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Trial registered on ANZCTR


Registration number
ACTRN12618001062213
Ethics application status
Approved
Date submitted
15/06/2018
Date registered
26/06/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Standing Tall - Cognition and Gait: A clinical trial of balance exercises delivered by an app to improve cognition and mobility in people with cognitive impairment.
Scientific title
Standing Tall - Cognition and Gait: A randomised controlled trial of balance and dual-task training delivered by an app to improve cognition and mobility in people with cognitive impairment
Secondary ID [1] 293944 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Standing Tall - COG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive impairment 306441 0
subjective cognitive impairment 306442 0
mobility 308460 0
Condition category
Condition code
Neurological 305528 305528 0 0
Dementias
Physical Medicine / Rehabilitation 307444 307444 0 0
Physiotherapy
Musculoskeletal 307445 307445 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Balance and dual-task training delivered by a computer application and tablet
Full description: Balance and dual-task training exercises will be delivered by a computer application. Examples include: standing semi-tandem, tandem, standing on one leg, squats, lunges, standing on foam, stepping onto a step or in different directions. Activities are progressed to be performed while doing an additional cognitive (eg reciting animals, remembering a location to step) or motor task (eg bending elbows). Instructions for each exercise are presented with text or via video on the tablet (provided to participants in the intervention group). A manual will be provided as well as a step and foam square to increase the exercise difficulty. An initial visit to the persons home by an exercise physiologist /physiotherapist will be undertaken to explain the use of the app and equipment, tailor the program to the person’s ability and optimise safety (approximately 1 week after the initial assessment). A further visit will occur in ~ weeks 3 and 8 to ensure correct use, as well as monthly phone calls. Features of the application include an activity planner, reminders and feedback, and participant adherence data is fed back to researchers via a secure server. This will be examined by the trainer and addressed in visits or phone calls as mentioned above.
The intervention will last 6 months with the following dose and progression (frequency is optional - the participants can choose to do the prescribed weekly minutes all at once or in part eg 10 min blocks):
Week Duration (min)
Weeks 1-2= 40min/week
Weeks 3-4=60min/week
Weeks 5-6=80min/week
Weeks 7-8=100min/week
Weeks 9-24 =120min/week
The difficulty of the exercises increases depending on the rating by the participant of each exercise - this is done by an inbuilt algorithm tested in our previous study - Delbaere Kim et al https://www.ncbi.nlm.nih.gov/pubmed/26493461#. Adherence is also recorded on the app and delivered to a secure server.
Both groups will receive a health education fact sheet for every week (most are designed for the study with a few from https://yourbrainmatters.org.au/5-simple-steps).
Intervention code [1] 300210 0
Treatment: Other
Comparator / control treatment
Monthly health fact sheets (most designed specifically for the study and a a few from https://yourbrainmatters.org.au/5-simple-steps)
Control group
Active

Outcomes
Primary outcome [1] 304655 0
Gait speed cm/s under single task using a Zeno walkway
Timepoint [1] 304655 0
6 months post-baseline assessment
Secondary outcome [1] 342702 0
Dual task using an alternate letter task (eg walking whilst reciting alternate letters of the alphabet).
Gait speed will be measured during single task and dual task using a Zeno walkway. The dual-task cost will be calculated as (dual task gait speed-single task gait speed)/single task gait speed
Timepoint [1] 342702 0
6 months post-baseline assessment
Secondary outcome [2] 342706 0
Simple hand reaction time using the Short Physical Performance battery
Timepoint [2] 342706 0
6 months post-baseline assessment
Secondary outcome [3] 342708 0
Activities of daily living with the Activities of Daily Living – Prevention Instrument
Timepoint [3] 342708 0
6 months post-baseline assessment
Secondary outcome [4] 342709 0
Falls (exploratory outcome) using a monthly standardised questionnaire created for the study
Timepoint [4] 342709 0
6-months post-baseline assessment
Secondary outcome [5] 348461 0
Balance - 15 second step test using a stopwatch and step
Timepoint [5] 348461 0
6-months post baseline assessment
Secondary outcome [6] 348462 0
Balance - using the total score of the Frailty and Injuries: Cooperative Studies of Intervention Techniques test.
This test is timed using a stopwatch
Timepoint [6] 348462 0
6 months post baseline assessment
Secondary outcome [7] 348463 0
Cognition - Trails A-B test
(pen, stopwatch)
Timepoint [7] 348463 0
6 months post baseline assessment
Secondary outcome [8] 348464 0
Cognition - Victoria Stroop interference test
(Stop watch)
Timepoint [8] 348464 0
6 months post baseline assessment
Secondary outcome [9] 348465 0
Cognition - Rey Complex Figure Test
(pen)
Timepoint [9] 348465 0
6 months post baseline assessment
Secondary outcome [10] 348466 0
Cognition - Rey Verbal Learning Test
(pen)
Timepoint [10] 348466 0
6 months post baseline assessment
Secondary outcome [11] 348467 0
Cognition - Digit Symbol Coding Test (Wechsler Adult Intelligence Scale)
(pen)
Timepoint [11] 348467 0
6 months post baseline assessment
Secondary outcome [12] 348468 0
Cognition - Montreal Cognitive Test
(pen)
Timepoint [12] 348468 0
6- months post baseline assessment
Secondary outcome [13] 348469 0
Cognition - Naming as many animals as possible in 1 minute
Timepoint [13] 348469 0
6 months post baseline assessment
Secondary outcome [14] 348470 0
Functional lower limb muscle strength with the timed 5 sit to stand test
Equipment - stopwatch and a chair
Timepoint [14] 348470 0
6 months post baseline assessment
Secondary outcome [15] 348471 0
Grip strength using a dynamometer
Timepoint [15] 348471 0
6 months post baseline assessment
Secondary outcome [16] 348473 0
Activity Balance Confidence Scale questionnaire
Timepoint [16] 348473 0
6 months post baseline assessment
Secondary outcome [17] 348474 0
Life Space Questionnaire to assess mobility (not necessarily walking) with respect to reaching different locations or life-space
Timepoint [17] 348474 0
6 months post baseline assessment

