ANZCTR search results

The positive influence of exercise on cognitive decline in older adults is established and previous research has demonstrated that exercise increases the hippocampus volume, a region of the brain that is responsible for creating and storing new memories. However, it is not known whether the intensity of exercise is important for improving cognitive function, and what mechanisms are involved in cognitive improvement with exercise. In mice, we have demonstrated that exercise acts directly on the brain to increase the growth of new brain cells (neurons) in this brain region, and as a result, learning and memory are improved. A compound known as growth hormone appears to be an important mediator for the growth of new neurons. In older adults, growth hormone levels are much lower than in younger adults, but exercise can increase growth hormone levels in the brain and the blood, and the greater the exercise intensity the greater the increase in growth hormone. Therefore, based on our results from mice, it is thought that growth hormone may be an important link between exercise, brain health and cognitive function. This project will investigate whether exercise can increase the production of important growth factors, leading to hippocampus volume increase and improved cognitive function in older adults. We are recruiting adults aged 65-85 years, who will be divided into three groups to complete either low-intensity (very easy), moderate-intensity (easy) exercise or aerobic-interval (hard) exercise three times per week for 6 months. All exercise will be supervised and monitored for participant safety using heart rate and perceived exertion. Cognitive function, fitness, blood hormones and hippocampus volume will be measured before beginning exercise, at mid-point (3 months) and following the conclusion of the exercise program (6 months), as well as following a 6-month follow-up period after the conclusion of the exercise. Results will be analysed to see whether the exercise changed cognitive function, and whether this changed is related to factors such as blood hormones and hippocampus volume. Our approach is the first systematic, multimodal approach to investigate the mechanistic and phenomenological effects of exercise on cognitive function, with the unique interchange between animal and human investigation. The overall aim of this project is to translate the beneficial effects of physical exercise observed within mice to older adults and develop robust biomarkers that can be used to evaluate the effectiveness of exercise interventions on cognitive function in humans. Exercise is a relatively cheap, safe, accessible and available treatment, which can be offered systematically to a large aging population. Therefore, the use of exercise as a prevention and treatment for cognitive decline will potentially benefit a large portion of the population and may provide a significant economic benefit, at both an individual and a societal level.

Glucosamine is used for the management of osteoarthritis. It shows inconsistent clinical outcomes in patients. Therefore, we propose that one possible explanation for the observed inconsistent clinical outcomes is variable inter-patient bioavailability of oral glucosamine. To test our hypothesis, we will recruit 24 healthy adult individuals, who will take two brands (Blackmores and DONA) of glucosamine supplements individually for total six days to reach a steady-state plasma concentration of glucosamine. On the sixth (last) day of dosing of each brand, we will collect their blood samples just before ingestion and then at 1, 1.5, 2, 3, 4, 5, 6, 10 and 12 hours after the ingestion of the last scheduled dose to analyse pharmacokinetic parameters at steady-state, including minimum, maximum and average plasma concentration. We will compare the obtained pharmacokinetic parameters to estimate the variation in absorption of glucosamine among the participants and across the two brands.

The purpose of the study is to evaluate the effects of head-down positioning (15 degrees below horizontal) in acute stroke, using both clinical and radiographic outcome measures. Primary Aim: 1) To demonstrate definitively whether body positioning improves cerebral blood flow in acute ischaemic stroke, as measured by CT perfusion imaging Secondary Aims: 1) To demonstrate (in ‘responders’) whether altered body position acutely affects neurologic function 2) To determine (in ‘responders’) whether altered body positioning (15 degrees head down) lessens the likelihood of progression of ‘penumbra’ to infarction, as assessed by 24 hour magnetic resonance imaging.

