ANZCTR search results

The study aims to evaluate the engagement with, interest in, and benefits of the use of a mobile app to enhance a virtual Meal Replacement Program conducted through a tertiary weight management clinic from both the patient and clinician point of view. It is hypothesised that using a specifically developed app while participating in a virtual weight loss program will enhance motivation and improve retention in the program that in turn will lead to greater weight loss. It is also hypothesised that the app will free up clinican time and allow for better monitoring of patients during the intensive phase of the program.

This clinical investigation is targeted at collecting clinical effectiveness and safety evidence of HP-OCT+ (Hyperparallel OCT®) instrument in visualising and measuring anterior and posterior ocular structures/parameters. It is hypothesised that the HP-OCT+ is not inferior to, or less safe than the current standard devices utilised to measure anterior and posterior ocular structures/parameters. In this investigation, about 70 subjects (eyes) will be recruited and divided into 6 groups, i.e. cataract, pseudophakic (monofocal or toric IOL), post-refractive surgery (phakic or pseudophakic with monofocal or toric IOL), phakic <30 years with no history of refractive surgery or ocular disease including cataract, corneal cylinder <2 D, phakic <30 years with no history of refractive surgery or ocular disease, corneal cylinder >2 D, and dry eye. The subject will be scanned/measured on HP-OCT+ instrument and the other four comparative instruments (HP-OCT, IOLMaster 700, Keratograph 5M and Innoveyes Sightmap). The measurement data obtained from different HP-OCT+ modalities (biometry, topography, wavefront, tear film test) will be then compared with the corresponding measurement from the comparative instruments, to investigate the agreement of HP-OCT+ with the comparative instruments. The repeatability of these HP-OCT+ measurements will also be determined.

Brief project background & objectives: Running is an important skill that enables children to participate in physical activity. Children with generalised joint hypermobility often have difficulty with running due to various factors including difficulty generating lower limb power, fear of movement (kinesiophobia), pain or fatigue. This impacts participation in physical activity and everyday life. A running intervention conducted by this research group has been demonstrated to assist children with cerebral palsy to achieve running goals. Objectives: This mixed methods study will investigate if a running intervention is a feasible and effective to improve running performance and reduce kinesiophobia for children with symptomatic joint hypermobility. Hypotheses: 1. Children with symptomatic joint hypermobility will achieve their running-related goals following a running intervention programme. 2. Children with symptomatic joint hypermobility will have reduced fear of movement following a running intervention programme. Significance of the project: There is currently no evidence with regards running or running interventions for children with hypermobility. Running is important for children’s participation in physical and social activities. Children with hypermobility can find it difficult to participate in physical activity, yet physical activity is critical for the health of children.

Magnesium is a crucial electrolyte and low serum magnesium concentrations must be treated promptly to avoid adverse effects. In the intensive care unit, critically ill patients are at risk of low magnesium concentrations magnesium ions are frequently administered via the enteral or parenteral (intravenous) route. There is sparse data as to which route to use but there is likely to be at least a tenfold cost differential between the enteral and parental preparations. In addition, there may be more waste and subsequent environmental impact associated with parenteral route. Given the potential but unproven advantages of the enteral route we wish to compare the safety and effectiveness of magnesium replacement via the enteral route and parenteral routes.

An evaluation study of the Arts on Prescription (AoP) in Hospitals program; a service prescribed to people admitted on the palliative care, rehabilitation, and older persons’ mental health wards of the participating hospitals to address health and well-being needs identified during their admission. The primary aim of the study is to assess the impact on psychological well-being from participation in the AoP in Hospitals program for individuals admitted to subacute hospitals, using the Positive Well-being Umbrella - Generic (PWU-G) and the Negative Well-being Umbrella - Generic (NWU-G). Secondary aims are (i) explore the perceived impact of the AoP in Hospitals program in a subacute hospital setting from the perspectives of service users, artists, and hospital staff, (ii) explore the perceived usability of the PWU-G and NWU-G as evaluation tools for the AoP in hospitals program from the perspectives of service users, artists, and hospital staff, and (iii) assess levels of participation in the AoP inhospitals program using the the Pittsburgh Rehabilitation Participation Scale (PRPS). it is hypothesised that participation in the AoP in hospitals program offered in subacute hospitals will contribute to improved psychological well-being among service users.

Individuals with intellectual disability suffer terrible health inequities compared to their healthy peers. This can lead to more dependence on health services and serious diseases in adulthood, which ultimately reduces their lifespan. Physical activity and regular exercise training are important factors that manage the symptoms of and protect against many age-related chronic diseases. Notably, individuals with intellectual disability exhibit much less physical activity compared to the average population, even in childhood. Current exercise prescription guidelines for young people with intellectual disability are vague and effective strategies to engage them in physical activity are sparse. The purpose of this randomised controlled trial is to determine the influence of individualised strength and conditioning (IS&C) versus games-based training (GBT) on health-related components of fitness in young people with intellectual disability. Health-related components of fitness such as cardiorespiratory fitness, muscular strength, body composition, balance, and agility will be assessed. Young people aged 12 to 17 years with an intellectual disability will be recruited from special schools in the local area (Ipswich, Queensland). Participants will be randomly assigned to one of three groups: IS&C; GBT; or a wait-list control group. Participants in the two treatment groups will complete twice-weekly supervised exercise training under the guidance of exercise professionals for 8 weeks. The exercise training will be performed at the University of Southern Queensland in the hours after school. The results from this project will determine effectiveness of IS&C and GBT at improving important health-related components of fitness that are indicative of health status and the risk of age-related diseases in youth with intellectual disability. They will provide evidence to establish if the two different training formats lead to meaningful improvements in health markers in youth with intellectual disability, which will guide exercise prescription recommendations. They will also elucidate whether the exercise training interventions improve long-term adoption and adherence to physical activity participation.

