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Trial registered on ANZCTR


Registration number
ACTRN12619001130156
Ethics application status
Approved
Date submitted
12/07/2019
Date registered
13/08/2019
Date last updated
13/08/2019
Date data sharing statement initially provided
13/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Standing Tall with Our Mob Program (STOMP) pilot trial to improve mobility, balance, physical activity, cognitive function and psychological well-being with older people in an urban Aboriginal community.
Scientific title
Standing Tall with Our Mob Program (STOMP): A randomized controlled pilot feasibility trial of a healthy and active ageing program with older people in an urban Aboriginal community to improve mobility, balance, physical activity, cognitive function and psychological well-being compared to health education.
Secondary ID [1] 298704 0
None
Universal Trial Number (UTN)
Trial acronym
STOMP Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor mobility 313605 0
Cognitive decline 313606 0
Depression 313607 0
Chronic disease 313608 0
Falls 313609 0
Physical Inactivity 313627 0
Condition category
Condition code
Public Health 312043 312043 0 0
Health promotion/education
Physical Medicine / Rehabilitation 312357 312357 0 0
Other physical medicine / rehabilitation
Mental Health 312358 312358 0 0
Studies of normal psychology, cognitive function and behaviour
Injuries and Accidents 312359 312359 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over the course of 16 weeks, the Intervention group will receive the Standing Tall with Our Mob Program, which incorporates tailored and progressive balance exercises (e.g., standing balance, stepping) and cognitive motor training (e.g., working memory or response inhibition exercises in combination with balance or stepping) delivered on a tablet computer using a mobile application (StandingTall-plus, developed at NeuRA and provided as part of the study). The mobile application provides the exercise intervention, through instruction videos and animations, and progress is tailored based on participant feedback following each exercise (i.e., rating ease or difficulty on 5-point scale). An exercise physiologist or trained research assistant will demonstrate how to use the program and ensure home-based exercises are performed safely during a one-off initial home visit. Participants will be instructed to build up to 2 hours of unsupervised home-based exercises per week using the app. Progress and adherence will be monitored via in-built weekly balance assessments and app usage data analytics. Additionally, participants will receive weekly fact sheet bulletins with information on healthy brain ageing topics and techniques (i.e., education program), which have been developed specifically for this study population. Throughout the duration of the study, optional 1-hour weekly group sessions will also be held with transport provided. The group sessions will provide social time, technology support as required and healthy ageing education or other group activities if and as per requested by study participants.
Intervention code [1] 314967 0
Prevention
Intervention code [2] 315009 0
Lifestyle
Comparator / control treatment
Both groups will receive a health promotion education program with a focus on general health concerns relevant to older adults (e.g. blood pressure, healthy diet, medications). The program will entail a series of fact sheets, developed specifically for the study population and will be provided to the participants through a website with weekly updates. The program has no therapeutic content and has been successfully used as a placebo in previous studies by NeuRA research teams. Adherence will be tracked automatically through the website.
Control group
Active

