Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001683820
Ethics application status
Approved
Date submitted
2/09/2021
Date registered
9/12/2021
Date last updated
7/10/2023
Date data sharing statement initially provided
9/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
StandingTall with our Mob Project (STOMP!): A holistic approach towards active and healthy ageing of Aboriginal and Torres Strait Islander peoples
Scientific title
StandingTall with our Mob Project (STOMP!): A cross-over design trial of healthy ageing programs and health education to improve quality of life in older Aboriginal and Torres Strait Islander peoples.
Secondary ID [1] 304310 0
Nil known
Universal Trial Number (UTN)
U1111-1284-9388
Trial acronym
STOMP
Linked study record
ACTRN12619001130156 is the pilot study for the exercise component of this trial.

Health condition
Health condition(s) or problem(s) studied:
Poor quality of life 322052 0
Poor mobility 324400 0
Cognitive decline 324401 0
Depression 324402 0
Chronic disease 324403 0
Falls 324404 0
Physical inactivity 324405 0
Condition category
Condition code
Public Health 319777 319777 0 0
Health promotion/education
Physical Medicine / Rehabilitation 321286 321286 0 0
Other physical medicine / rehabilitation
Mental Health 321287 321287 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention components
The intervention comprises 6 months of tailored balance and cognitive-motor exercises, and mindfulness, in addition to weekly health promotion newsletters.

StandingTall exercise
All participants will receive the StandingTall balance exercise program starting from week 1 to week 26 via a provided tablet computer. The home-based exercise training comprises standing balance (e.g. standing on a foam surface), transferring (e.g. sit-stand transitions), walking (e.g. walking in circles or to targets in a grid), stepping (e.g. step and lift) and box (e.g. step up and over a box) exercises. Instructions on how to perform each exercise will be provided within the StandingTall application with on-screen text, video demonstrations and voice-over instructions. The program is fully optimised to deliver unsupervised and individually tailored balance exercises that increase in difficulty over time. The intensity of the balance exercises will be monitored continuously using a modified rate of perceived exertion (RPE) scale and adjusted as performance improves to ensure that exercises remain challenging. Participants will be instructed to complete 40 min/wk of exercise in the first 2 weeks. This weekly exercise dosage will increase by 20 min fortnightly, to finally reach a dose of 1 hr/wk. Participants have full autonomy to choose the timing and duration of their sessions to achieve their weekly dose. Additionally, the StandingTall cognitive-motor training program is introduced within the StandingTall application from week 5 to week 26. Concomitant cognitive tasks, relying primarily on executive function, are added to the StandingTall balance exercises by using auditory and visual cues. Three core executive functions are engaged: inhibition (the ability to consciously override automated or dominant responses), working memory (the ability to hold, process, and manipulate information in mind) and task shifting (the ability to switch flexibly between tasks or mental sets). Participants will receive 1 hour per week of the StandingTall cognitive-motor program. StandingTall cognitive-motor exercises are integrated into the StandingTall application and will alternate with balance exercises each training session from Monday to Wednesday. If the participant has not reached the recommended dosage of 1 hour for the week by Thursday, the program will push cognitive exercises until the 1-hour goal is reached. The combined maximum dosage for the two programs will total 2hrs/wk. Participants will be invited to attend a weekly in-person group, providing an opportunity for exercise practice, technological support, socialisation and presentation of the weekly education content.

