ANZCTR search results

A Phase I study of LJPC-401 in healthy adult volunteers. LJPC-401 is being developed to treat conditions characterized by iron overload, such as hemochromatosis and beta thalassemia. Bellberry Human Research Ethics Committee approval has been received.

There has been an increasing move by healthcare providers towards telehealth services (i.e., the remote delivery of healthcare services over the internet). In the university environment the use of telehealth technology has the potential to enable healthcare students to interact with patient populations and build valuable clinical communication skills without leaving the university campus. Research has suggested that while speech pathology students have the theoretical knowledge to treat aphasia (an acquired language disorder often resulting from stroke) they are not confident communicating with this clinical population. Our project will develop and evaluate a telehealth program to train speech pathology students in strategies for communicating effectively with patients with aphasia, and evaluate the clinical useability of telehealth for student clinical learning. The effects of different types of feedback on learning will also be investigated. While targeting speech pathology students in this current application, the intention is to develop a model to be used for other student cohorts who interact with other clinical populations with a range of communication difficulties. This will contribute to the development of new telehealth-driven approaches to clinical education.

According to the most recent Stress and Wellbeing Survey, 35% of Australians experience a significant level of distress in their lives and just over a quarter report having moderate to extremely severe depression symptoms. Unfortunately, the majority of sufferers do not seek help for their stress. When they do, Australians are tend to approach family and friends, and only 15% report seeking help from a psychologist or other mental health specialist. Some of the reluctance to engage in help-seeking is related to the stigma of the perception of not coping, whilst some is also related to the perception of malingering or feigning illness. There is a key issue in this context. Whilst the use of pen and paper/technology based questionnaires is commonplace to screen for stress there are concerns over their false positive rate and predictive ability. Measures of heart rate variability (HRV), the beat-to-beat temporal changes in the heart rate (HR), may provide an alternative for stress assessment. These beat-to-beat changes are commonly used as a quantitative marker depicting the activity of the autonomic nervous system (ANS), thus related to mental stress. It has been suggested that changes in HR over 24 hours, or circadian heart rate (CHR) changes, may present adjunct information for stress assessment as circadian dysregulation is present in varying degrees in all psychiatric illnesses. As such, it has been proposed that HR profiling algorithms might provide an objective and predictive measure of stress and inform the likelihood of stress becoming a clinical illness. This study aims to assess whether a currently available HR monitoring device, worn over 24 hours, thus measuring CHR, can provide objective indications of stress. CHR will be monitored 4 times: twice in the first week and twice again after 2-3 weeks. Measures of CHR will be compared with data obtained from self-report measures to evaluate consistency of results and cross-sectional and predictive validity.

In a sample of adolescents (n=220), the current study will examine whether cognitive training is effective in reducing a range of psychopathology in youth at high risk for developing a mental illness. We hypothesise that at the end of the intervention those in the experimental group will show less psychopathology as indexed by a standardised behavioural measure. Adolescents aged 16-24 years and at risk for a range of mental disorders will be selected based on scores from the Substance Use Risk Profile Scale (SURPS). Further inclusion criteria include: willingness and competence to give informed consent; readily available computer access; adequate English comprehension. Exclusion criteria include: meeting criteria for an affective, anxiety or substance use disorder according to structured diagnostic interview (Mini International Neuropsychiatric Interview Version 5.0.0; MINI); currently involved in psychotherapy or taking antidepressant or anxiety medications, benzodiazepines, opiate, thyroid, anticonvulsant or antipsychotic medications; history of neurological or cardiovascular disorders, brain surgery, electroconvulsive or radiation treatment, brain haemorrhage or tumour, stroke, seizures or epilepsy, diabetes, hypo- or hyperthyroidism. This study will be a randomised controlled trial with a 12-month follow-up period. Participants will be randomly allocated to one of two groups: (1) cognitive training condition, or (2) active control condition. The training tasks for both the intervention and control conditions will consist of serious gaming tasks based on classic paradigms used in cognitive neuroscience research. The intervention program will consist of games designed to target circuitry critical for executive functioning. Control games will have similar visual appeal and motivational enhancements but lack executive functioning training potential. For both conditions, training will take ~1 hour per day, 5 days per week, over 5 weeks (25 hours in total). Outcome assessments will be conducted at baseline, post-training, 3-month follow-up, 6-month follow-up and 12-month follow-up on the participant’s personal computer at home. Each assessment will consist of the following: (1) assessment of risk factors for mental illness (Strengths and Difficulties Questionnaire); (2) structured diagnostic interview (the MINI International Neuropsychiatric Interview Child Version) to determine the prevalence of substance use, anxiety and affective disorders; (3) alcohol consumption; (4) functioning and disability; (4) personality as measured by the SURPS; and (5) online executive functioning assessment focusing on working memory (n-back task), task shifting (trail-making task) and inhibition (Stroop interference task).

