Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
Please note the ANZCTR will be unattended on Monday the 7th of October for the Labour Day public holiday.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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 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.
Query!
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.
Query!
Secondary ID [1]
298704
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
STOMP Pilot
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Poor mobility
313605
0
Query!
Cognitive decline
313606
0
Query!
Depression
313607
0
Query!
Chronic disease
313608
0
Query!
Falls
313609
0
Query!
Physical Inactivity
313627
0
Query!
Condition category
Condition code
Public Health
312043
312043
0
0
Query!
Health promotion/education
Query!
Physical Medicine / Rehabilitation
312357
312357
0
0
Query!
Other physical medicine / rehabilitation
Query!
Mental Health
312358
312358
0
0
Query!
Studies of normal psychology, cognitive function and behaviour
Query!
Injuries and Accidents
312359
312359
0
0
Query!
Other injuries and accidents
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
314967
0
Prevention
Query!
Intervention code [2]
315009
0
Lifestyle
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
320676
0
Dual task walking ability measured by timed 10-metre walking test with cognitive dual task
Query!
Assessment method [1]
320676
0
Query!
Timepoint [1]
320676
0
At baseline and at 4 months post-randomization
Query!
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
Query!
Assessment method [1]
372464
0
Query!
Timepoint [1]
372464
0
At 4 months post-randomization
Query!
Secondary outcome [2]
372499
0
Level of physical activity and mobility monitoring daily activities over 1 week using a wearable sensor
Query!
Assessment method [2]
372499
0
Query!
Timepoint [2]
372499
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [3]
372500
0
Self-reported level of incidental and planned physical activity assessed via the Incidental and Planned Exercise Questionnaire
Query!
Assessment method [3]
372500
0
Query!
Timepoint [3]
372500
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [4]
372501
0
Global cognitive function measured using the Addenbrooke's Cognitive Examination Revised
Query!
Assessment method [4]
372501
0
Query!
Timepoint [4]
372501
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [5]
372506
0
Measure of fears associated with falling assessed via the Iconographical Falls Efficacy Scale (Icon-FES)
Query!
Assessment method [5]
372506
0
Query!
Timepoint [5]
372506
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [6]
372510
0
Dementia Knowledge Assessment Tool Version 2 (DKAT2)
Query!
Assessment method [6]
372510
0
Query!
Timepoint [6]
372510
0
At baseline and at 4 months post-randomization
Query!
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
Query!
Assessment method [7]
372536
0
Query!
Timepoint [7]
372536
0
At 4 months post-randomization
Query!
Secondary outcome [8]
372663
0
Edge contrast sensitivity – The Melbourne Edge Test
Query!
Assessment method [8]
372663
0
Query!
Timepoint [8]
372663
0
At baseline and at 4 months post-randomization
Query!
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.
Query!
Assessment method [9]
372664
0
Query!
Timepoint [9]
372664
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [10]
372665
0
Romberg Balance Assessment
Query!
Assessment method [10]
372665
0
Query!
Timepoint [10]
372665
0
At baseline and at 4 months post-randomization
Query!
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.
Query!
Assessment method [11]
372666
0
Query!
Timepoint [11]
372666
0
At baseline and at 4 months post-randomization
Query!
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.
Query!
Assessment method [12]
372667
0
Query!
Timepoint [12]
372667
0
At baseline and at 4 months post-randomization
Query!
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.
Query!
Assessment method [13]
372668
0
Query!
Timepoint [13]
372668
0
At baseline and at 4 months post-randomization
Query!
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.
Query!
Assessment method [14]
372669
0
Query!
Timepoint [14]
372669
0
At baseline and at 4 months post-randomization
Query!
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.
Query!
Assessment method [15]
372670
0
Query!
Timepoint [15]
372670
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [16]
372671
0
5 Timed Sit-to-Stand Test
Query!
Assessment method [16]
372671
0
Query!
Timepoint [16]
372671
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [17]
372672
0
3m Timed Up-and-Go Test (TUG)
Query!
Assessment method [17]
372672
0
Query!
Timepoint [17]
372672
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [18]
372674
0
Grip Strength Test - a validated measure of physical frailty in older people.
Equipment: Hand dynamometer
Query!
Assessment method [18]
372674
0
Query!
Timepoint [18]
372674
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [19]
372675
0
Blood Pressure
Equipment: OMRON digital blood pressure monitor
Query!
Assessment method [19]
372675
0
Query!
Timepoint [19]
372675
0
At baseline and at 4 months post-randomization
Query!
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
Query!
Assessment method [20]
372676
0
Query!
Timepoint [20]
372676
0
At baseline and at 4 months post-randomization
Query!
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.
Query!
Assessment method [21]
372685
0
Query!
Timepoint [21]
372685
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [22]
372686
0
Reaction Stick Assessment - Simple and Recognition Reaction Time
Query!
Assessment method [22]
372686
0
Query!
Timepoint [22]
372686
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [23]
372687
0
Hearing Asessment using ShoeBOX
Query!
Assessment method [23]
372687
0
Query!
Timepoint [23]
372687
0
At 4 months post-randomization.
Query!
Secondary outcome [24]
372689
0
modified Kimberly Indigenous Cognitive Examination screen
Query!
Assessment method [24]
372689
0
Query!
Timepoint [24]
372689
0
At baseline and at 4 months post-randomization
Query!
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.
Query!
Assessment method [25]
372690
0
Query!
Timepoint [25]
372690
0
At baseline and at 4 months post-randomization
Query!
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.
Query!
Assessment method [26]
372692
0
Query!
Timepoint [26]
372692
0
At baseline and at 4 months post-randomization
Query!
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.