Ngarraanga Giinganay
The Ngarraanga Giinganay mindfulness program is based on the 8-week mindfulness-based stress reduction (MBSR) program: Kabat-Zinn, J. (2003). Mindfulness-based interventions in context: past, present, and future. Modifications have been made to ensure a strong cultural focus. Specific elements of the Ngarraanga Giinganay program will be adapted to be relevant to each specific community where the program is being run. The program involves 8 facilitator-led group sessions (one per week, approx. 1.5 hours per session, up to 15 people per group) that cover information and exercises within the context of mindfulness. The sessions are: (1) Automatic Pilot: Introduction to Mindfulness; (2) Dealing with Barriers; (3) Awareness of Breath; (4) Grounded/Rooted; (5) Fluid/Flowing; (6) Movement of Life; (7) Connection; (8) Wholeness. Each weekly session centres on a theme and includes relevant content. For example, Session 3 ‘Awareness of Breath’ includes a teaching on the air element, information about stress responses and reactivity, and specific breathing exercises. The teachings present new information each week; new exercises are also introduced and repeated throughout the program. Participants will also be guided to engage in mindfulness practice at home, in between sessions, as much as possible, and ideally once per day. A checklist will be provided and also discussed at the end of each session, specifying the suggested minimum amount of activity that participants should try to engage in. However, this is a general guide, as it is encouraged that participants aim to do various daily activities mindfully in ways that fit in with their existing daily life. The weekly home practice checklists will be collected at follow-up (6 months post-randomisation) as a measure of adherence to the home practice.

Sessions will be facilitated by a qualified clinical consultant previously involved in the development of the mindfulness program and with experience facilitating the program in the Ngarraanga Giinganay pilot study. A local Elder from each study community will also be employed to co-facilitate the mindfulness group sessions.

Facilitators will be provided with training and the study manual/facilitators guidebook. The manual/guidebook has been designed specifically for the study, based on the Ngarraanga Giinganay pilot study (incorporating relevant feedback from the pilot). Manuals/guidebooks are also developed specifically for communities, incorporating information, language and artwork specific to the local area. Hence, these materials are specific to each community within the study.

Facilitator training sessions will be run 1 month prior to group commencement. The training will include 1 full day run by two research team members who were involved in the development of the mindfulness program and have experience facilitating the program in a previous pilot study. A clinical psychologist will also be present to assist in training and support for facilitators. Given the program can be run via videoconference, health-related travel restrictions and the locations of communities, training will likely be delivered via videoconference. This is in line with the pilot study, as part of the training was delivered this way. Where possible, some training may be delivered in person (but this is not seen as necessary to sufficiently train facilitators). Facilitators will also complete some preparation in their own time (up to 2 cumulative days) using the study manual/guidebook. Facilitators will also be invited to observe a mindfulness session where possible. A 1.5hr follow-up training session will then be held for facilitators to practice delivering a mindfulness session. Additionally, weekly 1hr facilitator support meetings will be held via videoconference for all facilitators for the duration of the study to debrief on the previous week.

After participants complete the 8 week mindfulness program they will be given indefinite access to online audio recordings of the mindfulness program. Session attendance lists will be used to monitor adherence to the group sessions.

STOMP Healthy Education Fact Sheets
All participants will receive weekly health promotion newsletters, in addition to usual care. The newsletters will be distributed at the weekly in-person exercise sessions or as a REDCap survey via email and will take approximately 10 minutes to read per week.

Participants are requested to answer a brief qualitative question at the end of each newsletter regarding the information included. Completion of this qualitative question serves as a measure of adherence to the newsletters. Monthly quizzes will also be disseminated via RedCAP assessing the previous 4 newsletters.

The health promotion information focuses on health-related information relevant to healthy ageing based on current research and guidelines.

The study will comprise two study arms. All participants will receive the home-based StandingTall exercise program from enrolment, for the duration of the trial (6 months). Half of the participants will also receive the 8-week Ngarraanga Giinganay mindfulness program from enrolment (Group 1). The other half of participants will receive the Ngarraanga Giinganay mindfulness program after three months (Group 2). Allocation to one of the two study groups will be performed using a randomisation table created by an independent staff member via Blinders software. People living in the same household will be allocated together, and randomised in their own blocks to ensure that both groups have an equal number of family groups. For the duration of the trial, all participants will also receive the STOMP! healthy ageing education program.
Intervention code [1] 320654 0
Prevention
Comparator / control treatment
The re-design of the study enables a two-arm cross over style trial. This allows Group 1 to access the Ngarraanga Giinganay mindfulness program from enrolment and Group 2 after 3 months on the trial. Allocation to groups will be randomised using Blinders software. All participants will undergo a 3-month follow-up assessment. The addition of a 3-month follow-up assessment at the halfway point of the study will allow us to examine the difference between groups, specifically regarding effectiveness of the Ngarraanga Giinganay mindfulness program.
Control group
Active

