Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001037998
Ethics application status
Approved
Date submitted
18/08/2020
Date registered
12/10/2020
Date last updated
13/09/2022
Date data sharing statement initially provided
12/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Balance on the Brain: A multi-modal exercise program for people with mild cognitive impairment
Scientific title
Balance on the Brain: A randomised controlled trial testing the physical health, falls prevention, quality of life, and cognition for people with mild cognitive impairment.
Secondary ID [1] 302062 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 318661 0
Condition category
Condition code
Neurological 316680 316680 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Balance on the Brain study RCT is to be conducted between 2020 and 2024 in adults aged 50 years and over with mild cognitive impairment (MCI), with assessments at baseline (0 months), 6 and 12 months. The intervention group will receive a multi-modal (balance and walking) program delivered by qualified physiotherapists in their home (one-to-one). The level of intensity will be individualised and assessed based on levels included within the intervention (ie levels on the app, which progressively increases over time as the participant improves and balance activities progressing from feet apart, to feet together to semi-tandem and tandem stance and walk etc). The app being used in this project is called CY Research which can only be accessed by trial participants through a password. However, the Clock Yourself app which is almost identical is available on line for anyone to use. The participants will be guided in building up to 120 minutes of balance training per week and 150 minutes of walking. Strategies used to assess adherence will be the completion of a monthly calendar for physical activity and falls and a monthly phone call confirming physical activity and falls undertaken.
We will evaluate the physical health, quality of life, cognition and falls rate during the 6-month intervention and then the following 6-months to determine whether it was maintained and had an effect. At the completion of the study data collection we will access health services data from the WA Dept Health data linkage service (approval received) and Service Australia (under review) to undertake the economic evaluation of the intervention.
Intervention code [1] 318363 0
Treatment: Other
Comparator / control treatment
All participants (intervention and control) will receive a health promotion flyer designed specifically for this study. The control group will continue with usual care.
Control group
Active

Outcomes
Primary outcome [1] 324807 0
Balance: using the four square step test
Timepoint [1] 324807 0
The primary outcome will be measured at baseline, 6 months (post-intervention, primary endpoint) and 12 months (post enrolment)
Primary outcome [2] 324808 0
Falls: using a calendar and monthly phone calls
Timepoint [2] 324808 0
Falls rates will be measured monthly using a calendar and monthly phone calls and will be calculated (from baseline) at 6 (primary endpoint) and 12 months (post enrolment).
Secondary outcome [1] 385790 0
Physical health: Short Physical Performance Battery (SPPB)
Timepoint [1] 385790 0
Measured at baseline, 6 (post-intervention) and 12 (follow-up) months
Secondary outcome [2] 385791 0
Quality of Life using the QoL-AD tool
Timepoint [2] 385791 0
Measured at baseline, 6 (post-intervention) and 12 (follow-up) months
Secondary outcome [3] 385792 0
Cognition: using the Montreal Cognitive Assessment (MoCA) tool
Timepoint [3] 385792 0
Measured at baseline, 6 (post-intervention) and 12 (follow-up) months
Secondary outcome [4] 385793 0
Secondary Falls outcome - Number of fallers, assessed using a monthly calendar and monthly phone calls confirming the calendar data (ie gold standard for measuring falls data)
Timepoint [4] 385793 0
Measured at baseline, 6 (post-intervention) and 12 (follow-up) months
Secondary outcome [5] 385794 0
Secondary Falls outcome - Falls injuries, assessed using a monthly calendar and monthly phone calls confirming the calendar data (ie gold standard for measuring falls data)
Timepoint [5] 385794 0
Measured at baseline, 6 (post-intervention) and 12 (follow-up) months
Secondary outcome [6] 385795 0
Secondary Falls outcome - Fear of falling assessed using the Falls Efficacy Scale - International.
Timepoint [6] 385795 0
Measured at baseline, 6 (post-intervention) and 12 (follow-up) months
Secondary outcome [7] 385796 0
Physical activity: accelerometer data (e.g. time spent in sedentary, upright, sitting, standing and stepping, step count, stepping intensity and duration of activity) and the Physical Activity Scale for the Elderly (PASE)
Timepoint [7] 385796 0
Measured at baseline, 6 (post-intervention) and 12 (follow-up) months
Secondary outcome [8] 386932 0
Physical health: 6 Minute Walk Test (6MWT),
Timepoint [8] 386932 0
Measured at baseline, 6 (post-intervention) and 12 (follow-up) months
Secondary outcome [9] 386933 0
Physical health: Timed-Up-and-Go (TUG)
Timepoint [9] 386933 0
Measured at baseline, 6 (post-intervention) and 12 (follow-up) months

Eligibility
Key inclusion criteria
Adults over 50 years of age, living in the community with a diagnosis of mild cognitive impairment, consistent with the Petersen criteria (Petersen R, Smith G, Ivnik R, Tangalos E, Kokmen E. Mild cognitive impairment: Clinical characterisation and outcome. Arch Neurol. 1999;56(3):303-308), including self-reported memory complaint, a Clinical Dementia Rating (CDR) of (equal to) 0.5; and Standardised Mini-Mental Status Examination (SMMSE) score of 24 or above. Other inclusion criteria are: not meeting Australian physical activity guidelines (ie <150 minutes of moderate intensity physical activity a week), not participating in balance training regularly (ie < twice a week) and absence of unstable disease precluding exercise.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable medical condition, terminal illness, diagnosis of significant cognitive impairment and/or chronic mental illness (e.g. schizophrenia), severe sensory impairment affecting mobility, living in residential aged care, drinking more than 4 standard alcoholic drinks per day (i.e. >28/week), score >6 for the Geriatric Depression Scale-15 item (GDS-15) and lack of fluency in written and spoken English.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A concealed, computer-generated sequence of randomly selected permuted blocks (block size equal to 6) in a 1:1 ratio will be generated by a statistician not involved in the study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Rate of falls will be analysed using negative binomial regression with adjustment for the participant’s length of observation in the study. The primary analysis will be intention-to-treat which will be performed at baseline, 6 and 12 months using a mixed-effects model with repeated measures.