Justification: Many healthcare practices do not align with current research evidence, prompting healthcare governance agencies to invest in efforts to increase translation of current knowledge into widespread practise. A common approach is the simple dissemination of text-based summaries. While this approach has demonstrated some success, other modes of transmission such as video may be more effective given that is how many of us increasingly consume information. Video-based approaches have emerged as a new way for journal publishers to communicate study results by providing video abstracts. A recent study reported increased knowledge as a result of a web-based video education series that aimed to build capacity for evidence-informed decision-making. However, further evaluative research is needed, due to the paucity of evidence supporting the effect of video mode dissemination for research findings. Aim: This study aims to evaluate the efficacy of video versus written research dissemination strategies for promoting knowledge translation in nursing and allied health using a novel helix crossover randomised design. Participants: Registered nurses and allied health professionals from all inpatient wards at the Kingston Centre will be sampled. Method: This single centre study will be evaluated using a 3-group helix crossover randomised study design, which enables each group to experience each condition, but in a different sequence. The 3 conditions are video-based evidence-summary (a), written-based evidence-summary (b), and usual care control condition (no intervention) (c). The material to be disseminated relates to the use of bedside pressure sensor alarms to prevent falls (S1), written falls prevention patient education (S2), and physical activity after diagnosis of deep vein thrombosis (S3). This study will be conducted as a 3 level helical crossover model as follows: S1a S2b S3c / S1b S2c S3a / S1c S2a S3b. The evaluation will be broadly based on the four levels of the Kirkpatrick Evaluation Model Hierarchy framework, designed to evaluate training programs: (1) reaction, (2) learning, and (3) behaviour, and (4) results Outcomes: Primary outcome: alignment between self reported rating of treatment benefit and current research evidence. Secondary outcomes: (1) self reported confidence of judgement of treatment benefit, (2) self reported perception of whether practice should be implemented or de-implemented, (3) self reported perception of the value of dissemination mode.

The study is interventional, employing devices, behavioural approaches and diagnostic procedures. The behavioural change aims to instil and continue abdominal breathing by the participants during sleep. Firstly this will be attempted by instructions, training, participant's abdominal muscle awareness during breathing, This will be assisted with Biofeedback. Secondly supporting activity via EMS and APAP devices may need to be utilised. Thirdly diagnostic procedure via Polysomnographic (PSG) sleep studies will authenticate definitive outcomes. The interventions will delivered by themselves and staff trained by Dr Peter Keller and Ms Thanusha Sothiratnam with 26 years and 14 years of experience respectively in the field of sleep diagnosis and treatment. The mode of delivery will be face to face preferably in group sessions (individually if requested by participants), employing instructions, training and devices, as well as remote monitoring via telephone and internet.

This is an exploratory study using a new clinical NMN prototype to determine the regional depositions in the nasal cavity of aerosols using different pulse frequency modes in healthy volunteers. The main objective of the study is to determine the optimal frequency for the NMN that will provide the basis for future in vivo sinus targeting of drug delivery systems. The primary endpoint of this study is the total area of distribution (mm2) of radiolabelled saline immediately after administration by the NMN (T0) in the different regions of the sinus cavity.

Cardiovascular disease (CVD) is the leading cause of death and disability. Ageing is associated with a number of traditional CVD risk factors, including high blood pressure and high cholesterol, as well as changes to the structure of our heart and blood vessels, which over time contribute to an increased risk of cardiovascular events. Statins are common cholesterol-lowering drugs that have been shown to reduce the risk of developing heart disease. Nutraceuticals are food components or active ingredients in food that may be used as therapeutic agents to help lower cholesterol and modify risk of heart disease. This project will investigate the effect of statins and nutraceuticals, either alone or in combination, on markers of heart and blood vessel function in people at moderate risk of heart disease. We hypothesise that statin therapy will delay the cardiovascular ageing process, as evidenced by improvements in structural and functional outcomes. These improvements will be further enhanced with adjunct nutraceutical therapy. In addition to the beneficial effects on risk factors for heart disease, nutraceutical compounds will offer additional benefit through changes to the gut microbiome, including improvements in bacterial diversity and composition, as well as alterations in the production of important short chain fatty acids and bile acids.

Research indicates that people living with HIV have higher risk of heart disease. This is partly due to the effects of anti-HIV drugs, and partly due to the effects of HIV itself, however it is not understood how HIV might cause heart disease. We intend to collect information from participants to help compare the changes in the structure and function of 'good cholesterol' or high density lipoprotein (HDL) which are known to be affected by HIV and treatment for HIV. In addition, we intend to study traditional risk factors of heart disease such as cholesterol levels and artery health to understand how they change with HIV disease indicators such as viral load and CD4 cell count. To do this, we will recruit three groups of participants. a) HIV-positive participants who are not on anti-HIV treatment, b) HIV-positive participants who are about to commence their anti-HIV treatment and c) healthy matched controls. At baseline, participants will be asked to complete a lifestyle and clinical observation survey and blood will be collected for laboratory analysis. Bloods will provide us with information on their HDL, lipid profile, heart disease markers as well as HIV progression. Participants will also have the wall of their carotid artery assessed by ultrasound, a measurement known as carotid intima-media thickness (cIMT) as an indicator of artery health. Participants will be followed-up once a year for three years (four visits in total). At each visit, anthropometric, bloods and cIMT measurements are collected. This information may lead to the development of new markers of heart disease for physicians to better monitor and treat heart disease in people living with HIV.