Outcomes
Primary outcome [1] 320676 0
Dual task walking ability measured by timed 10-metre walking test with cognitive dual task
Timepoint [1] 320676 0
At baseline and at 4 months post-randomization
Secondary outcome [1] 372464 0
Adherence to the intervention as weekly training dose and total training dose recorded by the tablet computer and monitored following data transfer to server
Timepoint [1] 372464 0
At 4 months post-randomization
Secondary outcome [2] 372499 0
Level of physical activity and mobility monitoring daily activities over 1 week using a wearable sensor
Timepoint [2] 372499 0
At baseline and at 4 months post-randomization
Secondary outcome [3] 372500 0
Self-reported level of incidental and planned physical activity assessed via the Incidental and Planned Exercise Questionnaire
Timepoint [3] 372500 0
At baseline and at 4 months post-randomization
Secondary outcome [4] 372501 0
Global cognitive function measured using the Addenbrooke's Cognitive Examination Revised
Timepoint [4] 372501 0
At baseline and at 4 months post-randomization
Secondary outcome [5] 372506 0
Measure of fears associated with falling assessed via the Iconographical Falls Efficacy Scale (Icon-FES)
Timepoint [5] 372506 0
At baseline and at 4 months post-randomization
Secondary outcome [6] 372510 0
Dementia Knowledge Assessment Tool Version 2 (DKAT2)
Timepoint [6] 372510 0
At baseline and at 4 months post-randomization
Secondary outcome [7] 372536 0
Adverse events due to system use (e.g. falls) monitored by self-report through monthly diaries and weekly face-to-face sessions
Timepoint [7] 372536 0
At 4 months post-randomization
Secondary outcome [8] 372663 0
Edge contrast sensitivity – The Melbourne Edge Test
Timepoint [8] 372663 0
At baseline and at 4 months post-randomization
Secondary outcome [9] 372664 0
Hand Reaction Time Test
Equipment: A computer mouse with an LED light
Participant is instructed to click the right mouse button as soon as the light turns on. Reaction time is recorded by the computer.
Timepoint [9] 372664 0
At baseline and at 4 months post-randomization
Secondary outcome [10] 372665 0
Romberg Balance Assessment
Timepoint [10] 372665 0
At baseline and at 4 months post-randomization
Secondary outcome [11] 372666 0
Postural Sway Test
Equipment: Swaymeter and computer tablet
Swaymeter is fitted around participant's waist and the attached stylus is positioned in the centre of a computer tablet behind the the participant. The tablet is positioned on a raised table such that the arm of the swaymeter is horizontal. Postural sway is recorded by a mobile application.

Sturnieks, D. L., Arnold, R., & Lord, S. R. (2011). Validity and reliability of the Swaymeter device for measuring postural sway. BMC geriatrics, 11(1), 63.
Timepoint [11] 372666 0
At baseline and at 4 months post-randomization
Secondary outcome [12] 372667 0
Maximal Balance Range (MBR)
Equipment: Swaymeter
Swaymeter is fitted around participant's waist and the attached pen is positioned in the centre of a test paper on a raised table in front of the participant. Participant is instructed to lean as far forward as possible from the ankles while keeping heels on the floor then as far backwards as possible keeping toes on the floor and without moving feet or bending at the waist. Test is completed twice.
Timepoint [12] 372667 0
At baseline and at 4 months post-randomization
Secondary outcome [13] 372668 0
Co-ordinated Stability Test (CoStab)
Requires participants to adjust balance by leaning or rotating their body without moving their feet. Measures a participant’s ability to adjust balance in a steady and coordinated way while placing them near or at the limits of their equilibrium.
Timepoint [13] 372668 0
At baseline and at 4 months post-randomization
Secondary outcome [14] 372669 0
Lower limb Proprioception
Equipment: Tall chair and perspex sheet
Medial aspect of great toes or the medial point of the first metatarsal joint for those with severe Hallux valgus marked with pen to indicate matching reference points. Performance assessed by measuring how closely subjects can align reference points on either side of perspex sheet positioned between their legs. Perspex is marked like a protractor with lines at two degrees apart (so that matching can be made to an accuracy of one degree). Participants have one practice trial with eyes open followed by 5 test trials with eyes closed. Radial disparity recorded.

Timepoint [14] 372669 0
At baseline and at 4 months post-randomization
Secondary outcome [15] 372670 0
Knee Extension Strength
Equipment: Dynamometer and tall chair
Hook connected to dynamometer attached over horizontal bar at back of tall test chair. With participant seated on chair with the hips at 90º and knees at 90º, centre of the strap attached to dynamometer positioned approximately 10cm above the lateral malleolus. Other leg should be in a relaxed position. Participant is instructed to push against the strap as strongly as they can. Peak performance is recorded by dynamometer (in kg). Test is completed 3 times.
Timepoint [15] 372670 0
At baseline and at 4 months post-randomization
Secondary outcome [16] 372671 0
5 Timed Sit-to-Stand Test
Timepoint [16] 372671 0
At baseline and at 4 months post-randomization
Secondary outcome [17] 372672 0
3m Timed Up-and-Go Test (TUG)
Timepoint [17] 372672 0
At baseline and at 4 months post-randomization
Secondary outcome [18] 372674 0
Grip Strength Test - a validated measure of physical frailty in older people.
Equipment: Hand dynamometer
Timepoint [18] 372674 0
At baseline and at 4 months post-randomization
Secondary outcome [19] 372675 0
Blood Pressure
Equipment: OMRON digital blood pressure monitor
Timepoint [19] 372675 0
At baseline and at 4 months post-randomization
Secondary outcome [20] 372676 0
Height and Weight Measurements (BMI) using a tape measure and balance scales, respectively.
BMI is calculated by dividing (weight in kilograms) by (height in metres)^2
Timepoint [20] 372676 0
At baseline and at 4 months post-randomization
Secondary outcome [21] 372685 0
Wasit-to-Hip Ratio (WHR)
A dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement in cm divided by hip measurement in cm, measured using a tape measure.
Timepoint [21] 372685 0
At baseline and at 4 months post-randomization
Secondary outcome [22] 372686 0
Reaction Stick Assessment - Simple and Recognition Reaction Time
Timepoint [22] 372686 0
At baseline and at 4 months post-randomization
Secondary outcome [23] 372687 0
Hearing Asessment using ShoeBOX

