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Does early post-operative physical activity predict recovery of function six months after lumbar spinal surgery?
Expand descriptionIt is currently not known whether the amount of walking patients do following lumbar spinal surgery is associated with post-operative outcome, therefore there is considerable variation in the advice provided to patients regarding walking and physical activity in the period immediately following surgery. This research aims to establish whether the amount of physical activity patients do in the week following lumbar spinal surgery predicts recovery of function at six months. All patients admitted to St Vincent’s Private Hospital Fitzroy (SVPHF) for lumbar spinal surgery aged 18 years and over will be invited to take part in this study. Recruitment will take place over a six-month period, with an estimated 250-300 participants. Participation will involve completing a series of short questionnaires pre-operatively and at six months post-operatively. To measure physical activity in the week following surgery each participant will be required to wear a small device, called an accelerometer, fixed to the thigh with a waterproof dressing. During this first post-operative week participants will also be asked about pain, whether they require assistance while walking, and post-operative complications. Where patients are discharged prior to the seven-day monitoring period finishing they will be provided with daily questionnaires to complete and a reply paid envelope to return the accelerometer to the research team. There will be no changes to standard post-operative care currently provided by any of the staff at SVPHF, including advice regarding walking and physical activity immediately following surgery. The findings from this research will enable all health professionals involved in the post-operative rehabilitation process to provide consistent advice about activity levels following surgery, including information provided in educational resources. It will also build the foundation for further research into interventions designed to optimise post-operative activity.
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Efficacy of oral, capsulised, frozen faecal matter transplant for the treatment of clostridium difficile diarrhoea.
Expand descriptionThe majority of reported FMT procedures have been performed with fresh stool suspensions from related donors. This approach has practical barriers that hinder the development of scientifically sound treatment protocols. The use of fresh donations requires prior identification and screening of a suitable donor, thus precluding the use of FMT in acute situations. Furthermore, the limited viability of fresh samples, usually estimated at up to 6 hours, makes thorough screening of donors and donation aliquots impractical. To address these issues Yongster and colleagues have studied the use of a pre-prepared, frozen inoculum from unrelated donors delivered by both endoscopic and capsulized routes, however both of these studies have been pilot studies. The capsulized form of FMT when compared to FMT delivered by endoscopic means this method may have positive effects on: The timing of the procedure due to reduced logistical issues, the safety of the procedure (reduced risk of endoscopic/anaesthesia complications) and a reduction of overall cost to the health budget Strengthening the evidence base and clinical experience behind frozen, oral FMT will be of benefit to patients, staff and health services. Patients will be offered oral FMT using pre-made frozen capsules with the FM souced from unrelated donors
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Electrical stimulation cycling exercise in persons with cerebral palsy
Expand descriptionAim: The primary aim of this project is to evaluate the feasibility of functional electrical stimulation cycling exercise for persons moderately affected cerebral palsy. Electrical stimulation uses brief electrical pulses applied via gel-electrodes to the muscles to produce muscle contractions in weak or paralyzed muscles. Functional Electrical Stimulation cycling devices rhythmically apply electrical stimulation to the leg muscles to induce muscle contractions that can cause paralyzed legs to pedal a stationary exercycle and exercise the legs. Electrical stimulation exercises has many disadvantages, including the cost of equipment, the time invested in setting up the equipment each session and the low intensity of exercise it provides. However, persons with CP who have more severe mobility limitations often have less options for exercise, and even though it has many drawbacks electrical stimulation may be a good exercise mode for this population. Intervention: In this project twelve adolescents with moderate CP (i.e. gross motor function classification scale III) will perform 8 weeks of functional electrical cycling training at the Faculty of Health Sciences, University of Sydney. The method of functional electrical stimulation cycling which will be employed is one which we have shown to produce better enhancements in muscle mass than prior methods of electrical stimulation cycling. Participants will perform cycling two times per week and each session will involve 45min of exercise. Eight muscle groups will be electrically stimulated via self-adhesive gel electrodes. The quadriceps, gluteal muscles, hamstrings, and calf muscles of each leg will be electrically stimulated. We will measure the outcome variables before and after the 8 week intervention. Hypothesis: The primary hypothesis tested is that our method of electrical stimulation cycling is a feasible form of exercise for persons with moderate CP. We believe that appropriately designed ES-cycling exercise can enhance the exercise options that persons with moderate cerebral palsy can currently perform. We will measure feasibility through adherence to the program and test outcome measures related to health and function. Secondary hypotheses include that regular exercise with an appropriate ES cycling system results in leg muscle hypertrophy (assessed via ultrasound and leg circumference measures) in people with moderate CP and consequently produces improvements in lower limb function, and quality of life. Evaluation of our secondary hypotheses also include measures of perceived quality of life, cycling ability, leg extension strength, leg flexion strength, gait and leg function, and spasticity/tonus.
