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Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT): Effect of intensive blood pressure lowering treatment provided by a Triple Pill strategy on the time to first occurence of recurrent stroke in patients with a history of acute stroke due to intracerebral haemorrhage.
Acute intracerebral haemorrhage (ICH) is the most serious and least treatable form of stroke, accounting for at least 10% of the 20 million new strokes (including 50,000+ Australians) that occur in the world each year. Survivors of ICH are at high risk of recurrent ICH and other serious cardiovascular events. While there is strong evidence that this risk can be reduced by lowering the BP of patients after ICH, such as from the PROGRESS trial undertaken by several of the applicants, many patients with ICH do not receive blood pressure lowering and if they do, receive treatment so that their BP is inadequately controlled. The aim of this study is to demonstrate the superiority of a combination of fixed low-dose generic BP lowering agents as a “Triple Pill” strategy on top of standard of care for the prevention of recurrent stroke in patients with a history of ICH and high normal or low grade hypertension in a large-scale, international, double-blind, placebo-controlled, randomised controlled trial.
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Does a performance-focused swimming training program improve health, fitness and functioning in people with cerebral palsy?
It is known that moderate-intensity physical activity enhances health, fitness and functioning in people with cerebral palsy (CP). Anecdotal evidence indicates high training loads designed to develop Paralympic swimmers may elicit excellent clinical outcomes. The primary aim of the program of research will be to evaluate the therapeutic benefit of a performance-focused swimming intervention for people with cerebral palsy who have high support needs. We hypothesise that outcomes of the study will substantiate the anecdotal evidence. Specifically, that high training loads will improve health, fitness and functioning in people with cerebral palsy who have high support needs. 3 young people with moderate to severe cerebral palsy who are insufficiently active for health, but are interested in participating in competitive sport, will be recruited. The study will adopt a concurrent multiple baseline design with 5 phases: A1-B1-A2-B2-A3. The first phase is a baseline testing phase (A1) for participants 1, 2 and 3 lasting 10 weeks, 16 weeks and 22 weeks respectively. There will be 5, 8 and 11 baseline data points for participants 1, 2 and 3 respectively. The intervention will then be introduced to participants in a staggered sequence. The first part of the intervention is a 16 week performance-focused swimming training phase (B1) during which there will be 8 data collection points. The training program will comprise of moderate to high intensity swimming, aerobic, strength, neuromotor and flexibility training which is individually tailored to optimise swimming performance. The intensity and duration of training sessions will vary but will be steadily increased throughout the phase. This phase will be followed by a 5-week maintenance phase (A2), in which there will be no training. There will be 5 data collection points in this phase. Participants will then undergo the second part of the intervention - a further 16 week training phase (B2), which will mirror phase B1. There will be 8 data collection points in this phase. Finally, participants will undergo a further 5 week maintenance phase in which there will be no training. There will be 5 data collection points in this phase, which will mirror phase A2. Outcomes will relate to health, fitness and functioning, and findings are expected to provide an indication of the therapeutic value of sports participation for the population of interest. The study is expected to have implications for neurological rehabilitation.
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Promoting physical activity after stroke via self-management: A pilot randomised trial.
This study aims to determine whether self-management, and self-management support from a physiotherapist, can assist people after mild stroke to increase physical activity levels. Self-management, in this case, is when patients make the decisions about their own health and physical activity, with the assistance and support of a physiotherapist. Physical activity is important after stroke because it reduces the risks associated with recurrent stroke, such as high blood pressure, high cholesterol and high blood sugars. Research has also shown a direct link between increased physical activity and decreased risk of stroke. Many people after mild stroke do not participate in a healthy amount of physical activity, even though they are physically capable of doing so. A physiotherapist will provide 5 sessions of support to people after mild stroke over a 3 month period, which will include education, generation of goals, barriers and solutions for being physically active, development of a weekly physical activity schedule, selection of strategies to monitor physical activity, feedback, encouragement and praise. It is expected that this will result in stroke survivors completing a healthy amount of physical activity each week, as well as improving their confidence in their ability to be physically active, and improving their health status, such as blood pressure, cholesterol, and blood sugars. This group will be compared with a control group, who receive an information booklet only.