Timepoint [23] 372687 0
At 4 months post-randomization.
Secondary outcome [24] 372689 0
modified Kimberly Indigenous Cognitive Examination screen
Timepoint [24] 372689 0
At baseline and at 4 months post-randomization
Secondary outcome [25] 372690 0
Digit Span Memory Test (WAIS-III)
A verbal auditory measure of attention span and working memory. Relates to function of the dorso-lateral prefrontal cortex.
Timepoint [25] 372690 0
At baseline and at 4 months post-randomization
Secondary outcome [26] 372692 0
Four Mountains Test
A test of spatial memory, thought to be dependent on the hippocampal formation, a part of the brain that is affected during the early stages of Alzheimer's Disease.
Timepoint [26] 372692 0
At baseline and at 4 months post-randomization
Secondary outcome [27] 372693 0
Trail Making Test
A neuropsychological test of visual attention and task switching. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.
Timepoint [27] 372693 0
At baseline and at 4 months post-randomization
Secondary outcome [28] 372694 0
modified Patient Health Questionnaire (mPHQ-9)
Timepoint [28] 372694 0
At baseline and at 4 months post-randomization
Secondary outcome [29] 372695 0
Connor-Davidson Resilience Scale (CD-RISC10)
Timepoint [29] 372695 0
At baseline and at 4 months post-randomization
Secondary outcome [30] 372696 0
Geriatric Anxiety Inventory Short Form (GAI-SF)
Timepoint [30] 372696 0
At baseline and at 4 months post-randomization
Secondary outcome [31] 372697 0
Negative Life Events Scale
Timepoint [31] 372697 0
At baseline and at 4 months post-randomization
Secondary outcome [32] 372698 0
Short Form Aboriginal Resilience and Recovery Questionnaire (ARRQ-24)
Timepoint [32] 372698 0
At baseline and at 4 months post-randomization
Secondary outcome [33] 372699 0
Mindful Attention Awareness Scale (MAAS)
Timepoint [33] 372699 0
At baseline and at 4 months post-randomization
Secondary outcome [34] 372700 0
World Health Organization Disability Assessment Scale (WHODAS 2.0)
Timepoint [34] 372700 0
At baseline and at 4 months post-randomization
Secondary outcome [35] 372701 0
European Quality of Life – 5 Dimensions (EQ5D)
Timepoint [35] 372701 0
At baseline and at 4 months post-randomization
Secondary outcome [36] 372702 0
Usability of the intervention is assessed using the System Usability Scale
Timepoint [36] 372702 0
At 4 months post-randomization
Secondary outcome [37] 372703 0
Enjoyment of the intervention using the Physical Activity Enjoyment Scale
Timepoint [37] 372703 0
At 4 months post-randomization
Secondary outcome [38] 372704 0
Acceptability of the intervention is assessed using the Attitudes to Falls-Related Interventions Scale
Timepoint [38] 372704 0
At 4 months post-randomization
Secondary outcome [39] 372705 0
Exercise self-efficacy is assessed using the Exercise Self-Efficacy Scale
Timepoint [39] 372705 0
At 4 months post-randomization
Secondary outcome [40] 373318 0
Resting Pulse
Equipment: OMRON blood pressure monitor
Timepoint [40] 373318 0
At baseline and 4 months post-randomization

