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myMoves for Seniors: Feasibility and acceptability of a remotely delivered self-management program to increase physical activity in seniors with a chronic health condition.
The myMoves Program is an innovative remotely delivered physical wellbeing program, which aims to empower Australians with chronic health conditions to build and maintain safe and healthy physical activity levels. The program has been developed using the successful approach used to develop similar mental health programs by Macquarie Universitiy’s eCentreClinic, which are now offered by Australia’s MindSpot Clinic (www.mindspot.org.au). The myMoves Program offers older Australians with a chronic health condition a convenient and effective way of improving their physical activity knowledge and skills. The program teaches, supports and empowers older Australians to create an active lifestyle that is right for them, and suits their personal needs and wants. Importantly, because it teaches the principles of managing physical activity levels, rather than prescribing activity, the myMoves program is appropriate for older Australians with a broad range of physical ability levels and can be drawn upon as their physical abilities change over time. The primary hypothesis for this study is that a remotely delivered self-management program, delivered via email and telephone, focused specifically on increasing physical activity will be feasible and acceptable to adults aged 65 years and over, living in the community with at least one chronic health condition.
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The effect of high energy diet on thoracic fat energy expenditure in lean and obese men.
The prevalence of obesity is epidemic in Australia, and current public health, surgical and pharmaceutical strategies have had limited success in alleviating this health crisis. While numerous options are currently available for treatment of complications associated with obesity, most do not result in sustained weight reduction. Fundamentally obesity results from an imbalance between energy intake and expenditure, therefore the search for new methods that correct this imbalance are essential for effective long-term treatment. Rodent studies demonstrate that some types of fat tissue can burn a significant amount of energy, therefore targeting fat tissue via increasing its energy expenditure in humans is potentially a powerful tool for the treatment of obesity related disorders. Therefore understanding energy expenditure in upper thoracic fat in response to increased energy intake will impact possible future treatments aimed at manipulating energy expenditure in this tissue. Aim: to determine whether energy expenditure in upper thoracic fat tissue is altered by overeating. Hypothesis: over-eating will increase energy expenditure in upper thoracic fat tissue.
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Efficacy of low-dose methadone as an antitussive for patients with malignancy. A pilot study.
The primary purpose of this trial is to evaluate the safety and efficacy of methadone for the treatment of chronic cough in cancer patients in palliative care. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, suffer from chronic cough following diagnosis of cancer, and are currently in palliative care. Study details Participants enrolled in this trial will receive 3 days treatment with methadone and 3 days treatment with a placebo (sham) treatment with a no treatment day in between (total of 7 days).. The order in which these are given is randomly allocated (by chance). Each treatment period involves taking two tablets per day, and there will be a break period of 1 day between each of the two treatments. Participants will be asked to complete a number of questionnaires relating to the severity of their cough, and provide a blood sample at the end of each 3 day treatment period. It is hoped that this trial will provide information on whether methadone is a safe and effective treatment for cough in cancer patients, which may be used to inform a larger clinical trial in the future.
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A trial to evaluate the effect of FLX-787 ODT on Motor Neuron Disease.
The study aims to evaluate the effects and safety of FLX-787 in patients with Motor Neuron Disease who experience muscle cramps and spasms. We aim to assess the effect of FLX-787 on pain/intensity and insomnia. Active/Placebo ODT is self administered morning and evening.
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Effects of extended exposure to lixisenatide on gastric emptying and postprandial glycaemia in patients with type 2 diabetes treated with metformin
The trial will follow a randomised, double-blind, placebo-controlled parallel group design. After providing written, informed consent, each subject will attend the Nuclear Medicine Department in the morning (0800) after an overnight fast under “baseline” conditions (day 0). If the subject is normally prescribed metformin, this will be held while fasting and will be taken with the first meal following gastric emptying study. The investigators will confirm the prescribed metformin dose and check that this remains stable at each visit. A standardised meal will be provided the evening before the study. An intravenous cannula will be inserted in each forearm, one for blood sampling and the other for IV infusion of glucose tracer (initial bolus of 28 micromol.kg-1 6,6-2H2 glucose, followed by continuous infusion at a rate of 0.28 micromol.min-1.kg-1 from t = -210 until t = 240 min). At t = -5min, a meal will be given while the subject sits against a gamma camera, consisting of 300ml 25% dextrose labelled with 20MBq 99mTc-calcium phytate, and also containing 1.5g [U-13C] glucose, and 1000mg paracetamol to measure gastric emptying simultaneously by the paracetamol absorption test. The meal will be consumed within 5 minutes. Gastric emptying will be assessed from the time of ingestion of the meal and for 240 min afterwards. Venous blood (~3 mL) will be sampled at t= -210, -20, -10, 0, 15, 30, 45, 60, 90, 120, 150, 180 and 240 min for subsequent analysis of blood glucose and plasma glucose tracer concentrations, and additional samples (~10 ml volume) at t = -210, -30, 0, 15, 30, 60, 90, 120, 150, 180 and 240 min, for measurement of plasma insulin, C-peptide, and glucagon. A further sample (5 mL) will be collected at t = -210 min to measure HbA1C and fructosamine. Heart rate and blood pressure will be monitored every 3 minutes between t = -60 min and t =240 min using an automated recording device ((DINAMAP ProCare 100, GE Medical Systems, Milwaukee, WI, USA). At the conclusion of the study, subjects will be offered a light meal before they leave the laboratory. On the following day (day 1), each subject will then commence a 56 day (8 week) intervention consisting of lixisenatide or matching placebo (saline) administered subcutaneously once daily, 30 min before breakfast, as detailed below. On the final day (day 56), he or she will return to the department for a second gastric emptying study that will be identical to the study protocol for day 0, other than for administration of the final dose of lixisenatide or placebo 30 min before meal ingestion. Intervention The intervention will consist of 56 days treatment with either lixisenatide or placebo (saline). Dosing of lixisenatide will be “stepped up” according to the following schedule: - 5 mcg days 1-7, 10 mcg days 8-14, 20 mcg days 15-56
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Long-term effects of Tai Chi in chronic obstructive pulmonary disease
This pilot study aims to investigate the effects of a maintenance Tai Chi intervention on exercise capacity and quality of life in people with chronic obstructive pulmonary disease (COPD). This will be a prospective cohort study where people with COPD will be recruited from two sites in Sydney, Concord Repatriation General Hospital and Mona Vale Community Health Centre. All participants will be asked to undertake an eight-week, twice weekly, supervised Tai Chi exercise program using Sun- style Tai Chi at one of the sites. On completion of the supervised program, participants will then be asked to continue with a home-based, unsupervised maintenance Tai Chi exercise program five times weekly for a six-month period. Outcomes will be measured at baseline, at eight weeks following the supervised Tai Chi program and again at three and six months into the maintenance Tai Chi program. Outcomes will include exercise capacity, quality of life, physical activity, balance, participants’ attitudes to management of their health care, compliance with short and long-term Tai Chi training, and satisfaction with the maintenance Tai Chi training.
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Efficacy of computer versus group memory training for memory rehabilitation post-stroke
Approximately half of all survivors of stroke experience memory impairment, which can significantly impact functional independence and quality of life. Two different approaches have typically been implemented in an effort to rehabilitate memory: restoration (computer based training) and compensation (group based training). Overall, there is no clear consensus as to whether either computer-based training or compensatory approaches to memory rehabilitation are effective or efficient for stroke patients. As a result, many survivors of stroke are purchasing costly computer training programs with unknown effectiveness. At Monash University, we are currently running a randomised controlled trial to explore the efficacy and cost efficiency of different approaches to memory rehabilitation post stroke. Eligible participants will be randomised into a waitlist control,memory group or computer training group and will receive free memory rehabilitation over a six week period. In doing so we aim to explore the most cost-efficient and effective way in which memory can be rehabilitated post stroke, thereby addressing a clear gap in service provision.
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The Food Obstruction in Oesophagus and Drugs Study: A Double Blinded Randomised Control Trial of Glucagon and Glyceryl Trinitrate Versus Placebo In Soft Food Bolus Impactions
The project aims to determine if the two commonly used drug regimens for soft food impactions in the oesophagus are better than placebo for passage of the obstructing bolus. Retrospective data from small and poorly-designed studies have led to the recommendations for the trial of glucagon, glyceryl trinitrate (GTN) or a combination of both in soft food bolus impactions as first line management prior to endoscopy. Retrospective data from a recent audit carried out at Freemantle has demonstrated that the rate of clinical resolution was not appreciably different between patients treated with drugs and patients not treated with drugs and that a strategy of proceeding straight to endoscopy might be preferable In order to definitively answer the question, we propose to prospectively assign patients to either a drug regimen of a) glucagon and GTN or b) placebo and observe the outcomes after 30 minutes after which the pharmacological properties of the drugs excludes a drug effect.
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The effect of donor white blood cell filtration to prevent donor cell survival in transfused trauma patients
The objectives of this study are to determine if leucoreduction is effective in reducing the incidence of transfusion associated microchimerism in major trauma patients and analyse the immune response and cytokine profiles to determine if immunosuppressive conditions enhance the formation of TAM.
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An interactive step training system to reduce falls in people with multiple sclerosis: a randomised controlled trial
Falls are common among people with multiple sclerosis (MS). About 60% of people with MS (PwMS) experience at least one fall each 6 months and about 30% have multiple falls. Increased fall risk and fear of falls have been shown to significantly affect quality of life and curtail activities among people with MS. Therefore, effective interventions to reduce fall risk in PwMS are urgently needed. Fall prevention and treatment strategies in MS are still at an early stage. Studies on falls in MS reveal important balance, coordination and cognitive determinants of falls. Based on these results, we propose a randomised single-blind controlled trial (RCT) to evaluate a step training intervention designed to prevent falls in PwMS. The proposed trial will enrol approximately 500 PwMS over a period of 36 months. Recruitment will initially take place in NSW and will be extended to other Australian states if required. It is expected that if the research confirms effectiveness of treatment strategies, implementation of clinical interventions will contribute to reduced fall rates in PwMS and associated injury-associated costs, reduced fear of falls and improved quality of life for PwMS.