ANZCTR - Registration

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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

7/06/2021

Date data sharing statement initially provided

13/08/2019

Date results information initially provided

7/06/2021

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]

None

Universal Trial Number (UTN)

Trial acronym

STOMP Pilot

Linked study record

Health condition

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

Poor mobility

Cognitive decline

Depression

Chronic disease

Falls

Physical Inactivity

Condition category

Condition code

Public Health

Health promotion/education

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Mental Health

Studies of normal psychology, cognitive function and behaviour

Injuries and Accidents

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]

Prevention

Intervention code [2]

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]

Dual task walking ability measured by timed 10-metre walking test with cognitive dual task

Timepoint [1]

At baseline and at 4 months post-randomization

Secondary outcome [1]

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]

At 4 months post-randomization

Secondary outcome [2]

Level of physical activity and mobility monitoring daily activities over 1 week using a wearable sensor

Timepoint [2]

At baseline and at 4 months post-randomization

Secondary outcome [3]

Self-reported level of incidental and planned physical activity assessed via the Incidental and Planned Exercise Questionnaire

Timepoint [3]

At baseline and at 4 months post-randomization

Secondary outcome [4]

Global cognitive function measured using the Addenbrooke's Cognitive Examination Revised

Timepoint [4]

At baseline and at 4 months post-randomization

Secondary outcome [5]

Measure of fears associated with falling assessed via the Iconographical Falls Efficacy Scale (Icon-FES)

Timepoint [5]

At baseline and at 4 months post-randomization

Secondary outcome [6]

Dementia Knowledge Assessment Tool Version 2 (DKAT2)

Timepoint [6]

At baseline and at 4 months post-randomization

Secondary outcome [7]

Adverse events due to system use (e.g. falls) monitored by self-report through monthly diaries and weekly face-to-face sessions

Timepoint [7]

At 4 months post-randomization

Secondary outcome [8]

Edge contrast sensitivity – The Melbourne Edge Test

Timepoint [8]

At baseline and at 4 months post-randomization

Secondary outcome [9]

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]

At baseline and at 4 months post-randomization

Secondary outcome [10]

Romberg Balance Assessment

Timepoint [10]

At baseline and at 4 months post-randomization

Secondary outcome [11]

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]

At baseline and at 4 months post-randomization

Secondary outcome [12]

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]

At baseline and at 4 months post-randomization

Secondary outcome [13]

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]

At baseline and at 4 months post-randomization

Secondary outcome [14]

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]

At baseline and at 4 months post-randomization

Secondary outcome [15]

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]

At baseline and at 4 months post-randomization

Secondary outcome [16]

5 Timed Sit-to-Stand Test

Timepoint [16]

At baseline and at 4 months post-randomization

Secondary outcome [17]

3m Timed Up-and-Go Test (TUG)

Timepoint [17]

At baseline and at 4 months post-randomization

Secondary outcome [18]

Grip Strength Test - a validated measure of physical frailty in older people.
Equipment: Hand dynamometer

Timepoint [18]

At baseline and at 4 months post-randomization

Secondary outcome [19]

Blood Pressure
Equipment: OMRON digital blood pressure monitor

Timepoint [19]

At baseline and at 4 months post-randomization

Secondary outcome [20]

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]

At baseline and at 4 months post-randomization

Secondary outcome [21]

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]

At baseline and at 4 months post-randomization

Secondary outcome [22]

Reaction Stick Assessment - Simple and Recognition Reaction Time

Timepoint [22]

At baseline and at 4 months post-randomization

Secondary outcome [23]

Hearing Asessment using ShoeBOX

Timepoint [23]

At 4 months post-randomization.

Secondary outcome [24]

modified Kimberly Indigenous Cognitive Examination screen

Timepoint [24]

At baseline and at 4 months post-randomization

Secondary outcome [25]

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]

At baseline and at 4 months post-randomization

Secondary outcome [26]

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]

At baseline and at 4 months post-randomization

Secondary outcome [27]

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]

At baseline and at 4 months post-randomization

Secondary outcome [28]

modified Patient Health Questionnaire (mPHQ-9)

Timepoint [28]

At baseline and at 4 months post-randomization

Secondary outcome [29]

Connor-Davidson Resilience Scale (CD-RISC10)

Timepoint [29]

At baseline and at 4 months post-randomization

Secondary outcome [30]

Geriatric Anxiety Inventory Short Form (GAI-SF)

Timepoint [30]

At baseline and at 4 months post-randomization

Secondary outcome [31]

