ANZCTR search results

Enteral feeding is standard of care in critically ill patients, however delivery is often inadequate with observational studies reporting patients only receive 60% of estimated energy needs. A primary reason for inadequate nutrient delivery is delayed gastric emptying, which occurs in up to 50% of mechanically ventilated critically ill patients. While standard enteral formulas contain 1 kcal/ml, it is common practice for an energy-dense formula (2kcal/ml) to be prescribed by clinicians to enable higher caloric delivery in a smaller volume, as a way of circumventing the effects of delayed gastric emptying. However, at present there is no evidence to support the concept that use of an energy-dense formula will enable greater calorie delivery and nutrient absorption. It has been demonstrated, in health, that gastric emptying occurs at a constant rate based on caloric delivery approximating 1-4 kcal/min and rather than volume dependent. Therefore, the aim of this study is to evaluate the effect of calorie concentration on the rate of gastric emptying in critically ill patients.

This research project will investigate the effect of a dairy-derived nutritional supplement on physical health, mobility and well-being when combined with a physical activity program in 45-65 year-old women identified as habitually sedentary. The project has been designed to determine whether supplementation augments the positive response to a healthy lifestyle that includes moderate-level physical activity, and therefore whether supplementation is a beneficial addition to a healthy, active lifestyle. This is a 4-month randomised controlled trial in which 240 healthy, sedentary women will be randomised to receive: 1) a Fortified Milk Product (FMP) containing addition protein, vitamin D and calcium or a Non-Fortified drink (NFD). All women will also be asked to undertake a supervised gym-based exercise program twice a week under the supervision of accredited exercise trainers and one home-based training session. The multimodal exercise program will consist of strength, mobility and balance/functional training. Participants will undergo testing at baseline and after completion of the intervention (week 16) in the clinical lab at Deakin University. The main outcome for the study is functional muscle power, Secondary outcomes include: muscle strength, function, mobility and balance, body composition, cardiovascular health (blood pressure), circulating bone, cartilage, inflammatory and hormonal markers and perceptions of health, Dietary and physical activity habits will also be assessed. This study is important as the findings will underpin more precise exercise and nutrition guidelines for the prevention (and management) of age-related loss in muscle health and function in sedentary middle-aged adults, along with the ongoing refinement of community-based initiatives for the management of these age-related changes.

Head injury is common, affecting Australians at a rate of 107 per 100,000 people. Its outcome varies from complete recovery to disability. Two recognised tools predict these outcomes, based on presentation: CRASH (Corticosteroid Randomisation after Significant Head injury) and IMPACT (International Mission for Prognosis and analysis of Clinical Trials in TBI (Traumatic Brain Injury)). Clinical studies independently validated them. One reported study compared them within a non-Australian community. Study Aim: To compare CRASH’s efficacy against IMPACT in predicting severe head injury outcomes. Research design: -Recruiting severe head injury patients admitted to Princess Alexandra Hospital as participants. -Collect symptom details from first admission and after six months. -Calculate participants’ CRASH and IMPACT scores and compare with actual outcomes. Reviewing participants after six months provides information relating initial presentation to recovery. The results would identify whether CRASH or IMPACT better predicts outcomes. This knowledge may influence future patient care and research.

Prevalence of obesity is increasing. Contrary to popular belief, literature has shown that overweight and mildly obese have infact been shown to have increased survival benefit compared to normal weight in non-cardiac and cardiac conditions. All the studies that have reported this paradoxical relationship were based on BMI; BMI is not a measure of body fat. This study is to investigate the association between obesity and postoperative in-hospital adverse outcomes following elective cardiac surgery. Several measures of obesity will be compared including BMI, WC, HC, NC and WHR . We will also be measuring body frailty and its association with adverse outcomes. The patients will be followed up until 2 years through phone contact and registries.

The treatment and pathophysiology of tremor in Multiple Sclerosis (MS) remains a significant challenge and unmet need, requiring further clinical research. We recently performed a phase II, randomized, controlled, crossover study demonstrating the efficacy of Botulinum toxin type A (BoNT-A) for treatment of MS tremor. This peer-reviewed NHMRC funded project proposes a detailed study of phenomenological, electrophysiological characteristics of MS tremor patients before and after BoNT-A or placebo treatment. The results of this study will help generate class I evidence that is required to translate treatment of MS tremor with BoNT-A into clinical practice. We aim to define predictors of the response to treatment and to better understand the underlying pathophysiology of MS tremor.

