ANZCTR search results

This study will assess the safety and practicality of combining two non-invasive brain treatments in healthy adults and adults recovering from a recent concussion. Photobiomodulation uses a headset and a small nasal applicator to deliver near-infrared light, while transcranial electrical stimulation delivers a weak electrical current through two pads on the scalp. Six adults aged 18 to 40 (three healthy adults and three with a recent concussion) will use both treatments together at home for 25 minutes per day over one week. Researchers will assess side effects, treatment tolerability, adherence and participants' ability to use the devices safely at home, alongside exploratory measures of concussion symptoms, mood, sleep, cognitive performance and brain activity. The findings will help determine whether the combined treatment is safe and feasible and inform the subsequent randomised controlled trial.

This single-centre prospective observational study investigates extracorporeal membrane oxygenation (ECMO) circuit performance using ultrasound dilution technology. The parent study (OXBV) assesses membrane oxygenator clot burden in all adult ECMO patients. A predefined sub-study (2TIPS) evaluates recirculation fraction exclusively in patients receiving veno-venous ECMO. Both studies utilise the Transonic ELSA® monitor and do not alter standard clinical care; we are comparing the use of this monitor, to the performance of our standard markers of clot burden and recirculation.

Evidence indicates that exercise is safe and improves many clinical outcomes, including physical fitness, functional abilities, fatigue, depression and cognitive function in people with MS. However, many people with MS do not engage in the levels of exercise needed to produce the best health outcomes for their condition. In this project, researchers will develop and test an online training program, targeting neurologists and nurses to promote exercise to their patients with MS. We will measure training success based on the healthcare providers’ confidence, knowledge and behaviour towards promoting exercise to people with MS after completing the online training program (PULSE-HCP); as well as the change in exercise levels of people with MS after they engage in a PULSE-HCP clinical consultation. First, six healthcare professionals will pilot-test the training and give feedback via interviews, which will be used to refine it. Around 33 healthcare professionals will then complete the refined training program and practice their exercise-promotion consultation to two persons with MS (66 total). To prepare for a large-scale roll-out of the framework, our team will identify the cost of healthcare provider training and the outcomes, mechanisms and contexts which make the framework realistic for delivery within the Australian healthcare system.

Compare the perception of comfort, biomechanics and physiological responses of cycling with a novel saddle compared to a reference cycling saddle. Participants cycling for a short duration on a cycle ergometer using each saddle in random order whilst perception of comfort, biomechanics and physiological responses will be monitored. Hypothesis is that the novel saddle will improve comfort and optimise cycling biomechanics compared to the control saddle.

Perfectionism, holding oneself to excessively high standards alongside harsh self-criticism, is rising among young people and is a transdiagnostic risk factor for anxiety, depression, eating disorders, and obsessive-compulsive disorder, as well as being associated with poorer wellbeing, stress, and burnout. Research has begun to develop brief, self-guided and online interventions to better which help address perfectionism, However, it is currently unknown which components of perfectionism interventions are most effective, as there are few if any trials that isolate and compare them. The proposed project addresses this gap in young adults aged 18 to 25 years. Using the Multiphase Optimisation Strategy (MOST) framework, we will test the individual and combined effects of common perfectionism intervention components delivered as brief online "micro-interventions", In doing so, we aim to identify the most effective and efficient combination, to inform the design of accessible, low-cost interventions for perfectionism that can produce change in the shortest time possible, better meeting the needs of young people and offering potential preventative benefit for serious mental health problems.

This study aims to investigate the feasibility of administering fibrinogen concentrate in the setting of severe traumatic bleeding in the prehospital setting. This is being done to evaluate the possibility of conducting a prehospital arm of the forthcoming FEISTY II study.