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Does Physitrack 'Registered Trademark' improve participation in exercise programmes in children with cerebral palsy?
Expand descriptionChildren with cerebral palsy (CP) and other physical disabilities are often prescribed individualised home exercise programmes by their therapists. These exercises may target flexibility, strength, endurance, gross motor development, balance, and sports skills. Home exercise programmes are used to complement the face-to-face physiotherapy sessions and help children to complete the number of exercise sessions, per week, required to achieve their goals. Physitrack 'Registered Trademark' is an online, app-based package for therapists to provide exercise programmes. It is designed to help people complete exercise programs with videos of exercises, audio and written instructions, a calendar, and capacity to communicate online with your therapist. We want to see if using Physitrack assists children with Cerebral Palsy to perform their exercises correctly, adhere to their exercise programme, and achieve their personal goals.
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The Efficacy of Caralluma for Anxiety in Adults
Expand descriptionThe aim of this study is to conduct a preliminary investigation of Caralluma supplement to examine its efficacy for reducing anxiety and stress in healthy adults over eight weeks. The study will assess 1 g/day compared to placebo. Satiety will also be measured to investigate any correlation between treatment effect for anxiety / stress and self-reported reduction in appetite. It is hypothesised that a reduction in anxiety and stress (i.e., a decrease in negative anxiety scores ) over eight weeks would be significantly greater in the active treatment group than in the placebo group. Regarding Caralluma’s effect on satiety, it is hypothesised that a decrease in the VAS score would be significantly greater in the active treatment group than in the placebo group. It is also hypothesised that a decrease in the VAS score for appetite would be positively correlated with a decrease in the anxiety and stress scales.
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Oral appliance with built in airway for the treatment of obstructive sleep apnoea.
Expand descriptionLike other oral appliances to treat snoring and sleep apnoea, the O2Vent brings the jaw forward to reduce airway collapse. However, it also has a built in airway to allow breathing through the device. This may make it suitable for use by patients who find it difficult to breathe exclusively through the nose. A recent pilot study showed that original design, the Oventus Clearway, was safe, effective and well tolerated with a 62% reduction in the number of times patients stopped or reduced their breathing during sleep. No difference in response rate was observed in patients with or without subjective symptoms of nasal congestion. The new generation Oventus device, the O2Vent, has the built in airway of the original design, however it is 2 parts, an upper and lower part. This makes it much easier to adjust and find the optimal jaw position.. The aims of the present study are to: 1. To demonstrate safety and efficacy of O2Vent oral appliance 2. To demonstrate that the incorporation of an enclosed airway into the O2Vent improves comfort and compliance 3. To confirm the equivalent response rate in subjects with nasal congestion using rhinomanometry as an objective measure of nasal congestion The above aims will be addressed using a randomized crossover study design with patients in one arm using the O2Vent with the built in airway open and in the other arm using the device with the built in airway closed.
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The DIRECT Study: Individualised dasatinib dosing for patients with chronic myelogenous leukaemia.
Expand descriptionThe primary purpose of this study is to evaluate the efficacy and safety of individualised dosing of dasatinib for elderly patients with chronic myelogenous leukaemia. Who is it for? You may be eligible to participate in this study if you are aged 18 years or over, and have been diagnosed with chronic myelogenous leukaemia in the chronic phase (CML-CP) in the previous three months. Study details All participants in this study will start taking dasatinib at 100mg per day. At day 7, a blood sample will be taken to measure the levels of dasatinib in the blood just prior to taking that day's dose. If the blood dasatinib level is above a certain point, then the daily dose will be decreased to 70mg per day. If the blood dasatinib level is adequately low, then the participant will continue taking 100mg per day. This process will be repeated on days 28 and 56, with further lower dose levels of 50mg per day and 50mg every other day available if blood dasatinib levels are above the specific concentration. The dose level may also be dropped at any time if signs of drug toxicity are present. Participants may also be escalated back up a dose level (up to a maximum of 100mg per day), if further blood tests every 3-6 months show that the drug has not sufficiently decreased markers of the leukaemia, i.e. treatment has not been adequately effective. Participants will continue taking the drug for the two year study period, followed by a further three years if it has proven to be safe and effective in these patients. It is hoped that the findings of this study will provide information on whether an individualised dose of dasatinib can be used in elderly CML-CP patients to minimise toxicity whilst maintaining the therapeutic effect to treat the disease.