Outcomes
Primary outcome [1] 327640 0
European Quality of Life Dimensions scale (EQ-5D-5L)
Questionnaire measure of health related quality of life.
Timepoint [1] 327640 0
At baseline and at 3 and 6 months post-randomisation.
Secondary outcome [1] 396056 0
Short Physical Performance Battery (SPPB)
A composite clinical measure combining gait speed, chair stand and balance tests to assess mobility in older people.
Timepoint [1] 396056 0
At baseline and 6 months post-randomisation
Secondary outcome [2] 396065 0
Aboriginal Resilience and Recovery Questionnaire (ARRQ). A measure designed to assess a range of strengths and resources associated with resilience, healing and recovery.
Timepoint [2] 396065 0
At baseline and at 3 and 6 months post-randomisation
Secondary outcome [3] 397484 0
Adherence
Adherence to the intervention as percentage of prescribed dose completed (i.e. for StandingTall, [minutes of exercise completed/minutes of exercise prescribed] monitored following automatic data transfer to a server and examined weekly. Participants not engaging in the minimum weekly training duration for 2 consecutive weeks will be contacted by telephone to discuss any issues and to encourage adherence for the the duration of the intervention; for Ngarraanga Giinganay, [number of group sessions attended/8 total program sessions held] measured via session attendance check lists recorded in REDCap weekly)
Timepoint [3] 397484 0
At 6 months post-randomisation
Secondary outcome [4] 397492 0
Timed 8-meter walk test (8MW)
Clinical measure of mobility - transferring, walking, turning.
Timepoint [4] 397492 0
At baseline and 6 months post-randomisation
Secondary outcome [5] 397493 0
Timed 8-meter walking test with cognitive dual task (8MDTW)
Measure of functional walking ability
Timepoint [5] 397493 0
At baseline and 6 months post-randomisation
Secondary outcome [6] 400521 0
Modified Five Facet Mindfulness Questionnaire short form (mFFMQ-SF)
24-item self-report questionnaire that measures five facets of mindfulness: observing, describing, acting with awareness, nonjudging, and nonreactivity.
Timepoint [6] 400521 0
At baseline and at 3 and 6 months post-randomisation.
Secondary outcome [7] 401345 0
Trail Making Test Part A
Measure of psychomotor speed
Timepoint [7] 401345 0
At baseline and at 3 and 6 months post-randomisation.
Secondary outcome [8] 401346 0
Trail Making Test part B
Measure of cognitive flexibility and switching attention
Timepoint [8] 401346 0
At baseline and at 3 and 6 months post-randomisation.
Secondary outcome [9] 401347 0
Animal Fluency Test
Brief test of verbal fluency and semantic memory
Timepoint [9] 401347 0
At baseline and at 3 and 6 months post-randomisation.
Secondary outcome [10] 403237 0
Incidental and Planned Exercise Questionnaire (IPEQ)
Self-report measure of level of incidental and planned physical activity
Timepoint [10] 403237 0
At baseline and 6 months post-randomisation
Secondary outcome [11] 403238 0
Modified Iconographical Falls Efficacy Scale - short form (Icon-FES)
Measure of fear associated with falling
Timepoint [11] 403238 0
At baseline and 6 months post-randomisation
Secondary outcome [12] 403239 0
Body mass index (BMI) calculated using Height and Weight measurements using a tape measure and balance scales, respectively
BMI is calculated by dividing (weight in kilograms) by (height in metres)^2
Timepoint [12] 403239 0
At baseline and 6 months post-randomisation
Secondary outcome [13] 403240 0
Blood Pressure
Equipment: OMRON digital blood pressure monitor
Timepoint [13] 403240 0
At baseline and at 3 and 6 months post-randomisation.
Secondary outcome [14] 403241 0
Depression, Anxiety and Stress Scales (DASS-21)
A 21-item measure of mood-related symptoms over the past week.
Timepoint [14] 403241 0
At baseline and at 3 and 6 months post-randomisation.
Secondary outcome [15] 403242 0
Brief Pain Inventory (BPI)
Questionnaire to assess the severity of pain and its impact on daily functioning.
Timepoint [15] 403242 0
At baseline and at 3 and 6 months post-randomisation.
Secondary outcome [16] 403243 0
Pittsburgh Sleep Quality Index (PSQI)
Questionnaire to measure subjective sleep quality and quantity based on the past month
Timepoint [16] 403243 0
At baseline and at 3 and 6 months post-randomisation.
Secondary outcome [17] 403244 0
What Matters 2 Adults tool (WM2A)
Aboriginal specific strengths-based measure of quality of life
Timepoint [17] 403244 0
At baseline and at 3 and 6 months post-randomisation.
Secondary outcome [18] 403248 0
Rate of falling in each group
Falls will be monitored monthly by REDCap survey distributed via email
Timepoint [18] 403248 0
At 6 months post-randomisation