Despite clinical guidelines recommending exercise for the management of knee osteoarthritis (OA), many Australians with painful knee OA are physically inactive. Pain during exercise can reduce initial and sustained exercise engagement, making it difficult for people with knee OA to maintain regular exercise. Although exercise can improve pain, function, and long-term health outcomes, new strategies are needed to improve exercise uptake and engagement in people with arthritis. Virtual reality (VR) technology holds promise as a strategy to reduce exercise barriers and increase exercise engagement and experiences, and thus, have greater effects on clinical outcomes including knee pain and physical function. This study will use a parallel-group randomised trial design. Participants will be randomised to one of two active treatment groups: VR-enhanced cycling with increased optic flow or VR-enhanced cycling with decreased optic flow. Both groups will receive two in-person, one-on-one treatment sessions per week over six weeks (total of twelve sessions). The sessions will be delivered by an allied health professional (physiotherapist, occupational therapist). The primary outcomes will be exercise engagement (total work during cycling) and experiences (affective valance via Feeling Scale). Secondary outcomes will include knee pain (WOMAC pain subscale), physical function (WOMAC function subscale), knee pain intensity during cycling (101-point NRS), perceived exertion during cycling (Borg scale), exercise engagement (average/maximal power, cycling duration), exercise enjoyment (101-point NRS, Physical Activity Enjoyment Scale), physical activity (The Active Australia survey), pain interference (BPI-PI), and motion sickness symptoms during cycling (FMS), pain self-efficacy (PSEQ), health related quality of life (EQ-5D), pain-related fear of movement (Brief FoM), bodily perception of the knee (FreKAQ), knee osteoarthritis conceptualization (OACS), pain catastrophizing (PCS), positive and negative affect (PANAS-SF), psychological distress (PHQ-4), fatigue level (ROF) and treatment expectation.

Human papilloma virus (HPV) is the most common viral infection of the reproductive system and is spread through contact with infected genital skin, mucous membranes, or bodily fluids. This study will assess an experimental vaccine called 10vHPV for the safety, reactivity, and immune response, in healthy adults, compared to Gardasil 9. There are two phases in this study - Phase 1 will include up to 36 healthy adults aged 18-25 years, Phase 2 will include 36 healthy adults aged 26-45 years. Participants will be randomised in a 2-to-1 ratio to receive either 10vHPV or Gardasil 9. 10vHPV or Gardasil 9 will be administered as a 0.5 mL single dose via intramuscular injection in the deltoid muscle of the upper arm. In Phase 1, participants will receive a single dose on Day 1, and in Phase 2, participants will receive a single dose on Day 1, then at 2 months (Day 60), and again at 6 months (Day 180). In Phase 1, the main objective is to assess the safety of a single dose of 10vHPV vaccine, compared to Gardasil 9, in healthy adults aged 18 to 25 years. In Phase 2, the main objective is to assess the safety of 3 doses of 10vHPV vaccine, compared to 3 doses of Gardasil 9 vaccine, in healthy adults aged 26 to 45 years.

This research project aims to investigate the complex relationship between hormonal changes during the menopausal transition and subsequent alterations in body composition, fat distribution, and metabolic parameters. Despite the well-documented increase in cardiovascular and metabolic disease risk following menopause, there remains a significant knowledge gap regarding the precise temporal relationship between hormonal shifts and body composition changes. This prospective longitudinal study will track women through the menopausal transition, employing advanced body composition assessment techniques and comprehensive metabolic profiling to establish clearer causative relationships and identify potential intervention windows.

Exercise is considered a cornerstone of therapy for type 2 diabetes (T2D) and for related metabolic dysfunction-associated fatty steatotic disease (MASLD). However, the benefits of exercise on liver fibroinflammation are unclear. Fibro-inflammation develops as MASLD progresses and is more likely to occur in people with T2D. Liver fibrosis is a key prognostic indicator for liver-related mortality. Moreover, long-term exercise maintenance remains a challenge to sustained health benefits in T2D and MASLD. This study will examine the efficacy of a 12-wk aerobic exercise intervention followed by 12-weeks self-directed maintenance supported by adherence building strategies for reducing liver fibro-inflammation, compared with a supervised stretch comparator. It is hypothesised that 12-wks of aerobic and resistance exercise will improve fibro-inflammation significantly more than the stretch control, and that improvement will be sustained at 12 weeks post intervention if exercise is also sustained. We hypothesise that benefits will be maintained at 12 months follow-up so long as exercise has been maintained.