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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

14/01/2021

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]

NHMRC 1086804

Universal Trial Number (UTN)

Trial acronym

smart+/-step

Linked study record

Health condition

Health condition(s) or problem(s) studied:

accidental falls

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Injuries and Accidents

Other injuries and accidents

Public Health

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]

Prevention

Intervention code [2]

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]

The rate of falling in each group: Falls will be monitored with supplied monthly fall diaries returned via mail.

Timepoint [1]

monthly from baseline to 12 months after baseline assessment

Secondary outcome [1]

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]

6 months after baseline assessment

Secondary outcome [2]

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]

6 months after baseline assessment

Secondary outcome [3]

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]

6 months after baseline assessment

Secondary outcome [4]

The Timed Up & Go test of mobility in a random subsample of 300 participants (100 per group).

Timepoint [4]

6 months after baseline assessment

Secondary outcome [5]

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]

6 months after baseline assessment

Secondary outcome [6]

Leaning balance will be measured in a random subsample of 300 participants (100 per group), using the coordinated stability test.

Timepoint [6]

6 months after baseline assessment

Secondary outcome [7]

Trail Making Test of executive function in a random subsample of 300 participants (100 per group).

Timepoint [7]

6 months after baseline assessment

Secondary outcome [8]

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]

6 months after baseline assessment

Secondary outcome [9]

Controlled Oral Word Association Test of semantic/verbal fluency in a random subsample of 300 participants (100 per group).

Timepoint [9]

6 months after baseline assessment

Secondary outcome [10]

Digit Span test of working memory in a random subsample of 300 participants (100 per group).

Timepoint [10]

6 months after baseline assessment

Secondary outcome [11]

The Wisconsin Card Sorting Test of set shifting will be undertaken in a random subsample of 300 participants (100 per group).

Timepoint [11]

6 months after baseline assessment

Secondary outcome [12]

The Addenbrooke's Cognitive Examination Revised test of global cognition in a random subsample of 300 participants (100 per group).

Timepoint [12]

6 months after baseline assessment

Secondary outcome [13]

Brain structural plasticity assessed via structural MRI in a subsample of 105 participants (35 per group).

Timepoint [13]

6 months after baseline assessment

Secondary outcome [14]

White matter plasticity determined with Diffusion Tractography Imaging in a subsample of 105 participants (35 per group).

Timepoint [14]

6 months after baseline assessment

Secondary outcome [15]

Brain functional network plasticity assessed using resting state fMRI in a subsample of 105 participants (35 per group).

Timepoint [15]

6 months after baseline assessment

Secondary outcome [16]

Brain neurometabolic changes assessed with 1H-Magnetic Resonance Spectroscopy in a subsample of 105 participants (35 per group).

Timepoint [16]

6 months after baseline assessment

Secondary outcome [17]

Concern about falling will be assessed with the icon-FES mobile application

Timepoint [17]

6 months after baseline assessment

Secondary outcome [18]

Pattern separation memory test in a random subsample of 105 participants (35 per group).

Timepoint [18]

6 months after baseline assessment

Secondary outcome [19]

Quality of life assessed using the EuroQol EQ-5D

Timepoint [19]

6 and 12 months after baseline assessment

Secondary outcome [20]

Cost-effectiveness of the intervention measured by intervention and medical costs

Timepoint [20]

12 months after baseline assessment

Secondary outcome [21]

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]

6 months after baseline assessment

Secondary outcome [22]

The Short Physical Performance Battery in a random subsample of 300 participants (100 per group).

Timepoint [22]

6 months after baseline assessment

Secondary outcome [23]

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]

6 months after baseline assessment in

Secondary outcome [24]

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]

6 months after baseline assessment

Secondary outcome [25]

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]

12 months after baseline assessment.

Secondary outcome [26]

The proportion of fallers in each group: Falls will be monitored with supplied monthly fall diaries returned via mail.

Timepoint [26]

monthly from baseline to 12 months after baseline assessment

Secondary outcome [27]

Health and disability assessed via the WHO Disability Assessment Schedule 2.0,

Timepoint [27]

6 and 12 months after baseline assessment.

Secondary outcome [28]

Symptoms of anxiety via the Generalized Anxiety Disorder Test (GAD-7),

Timepoint [28]

6 and 12 months after baseline assessment.

Secondary outcome [29]

Symptoms of depression via the Patient Health Questionnaire-9 (PHQ-9)

Timepoint [29]

6 and 12 months after baseline assessment.

Secondary outcome [30]

Function and disability via the Late-Life Function & Disability Instrument.

Timepoint [30]

6 and 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

Sex

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

Completed

Date of first participant enrolment

Anticipated

26/09/2016

Actual

10/11/2016

Date of last participant enrolment

Anticipated

30/09/2020

Actual

21/06/2019

Date of last data collection

Anticipated

21/07/2020

Actual

17/08/2020

Sample size

Target

750

Accrual to date

Final

769

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GHD Building Level 1
16 Marcus Clarke St
Canberra ACT 2601

Country [1]

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]

Individual

Name [1]

Prof Stephen Lord

Address [1]

Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Dr Jasmine Menant

Address [2]

Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Dr Kim Delbaere

Address [3]

Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

A/Prof Michael Valenzuela

Address [4]

Regenerative Neuroscience Group
Level 4, Building K
Brain and Mind Research Institute
94 Mallet St Camperdown
Sydney NSW 2050

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales Human Research Ethics Committee

Ethics committee address [1]

UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
University of New South Wales
NSW
2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/04/2015

Approval date [1]

08/09/2015

Ethics approval number [1]

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

Dr Daina Sturnieks

Address

Neuroscience Research Australia
Barker St
Randwick
NSW
2031

Country

Australia

Phone

+61 2 9399 1062

Fax

+61 2 9399 1204

[email protected]

Contact person for public queries

Name

Daina Sturnieks

Address

Neuroscience Research Australia
Barker St
Randwick
NSW
2031

Country

Australia

Phone

+61 2 9399 1062

Fax

+61 2 9399 1204

[email protected]

Contact person for scientific queries

Name

Daina Sturnieks

Address

Neuroscience Research Australia
Barker St
Randwick
NSW
2031

Country

Australia

Phone

+61 2 9399 1062

Fax

+61 2 9399 1204

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Link	Other Details	Attachment
3819	Study protocol	http://bmjopen.bmj.com/cgi/content/full/bmjopen-2019-029409
3820	Statistical analysis plan	https://osf.io/uqk5s	The statistical analysis plan was published on the... [More Details]
3821	Ethical approval			370903-(Uploaded-01-08-2019-15-47-00)-Study-related document.pdf

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	Effect of cognitive-only and cognitive-motor training on preventing falls in community-dwelling older people: Protocol for the smart+/-step randomised controlled trial.	2019	https://dx.doi.org/10.1136/bmjopen-2019-029409
Embase	Cognitive and Motor Cortical Activity During Cognitively Demanding Stepping Tasks in Older People at Low and High Risk of Falling.	2021	https://dx.doi.org/10.3389/fmed.2021.554231
Embase	Effects of gait adaptability training on falls and fall-related fractures in older adults: A systematic review and meta-analysis.	2021	https://dx.doi.org/10.1093/ageing/afab105
Embase	Cortical activation during gait adaptability in people with Parkinson's disease.	2022	https://dx.doi.org/10.1016/j.gaitpost.2021.10.038
Embase	Exergame and cognitive training for preventing falls in community-dwelling older people: a randomized controlled trial.	2024	https://dx.doi.org/10.1038/s41591-023-02739-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically