ANZCTR search results

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.

Asthma affects approximately 1:10 adults and 1:5 children. Although most subjects attained good control of their asthma with conventional treatment, there is a significant proportion who are resistant to conventional treatment and remain uncontrolled. Although there are several mechanisms that may explain incomplete asthma control, one important factor which is potentially easy to address, is the presence of severe small airways disease that is not effectively improved by inhaled corticosteroid treatment. The small airways are an important determinant of asthma control and severity. They are airways with an internal diameter of 2 mm or less and because of the branching nature of the airway tree, occupy a very large surface area compared to the larger and more proximal airways. We have recently shown that small airway function improves with high dose inhaled corticosteroid treatment in parallel with improving asthma control. Furthermore, asthma control and severity are strongly related to small airways function. It therefore follows that persisting small airways disease is an important determinant of severe asthma and that better treatment of the small airways will improve the treatment of severe asthma. The obvious problem with treating small airways that are severely affected by inflammation and tissue remodelling, is that it is difficult to deposit therapeutic aerosols there. This is because ventilation to those airways is poor, because of severe airway narrowing and closure. Therapeutic aerosols require ventilation to carry them to the target sites and so the worst affected airways receive less of the inhaled aerosols. There is a theoretical advantage of using fine particle aerosols, because they are more likely to be carried to areas where ventilation is poor. Particles greater than 3 – 5 um deposit in the medium to large airways, while smaller particles will be carried into smaller and narrowed airways. Therefore, we propose that small particle aerosols will be more effective in uncontrolled asthma than larger particle aerosols.

Cardiopulmonary bypass (CPB) is commonly used in cardiac surgery to maintain blood flow to the brain. However, loss of pulse pressure during CPB means that brain blood flow may be low and brain oxygen levels may fall. This may be bad and affect brain performance after surgery. Oxygen levels in the brain can be monitored with Near Infrared Spectroscopy (NIRS) and brain performance can be assessed with psychological tests. One way to improve brain blood flow and oxygen levels may be to target a slightly higher carbon dioxide (CO2) concentration in the blood during and after CPB. This is because even a slight increase in CO2 can open up the blood vessels to the brain, increase blood flow to it and increase oxygen levels for brain cells. However, targeting such slightly higher CO2 levels in this setting has not been formally studied. The aim of this study is to compare the changes in cerebral oxygen levels (SctO2) and psychological test-assessed brain performance when a mildly increased CO2 level is targeted compared with a normal CO2 level during and after CPB. We plan to study forty adult patients having CPB (twenty targeting normal CO2 levels and twenty targeting mildly increased CO2 levels), and to measure their SctO2 and psychological test performance prior to surgery and before hospital discharge. The information derived from our investigation will be used by doctors to improve oxygen levels in the brain of patients during and after CPB in the future.

The aim of this research is to test if participant retention in a commercially available meal replacement program (MRP; Impromy) is improved when the standard Impromy program is modified to enhance weight loss. Enhanced weight loss will be expected by incorporating 3 days per week of ‘additional calorie restriction’ and one day of ‘free eating’ per week, over 16 weeks. Impromy is a weight loss program developed in partnership with CSIRO, and validated by CSIRO. It is commercially available through pharmacies across Australia. The current program consists of an energy restricted weight loss diet that includes meal replacements, personalised support from trained pharmacy assistants and a phone application for additional support and monitoring. The outcomes of this study will inform development of the Impromy program with the goal of improving program retention and therefore overall weight loss. A second aim of this study is to investigate how the two dietary protocols affect , or are affected by: 1.Biological indicators of health, including changes in body fat and muscle, blood glucose and cholesterol levels, blood pressure, nutrient status, gut health and the gut bacteria, genetic & blood and buccal cell epigenetic markers and novel markers of metabolic health (including retinal vascularity). 2.Eating behaviours and food craving, well being, psychological outcomes, perceived health, cognitive function and gut comfort.

Activity pacing is an occupational therapy rehabilitation intervention commonly used with older adults who have deconditioned during an acute hospital admission. Activity pacing involves teaching people different techniques to regulate their level of activity and how they do their daily tasks. Activity pacing and energy conservation have been shown to have some effect with persistent pain populations and in people with chronic disease. Yet there is currently no evidence for use with the deconditioned older adult. For the purpose of this research, activity pacing will include seven activity pacing techniques - 1. Use self-monitoring to listening to your body 2. Use short regular rests during the day and during activities 3. Find a sustainable baseline and then gradually increase activity 4. Break tasks into manageable parts 5. Plan tasks and set goals 6. Alternate high energy tasks with low energy tasks 7. Prioritise tasks and delegate where able The aim of this study will be to evaluate the effectiveness of activity pacing with deconditioned older adults on their participation in everyday tasks. This will be done by comparing two groups- 1) occupational therapy rehabilitation with activity pacing, 2) occupational therapy rehabilitation with no activity pacing. A secondary aim will be to compare the effects of the two interventions on quality of life and well-being, knowledge of activity pacing techniques and symptom management (pain, fatigue and self-efficacy). Deconditioned older adults who are admitted to a private hospital from the acute setting will be invited to participate. A randomised controlled method will be used to compare the effectiveness of occupational therapy rehabilitation with activity pacing and occupational therapy rehabilitation with no activity pacing. The activity pacing intervention will be multi-faceted with individual sessions, group education, written handouts and a practical group allowing practice of the above activity pacing techniques. To ensure the second group (occupational therapy with no activity pacing) are not disadvantaged, patients will receive modified activity pacing education (two individual sessions- one education and one practical, written handouts) 2 days prior to discharge and after the completion of outcome measures.

When chronic kidney disease patients on dialysis have low calcium due to low vitamin D activity, calcitriol is the standard therapy used. However, it is costly and more likely to cause side effects of high calcium and high phosphate. On the other hand, cholecalciferol is cheaper with possibly less side effects on calcium and phosphate. The purpose of this study is to compare cholecalciferol to calcitriol as vitamin D therapy in patients with chronic kidney disease who are on dialysis. We will change study participants who are on calcitriol to cholecalciferol, and examine cholecalciferol’s effectiveness through its effects on blood results over 12 weeks. During recruitment, participants' age, gender, ethnicity, weight and height, smoking status, existing vitamin D therapy, kidney disease, time on dialysis, other medical conditions, dialysate calcium concentration, phosphate binders, and previous blood results will be obtained from them personally or through medical record. Baseline blood tests will be performed to analyze detailed components of the calcium and vitamin D metabolism systems. If they meet the inclusion criteria, their calcitriol therapy will be changed over to cholecalciferol. Further 3 sets of blood tests will be done at 4-week, 8-week, and 12-week period to monitor treatment effects and determine need for therapy adjustment. We would estimate the proportion of patients on maintenance calcitriol who can be changed successfully to cholecalciferol therapy. We hypothesize that the use of cholecalciferol for maintenance therapy in adult chronic kidney disease patients on dialysis is comparable to the use of calcitriol, as shown by successful change from calcitriol to cholecalciferol therapy in a worthwhile proportion of patients.

This pilot randomised controlled trial will be the first to investigate if supervised progressive resistance training (strength training) is safe and feasible for adolescents and young adults with Prader Willi syndrome aged 13-39 years. It will also investigate the effect of the training on body composition (including muscle mass), muscle strength, muscle performance, and physical activity. Twenty-two adolescents and young adults with Prader Willi syndrome will be recruited through the Prader Willi Syndrome Association of Victoria and through the Prader Willi Syndrome register. Participants will be randomly allocated to either a 10-week twice a week community gymnasium based progressive resistance training program supervised by a physiotherapist (n=11) or a waitlisted control group (n=11). The training program will comprise 7 exercises on pin-loaded weight machines: 3exercises for the arms, 3 exercises for the legs and 1 exercise for the trunk which will take 45-60 minutes to complete each session. Participants will be assessed before they start the intervention and again after they complete the intervention.

A profusion of imaging and lesion based research now indicates that the dorsolateral prefrontal cortex (DLPFC) is a vital substrate for a number of important cognitive functions, particularly working memory (WM). Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique which applies a very weak current to the scalp which can transiently alter underlying brain function as well as behaviour. When applied over the DLPFC, tDCS has been shown to both enhance WM performance in healthy individuals and ameliorate its dysfunction in clinical cohorts. These changes are hypothesised to be due the ability for tDCS to alter the excitability of neurons within the brain, which in tern leads to neuroplasticity-related changes in cognitive function. Nevertheless, to date, the level with which tDCS can modulate cognition remains relatively modest and, as such, research is needed to explore ways of improving the clinical efficacy of this technology. There is currently some limited evidence to suggest that combining tDCS delivery with a cognitive task may have a synergistic effect, leading to greater subsequent improvements in cognition. However, this finding has yet to be systematically explored. The current project, therefore, aims to investigate this potential task-dependency effect in detail in a cohort of healthy adult participants utilising both behavioural and neurophysiological outcome measures.