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Evaluating the effectiveness of using Peer-Dialogue Assessment (PDA) for improving pre-service teacher's perceived confidence and competence to teach physical education
The use of feedback has been shown to be important for learning. However, the feedback literature increasingly reports dissatisfaction among learners. University students are not only reporting that they do not receive feedback that is helpful for their learning but educators report the burden of giving feedback (that is often not used to improve performance). The use of Peer Dialogue Assessment (PDA) has been presented as a method of providing feedback for learners in the tertiary setting and has the potential to be a useful learning tool when used in teacher education programs. Peer Dialogue Assessment positions learners as active in seeking, generating and using feedback to improve or change their task performance. This method uses peers to initiate feedback in the form of 2-way dialogue (or discussion) after a performance and may serve to be a sustainable assessment for learning tool for use in teacher education programs. The aim of this study is to evaluate the effectiveness of using PDA for improving pre-service teacher's perceived confidence and competence to teach physical education.The following questions will be addressed: 1. What experience do undergraduate students in the BT (HPE / Primary)(Hons) programs have with assessment of teaching performance at the UoN? 2. What impact does PDA have on student's perceived competence to teach physical education? 3. What impact does PDA have on student's confidence to PE and Sport? 4. What impact does PDA have on student's self-efficacy to teach? 5. Did staff and students find the introduction of PDA in a pre-service physical education course useful as a learning tool and for improving teaching performance? It is hypothesised that confidence and competence of undergraduate students in the BT (HPE/ Primary)(Hons) will improve as a result of completing an undergraduate course with PDA embedded.
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Home assessment visits prior to discharge from hospital for patients after hip fracture: A randomised controlled trial
Leaving hospital and getting back home after a hip fracture can be challenging and involve some adjustments. Participating in some form of rehabilitation has been shown to help. As part of this rehabilitation, occupational therapists are trained to assist people to overcome various problems in order to live more independent lives. They may assist with the return to home life through the development of new skills for daily living, such as household tasks and personal care. They may also make or facilitate changes to the home environment to make life easier and safer. The hospital environment can be very different to home and sometimes occupational therapists take people on a visit from hospital to their home to help to plan for discharge. These visits may have benefits such as preventing falls at home or improved ability to complete activities around the home but these home visits can be time consuming and tiring for some patients. The aim of this study is to find out if going home from hospital for a short visit with an occupational therapist prior to being discharged provides benefits for people following hip fracture compared with hospital- based discharge planning. The results will help guide health professionals to prescribe treatments to support patients to return home after a hip fracture and to make sure that these treatments are targeted to patients who will get the most benefit.
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A multicentre, randomized, controlled trial of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with placebo.
At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe. However we know that accidental exposure is common. Research shows that 50% of children with a peanut allergy are accidentally exposed to peanut within 2 years. Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy. In oral immunotherapy, patients with food allergy are given small amounts of the food they are allergic to and tested for food allergy after a set amount of time. Results have been mixed. Studies suggest that oral immunotherapy can induce desensitization (short term ability to tolerate the food allergen while the patient continues on therapy) but has a limited ability to induce sustained unresponsiveness (longer term ability to tolerate the food allergen after treatment is stopped for at least 2-4 weeks or longer). We previously conducted a Randomized Controlled Trial to evaluate a novel combination treatment approach involving administration of probiotic together with oral immunotherapy - Probiotic and Peanut Oral Immunotherapy (PPOIT). In our study we found that just over 80% of children who received PPOIT tolerated peanut after stopping treatment for more than 2 weeks compared with only 4% in the placebo group. PPOIT was highly effective at inducing sustained unresponsiveness - if 9 children were treated with PPOIT, 7 would benefit. PPOIT participants received a daily dose of probiotic together with peanut protein (peanut flour) for 18 months. The probiotic was taken as a fixed daily dose. The dose of peanut protein was commenced at very low levels then increased every 2 weeks over a period of 8 months to reach a maintenance dose of 2g peanut protein. This study (PPOIT-III) will build on our previous PPOIT and PPOIT-II study. PPOIT-III is a multi- site randomized controlled trial to evaluate the effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with Placebo. Children will take increasing doses of peanut protein and a set amount of probiotic until a total of 18 months treatment is completed. Children will be tested for peanut allergy at the start of the study, at the end of PPOIT treatment T1 (18 months) and T2 (8 weeks) and T3 (1year) after treatment. The discovery of a safe and tolerable treatment for food allergy will have great public health benefit.
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Outpatient Terlipressin Infusion for the Treatment of Refractory Ascites.