Negative Life Events Scale

Timepoint [31]

At baseline and at 4 months post-randomization

Secondary outcome [32]

Short Form Aboriginal Resilience and Recovery Questionnaire (ARRQ-24)

Timepoint [32]

At baseline and at 4 months post-randomization

Secondary outcome [33]

Mindful Attention Awareness Scale (MAAS)

Timepoint [33]

At baseline and at 4 months post-randomization

Secondary outcome [34]

World Health Organization Disability Assessment Scale (WHODAS 2.0)

Timepoint [34]

At baseline and at 4 months post-randomization

Secondary outcome [35]

European Quality of Life – 5 Dimensions (EQ5D)

Timepoint [35]

At baseline and at 4 months post-randomization

Secondary outcome [36]

Usability of the intervention is assessed using the System Usability Scale

Timepoint [36]

At 4 months post-randomization

Secondary outcome [37]

Enjoyment of the intervention using the Physical Activity Enjoyment Scale

Timepoint [37]

At 4 months post-randomization

Secondary outcome [38]

Acceptability of the intervention is assessed using the Attitudes to Falls-Related Interventions Scale

Timepoint [38]

At 4 months post-randomization

Secondary outcome [39]

Exercise self-efficacy is assessed using the Exercise Self-Efficacy Scale

Timepoint [39]

At 4 months post-randomization

Secondary outcome [40]

Resting Pulse
Equipment: OMRON blood pressure monitor

Timepoint [40]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

Actual

5/06/2019

Date of last participant enrolment

Anticipated

16/08/2019

Actual

15/08/2019

Date of last data collection

Anticipated

20/12/2019

Actual

19/12/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health & Medical Research Council

Address [1]

GHD Building Level 1
16 Marcus Clarke St
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Other

Name

Neuroscience Research Australia

Address

139 Barker St
Randwick NSW 2031

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Aboriginal Health & Medical Research Council NSW Ethics Committee

Ethics committee address [1]

Level 3, 66 Wentworth Avenue
Surry Hills NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/03/2016

Approval date [1]

21/04/2016

Ethics approval number [1]

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

Madeleine Nichols, Alison Timbery, Laura Jamieson, Wendy Allan,Gail Daylight, Tony Broe, Gail Garvey, Kim Delbaere, Kylie Radford. Standing Tall with Our Mob: Collaborative co-design of a healthy and active ageing program using mobile technology [abstract]. In: The Lowitja Institute International Indigenous Health and Wellbeing Conference 2019.; 18-20 June 2019; Darwin, Australia

Madeleine Nichols, Alison Timbery, Laura Jamieson, Wendy Allan, Gail Daylight, G A (Tony) Broe, Gail Garvey, Kim Delbaere, Kylie Radford. Standing Tall with Our Mob: Collaborative co-design of a healthy and active ageing program using mobile technology [abstract]. In: Aboriginal Chronic Conditions Network 2019 Conference.; 27-28 August 2019; Sydney, Australia

Madeleine Nichols, Alison Timbery, Pam Wettasinghe, Laura Jamieson, Wendy Allan, Gail Daylight, G A (Tony) Broe, Gail Garvey, Kim Delbaere, Kylie Radford. Standing Tall with Our Mob: Dual Task Training to Promote Healthy Brain Ageing and Reduce Falls Risk among Older Aboriginal Australians [abstract]. In: 52nd Australian Association of Geriatrics Conference.; 5-8 November 2019; Sydney, Australia

Contacts

Principal investigator

Name

Dr Kylie Radford

Address

Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031

Country

Australia

Phone

+61293991269

Fax

[email protected]

Contact person for public queries

Name

Ms Madeleine Veinovic

Address

Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031

Country

Australia

Phone

+61 293991260

Fax

[email protected]

Contact person for scientific queries

Name

Dr Kylie Radford

Address

Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031

Country

Australia

Phone

+61293991269

Fax

[email protected]

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: [email protected]), 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?

Doc. No.	Type	Email
2985	Study protocol	[email protected]
2987	Ethical approval	[email protected]
2988	Informed consent form	[email protected]

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details	Attachment
Conference abstract	No	Kylie Radford, Madeleine Nichols, Alison Timbery, ... [More Details]	377945-(Uploaded-20-05-2021-08-36-05)-Other results publication.pdf
Basic results	No		377945-(Uploaded-20-05-2021-14-28-29)-Basic results summary.docx
Plain language summary	No	High rates of dementia have been observed in Abori... [More Details]

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No additional documents have been identified.

Trial Review

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