ANZCTR search results

The aim of this project is to assess the effectiveness of a 10 day intervention of individualised vibrotactile neurofeedback training (iVNT) on balance performance and postural stability in an elderly population with moderate to severe hearing loss and self-reported dizziness. Two-hundred and seven participants will be recruited across Brisbane, Berlin and New York (69 per site) and they will be randomised to one of the three groups: intervention, placebo and control. The first 3 to 5 days of training will occur at the campus location and the following sessions will occur in-home with support provided as needed. The intervention involves the participant wearing a device that delivers vibrotactile neurofeedback during set training tasks. The primary outcome measure will be to determine the effect of training on balance immediately after the two-week intervention period. Secondary outcome measures are to determine the effect of training on balance at six months after the start of training; and on dizziness, gait speed under single and dual task conditions, balance confidence, and physical activity at 2 weeks and six months after the start of training.

The aim of the Omega Kid Study is to investigate the effect of omega-3 supplementation on behavioural outcomes such as self-regulation and executive function in preschool aged children. The study is parallel in design and placebo controlled with the intervention period lasting 12 weeks. Assessments will be conducted at baseline and at 12 weeks, after the intervention period. It is hypothesised that children who receive an active omega-3 supplement will show improvements in self-regulation and executive function, when compared to a matched placebo control group.

This is a randomised, double blinded, placebo controlled trial to assess antiarrhythmic properties of phenytoin and dantrolene, their efficacy and safety for treating arrhythmias and heart failure. The study will compare all the 3 arms together: phenytoin versus dantrolene, phenytoin versus placebo and dantrolene versus placebo. Randomisation will occur after consent is obtained and on enrolment into the study, 105 participants will be randomised in a 1:1:1 ratio to one of 3 arms: • 35 will receive phenytoin • 35 will receive dantrolene • 35 will receive placebo The participants then will be followed in a 2 month interval visits. The visit numbers can increase if there are any concerns regarding the procedure or medication adverse effects (AEs). Repeat blood tests (liver function test and biochemistry profile, medications serum level) and device data collection will be performed prior to office visits. At these office visits, blood test results, occurrence of ventricular arrhythmia, heart failure symptoms (assessed by New York Heart Association (NYHA) functional class and Minnesota Living with Heart Failure Questionnaire) and medications adverse effects will be reviewed. Participants will also have Six-Minute Walk Test (6MWT) at the screening visit, 6 months visit and the last visit of the study.

In Australians 65 years and older, 19% of hospital admissions to medical wards are associated with serious side-effects from medications. Almost 90% of these admissions are preventable through safer use of medicines. The research team have developed a novel method of identifying people at risk of these problems. In this study hospital pharmacists will assess the risk of serious side-effects in people admitted to hospital and make recommendations to reduce this risk to hospital staff, general practitioners and pharmacists. We will test whether this strategy reduces the risk of these events compared to standard care in the 12 months following hospital discharge. We hypothesize that ADR risk assessment on admission to hospital and communication of this risk, with recommendations that target the specific risk factors identified, will reduce the incidence of ADRs occurring during admission and in the 12-months post-discharge.

This study aims to investigate the biopsychosocial impacts of visual arts on individuals with chronic pain. Twenty participants on the waiting list of pain management program at Royal Prince Alfred Hospital will be recruited and randomised into intervention and control groups. The intervention group will receive five sessions (3hrs/session) of art observation and reflective art creation at the Art Gallery of NSW. Stress and inflammatory bio-marker (saliva cortisol-level) and several patient reported outcome measures will be recorded before, during and after the intervention. Each art-making session will be followed by a semi-structured group discussion. The discussions will be recorded for further analysis. The control group will continue with their usual medical care. We hypothesise that this research will identify : (a) whether making visual art produces physiological benefits for chronic pain sufferers, and (b) whether art-making is experienced as beneficial by chronic pain sufferers and identify why or why not.