Eligibility
Key inclusion criteria
• Self-identify as an Aboriginal and/or Torres Strait Islander person
• Aged 45 years or older
• Can commit to the 16-week program
• Are able to walk household distances without a walking aid
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Any medical condition that would prevent safe engagement with the exercise program
• Dementia diagnosis

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)
Allocation to the intervention or control group will be performed using a randomization table created by an independent staff member via RedCAP Software. Assessors who will be blinded to group allocation will conduct outcome assessments. Due to the nature of the trial, the participants will not be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization will be used to produce equal numbers in the intervention and control groups.
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)
NSW

Funding & Sponsors
Funding source category [1] 303257 0
Government body
Name [1] 303257 0
National Health & Medical Research Council
Address [1] 303257 0
GHD Building Level 1
16 Marcus Clarke St
Canberra ACT 2601
Country [1] 303257 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker St
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 303376 0
None
Name [1] 303376 0
None
Address [1] 303376 0
None
Country [1] 303376 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303796 0
Aboriginal Health & Medical Research Council NSW Ethics Committee
Ethics committee address [1] 303796 0
Level 3, 66 Wentworth Avenue
Surry Hills NSW 2010
Ethics committee country [1] 303796 0
Australia
Date submitted for ethics approval [1] 303796 0
23/03/2016
Approval date [1] 303796 0
21/04/2016
Ethics approval number [1] 303796 0
1171/16

Summary
Brief summary
The Koori Active and Healthy Ageing Project aims to develop new, effective, culturally appropriate healthy ageing approaches in collaboration with older Aboriginal people and partner communities in regional and urban NSW. A balance-based exercise mobile application developed at NeuRA was the preferred option selected by partnering communities and has been redeveloped to provide a culturally appropriate interface, incorporating cognitive activities to boost the potential benefits for healthy brain ageing and maintaining functional independence. To evaluate the feasibility of this program, a pilot randomised control trial, developed in collaboration with Aboriginal health workers, will be conducted, with key outcomes including improvements in dual task walking speed, physical activity, balance and fall risk, cognitive function, and social and emotional well-being. By implementing a technological platform, this program has the potential to improve access to dementia prevention, enable low-cost individualised program tailoring and facilitate transferability across diverse community settings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94838 0
Dr Kylie Radford
Address 94838 0
Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031
Country 94838 0
Australia
Phone 94838 0
+61293991269
Fax 94838 0
Email 94838 0
k.radford@neura.edu.au
Contact person for public queries
Name 94839 0
Ms Madeleine Nichols
Address 94839 0
Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031
Country 94839 0
Australia
Phone 94839 0
+61 293991260
Fax 94839 0
Email 94839 0
m.nichols@neura.edu.au
Contact person for scientific queries
Name 94840 0
Dr Kylie Radford
Address 94840 0
Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031
Country 94840 0
Australia
Phone 94840 0
+61293991269
Fax 94840 0
Email 94840 0
k.radford@neura.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?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Following the publication of the main results; no end date.
Available to whom?
Researchers who provide a methodologically and ethically sound proposal, on a case-by-case basis
Available for what types of analyses?
On a case-by-case basis
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Dr Kylie Radford: k.radford@neura.ed.au), with support from the NeuRA Aboriginal Health & Ageing Program Steering Committee, and with approval from the AH&MRC NSW Ethics Committee
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2985 0
Study protocol
Citation [1] 2985 0
Link [1] 2985 0
Email [1] 2985 0
k.radford@neura.edu.au
Other [1] 2985 0
Attachment [1] 2985 0
Type [2] 2987 0
Ethical approval
Citation [2] 2987 0
Link [2] 2987 0
Email [2] 2987 0
k.radford@neura.edu.au
Other [2] 2987 0
Attachment [2] 2987 0
Type [3] 2988 0
Informed consent form
Citation [3] 2988 0
Link [3] 2988 0
Email [3] 2988 0
k.radford@neura.edu.au
Other [3] 2988 0
Attachment [3] 2988 0
Summary results
No Results