ANZCTR search results

Effect of Yeast protein compared to whey protein and a placebo on muscle mass and performance in an Adult Population – A double blind, randomised controlled trial. The aim of this study is to assess the effectiveness of yeast protein for increasing muscle mass and strength compared to whey protein and a placebo in otherwise healthy adults aged over 40 years old. Yeast protein supplementation is hypothesised to result in equivalent muscle gains when compared to whey protein and superior gains when compared to a placebo.

The PERKS-International trial, which has received funding from the Australian National Health and Medical Research Council (application ID APP1182071), will be of 4 years (2021-2024) duration and involve 790 participants who will be recruited and followed for at least 12 months. The Menzies Institute for Medical Research, University of Tasmania will be responsible for co-ordination of the PERKS-International trial. This is a Phase III, prospective, pragmatic, open-label, single blinded endpoint 2 arm randomised controlled trial (RCT) including 790 participants across Australia and New Zealand. Participants will be adults aged >35 and <=75 years with two or more modifiable risk factors (smoking, overweight, low physical activity, poor diet, high blood pressure, high total cholesterol or high blood glucose). Participants will be randomised using a stratified block approach to either the intervention or usual care group. After undergoing a detailed health assessment, participants will be randomised to receive feedback on their risk factors for stroke in one of two ways. Our hypothesis is that those who receive feedback using one method (intervention group - IG) will have better improvements in their risk factors as compared to people who receive the information about their risk factors using the other method (usual care group - UCG). Blinded assessments will be conducted face-to-face at baseline and 6 months and by online or telephone assessment at 3 and 12 months. The primary outcome is the change in the total combined cardiovascular risk factor score (LS7 score) from baseline to 6 months post-randomisation in the intervention group compared to usual care group.

The study will take place over 7 days in a free living environment. It will involve toddlers between the ages of 2 and 7 who have had type 1 diabetes for greater than 1 year. During this 7 day time period we will monitor their blood glucose levels through the use of a continuous glucose monitor, along with the amount of exercise they undertake which will be done using accelerometers. At the end of the 7 day period parents will be asked two complete two surveys, one around the fear of hypoglycaemia and the other around the barriers to physical activity. Accelerometer data will then be compared to an aged matched population group. This will help us gather information young children with type 1 diabetes and how they are participating in exercise.

This project will compare leading methods for technology-assisted dietary assessment. Excessive cost and questionable accuracy limit the routine use of dietary assessment and undermine decision making in Australia. Three technology 24-hour recall methods of assessing diet will be compared . The approach will confirm if the use of food images and automated methods provide new approaches to improve accuracy and consumer acceptability. The outcomes of this project will lead to more accurate and acceptable methods to assess dietary intake to inform effective government decision making about the types, amounts and drivers of food consumption of the population.

Atrial fibrillation (AF) is the most common arrhythmia in Australia and confers a significant risk of stroke, heart failure and death. Furthermore, patients with symptomatic AF represent a growing burden on the Australian healthcare system. In view of this epidemic, new approaches to preventing and managing the symptoms and complications of AF are required. Sodium-glucose co-transporter-2 (SGLT2) inhibitors are new class of medications designed with diabetes in mind via the renal excretion of glucose. However, in addition to lowering blood glucose, these agents also appear to have significant pleiotropic effects on multiple cardiometabolic factors that are associated with AF.There is strong rationale for the potential benefit of SGLT2 inhibition in patients with AF. However, this class of medications have not been previously tested in these individuals. This study is a Phase II, investigator-initiated, multicenter, randomised controlled trial, investigating the use of Empagliflozin, a SGLT2 inhibitor in patients with AF. It is anticipated that SGLT2 inhibition with Empagliflozin will significantly reduce AF symptoms and arrhythmia burden. A total of 300 participants with symptomatic paroxysmal or persistent AF will be recruited and randomised in 1:1 ratio to Empagliflozin or Placebo. Participants will attend follow up clinic visits every 3 months for a 1-year period.

