ANZCTR search results

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.

Major depressive disorder (MDD) is a common mental health condition, and many people do not improve with standard treatments such as antidepressant medications. This study is investigating whether a more personalised form of transcranial magnetic stimulation (TMS), a non-invasive treatment that uses magnetic pulses to stimulate specific areas of the brain, can improve outcomes for people with treatment-resistant depression. Instead of using standard methods to identify where to stimulate the brain, this approach uses MRI scans to target brain areas that are more closely linked to depression. The study will also use an accelerated treatment schedule, with multiple TMS sessions each day over five consecutive days, which may be more effective than the standard once-daily approach. In addition, the study will investigate whether taking a 100 mg dose of D-cycloserine (DCS), a medication that may enhance the brain's response to TMS, before the first treatment session each day further improves outcomes compared with placebo.

Some women experience post-traumatic stress disorder (PTSD) after a difficult or traumatic childbirth. These experiences can affect their emotional wellbeing and may make it harder to feel connected with and respond to their baby in everyday interactions. Early parent–infant relationships are important for a child’s social, emotional, and mental health development. This study aims to compare two brief psychological treatments for mothers experiencing post-traumatic stress symptoms following childbirth. The two treatments are imagery rescripting, a therapy that helps people process and change the meaning of distressing memories, and relaxation training, which teaches skills to reduce stress and promote relaxation. The study will examine whether either treatment can improve mothers' wellbeing and strengthen their relationship and interactions with their infant. Around 100 mothers and their infants will take part. Mothers who have symptoms of childbirth-related PTSD will be randomly assigned to receive either four sessions of imagery rescripting or four sessions of relaxation training. Researchers will assess whether the treatments help improve mother–infant bonding and interaction, reduce PTSD, anxiety, and depression symptoms, and support positive infant development. The findings may help identify effective ways to support mothers recovering from birth trauma and promote healthy early relationships between mothers and their babies.

This study aims to determine whether playing white noise overnight can improve sleep for patients in the intensive care unit who are not receiving mechanical ventilation. Poor sleep is common in the ICU because of noise from alarms, equipment, staff activity and patient care. Patients in the study will experience both a night with white noise and a night without white noise, allowing their sleep to be compared between the two conditions. Sleep will be assessed using a wrist-worn activity monitor (actigraphy) and a patient-completed sleep questionnaire (Richards-Campbell Sleep Questionnaire). The study will also examine how closely sleep measurements from the activity monitor agree with patients’ own assessments of their sleep.