Type 2 diabetes is increasing worldwide and can cause serious health complications if left uncontrolled. In 2014 it was estimated that 9% of the global adult population suffered from diabetes, of which 90% could be attributed to type 2 diabetes. Optimal blood glucose control reduces the risk of diabetes-related complications. There are currently a number of drugs on the market to control blood sugar levels; however they produce unpleasant side effects. Marine polyphenols have shown potential to improve blood glucose control without producing side effects. While polyphenols are found in both terrestrial plants and marine algae, this study will focus solely on those commercially available from marine sources. Marine polyphenols, or phlorotannins, are most commonly found in brown algae. There are a number of advantages to cultivating marine algae compared with terrestrial plants, and marine-derived compounds are rapidly growing in popularity in the food industry, especially with the current consumer preference for natural health products over synthetic ones. There is promising research regarding the antidiabetic effects of marine polyphenols in animal and in vitro studies. However, it is yet to be determined if the same health effects are consistently true in a human population. If so, marine polyphenols may be useful for controlling blood sugar levels, resulting in fewer side effects and a reduced risk of complications for people with type 2 diabetes. Marine polyphenols may also be useful for people with prediabetes to lower blood sugar levels and prevent progression to type 2 diabetes. This study aims to: 1. Determine the effect of commercially available doses of marine polyphenols in supplement form on postprandial blood glucose and insulin following a glucose load, compared to placebo in a human population. 2. Determine how well different doses of polyphenols are accepted through completion of an intolerance symptoms questionnaire. 3. Examine the effects of commercially available doses (Marinova) of marine polyphenols in supplement form on changes in blood glucose and insulin following a glucose load, in the evening. Blood glucose rises higher and stays high for longer following consumption of carbohydrates in the evening, compared to the morning.

This study seeks to expand on previous research, which found that the consumption inorganic nitrate can significantly lower blood pressure (BP) via increasing the availability of nitric oxide (NO) within the circulation. Nitrate supplementation increases NO in a two-step process 1) Nitrate to nitrite and 2) Nitrite to NO. Step one is highly dependent on oral bacteria to facilitate the reduction of nitrate to nitrite within the saliva. However, the magnitude of this conversion appears to vary from person to person and even potentially from day to day in the same individual. This variability is not completely understood but appears to be facilitated by the amount and make-up of oral bacteria in the mouth., As a result, the primary aim of this study is to determine the relationship between the type and amount of oral bacteria and the concentration of nitrite in the plasma following a high inorganic nitrate beverage (beetroot Juice). Observing the relationship between the change in plasma nitrite concentration and the change in brachial artery blood pressure following a high inorganic nitrate beverage (beetroot Juice) is a secondary aim of the study. Participants will complete only one testing visit. Upon arrival, baseline data collection will include blood pressure, a saliva sample (to identify particular markers on the cells and pH of the oral cavity which may influence bacteria in the mouth), tongue swab (to identify the present oral bacteria) and a blood draw (for resting plasma nitrate and nitrite levels) will be taken. Participants will then be asked to consume a beverage high in inorganic nitrate (beetroot juice). Two and a half hours following supplementation participants will undergo repeat testing measures including another blood draw and BP. To our knowledge, no other trial has used this particular model when examining the role of oral bacteria in inorganic nitrate to nitrite conversion and therefore the current study is a pilot study to help inform us of sample size requirements in a heterogeneous population and whether particular bacterial species are more or less relevant. For patients with cardiovascular disease, nitrate supplementation provides a potential alternative source of NO, which we know they often cannot produce the same as healthy subjects do. The results of this study may contribute to our understanding of this process that could be used as an intervention for blood pressure in the future.