The aim of this study is to examine whether subgroup classification of chronic low back pain patients results in differing effects from a device based isolated, targeted and progressive resistance strength rehabilitation programme (24 Sessions) on respective measures of spinal strength, range of motion and pain and disability. The sustainability of the results will be examined in a 12 month followup. It is hypothesized that all groups will respond positively to the device based rehabilitation as the specific nature of the exercise addresses the underlying weak spinal musculature as a major factor in all patients with chronic low back pain.

Most children receiving inpatient care at the Queensland Children's Hospital will require the insertion of a PIVC. Two thirds of healthcare consumers describe peripheral intravenous catheter (PIVC) insertion, as the ‘worst’ thing to happen during hospital admission, describing it as painful, frustrating and stressful. Despite their importance, PIVCs can be hard to insert with unacceptably high rates of first attempt insertion failure reported. This study aims to determine the efficacy of ultrasound guided PIVC insertion compared to landmark technique to increase first time insertion success in children aged <18 years.

Over the last few years, there has been a significant increase in the use of robotic-assisted surgery (RAS) in total knee arthroplasty (TKA), as well as increasing adoption of kinematic alignment (KA) strategies. Given the significant expenditure required for robotic-assisted surgery, along with increasing use of kinematic alignment, rigorous clinical evidence is required to guide practice in these areas. The RASKAL study will be assessing patient outcomes by comparing 2 different assistance (Robotic- RAS/Computer-CAS) and alignment (Kinetic -KA/Mechanical-MA) techniques currently used in Total Knee Arthroplasty in Australia. The study will be assessing patient outcomes by comparing 2 different assistance (Robotic- RAS/Computer-CAS) and alignment (Kinetic -KA/Mechanical-MA) techniques currently used in Total Knee Arthroplasty in Australia. The primary aim of the study is to determine if there is a difference between the groups measured by Patient Reported Outcome Measures (PROMs) over 2 years. The study will be nested within the AOANJRR utilising the RAPID (Real time Automated Platform for Integrated Data capture) system and will be conducted in around 10 sites (across NSW and WA) with 15 surgeons.

This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II, vs placebo, to investigate the mechanisms by which this herbal preparation may exert its gastrointestinal symptom relieving effects. Participants will attend two visits at which they will receive either STW5-II or placebo, and gastric emptying will be measured for the following three hours. The hypothesis is that STW5-II will increase meal retention in the proximal stomach and decrease content in the antrum, without affecting overall gastric emptying.

We propose treating hypertensive moderate heart failure by directly treating aortic stiffness (increasing aortic distensibility; increasing expansion and contraction). Our passive recoil extra aortic balloon counterpulsation device, the BioQ Cardiac Assist device (BioQ CA), reduces aortic stiffness leading to a reduction in afterload, achieving reduced pulse and mean aortic pressures in pilot animal testing by 27% and 10% respectively, and improved left coronary artery (LCA) blood flow by 39%. The device is minimally invasive, non-blood contacting, failure mode safe, and requires no pump, leads, or ECG timing, and is a cost effective approach. Additionally, the device offers the ability to adjust its performance post implantation (for future chronic studies) by changing balloon pressure via a subcutaneous inflation port. Device proof-of-principle has been established where the BioQ CA device has shown to operate as a counterpulsation device by decreasing heart load, reducing pulse and mean pressures, and improving left coronary artery blood flow. These changes are within the range of improvement achieved with pump powered Intra-Aortic Balloon Pump (IABP) and extra-aortic balloon (EAB) systems, and the blood pressure reduction achieved with renal denervation and barostim modulation, demonstrating our passive recoil counterpulsation device is competitive on performance yet with the advantages of being a simple self-powered, stand alone device, offering superior cost savings compared to other technology approaches. More recently the device was implanted in two patients in India prior to scheduled coronary artery bypass grafting (CABG). Devices were attached around the ascending aorta for approx. 30 minutes with increases in left coronary artery (LCA) blood flow of 30% to 100% measured, cardiac output improvements of up to 18%, and heart rate decreased by 8%. Patients recovered normally and were released from hospital with no adverse events. This data is very competitive and justifies further acute studies before considering a chronic human study. In this pilot study, we propose to test up to 40 patients with the device for 30 minutes on consenting patients who are scheduled for CABG. Testing will be done during vessel harvesting to minimise procedure time. We aim to measure LCA blood flow, arterial blood pressures, and cardiac output.