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Observing activity levels within an Acute Stroke and Sub-Acute Inpatient Rehabilitation Unit pre and post transition to a new hospital
Expand descriptionRehabilitation is required for functional recovery from many acute illnesses such as stroke, orthopedic fractures and de-conditioning seen during extended hospitalization. Unfortunately, research into physical, social and cognitive activity of patients undergoing rehabilitation has shown that patients spend almost all of their time alone, inactive and disengaged. There is increasing interest in how changing the physical environment may improve activity levels, and therefore recovery, but it is currently unknown what impact changing design features such as single vs. multi- bedrooms and proximity to outdoor areas and communal spaces has on physical activity levels. The move to the new Kawana Hospital provides a unique opportuntity to examine this, and consequently this study will determine how changes in hospital design influences physical, social and cognitive activity levels of patients in Acute Stroke and Rehabilitation Units. This prospective observational study will examine the effects of the change in physical environment with transition to a new hospital by observing total activity levels using behavioral mapping and accelerometers in patients recovering in acute stroke and sub-acute rehabilitation units before and after transition. By embedding the use of advanced technologies such as Actigraph and Stepwatch accelerometers, and the building of collaborative networks with the University of the Sunshine Coast, our hospital and health service is set to lead the development of interventions that may guide national and international treatment guidelines.
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Early PARacetamol (EPAR) to promote early closure of the ductus arteriosus in preterm infants
Expand descriptionThe optimal management of PDA is highly controversial with a lack of consensus regarding the need to treat, timing of intervention, the most appropriate pharmacological agents (including dose, dose intervals, duration, repeat courses, routes of administration) and the role of surgical intervention. Traditionally, the medications we use to treat PDA are non-steroidal anti-inflammatory drugs (NSAIDs), which decrease prostaglandin production by inhibiting cyclooxygenases (COX). The most commonly used medications, indomethacin and ibuprofen, have a success rate of approximately 70% - 85%. Unfortunately these medications are associated a number of unwanted adverse effects due to decreased blood flow to the brain, gastrointestinal tract and kidneys. Exposure to these medications puts vulnerable preterm infants at risk of significant complications such as intestinal perforation and necrotising enterocolitis. The alternative to medications is surgical intervention, which also carries significant risks, particularly for extreme preterm infants. Paracetamol is a medication with an excellent safety profile in infants when used to treat mild to moderate pain and fever. Although the mechanism of action of paracetamol is not completely understood, part of its spectrum of activity resembles that of a COX-2 selective inhibitor. Similar to traditional NSAIDs, this results in decreased prostaglandin production. It is therefore intuitive that this may also be effective in promoting ductal closure without the adverse effects associated with NSAIDs. Early experiences with the use of paracetamol for ductal closure have been encouraging. Paracetamol appears to have similar efficacy to NSAIDs, without the gastrointestinal complications associated with NSAIDs, and is well tolerated in the preterm infant population. It has been suggested as a safe alternative medication in situations where other medications have failed or are contraindicated. The aims of this study are to study the effect of early treatment of patent ductus arteriosus with paracetamol and to examine the safety and efficacy profile of paracetamol during the early postnatal period. We hypothesise that early treatment with paracetamol will reduce the number of infants requiring intervention for PDA and that the use of paracetamol in preterm infants with a patent ductus arteriosus will result in a higher rate of ductal closure compared with placebo. We also am to show that paracetamol can be used safely in preterm infants during the early postnatal period.
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Nasal High-Frequency Oscillation to Improve Respiratory Stability of Preterm Infants: A Randomized Crossover Study
Expand descriptionIntermittent hypoxia (pulse oximetry saturation <80%) and bradycardia (pulse rate <80 beats per minute) frequently occur in preterm infants, often associated with apnoea of prematurity. Such episodes of hypoxia and re-oxygenation have the potential to trigger a pro-inflammatory cascade leading to multisystem morbidity including retinopathy of prematurity, impaired growth, longer-term cardiorespiratory instability, and poor neurodevelopmental outcome. Widely used treatments such as methylxanthines and continuous positive airway pressure (CPAP) are sometimes insufficient and endotracheal intubation and mechanical ventilation are required. Nasal CPAP is the most widely used from of 'non-invasive' ventilation (NIV) in very preterm infants. NIV refers to respiratory support without the need for an endotracheal tube, usually delivered via nasal prongs. Nasal CPAP is an alternative to mechanical ventilation in preterm infants soon after birth. A meta-analysis comparing early CPAP with intubation and mechanical ventilation showed that CPAP reduce the risk of the combined outcome of death or bronchopulmonary dysplasia (BPD). CPAP failure primarily occurs due to AOP, oxygen requirements pre-specified thresholds, and hypercapnia related to hypoventilation. Ventilation failure in infants treated with CPAP may be due to inadequate alveolar ventilation and carbon dioxide elimination. High-frequency oscillatory ventilation (HFOV) delivered via an endotracheal tube leads to excellent carbon dioxide removal using a tidal volume less than the volume of the dead space. HFOV, which has until recently only been delivered via endotracheal tube, uses oscillations of low amplitude and high frequencies quite different from those of normal respiration. It may cause less lung injury than conventional mechanical ventilation. The combination of HFOV and NIV could provide lung-protection, improved oxygenation, better gas exchange, and reduced rates of AOP compared to NIV alone. Therefore, we aim to assess the effect of nHFO versus CPAP therapy in very preterm infants born <30 weeks’ gestation on the cumulative event rate of all bradycardias (< 80 bpm) and desaturations (< 80%) during a 120-minute recording period for each therapy. We hypothesize that in very preterm infants, nHFO is associated with a significant decrease in the number of bradycardias and desaturations compared with CPAP.