Eligibility
Key inclusion criteria
• Aged 45 years and over
• Identify as Aboriginal and/or Torres Strait Islander person or the partner or carer of an
Aboriginal and/or Torres Strait Islander person
• Live in Sydney or the Mid North Coast of NSW
• English-speaking
• Independent in basic activities of daily living and able to walk 10 meters unassisted or with a walking aid
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Having an acute psychiatric condition with psychosis
• Having an unstable medical condition that precludes exercise participation
• Having a progressive neurological condition such as Parkinson’s disease, Multiple Sclerosis, Alzheimer’s disease
• Currently participating in a mindfulness or balance-based exercise program (>1hr/wk)

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 one of the two study groups will be performed using a randomisation table created by an independent staff member via Blinders software. People living in the same household will be allocated together, and randomised in their own blocks to ensure that both groups have an equal number of family groups. Allocation will be concealed until one week after baseline to ensure blinding of the assessors. Assessors will be blinded at baseline and 3-month assessments however 6-month assessments will use non-blinded assessors, participants will be aware of their group allocation but are reminded to not disclose this during assessments by blinded assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation 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
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A cognitive z-score composite will be derived from Trail Making Test part A and B, plus the Animal Fluency Test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/01/2022
Actual
15/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308684 0
Government body
Name [1] 308684 0
Nation Health and Medical Research Council
Country [1] 308684 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker St
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 309572 0
None
Name [1] 309572 0
Address [1] 309572 0
Country [1] 309572 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308606 0
Aboriginal Health and Medical Research Council NSW Ethics Committee
Ethics committee address [1] 308606 0
Ethics committee country [1] 308606 0
Australia
Date submitted for ethics approval [1] 308606 0
27/09/2018
Approval date [1] 308606 0
03/12/2018
Ethics approval number [1] 308606 0
1445/18

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111306 0
Prof Kim Delbaere
Address 111306 0
Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031
Country 111306 0
Australia
Phone 111306 0
+61 293991066
Fax 111306 0
Email 111306 0
[email protected]
Contact person for public queries
Name 111307 0
Louise Lavrencic
Address 111307 0
Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031
Country 111307 0
Australia
Phone 111307 0
+61 293991619
Fax 111307 0
Email 111307 0
[email protected]
Contact person for scientific queries
Name 111308 0
Kim Delbaere
Address 111308 0
Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker St
Randwick NSW 2031
Country 111308 0
Australia
Phone 111308 0
+61 293991066
Fax 111308 0
Email 111308 0
[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.TypeCitationLinkEmailOther DetailsAttachment
11765Study protocol  [email protected]
11766Informed consent form  [email protected]
11767Ethical approval  [email protected]



Results publications and other study-related documents

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