This is open label, cross over study to evaluate the safety, tolerability, pharmacokinetics (PK) food effects of AC-101 following oral single/multiple ascending dose administration in healthy male and female participants. The impact of food (high-fat breakfast) on the rate and extent of absorption will be evaluated. Food Effect (FE) study enrolling 1 cohort of subjects (Part 2) to receive AC-101 under both fasted and fed conditions for investigating the effect of food. In this part of the study the dose given in Fed Period will be administered 30 minutes after starting a high-fat breakfast. A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal will provide to the subject 30 min prior to dosing. This test meal should derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively.

Individuals with Cerebral Palsy who are reliant on wheelchairs for mobility have significantly reduced options for participating in physical activity and movement. For those with significant disabilities encompassing not only the musculoskeletal system but also cognition, behaviour and communication face a unique set of challenges requiring new and novel treatment options. In addition to the barriers of access and transport consideration also needs to be given to the timing of medications and feeds. The MOTOmed is a motorised movement (cycling) device, accessed from a person’s wheelchair that provides an option to move for non-ambulant adults with CP. The passive rhythmical cycling motion provides movement at the hip, knee and ankle joints that is otherwise not possible for those with a lack of independent and functional active movement. This movement opportunity may be beneficial given that adults with CP are otherwise in static postures for the majority of their day and night. This study will explore the frequency of use of the MOTOmed within the home, analyse data retrieved from the MOTOmed regarding usage and gain perspectives on the experience and perceived benefits of a home-based motorised cycling intervention. Those involved in the study will use the MOTOmed a minimum of four times per week over a 4 week period. A questionnaire at the completion of the study will enable participants to provide feedback on how the use of the MOTOmed impacted areas such as muscle tone / spasticity, sleep, mood, level of alertness and interactions with others alongside information on if it is an appropriate method of increasing physical activity and movement, where they would ideally like to access the device and if they would like to continue using it given the opportunity to do so. Additional information is downloaded from the MOTOmed such as number of spasms, duration and distance covered with each use.

We aim to develop a population pharmacokinetic model for lidocaine administration by intravenous infusion and identify clinically important covariates by conducting a prospective, single-centre, exploratory interventional study. It is anticipated that this project will provide data to inform a model which will facilitate accurate and potentially safer dosing of intravenous lidocaine. We plan to recruit 40 female adult patients undergoing breast reconstruction surgery. Patients will receive a bolus dose of lidocaine followed by an intravenous infusion. Dosing will be calculated using lean body weight and based on the dosing protocol approved and used in the LOLIPOP Pilot Trial (1) which has proven it to be safe and feasible. As an additional safety feature, we will be using half the dose of that used in LOLIPOP. This is because, unlike the LOLIPOP Trial, pain is not one of our outcome measures. Our primary aim of examining serial serum lidocaine concentrations and the potential formulation of a pharmacokinetic model is achievable at these lower doses. Lidocaine samples will be taken at hourly intervals throughout the duration of the infusion, and twice postoperatively between 8 and 26 hours of ceasing the infusion Current research (including the LOLIPOP Trial) is focussed on the analgesic properties of intravenous lidocaine. Several studies have already demonstrated a reduction in pain scores and a decrease in peri-operative opioid consumption. The goal of intravenous infusion is to establish and maintain therapeutic plasma concentrations of 0.5-5 mcg/mL, whilst avoiding higher doses that may result in toxicity. Lidocaine has complex pharmacokinetics and demonstrates non-linear (time-dependent) pharmacokinetics with prolonged infusion, including increasing plasma concentrations and prolonging elimination half-life. Establishing a population-based pharmacokinetic model will facilitate a dosing regimen that maintains plasma lidocaine concentrations within a safe therapeutic window. This will improve the safety of intravenous lidocaine infusion by decreasing the risks of systemic toxicity, and potentially improve its efficacy by maintaining effective therapeutic plasma levels. [1] Toner A.J. BMA, Schug S.A., Corcoran T.B. A pilot multicentre randomised controlled trial of lidocaine infusion in women undergoing breast cancer surgery. Anaesthesia. 2021. ClinicalTrials.gov registration ID: NCT05072314

At The Northern Hospital, on average, 1 in 4 women will require their labour to be induced with oxytocin. Currently, this medication is given as a continuous infusion intravenously, with the amount of oxytocin given increased every 30 minutes until 4 uterine contractions within 10 minutes are regularly observed. However, the body normally releases this hormone in a 'pulsatile' or intermittent fashion every 3-5 minutes during labour, rather then releasing it continuously. The hypothesis being tested is whether giving oxytocin intravenously in a pulsatile fashion, which mimicks the physiological process, leads to better obstetric outcomes, in particular, a shorter duration of labour, more successful vaginal deliveries, less postpartum haemorrhage and less requirement for epidural analgesia, when compared to the current process of providing oxytocin in a continuous fashion. This hypothesis will be tested by a randomised controlled trial of 412 participants, Half of the participants will be randomised to continous infusion of oxytocin, whereas the other half will be randomised to pulsatile oxytocin. The primary outcome of interest will be the duration of labour as defined by the commencement of oxytocin, until the birth of the neonate.