There is an urgent and growing need to minimise iatrogenic harm from potentially inappropriate polypharmacy (PIP) in ageing populations with multimorbidity. ‘Deprescribing’ aims to minimise PIP. It is the process of clinician-supervised identification and withdrawal (or dose reduction) of medicines where the harms exceed the benefits in the context of an individual patient’s care goals, current function, life expectancy, values and preferences. General practitioners (GPs), with tacit knowledge of, and an ongoing relationship with, their patients, play a central role in coordinating and delivering healthcare to older patients who are prescribed medicines for multiple health conditions. Research suggests that patients are receptive to discontinuing medicines if their general practitioner feels it is appropriate and worthwhile. This study aimed to assess the feasibility, effectiveness and safety of a multi-faceted GP-led intervention to minimise PIP in community-living older Australians. Unlike most other deprescribing studies, this intervention leveraged the existing therapeutic relationship between GPs and their usual patients and used an individually-tailored versus a drug class-specific approach to deprescribing. Recognising the time constraints for GPs in routine care and the potential facilitative role of pharmacists in deprescribing, GPs had the option of referring patients to one of the participating pharmacists for a Home Medicines Review to augment the deprescribing process in this study.

This study will use sham placebo treatments, ostensibly a benzodiazepine medicines being tested to assess their effectiveness for experimentally-induced anxiety, to assess the influence of choice of treatment (no choice, choice of 2 treatments, choice of 10 treatments) on the nocebo effect (assessed via self-reported physical symptoms that are described as benzodiazepine side effects). To assess the development and magnitude of the nocebo effect, placebo-treated participants will be compared to a no treatment control condition. It is hypothesised that a nocebo effect will be seen across the three groups of placebo-treated participants. It is also hypothesised that, compared to the no choice group, the 2 choice group will report lower physical symptoms scores, and the 10 choice group will report higher or at least equivalent physical symptoms scores.

The overall aim for this project is to conduct a randomised controlled trial to examine the efficacy of GoodForm, an education program that aims to reduce body dissatisfaction, appearance and performance enhancing substance [APES] use, and lenient attitudes towards doping in sport) in 600 boys aged 14-5. This program will run within the Health and Physical Education curriculum. Boys have typically been overlooked in body image research, and there are no effective intervention programs for boys. There is evidence that body image, the use of supplements, and attitudes towards doping in sport are interrelated and contribute to anabolic steroid use in adolescent boys. The theoretical frameworks underpinning body image and intentions to use supplements are very different for boys and girls. We will focus only on boys in order to confirm approaches that can be used to target these behaviours in a single sex setting to fill this gap in the literature. In this research, we will ask teachers of grade 9 and 10 boys to implement GoodForm, the 4 session program that we have developed. We will measure body image, use and intentions to use APES, and attitudes towards doping in sport before and after boys receive the program to determine impact. This is the first trial of an antidoping program that targets the behaviours that might lead to boys using muscle-building supplements in the world.

Most people who have schizophrenia and are treated with either clozapine or another antipsychotic medication, are at increased risk of getting metabolic syndrome and cardiovascular disease. The research study is looking at whether a simple change in lifestyle including engaging in regular physical activity and modifying diet can help to improve the quality of physical and mental health of people with schizophrenia.

In an extreme heat context, dehydration has been demonstrated to increase cardiovascular strain and exacerbate core temperature rises. Naturally then, when heatwaves strike in areas where access to clean drinking water is limited, human health suffers. Although clean drinking water is often in short supply in these areas, there may be plentiful access to water that is not safe to consume, but can be doused on the skin, taking the place of sweat. We therefore wish to investigate whether dousing of water on the skin may slow an individual’s rate of dehydration, thereby reducing the amount of fluid they must consume to offset any hydration related exacerbations of physiological strain. To achieve this, we will compare resultant dehydration, as well as thermal and cardiovascular outcomes during a four hour passive heatwave exposure (45°C/ 15% relative humidity) during three different interventions: 1. Full fluid replacement, sham dousing (FFR-S) (comparator) 2. Quarter fluid replacement, sham dousing (QFR-S) 3. Quarter fluid replacement, optimal dousing (QFR-F) Participants will complete only one exposure each, and will fit into one of three age brackets: 1. 18-40 years 2. 45-55 years 3. 65 + years The research hypotheses going into this study are: 1. Resultant dehydration will be less in QFR-F than in QFR-S. 2. Heat related thermal and cardiovascular strain will be least inn FFR-S, followed by QFR-F and greatest in QFR-S. 3. During FFR-S and QFR-S the 65+ years age group will have a greater change in core temperature than the 45-55 years age group who will have a greater change in core temperature than the 18-40 years age group. During QFR-F all age groups will have similar changes in core temperature.