Eligibility
Key inclusion criteria
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures
3. Ability to perform exercises and be willing to adhere to the study intervention regimen for 6 months and attend the pre and post assessments
4. Cognitive impairment (Montreal cognitive assessment 19-26 or medical diagnosis) or reporting a subjective cognitive complaint
5. Ability to walk in own home without a gait aide or needing to hold onto furniture
6. Sufficient vision and English language to read & understand the instructions on the tablet
7. Accept that they may be randomised to either intervention
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unstable or acute medical condition that precludes participation
2. Neurological condition such as Parkinson’s disease or multiple sclerosis, stroke
3. Diagnosis of dementia by a health professional OR a score of < 19 on the Montreal Cognitive Assessment OR a score of 19-26 on the Montreal Cognitive Assessment AND a score of >9 on the Functional Activities Questionnaire OR Clinical judgement by psychologist/study staff that participant is unable to carry out the exercises safely and independently and the participant has no partner/friend to assist with the program at home.
4. Residing in a nursing home
5. Currently participating in another clinical trial that would bias outcomes
6. Currently participating in another exercise program designed to improve balance.
7. Chest pain or dizziness with exercise
8. Substantial shortness of breath when walking
9. Life expectancy less than 12 months
10. Insufficient vision to use the computer application.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
stratified for age <70 years
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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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)
TAS
Recruitment postcode(s) [1] 21566 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 298572 0
Government body
Name [1] 298572 0
National Health and Medical Research Council
Address [1] 298572 0
GPO Box 1421 Canberra ACT 2601
Country [1] 298572 0
Australia
Primary sponsor type
Individual
Name
Dr Michele Callisaya
Address
University of Tasmania
Private Bag 23
Hobart Tasmania 7001
Country
Australia
Secondary sponsor category [1] 297875 0
None
Name [1] 297875 0
Address [1] 297875 0
Country [1] 297875 0
Other collaborator category [1] 279937 0
Individual
Name [1] 279937 0
Associate Professor Kim Delbaere
Address [1] 279937 0
NeuRA
Neuroscience Research Australia
Margarete Ainsworth Building; PO Box 1165
Barker Street Randwick Sydney NSW 2031 Australia

Country [1] 279937 0
Australia
Other collaborator category [2] 279938 0
Individual
Name [2] 279938 0
Prof Velandai Srikanth
Address [2] 279938 0
Department of Medicine Monash University Peninsula Health PO Box 52 Frankston Victoria 3199. AUSTRALIA
Country [2] 279938 0
Australia
Other collaborator category [3] 279939 0
Individual
Name [3] 279939 0
Dr Maree Farrow
Address [3] 279939 0
University of Tasmania
17 Liverpool Street
Hobart Tas 7000
Country [3] 279939 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299538 0
Tasmanian Health & Medical Research Ethics Committee [EC00337]
Ethics committee address [1] 299538 0
Menzies Institute for Medical Research - University of Tasmania
Building 1, First Floor, 301 Sandy Bay Road
Hobart TAS 7001
Ethics committee country [1] 299538 0
Australia
Date submitted for ethics approval [1] 299538 0
Approval date [1] 299538 0
31/01/2018
Ethics approval number [1] 299538 0
H0016983

Summary
Brief summary
Mobility and falls are common in people with cognitive impairment/complaints. We aim to test whether a balance and cognitive training program delivered at home via a computer application and tablet will improve risk factors for falls such as mobility, balance and brain function.

Hypotheses
Compared to a health education program, a 6-month home-based exercise training program delivered via a tablet computer (Standing Tall-COG) will improve the following in people with cognitive impairment (this term includes both objective and subjective cognitive complaints).

Primary Outcome
1. Gait speed

Secondary Outcome
2. Gait and cognitive dual-task cost
3. Balance under single and dual-task
4. Muscle strength, reaction time
5. Cognitive function
6. Activities of daily living
7. Balance confidence
8. LifeSpace
Exploratory outcome - falls over 6 months
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80774 0
Dr Michele Callisaya
Address 80774 0
Menzies Institute for Medical Research - University of Tasmania
Private Bag 23
Hobart Tasmania 7001
Country 80774 0
Australia
Phone 80774 0
+61362264785
Fax 80774 0
Email 80774 0
michele.callisaya@utas.edu.au
Contact person for public queries
Name 80775 0
Dr Michele Callisaya
Address 80775 0
Menzies Institute for Medical Research - University of Tasmania
Private Bag 23
Hobart Tasmania 7001
Country 80775 0
Australia
Phone 80775 0
+61362264785
Fax 80775 0
Email 80775 0
michele.callisaya@utas.edu.au
Contact person for scientific queries
Name 80776 0
Dr Michele Callisaya
Address 80776 0
Menzies Institute for Medical Research - University of Tasmania
Private Bag 23
Hobart Tasmania 7001
Country 80776 0
Australia
Phone 80776 0
+61362264785
Fax 80776 0
Email 80776 0
michele.callisaya@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non identifiable data will be available by request to the CI
When will data be available (start and end dates)?
After publication of the trial to 5 years after publication.
Available to whom?
Researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of the CI
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator and requirement to sign data access agreement
What supporting documents are/will be available?
No other documents available
Summary results
No Results