RecruitingACTRN12621001683820

StandingTall with our Mob Project (STOMP!): A holistic approach towards active and healthy ageing of Aboriginal and Torres Strait Islander peoples

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.


Sponsor

Neuroscience Research Australia

Enrollment

100 participants

Start Date

Aug 15, 2022

Study Type

Interventional

Conditions

Summary

StandingTall-with our Mob is culturally-safe and tailored to Aboriginal Australians, and has shown excellent indicative success in pilot research studies. It considers underlying social determinants of Indigenous health and well-being whilst meeting evidence-based guidelines to safely and sustainably advance healthy ageing through exercise, cognitive training and stress reduction. The program combines home-based and group-based sessions with traditional and technology-driven methodologies across three key components: (i) a home-based exercise program offering balance exercises through mobile technology; (ii) a home-based cognitive-motor program focusing on training executive function, attention and working memory using a dual-task paradigm through mobile technology, and (iii) a group mindfulness-based stress-reduction program, to improve social and emotional well-being and reduce the impact of stress through cultural connection. This project comprises a cross-over style trial to determine adherence and effectiveness of our holistic healthy ageing program in 100 older Aboriginal people (aged 45+ years) over 6-months. We hypothesise that our holistic, multifaceted program will lead to improved mobility, cognitive function, and quality of life in Aboriginal Australians. Principles of inclusiveness and attendance flexibility, and acknowledgment of Aboriginal culture are incorporated in all activities.


Eligibility

Sex: Both males and femalesMin Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Aboriginal and Torres Strait Islander peoples experience higher rates of falls, cognitive decline, and chronic illness as they age, often at younger ages than non-Indigenous Australians. The StandingTall with our Mob (STOMP!) programme has been specifically designed to be culturally safe and relevant for Aboriginal communities, combining balance and exercise training delivered through a mobile app, cognitive training games, and group mindfulness sessions that incorporate cultural connection and stress reduction. This crossover trial will test whether this holistic programme improves mobility, cognitive function, and quality of life in 100 older Aboriginal Australians over six months. The programme can be done partly at home (through the app) and partly in groups, offering flexibility. Community organisations and health services are involved to ensure the programme is sustainable and genuinely useful. You may be eligible if you are 45 years or older, identify as Aboriginal and/or Torres Strait Islander (or are the partner or carer of someone who does), live in Sydney or the Mid North Coast of NSW, speak English, and can walk 10 metres independently or with a walking aid. People with unstable medical conditions, progressive neurological conditions, or who are already doing regular balance or mindfulness programmes are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention components The intervention comprises 6 months of tailored balance and cognitive-motor exercises, and mindfulness, in addition to weekly health promotion newsletters. StandingTall ex

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.


Locations(1)

NSW, Australia

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