Preeclampsia is a common, serious complication of pregnancy, affecting 5-8% of pregnancies. It is responsible for 70,000 maternal and 500,000 infant deaths globally every year, with this burden largely shouldered by lower-middle income populations. Currently there is no medical treatment for preeclampsia and the only way to stop disease progression is delivery of the pregnancy. When this occurs at early gestations, the serious potential complications of prematurity are inflicted on the newborn. The establishment of a safe preventative treatment for preeclampsia would therefore be a major advance in the clinical care of pregnant women and their babies. Laboratory work undertaken by the Translational Obstetrics Group at the University of Melbourne has shown that Proton Pump Inhibitor (PPI) drugs may play an important role in preventing or treating preeclampsia. Esomeprazole, was shown to be particularly effective at reducing high blood pressure associated with preeclampsia in animal studies and when tested on donated human placental tissues. The drugs were also observed to reduce and partially reverse damage to the blood vessel linings (endothelium) caused by preeclampsia. Another study has shown that women who have a high risk of developing preeclampsia and are coincidentally taking PPIs have lower levels of preeclampsia biomarkers present in their bloodstream than other high-risk women who are not taking PPIs. In large studies of >1,000,000 pregnant women, PPIs (commonly prescribed in pregnancy to treat symptoms of acid reflux) have been shown to be safe to take, with no increase in the risk of fetal malformation (structural damage to the baby), premature birth, or miscarriage. Given these promising early results, coupled with esomeprazole’s established low-risk harm profile in pregnancy, we propose to progress this concept by undertaking a clinical trial to evaluate esomeprazole as a preventative therapy for preeclampsia. We plan to recruit a total of 5,500 women with a Body Mass Index (BMI) =>30kg/m² at the time of their first hospital visit, from a number of different hospital sites in Australia, Chile and the UK, leading up to the birth of their first baby. This group of women has been chosen because they have a higher risk of developing preeclampsia than other pregnant women. We will randomly allocate these women to either receive 40mg oral esomeprazole, or an inert placebo (sugar pill), each day from recruitment until the birth of their baby. We will monitor for the diagnosis of preeclampsia in these two groups, as well as collecting information about the outcomes of the women and their babies. We will also monitor key biochemical features of preeclampsia in a subset of women who are recruited at the Mercy Hospital for Women. At the completion of this study, we hope to have sufficient evidence to justify recommending routine esomeprazole therapy as a preventative treatment for preeclampsia in pregnant women with a BMI =>30kg/m².

This study aims to evaluate the effectiveness of a 6- week comprehensive supervised pre-surgical exercise program in prostate cancer patients scheduled for prostatectomy. Who is it for? You may be eligible to join this study if you are a male aged between 45 and 80 years of age and have been diagnosed with localised prostate cancer with at least seven weeks to until scheduled surgery date. Study details Study participants will be allocated by chance to one of the two groups. The first group will receive a 6- week comprehensive supervised pre-surgical exercise program consisting of progressive resistance and aerobic exercise. The second group will receive usual care during the pre-surgery period along with information on performing exercises on the trunk stabilising muscles similar to the exercise intervention. This group will be provided with an option to partake in the home-exercise intervention of 6 weeks prior to surgery. Testing will be conducted at baseline, pre-surgery and 6 weeks post- surgery (6PS). Testing will involve, strength and aerobic tests, a body scan, questionnaires and a 24-hr pad test. In addition, a 24-hr pad test will be undertaken after discharge from hospital and at the 12 weeks after surgery. This research is a critical step in a series of studies required to determine the most effective and efficient ways to maximize prostate cancer patient health and therefore lay the foundation for future research.