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Canadian-Australian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease
Expand descriptionCardiovascular disease is the commonest cause of death while on the kidney transplant waiting list and after transplantation. Current standard care involves screening for coronary artery disease prior to waitlist entry, then every 1-2 years, according to perceived risk, until transplanted. The aim of screening is two-fold. Firstly to identify patients with asymptomatic coronary disease to enable either correction, by bypass surgery or angioplasty, or removal of the patient from the list, with the ultimate aim of preventing premature cardiovascular mortality at the time of, or soon after kidney transplantation. Secondly, from a societal perspective, to prevent mis-direction of scarce donor organs into recipients who experience early mortality. This current screening strategy is not evidence based, has substantial known and potential harms, and is very costly. Two major issues of uncertainty require addressing in sequence: (1) whether to periodically screen asymptomatic wait-listed patients for occult coronary artery disease; and (2) whether to revascularise coronary stenoses in asymptomatic patients prior to transplantation. The CARSK study seeks to address the first of these 2 issues. CARSK aims to 1. Test the hypothesis that after screening for wait list entry, no further screening for coronary artery disease (CAD) is non-inferior to the current standard care which is screening all asymptomatic wait-listed patients for CAD at regular intervals. 2. Compare the benefits and costs of not screening versus regular CAD screening from a health system perspective.
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Comparison of two exercise approaches for the management of low Back pain in the emergency department setting.
Expand descriptionAcute low back pain (LBP) is a common presentation to the emergency department (ED). It is also a major health condition associated with high rates of absenteeism from work and more frequent use of health services. As per the international back pain guidelines, primary contact practitioner aim is to classify back pain and rule out serious pathology. The mechanical low back pain group (back pain from a musculoskeletal cause) makes up 90% of presentations to ED. Currently in ED standard treatment comprises of subjective and objective assessment (RMO/ED registrar, or Physiotherapist):,radiological investigations as appropriate for the individual. Management will include patient education and assurance, symptom relief by analgesia (NSAIDS, paracetamol & opioids if necessary), as well as recommendation to stay as active as possible including return to work. Depending on their response to the analgesia patients are discharged with gentle exercises & Physiotherapy follow-up. Despite these forms of care twenty five percent (RBWH ED statistics) of low back pain patients are admitted to the short stay unit for overnight analgesia due to difficulties coping with the pain. They are then discharged after 1-2 days. Apart from adding to the cost , this also blocks a bed for other emergency patients. Effective treatment of acute LBP is important because it prevents patients from developing chronic LBP which needs more costly and complex investigations and treatment. Presently treatment for patients presenting to ED with back pain lacks an individualised approach with respect to alleviating mechanical low back pain. We propose this may be improved with the use of a McKenzie approach to management of back pain in the ED setting. The McKenzie method of mechanical diagnosis & therapy is an active exercise approach involving repeated movements, sustained positions and therapeutic forces, it has an educational component with the purpose of minimising pain, disability, and improving spinal mobility. Currently data suggesting effectiveness of this method in an ED setup is lacking. Therefore the purpose of this study is to compare if more benefits are gained with a ‘McKenzie exercise’ approach compared to a ‘stability/mobility’ exercise approach for patients who are treated by a Physiotherapist for low back pain in ED. We anticipate the findings of the study will be informative to the best approach to management of these patients in ED.
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Does treatment of Obstructive Sleep Apnoea in patients with Mild Cognitive Impairment improve cognition and mood?
Expand descriptionSleep-related breathing disorder has been commonly reported in elderly individuals with mild cognitive impairment. This project is interested in examining the prevalence of Obstructive Sleep Apnoea (OSA) in patients attending the Cognitive, Dementia, and Memory Service (CDAMS) at Northern Health and Austin Health. Also, this project aims to determine if 3 months of CPAP therapy for OSA in patients with memory impairments improves mood and memory. Firstly, patients attending CDAMS with memory impairment will be screened for OSA and patients who have a high risk of OSA will be invited to take part in Phase 1. Interested participants will be invited to attend the RMIT Sleep Laboratory for a 90-minute neuropsychological testing session and an overnight diagnostic polysomnography (PSG). Healthy age-matched controls will also undergo the same neuropsychological testing and overnight PSG to investigate differences in cognition and memory of individuals with memory impairment and healthy individuals. Patients who are diagnosed with OSA and recommended Continuous Positive Airway Pressure (CPAP) by the study physician will be invited to participate in Phase 2 the project. Participants will be randomised to either an immediate CPAP group or a 3-month wait-list group. Participants in the immediate CPAP condition will be given an auto-titrating PAP machine and asked to use their CPAP at home. After 3 months of CPAP therapy, participants will attend a second appointment at the Sleep Laboratory to complete follow-up tests and questionnaires. Patients in the wait-list condition will commence CPAP after 3 months and the same follow-up procedures will be followed as per the immediate CPAP group.