People with end stage kidney disease require renal dialysis to maintain health. These people are attached to dialysis machines for 4 hours at least 3 times per week. Both the kidney disease and the dialysis lead to an accelerated physical deterioration, resulting in decreased strength and reduced capacity to perform activities of daily living. At present, exercise recommendations suggest moderate to high intensity exercise that incorporates both resistance training and aerobic training. To satisfy this requirement it is recommended that 30-60 minutes of exercise training be completed on both dialysis and non-dialysis days. This is very poorly adhered to by patients undergoing dialysis due to decreased exercise capacity, contraindication to high intensities of exercise training, elevated fatigue, and a preference for not doing exercise training on non-dialysis days. Blood flow restriction (BFR) exercise training elicits significant muscle size and strength increases with low intensities. BFR with aerobic exercise training produces muscle size and strength that is not commonly achieved with non-BFR aerobic exercise training. This has previously been performed in older adult populations, and also with individuals with stable ischaemic heart disease with promising results and can easily be performed during haemodialysis. This study aims to measure the effect of 3 months of intradialytic BFR exercise training on lower limb strength, muscle size, physical function, and quality of life. Participants will be recruited from 4 Victorian outpatient and private dialysis units administered by Eastern Health. Participants will be randomly allocated into 3 groups (20 patients in each). The groups will perform one of: BFR aerobic exercise training (BFR AT), non-BFR aerobic exercise training (AT), or non-exercise controls. The BFR AT group will complete 2 bouts of 10 minutes cycling with BFR applied. The AT group will complete 20 minutes of continuous cycling. and the control group will undergo usual-care haemodialysis with no exercise. It is expected that the BFR AT group will exhibit greater increases in muscle size and strength, as well as greater levels of physical function compared to the AT group following exercise training intervention. Both the BFR AT and AT group will demonstrate greater muscle size and strength than the usual care control group. This study will demonstrate that BFR is a potential alternative to the burdensome exercise recommendations that are, at present, extremely poorly adhered to, or altogether ignored by dialysis patients.

The intention of the trial is to study the pharmacokinetics (PK) of CRD-102 in patients with heart failure following 30 days of administration. It is hypothesized that CRD-102 is able to improve heart function and quality of life. Prior to conducting a phase 2 trial, Cardiora needs to better understand the PK profile of CRD-102, how it is absorbed and cleared from the body. This trial intends to study the PK effects of different doses of CRD-102. A dose of 14 mg twice daily will be administered to up to 15 patients, and following this 18mg twice daily will be trialled.

Previous reviews have investigated the impact of technology-based overweight and obesity interventions in childhood with some studies reporting changes in adiposity, dietary and/or physical activity outcomes. Parent-focussed eHealth studies have not been well investigated to date and there is an absence of studies targeting children under the age of five years, an age group where parental influence is probably the most profound. This study is a two-arm randomised controlled trial, underpinned by Social Cognitive Theory. To be eligible to participate, children must be pre-school-aged (2-5 years) and overweight or obese or be at risk of becoming overweight or obese. The Time2bHealthy intervention is a 12-week online behaviour change program, consisting of modules on nutrition, physical activity, screen-time and sleep. The key component of the program is the setting and revision of goals following completion of each of the modules. The control group will receive emails directing them to various topics on an evidence-based parenting website. The purpose of the study is to determine the efficacy of a parent-focussed lifestyle behaviour change program in facilitating behaviour change among families with a preschool aged child who is overweight or at risk of becoming overweight. The study aims to bring about change via an online program where parents are the agents of change. Outcomes such as child body mass index, diet, physical activity, screen-time, sleep and parent self-efficacy will be assessed. The study will make an important contribution to the literature by addressing an acknowledged gap in regard to internet interventions for the prevention and/or treatment of childhood obesity where parents are the agent of change as there is currently an absence of randomised controlled trails in the preschool age group.

Aims: The aim of this project is to assess the acute effects of water-based exercise in people with stable heart disease. This study is conducted in conjunction with a water-based training study to investigate the effects of water-based exercise training in people with stable coronary heart disease. Justification: Exercise is an important component of rehabilitation and preventing recurrent heart problems in people with heart disease. However, exercise participation is sub-optimal in this population and increasing the range of exercise options for people with heart disease may increase exercise participation. For example, water-based exercise may be more appealing to people with heart disease who have other health issues, such as arthritis or obesity, which may make land-based exercise difficult or painful. Furthermore, preliminary research suggests that water-based exercise may have additional vascular and brain benefits due to the effects of water immersion on blood flow. However, this has not previously been investigated in people with heart disease. Participants: Patients who have had a heart attack or bypass surgery at least six months prior to enrolment, or documented blockages in the arteries of their heart based on the results of an angiogram (a scan of the heart) will be recruited to the study. Participants must be medically stable prior to participation and not be undertaking a formal exercise program. Design and methods: This crossover study will compare the acute responses to low and moderate intensity exercise in the water with matched intensities on land. This will involve one endurance capacity assessment and one exercise session in 15 participants. The order of conditions will be randomised. Study A will acutely assess blood flow to the arm and brain, along with assessing systemic haemodynamics.