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The effect of upper airway surgery on obstructive sleep apnoea
Expand descriptionObstructive sleep apnoea (OSA) affects 1.5 million Australians and results in significant morbidity and mortality. However, half of patients cannot tolerate the leading treatment, continuous positive airways pressure (CPAP). For those intolerant of CPAP, a common treatment alternative involves upper airway surgery (UAS). Unfortunately, a significant number of patients referred for this treatment do not respond and suffer from residual OSA with its inherent cardiovascular and neurocognitive consequences. Furthermore, current clinical predictive tools are poor at identifying responders to UAS and there are no proven additional therapies to offer those patients failing UAS treatment. The key to providing better predictors of OSA resolution with UAS is to understand how these interventions affect the physiology responsible for OSA. It is clear that UAS improves upper airway anatomy/collapsibility. However, poor upper airway anatomy is not the only factor contributing to OSA. Recent evidence suggests that several additional, nonanatomical, physiological traits contribute to the pathogenesis of OSA including: 1) an oversensitive ventilatory control system (i.e. high loop gain), 2) a low respiratory arousal threshold, and 3) poor pharyngeal dilator muscle effectiveness characterised by an inability of the pharyngeal muscles to hold open or stiffen the airway during sleep. However, it is not known how UAS alter these nonanatomical traits and whether abnormalities in these traits are the reason for the variability in the success of UAS treatments. Furthermore, it is also not known if targeting non anatomical traits with additional treatments (i.e. combination therapy) will improve outcomes for those patients who have had only a partial response to UAS. Our goal is to be able to accurately identify which OSA patients are good candidates for UAS therapy by identifying robust predictors of OSA resolution with these interventions. Furthermore, we aim to offer additional treatments to ‘salvage’ those patients who have failed to respond completely to UAS.
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A smartphone intervention to improve health in truck drivers
Expand descriptionTruck drivers are highly susceptible to cardiovascular disease (CVD), type 2 diabetes, obesity, high blood pressure and stress. Employees within this industry are typically older men and therefore more likely to develop CVD related conditions, compared to other occupational groups. Furthermore, inflexible and unhealthy work conditions often mean truck drivers are particularly inactive, engage in long periods of sedentary behaviour (or sitting), and have poor diets consisting of high fat convenience food, and drinks with high fat or sugar content. Effective strategies need to be developed to counter these poor lifestyle choices, but to date, no intervention study has targeted inactivity, sedentary time and diet in truck drivers; consequently, evidence is lacking on how best to empower drivers towards active living and healthy eating/drinking approaches. This study will test the feasibility of a new intervention (termed 'Shifting Gears'), designed to promote healthy lifestyle choices, and reduce cardiovascular risk, in Australian truck drivers. The study aims to develop and implement active living and healthy eating/drinking strategies in driver breaks, and evaluate the efficacy of these strategies over a six month intervention period, using measured changes in physical activity, sedentary behaviour and healthy food/drink options, as the main study outcomes.
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Short-term exercise training and its effect on glucose tolerance and immune function
Expand descriptionCurrent evidence suggests exercise plays an important role in the management of blood glucose levels for individuals with T2DM.The comparison on mode of exercise on glucose regulation is not well understood and limited. Previous research have investigated treadmill or cycling exercise on glucose tolerance separately, however the comparison between the two modes of exercise on glucose regulation is limited. We seek to determine which mode of exercise would be more effective in managing glucose tolerance since walking/running is freely accessible without having the need to sign up to a gym or to invest in a bicycle. It is now understood that type 2 diabetes is associated with a chronic state of inflammation. Recent evidence have shown that exercise is beneficial in improving inflammation along with reducing insulin resistance. We aim to identify whether the mode of exercise influences the level of inflammation and glucose tolerance following a two-week training period. Findings of this study may help inform future exercise prescription to improving health status in this population.
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Screening for Human Papilloma virus (HPV) Infection in Kidney Transplant Recipients for Anal Neoplasia (TAN) - A Prevalence and Feasibility Study
Expand descriptionThe primary purpose of this trial is to evaluate the feasibility of providing screening for human papilloma virus (HPV) infection of the anus in patients who have had or who are on the waiting list for a kidney transplant at Westmead Hospital. The trial also aims to provide initial estimates of the prevalence of HPV infection in this population. Who is it for? You may be eligible to enroll in this trial if you are aged over 18 years, and you have had or are on the waiting list for a kidney transplant at Westmead Hospital. Study details At a routine assessment visit, all participants will complete a questionnaire for demographic and sexual behaviour information, and have an anal swab taken. The sample will be analysed for different types of HPV infection and to see if any abnormal cells are present. Any participant with either a significant cytological abnormality, or in whom high risk HPV is detected, will be referred for further investigation at a specialist clinic. It is hoped that this trial will provide information on whether it is feasible to collect this information in transplant recipients, as well as providing initial estimates of the prevalence of HPV.