Although most patients with cirrhosis complicated by ascites initially respond to salt restriction and diuretics, as their liver disease progresses many lose diuretic responsiveness and develop refractory ascites, a condition for which there is no established drug treatment. Terlipressin is a synthetic analogue of vasopressin that causes splanchnic vasoconstriction, consequently improving renal blood flow and kidney function, and thus may ameliorate many of the pathophysiological changes that result in ascites formation. Its short half-life and bolus dose administration have previously precluded its long term use to treat ascites or other complications of cirrhosis. We performed a 4 week prospective trial of outpatient continuous terlipressin infusion in 5 patients with refractory ascites to examine its safety, practicality and efficacy in reducing ascites formation.
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Cerebral oxygenation and carbon dioxide in patients undergoing surgery
Measurement of actual cerebral blood flow during surgery is difficult due to the invasive or unpractical nature of the measurement tools needed. In contrast, cerebral oximetry is the continuous non-invasive measurement of cerebral oxygenation (amount of oxygen in the blood) and perfusion (the delivery of blood to the tissues of the brain). This allows anaesthetists to make critical decisions to maximise oxygen delivery and improve patient outcomes. Cerebral oximetry has been studied for more than 30 years and been commercially available for more than 2 decades. Numerous studies demonstrate that increases in blood carbon dioxide (PaCO2) increase blood flow to the brain. Carbon dioxide is a normal waste product of body metabolism, and is eliminated via the lungs. However, there are no physiological studies to date comparing the effects of normal blood carbon dioxide (normocapnia - defined as PaCO2 levels between 35-40 mmHg) and mildly elevated carbon dioxide levels (mild hypercapnia - defined as PaCO2 levels between 45-55 mmHg) on cerebral oximetry in patients undergoing major surgery. The primary aim of this study is to evaluate the effects of changes in PaCO2 on cerebral oximetry in patients undergoing major surgery. Secondary aims include the evaluation of the effects of normocapnia and mild hypercapnia on acid base blood variables, serum potassium levels, and postoperative delirium. A total of 40 subjects will be included at the Austin Hospital
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A study to investigate the relationship between stress and weight
Dietary restriction (dieting) is the most popular method for weight loss and is commonly the first strategy prescribed for weight loss in treating obesity. However, dietary interventions are often ineffective because energy restriction triggers the so-called “famine reaction”, a survival mechanism used by the body in order to conserve energy in times of starvation. The famine reaction involves a series of metabolic and behavioural adaptations including compensatory changes in metabolic rate, appetite and neuroendocrine hormones as well as a loss in metabolically active lean tissue in order to reduce energy requirements. Little is known about the underlying mechanisms involved in the famine reaction or whether different dietary restriction interventions can alter this response leading to more efficient and sustained weight loss. Our research group has found that a novel intermittent diet approach results in greater weight loss, reduced levels of stress hormone cortisol in blood and attenuation of the famine reaction. It is well known that dieting is psychologically stressful, and there are strong connections between stress and weight control through elevations of cortisol. Cortisol promotes central adiposity (obesity) and muscle loss and may lead to reductions in metabolic rate. Cortisol also stimulates appetite and cravings for sweet and fatty foods. For these reasons cortisol likely plays a major role in causing diet failure and resistance to weight loss. Therefore, one aspect of our study is to better understand the relationship between stress and weight loss. In order to investigate these, we firstly need to establish laboratory methods at Bond University and optimal conditions for measuring cortisol in lean healthy and obese humans. These studies will then enable us to apply these skills and perform larger weight loss interventions. The information gained for these studies will provide a greater understanding on the underlying mechanisms involved in the famine reaction and why individuals with obesity struggle to achieve weight loss goals; thereby, leading to new therapeutic strategies to target obesity.
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Effect of balance and exercise training on chemotherapy-induced peripheral neuropathy
The primary purpose of this trial is to evaluate the efficacy of an exercise and balance training intervention in patients with chemotherapy-induced peripheral neuropathy (CIPN) on functional, neurophysiological, and quality of life outcomes. Who is it for? Cancer survivors at least 3 months-post treatment, aged 18 or over, and with grade 2 or 3 CIPN. Study details All participants in this study will first complete an 8 week wait period to assess the rate of adaptive improvements occurring 'naturally' (e.g. without an exercise intervention). Participants will then complete an 8 week exercise program involving a combination of supervised and unsupervised exercise sessions, totaling three 45-60 minutes sessions per week. Sessions will include a combination of cardiovascular training, strength training and balance training. Participants will be asked to complete a number of assessments and questionnaires at enrolment, after the 8 week wait period and again after the 8 week exercise program. Assessments will include physical function tests, nerve testing, and quality of life questionnaires. This pilot study is being conducted to provide insight regarding the efficacy of exercise and balance training for the treatment of CIPN.