Query!
Assessment method [27]
372693
0
Query!
Timepoint [27]
372693
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [28]
372694
0
modified Patient Health Questionnaire (mPHQ-9)
Query!
Assessment method [28]
372694
0
Query!
Timepoint [28]
372694
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [29]
372695
0
Connor-Davidson Resilience Scale (CD-RISC10)
Query!
Assessment method [29]
372695
0
Query!
Timepoint [29]
372695
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [30]
372696
0
Geriatric Anxiety Inventory Short Form (GAI-SF)
Query!
Assessment method [30]
372696
0
Query!
Timepoint [30]
372696
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [31]
372697
0
Negative Life Events Scale
Query!
Assessment method [31]
372697
0
Query!
Timepoint [31]
372697
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [32]
372698
0
Short Form Aboriginal Resilience and Recovery Questionnaire (ARRQ-24)
Query!
Assessment method [32]
372698
0
Query!
Timepoint [32]
372698
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [33]
372699
0
Mindful Attention Awareness Scale (MAAS)
Query!
Assessment method [33]
372699
0
Query!
Timepoint [33]
372699
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [34]
372700
0
World Health Organization Disability Assessment Scale (WHODAS 2.0)
Query!
Assessment method [34]
372700
0
Query!
Timepoint [34]
372700
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [35]
372701
0
European Quality of Life – 5 Dimensions (EQ5D)
Query!
Assessment method [35]
372701
0
Query!
Timepoint [35]
372701
0
At baseline and at 4 months post-randomization
Query!
Secondary outcome [36]
372702
0
Usability of the intervention is assessed using the System Usability Scale
Query!
Assessment method [36]
372702
0
Query!
Timepoint [36]
372702
0
At 4 months post-randomization
Query!
Secondary outcome [37]
372703
0
Enjoyment of the intervention using the Physical Activity Enjoyment Scale
Query!
Assessment method [37]
372703
0
Query!
Timepoint [37]
372703
0
At 4 months post-randomization
Query!
Secondary outcome [38]
372704
0
Acceptability of the intervention is assessed using the Attitudes to Falls-Related Interventions Scale
Query!
Assessment method [38]
372704
0
Query!
Timepoint [38]
372704
0
At 4 months post-randomization
Query!
Secondary outcome [39]
372705
0
Exercise self-efficacy is assessed using the Exercise Self-Efficacy Scale
Query!
Assessment method [39]
372705
0
Query!
Timepoint [39]
372705
0
At 4 months post-randomization
Query!
Secondary outcome [40]
373318
0
Resting Pulse
Equipment: OMRON blood pressure monitor
Query!
Assessment method [40]
373318
0
Query!
Timepoint [40]
373318
0
At baseline and 4 months post-randomization
Query!
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
Query!
Minimum age
45
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
• Any medical condition that would prevent safe engagement with the exercise program
• Dementia diagnosis
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
5/06/2019
Query!
Date of last participant enrolment
Anticipated
16/08/2019
Query!
Actual
15/08/2019
Query!
Date of last data collection
Anticipated
20/12/2019
Query!
Actual
19/12/2019
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
18
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Funding & Sponsors
Funding source category [1]
303257
0
Government body
Query!
Name [1]
303257
0
National Health & Medical Research Council
Query!
Address [1]
303257
0
GHD Building Level 1
16 Marcus Clarke St
Canberra ACT 2601
Query!
Country [1]
303257
0
Australia
Query!
Primary sponsor type
Other
Query!
Name
Neuroscience Research Australia
Query!
Address
139 Barker St
Randwick NSW 2031
Query!
Country
Australia
Query!
Secondary sponsor category [1]
303376
0
None
Query!
Name [1]
303376
0
None
Query!
Address [1]
303376
0
None
Query!
Country [1]
303376
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
303796
0
Aboriginal Health & Medical Research Council NSW Ethics Committee
Query!
Ethics committee address [1]
303796
0
Level 3, 66 Wentworth Avenue Surry Hills NSW 2010
Query!
Ethics committee country [1]
303796
0
Australia
Query!
Date submitted for ethics approval [1]
303796
0
23/03/2016
Query!
Approval date [1]
303796
0
21/04/2016
Query!
Ethics approval number [1]
303796
0
1171/16
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
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
Query!
Contacts
Principal investigator
Name
94838
0
Dr Kylie Radford
Query!
Address
94838
0
Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031
Query!
Country
94838
0
Australia
Query!
Phone
94838
0
+61293991269
Query!
Fax
94838
0
Query!
Email
94838
0
k.radford@neura.edu.au
Query!
Contact person for public queries
Name
94839
0
Madeleine Veinovic
Query!
Address
94839
0
Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031
Query!
Country
94839
0
Australia
Query!
Phone
94839
0
+61 293991260
Query!
Fax
94839
0
Query!
Email
94839
0
m.veinovic@neura.edu.au
Query!
Contact person for scientific queries
Name
94840
0
Kylie Radford
Query!
Address
94840
0
Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031
Query!
Country
94840
0
Australia
Query!
Phone
94840
0
+61293991269
Query!
Fax
94840
0
Query!
Email
94840
0
k.radford@neura.edu.au
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
Query!
When will data be available (start and end dates)?
Following the publication of the main results; no end date.
Query!
Available to whom?
Researchers who provide a methodologically and ethically sound proposal, on a case-by-case basis
Query!
Available for what types of analyses?
On a case-by-case basis
Query!
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
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
k.radford@neura.edu.au
Ethical approval
k.radford@neura.edu.au
Informed consent form
k.radford@neura.edu.au
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
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
]
Documents added automatically
No additional documents have been identified.
Download to PDF