Economic analysis: An incremental cost-utility analysis will be undertaken to compare the mean incremental cost and QALY profiles for each group according to intervention status. We will also estimate cost effectiveness utilising measurement of the change in other outcomes (i.e. falls rate, falls injuries, balance, physical function etc) where a significant difference is observed between the intervention and control groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/10/2020
Actual
22/01/2021
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
396
Accrual to date
90
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 17270 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [2] 17271 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [3] 17272 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [4] 17273 0
Royal Perth Hospital - Perth
Recruitment hospital [5] 17274 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [6] 23155 0
Osborne Park Hospital - Stirling
Recruitment postcode(s) [1] 30983 0
6160 - Fremantle
Recruitment postcode(s) [2] 30984 0
6168 - Cooloongup
Recruitment postcode(s) [3] 30985 0
6009 - Nedlands
Recruitment postcode(s) [4] 30986 0
6000 - Perth
Recruitment postcode(s) [5] 30987 0
6112 - Armadale
Recruitment postcode(s) [6] 38513 0
6021 - Stirling

Funding & Sponsors
Funding source category [1] 306484 0
University
Name [1] 306484 0
Curtin University
Country [1] 306484 0
Australia
Funding source category [2] 306486 0
Government body
Name [2] 306486 0
National Health and Medical Research Council (NHMRC)
Country [2] 306486 0
Australia
Primary sponsor type
Individual
Name
Elissa Burton
Address
School of Allied Health & enAble Institute
Curtin University
Kent Street
Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 307008 0
None
Name [1] 307008 0
Address [1] 307008 0
Country [1] 307008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306688 0
South Metropolitan Health Service HREC
Ethics committee address [1] 306688 0
14 Barry Marshall Parade,
Murdoch WA 6150
Ethics committee country [1] 306688 0
Australia
Date submitted for ethics approval [1] 306688 0
11/04/2020
Approval date [1] 306688 0
15/06/2020
Ethics approval number [1] 306688 0
RGS3930
Ethics committee name [2] 306690 0
WA Department of Health HREC
Ethics committee address [2] 306690 0
PO Box 8172
Perth Business Centre
Perth WA 6849
Ethics committee country [2] 306690 0
Australia
Date submitted for ethics approval [2] 306690 0
17/07/2020
Approval date [2] 306690 0
13/08/2020
Ethics approval number [2] 306690 0
RGS3930
Ethics committee name [3] 306691 0
Curtin University HREC
Ethics committee address [3] 306691 0
Kent Street
Bentley WA 6102
Ethics committee country [3] 306691 0
Australia
Date submitted for ethics approval [3] 306691 0
19/06/2020
Approval date [3] 306691 0
14/07/2020
Ethics approval number [3] 306691 0
HRE2020-0378

Summary
Brief summary
This study will be a large randomised controlled trial that looks at the benefits of a multi-modal exercise intervention (i.e. balance and walking program) for people with mild cognitive impairment. The primary aim of this research is to determine whether a balance-focused multimodal exercise intervention improves physical health and quality of life; and reduces the rate of cognitive decline and falls for people with mild cognitive impairment. The secondary aim is to evaluate whether a balance-focused multimodal exercise program is cost-effective from a health care perspective.
Trial website
To be confirmed
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104682 0
Dr Elissa Burton
Address 104682 0
School of Allied Health & enAble Institute, Curtin University GPO Box U1987 Perth WA 6845
Country 104682 0
Australia
Phone 104682 0
+61 8 9266 4926
Fax 104682 0
Email 104682 0
[email protected]
Contact person for public queries
Name 104683 0
Elissa Burton
Address 104683 0
School of Allied Health & enAble Institute, Curtin University GPO Box U1987 Perth WA 6845
Country 104683 0
Australia
Phone 104683 0
+61 8 9266 4926
Fax 104683 0
Email 104683 0
[email protected]
Contact person for scientific queries
Name 104684 0
Elissa Burton
Address 104684 0
School of Allied Health & enAble Institute, Curtin University GPO Box U1987 Perth WA 6845
Country 104684 0
Australia
Phone 104684 0
+61 8 9266 4926
Fax 104684 0
Email 104684 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The participants have only consented to their data being used for the Balance on the Brain Project and any sharing of data would need new ethics approval and additional consent.
The current researchers will still be actively using the data for several years after the data are collected.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBalance on the Brain: A randomised controlled trial evaluating the effect of a multimodal exercise programme on physical performance, falls, quality of life and cognition for people with mild cognitive impairment-study protocol.2022https://dx.doi.org/10.1136/bmjopen-2021-054725
N.B. These documents automatically identified may not have been verified by the study sponsor.