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Effects of Kinesio tape colour on lower limb performance
Expand descriptionMaximising performance and facilitating recovery following injury are important goals for athletes. An ever-expanding industry is dedicated to the provision of therapeutic products designed to optimise function. One example of such product is the Kinesio tape, which is claimed to promote healing and facilitate neuromuscular activity, leading to an improved performance. There is also suggestion that the colour of the tape may influence performance. This crossover randomised study will determine if lower limb performance is influenced by (1) the application of Kinesio tape and (2) by the colour of Kinesio tape in healthy individuals. For that aim, healthy participants will be assessed in 5 conditions that will be allocated in random order: (1) red Kinesio tape; (2) blue Kinesio tape; (3) beige colour Kinesio tape; (4) beige colour Kinesio tape with no tension (sham); and (5) no tape (control). The tape will be applied to vastus lateralis, vastus medialis and rectus femoris muslces of the dominant leg. The primary outcome will be the performance of participants on the horizontal jump test. Secondary outcomes include: (1) knee extensor torque and (2) neuromuscular function (motor evoqued potentials of the rectus femoris muscle).
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Health outcomes following SYNVISC-ONE in Knee Osteoarthritis
Expand descriptionAims: The goals of the LOBRAS study, were: 1) To evaluate the group-level response to Synvisc-One in knee OA, using patient-centred measures of beneficial and adverse outcome; and 2) To evaluate response and state-attainment criteria and age-specific and gender-specific benchmarks, at the individual patient level, to assess the therapeutic response to Synvisc-One in knee OA. Methods: The LOBRAS study involved a one year long multi-centre, pragmatic, “real-world” evaluation of the response to Synvisc-One, in 131 patients with knee OA. LOBRAS employed an open, quasi-experimental, one group, repeated measures design, and involved consented patients in Australia, fulfilling inclusion/exclusion criteria, and under the care of a medical specialist (Orthopaedic Surgeon, Rheumatologist, Sports and Exercise Medicine Physician), in routine clinical practice. Prior to, and for 52 weeks following, intra-articular Synvisc-One, patients were repeatedly evaluated, using the WOMAC NRS4.1 Index and the SF-36 questionnaire. The WOMAC NRS4.1 was administered by mobile phone (with paper back-up) at baseline, then once weekly for 12 weeks, and once every four weeks thereafter. The SF-36 was administered on paper, at baseline, then every four weeks thereafter. Patients were also monitored for adverse events. Data Analyses: The following analyses were pre-planned: Effectiveness analyses: Primary: Repeated measures analysis based on 26 week outcome for WOMAC pain, stiffness, function and total index scores, using continuous data. Secondary: Repeated measures analysis based on 52 week outcome for WOMAC pain, stiffness, function and total index scores, using continuous data. Responder analyses based on WOMAC pain, stiffness, function and total index scores, using categorical data. a) OMERACT-OARSI Responder Criteria b) Minimum Perceptible Clinical Improvement (MPCI) c) Minimum Clinically Important Improvement (MCII 75) d) WOMAC 20-50-70 Responder Criteria State-attainment analyses based on WOMAC pain, stiffness, function and total index scores, using categorical data. a) Bellamy Low Intensity Symptom State-attainment (BLISS) Index b) WOMAC Age- and Gender-specific normative values c) Patient Acceptable Symptom Severity (PASS 75) Utility analysis using the WOMAC-HUI model for deriving HUI-3 utility values from WOMAC scores Comparison of 26 week vs. 52 week outcomes for above analyses Change in SF-36v2 (BL to week 26 and week 52) Analysis of predictors of outcome at 26 weeks and 52 weeks including age, gender, BMI, KL Grade, Injection site, duration of OA, adverse events. Time to re-injection in repeat treatment subgroup Safety/Tolerability Analyses: Descriptive analysis of adverse events
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The feasibility and effectiveness of trauma-focussed imaginal exposure for voice hearing following adverse life experiences: A pilot trial (The Recall study).
Expand descriptionThere is increasing evidence of a relationship between trauma and psychosis. Recent evidence also suggests that there are potential shared mechanisms involved in the genesis of posttraumatic intrusions and posttraumatic voice hearing. The Recall study is a pilot trial aiming to provide initial evidence regarding the acceptability, feasibility and effectiveness of applying established trauma-focussed treatments to voice hearing. In addition, in the spirit of the interventionist-causal approach, the study aims to provide a preliminary assessment of the effects of the intervention on the proposed mechanisms of change. The findings of the pilot study will inform future treatment trials using trauma-focussed therapies for post traumatic voice hearing.