 300 participants (100 per group).
Timepoint [21] 327692 0
6 months after baseline assessment
Secondary outcome [22] 327773 0
The Short Physical Performance Battery in a random subsample of 300 participants (100 per group).
Timepoint [22] 327773 0
6 months after baseline assessment
Secondary outcome [23] 327774 0
Gait step length will be measured in a random subsample of 300 participants (100 per group), with a GAITRite mat (CIR Systems Inc. Clifton, NJ) under single- and dual-task conditions.
Timepoint [23] 327774 0
6 months after baseline assessment in
Secondary outcome [24] 327857 0
Gait double support time will be measured in a random subsample of 300 participants (100 per group), with a GAITRite mat (CIR Systems Inc. Clifton, NJ) under single- and dual-task conditions.
Timepoint [24] 327857 0
6 months after baseline assessment
Secondary outcome [25] 340673 0
The rate of falling in each group per physical activity unit: Falls will be monitored with supplied monthly fall diaries returned via mail. Physical activity will be measured with Incidental and Planned Exercise Questionnaire (IPEQ).
Timepoint [25] 340673 0
12 months after baseline assessment.
Secondary outcome [26] 365420 0
The proportion of fallers in each group: Falls will be monitored with supplied monthly fall diaries returned via mail.
Timepoint [26] 365420 0
monthly from baseline to 12 months after baseline assessment

Eligibility
Key inclusion criteria
- Aged 65 years and older
- Community-dwelling
- Independent in activities of daily living;
- English-speaking
- Able to walk 10m without the use of a walking aid
- Willingness to give informed consent and comply with the study protocol
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Cognitive impairment (Pfeiffer Short Portable Mental Status Questionnaire; score <8)
- Acute psychiatric condition with psychosis
- Progressive neurological condition (such as Parkinson’s disease, Multiple Sclerosis)
- Unstable medical condition that would preclude safe participation
- Unable to read a computer screen
- Currently participating in a fall prevention research trial

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)
Volunteers will be screened for eligibility over the phone. Eligible participants will proceed to perform the baseline assessment. Following the baseline assessment, the participants will be randomly allocated to one of three groups (two intervention groups and one control group) using a web-based randomisation service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated random number schedule available from an external web-based randomisation service.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
3-arm trial
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be analysed with an intention-to-treat approach. For the primary outcome, the number of falls per person-year will be analysed using negative binomial regression to estimate the difference in fall rates between comparison groups.

For analyses of secondary outcomes, the rate of falls and proportion of fallers among the comparison groups will be compared using negative binomial regression and the relative risk statistic respectively. Complier average causal effect analysis will be used to explore intervention effects in people with greater adherence. The effect of group allocation on the continuously scored secondary outcome measures will be examined with Mixed-effects models.

A sample size calculation (5% significance level, 80% power, 33% effect, 20% dropout rate) was performed using the nbpower command in STATA and indicated a sample size of 750 will be necessary for this study. Our previous study of 500 older adults was used to calculate alpha (a measure of over-dispersion in the negative binomial regression model), found to be 1.2 [Delbaere, K., et al. 2010. J Am Geriatr Soc, 58, 1679-85.]. The control group rate of falls was assumed to be 0.8 fall/person-year and the incident rate ratio of 0.67 was based on meta-regression results from 41 RCTs investigating the effect of balance challenging exercise on falls rates [Sherrington, C., et al. 2008. J Am Geriatr Soc, 56, 2234-43.].

Recruitment
Recruitment status
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] 293871 0
Government body
Name [1] 293871 0
National Health and Medical Research Council
Address [1] 293871 0
GHD Building Level 1
16 Marcus Clarke St
Canberra ACT 2601
Country [1] 293871 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] 292698 0
Individual
Name [1] 292698 0
Prof Stephen Lord
Address [1] 292698 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country [1] 292698 0
Australia
Secondary sponsor category [2] 292701 0
Individual
Name [2] 292701 0
Dr Jasmine Menant
Address [2] 292701 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country [2] 292701 0
Australia
Secondary sponsor category [3] 292702 0
Individual
Name [3] 292702 0
Dr Kim Delbaere
Address [3] 292702 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country [3] 292702 0
Australia
Secondary sponsor category [4] 292703 0
Individual
Name [4] 292703 0
A/Prof Michael Valenzuela
Address [4] 292703 0
Regenerative Neuroscience Group
Level 4, Building K
Brain and Mind Research Institute
94 Mallet St Camperdown
Sydney NSW 2050
Country [4] 292703 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295291 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 295291 0
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
University of New South Wales
NSW
2052
Ethics committee country [1] 295291 0
Australia
Date submitted for ethics approval [1] 295291 0
02/04/2015
Approval date [1] 295291 0
08/09/2015
Ethics approval number [1] 295291 0
15203

Summary
Brief summary
No studies have examined the potential for cognitive or cognitive-motor training to prevent falls in older people, despite good evidence of fall-related cognitive and physical improvements following both intervention types. We have developed and validated a home-based computerised training intervention that can be delivered identically, either while seated (cognitive) or while standing and undertaking balance exercises (cognitive+motor). This unique design will allow us to assess whether cognitive and cognitive+motor training can prevent falls, as well as the neural, physiological, physical and neuropsychological mechanisms behind the intervention effects. We will conduct a randomised controlled trial of 750 older people, to determine the effects of cognitive and cognitive+motor training, compared with a no-intervention control group, in preventing falls and related physical, cognitive and neurological measures in older people. We hypothesise both interventions will significantly prevent falls and fall-related measures of physical and cognitive functions. Any differential effects of the interventions will provide valuable insights into the intervention components required for efficacious fall prevention, and those required for neural, neuropsychological and physical benefits.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66670 0
Dr Daina Sturnieks
Address 66670 0
Neuroscience Research Australia
Barker St
Randwick
NSW
2031
Country 66670 0
Australia
Phone 66670 0
+61 2 9399 1062
Fax 66670 0
+61 2 9399 1204
Email 66670 0
d.sturnieks@neura.edu.au
Contact person for public queries
Name 66671 0
Dr Daina Sturnieks
Address 66671 0
Neuroscience Research Australia
Barker St
Randwick
NSW
2031
Country 66671 0
Australia
Phone 66671 0
+61 2 9399 1062
Fax 66671 0
+61 2 9399 1204
Email 66671 0
d.sturnieks@neura.edu.au
Contact person for scientific queries
Name 66672 0
Dr Daina Sturnieks
Address 66672 0
Neuroscience Research Australia
Barker St
Randwick
NSW
2031
Country 66672 0
Australia
Phone 66672 0
+61 2 9399 1062
Fax 66672 0
+61 2 9399 1204
Email 66672 0
d.sturnieks@neura.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Approval will be sought from the ethics committee before it can be confirmed that IPD will be available.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Summary results
No Results