Patellofemoral Pain syndrome (PFPS) is a condition associated with anterior knee pain in the absence of other pathology. Kinematic variations have been identified in this condition. Physiotherapy management of this condition aims to correct neuromuscular imbalances and the use of patella taping is a common adjunct to manual therapy and exercise prescription. With the advancement in taping materials and variation in application methods further investigation into the influence patella taping has on knee kinematics is justified. Aim To investigate if the application of patella tape influences the knee kinematics in three planes of motion compared to baseline untaped data. Objectives Analyse knee kinematics during three functional tasks of walking, step descent and single leg squat for each individual Compare the effects of the two different taping materials (rigid and dynamic tape) on the repeated functional tasks versus the control data

Neural Regeneration Peptide 2945 (NRP2945) is an experimental drug being developed by CuroNZ Pty. Ltd for the potential treatment of severe childhood-related refractory epilepsy such as Lennox-Gastaut Syndrome (LGS). In animal models, NRP2945 has been shown to be a driver molecule in central nervous system (CNS) neural regeneration processes during stages of disease or injury. In this first time in human study, single ascending doses and multiple ascending doses of NRP2945 will be assessed in healthy male volunteers. NRP2945 will be administered by subcutaneous injection in the abdomen. Assessments of safety, tolerability, pharmacokinetics and pharmacodynamics parameters following administration of NRP2945 will guide decisions to further develop the drug.

A 2-arm randomised waitlist-controlled trial to test the efficacy of a m-health intervention to promote physical activity and sleep health in adults. The two main outcomes (MVPA and sleep quality) will be assessed after 3 months (primary endpoint) and followed up at the 6-month time point. The study will deliver a combined program including an app and message-based support to facilitate goal-setting, self-monitoring and feedback on progress towards goal for both behaviours. Physical inactivity is highly prevalent among adults and a large proportion of the population reports poor sleep health (characterised by inadequate sleep duration, low quality of sleep and inappropriate sleep timing, leaving people feeling insufficiently refreshed and unsatisfied with their sleep). Both behaviours independently influence risks for chronic disease and mortality and may have a bidirectional relationship, as such synergistic effects on health may be achieved. No studies to date have targeted the two behaviours simultaneously in a mobile device-delivered behaviour change intervention. In addition to testing the efficacy of such an intervention, we seek to identify potential moderators of intervention efficacy (e.g., age, gender, education) and test mediators of behaviour change (social cognitive factors, sleep hygiene).

Summary: Q fever is a highly infectious disease caused by Coxiella Burnettii. Each year in Australia there are over 450 cases notified, (2013 n= 485, 2014 n=452). This equates to approximately 8-10 cases per week. Currently there is an efficacious Q fever vaccine which is recommended for those considered to be in “occupational at risk” groups, such as abattoir workers, veterinarians and farmers. However, several recent studies have highlighted that the risk in the non-traditional “at risk” groups, such as children, metropolitan dwellers, is higher than previously thought. The epidemiology of Q fever disease in New South Wales has changed and amongst notified cases the relative importance of non-abattoir contact with livestock, wildlife or feral animals appears to be increasing. Importantly the only vaccine available in the world is QVax, manufactured by CSL and is only licensed for those over 15 years old. Therefore under current Australian Immunisation guidelines children under 15 years old, who are at risk of contracting Q fever, because they live on farms, near abattoirs or, are children of “at risk” workers cannot be vaccinated. The main reason for this age restriction is not because of an identified safety risk but because the initial trials did not include children under 15 and therefore restricted the licensure of the vaccine. Vaccinating children, particularly children of farmers or animal breeders, is an important preventive measure and has not been studied at all. In this pilot study the safety and efficacy of Q fever vaccine in children aged 10 to 15 years old will be measured.

This study investigates the effect of exercising different limbs (arm vs. leg), and timing (pre- vs. post-) on responses to vaccination. A single bout of exercise has been shown to improve vaccination responses, the proposed mechanisms include increased blood and lymph flow of the exercising muscle. This suggests that arm exercise would have stronger effects than leg exercise (if a vaccine is given in the arm). All studies of exercise effects on vaccinations have used exercise pre-vaccination. But post-vaccination exercise might be more effective as the antigen can benefits from increased blood and lymph flow and increased immune cell numbers.