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Does in-bed cycling with critically ill patients assist to maintain muscle mass and function?
Critically ill patients often require prolonged mechanical ventilation for periods greater than 48 hours. It has been identified that skeletal muscle wasting occurs early and rapidly during the first week of critical illness. Despite international recommendations to commence activity as early as possible with critically ill patients it has been identified that exercise interventions are rarely initiated when a patient is on mechanical ventilation. This leads to prolonged immobility and may contribute to the development of ICU Acquired Weakness (ICUAW). A randomised controlled trial (RCT) will compare outcomes of critically ill patients who receive standard physiotherapy (control group) and those who complete additional in-bed cycling intervention sessions. This will enable comparison of outcomes to assist clinicians to determine if additional in-bed cycling sessions may be beneficial with critically ill patients. Objectives: To determine: (1) if in-bed cycling in addition to standard care is effective in reducing the rate of rectus femoris (RF) cross-sectional area (CSA) atrophy and intensive care unit acquired weakness (ICUAW) in patients requiring > 48 hrs of mechanical ventilation compared to standard care; (2) whether in-bed cycling in addition to standard care improved functional and cognitive outcomes in patients requiring > 48 hours of mechanical ventilation compared to standard care. Trial Design: Two (parallel) arm, preliminary randomised control trial with assessor blinding. In summary, this study aims to examine if addition of an in-bed cycling intervention with critically ill patients reduces the loss of thigh muscle mass. Also to examine if in-bed cycling improves functional and cognitive outcomes post intensive care discharge.
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Short-term effects of Tulsi herbal tea on mood, stress, cognition and cardiovascular function
Tulsi or Holy Basil is an Indian herb used for centuries for coping with stress as well as for the treatment of Type 2 Diabetes (T2D) and other cardiometabolic disorders. Tulsi tea is widely available throughout the world as a caffeine free herbal tea with no reported side effects in literature associated with regular consumption of tulsi tea. Considerable evidence in animal models shows that tulsi improves cognition, immunity, stress and cardiometabolic disorders. Also accumulating evidence from human trials indicate that long-term tulsi ingestion improves mood, cognition and cardiometabolic function. However, there are no published reports on short term effects of tulsi on these pathways in humans. In addition, only a few of the clinical trials have looked at the effect of tulsi consumption in healthy adults who are infact the majority of the tea drinker population. Potential outcomes of this clinical trial are not only to support traditional effectiveness and safety of tulsi but also to stimulate further research into the numerous healing potentials of this Ayurvedic sacred herb. This project aims to explore time course of mood, cognition and cardiovascular functional changes after the consumption of a single cup of tulsi tea in healthy people. In addition, since cortisol is a well-established biomarker of mental stress, known to control blood pressure (Kelly et al., 1998) and high cortisol levels found to be associated with reduced cognitive function such as memory (Shirbin et al., 2013), therefore acute change in cortisol activity was also assessed.
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Personalised DVD home exercise programs to improve the physical and mental health of older patients after functional decline
This study seeks to determine whether providing a personalised Home Exercise Program (HEP) using an instructional DVD of the participant performing their exercise routine will increase the adherence to the HEP and improve the physical and mental state of older patients who have had functional decline, following illness, fracture or fall.
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Glucose lowering effect Of walking breaks in pregnancy study
The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide, with current Australian prevalence rates estimated to be between 13-16%. The primary goal of GDM management is to prevent hyperglycaemia, as there is a clear dose-dependent relationship between increased plasma glucose levels during pregnancy and adverse outcomes for both the mother and child. Compliance rates for exercise intervention trials in pregnant women are generally poor (reporting adherence as low as 16-55%). Furthermore, the majority of pregnant women do not reach the recommended levels of physical activity; and overall physical activity levels tend to decrease throughout pregnancy (particularly in caregiving, outdoor, household and recreational activities). The lack of adherence to an exercise regime could be due to feelings of tiredness and increasing immobility as pregnancy progresses, which would limit the ability or motivation for women to maintain exercise efforts for more than 10 min at a time, particularly for women who are not normally active. In light of the fact that brief (2-3 minutes), regular (every 20-30 minutes), light ambulatory activities have been demonstrated to be effective in improving postprandial glucose control in overweight/obese and T2D patients, consideration of the “breaks in sitting” approach may be appropriate for women at risk for or diagnosed with GDM. Given that post-challenge glucose is considered a surrogate for postprandial glycaemia, there is value in examining the effect of breaking up sitting in the context of routine screening for GDM. Based on past studies done within our laboratory, we anticipate that breaking up sitting will lower postprandial glucose responses compared to prolonged sitting without breaks, and may even prevent levels from entering the GDM range. The results of this trial will help inform the design and development of a larger, chronic study looking at breaking up sitting to improve pregnancy outcomes for mothers and offspring. Hypothesis: We hypothesise that regular, light intensity ambulatory breaks in sitting (2 minutes every 20 minutes) will lower post-OGTT glucose and insulin responses in women at risk for developing GDM, compared to sitting-only control. Study Design: A cross-over trial, involving women at risk of GDM, of two laboratory-based interventions undertaken during a standard 75g oral glucose tolerance test. Outcomes: Primary outcomes – postprandial glycaemic response calculated as the incremental area under the curve (iAUC) from half hourly blood sampling over a 4 hour period. Secondary outcomes – postprandial insulin response calculated as iAUC and mean blood pressure.
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Pilot study investigating how Extracorporeal Membrane Oxygenation (ECMO) affects the major breathing muscles.
The diaphragm; the major breathing muscle, as a result of life supporting mechanical ventilation reduces in size, thickness and function (Umbrello, 2016). Diaphragm atrophy and dysfunction as a result of mechanical ventilation can lead to critically ill patients having a higher intensive care unit (ICU) mortality rate, increased ICU length of stay (LOS), increased mechanical ventilation duration and a higher rate of re-intubation (Demoule et al, 2013;). There is currently no body of evidence regarding the onset or extent of diaphragm atrophy in patients who receive Extracorporeal Membrane Oxygenation (ECMO) therapy; a patient cohort predisposed to atrophy and dysfunction of the diaphragm due to very low lung volumes delivered by the breathing machine, deep sedation and immobility. By using diagnostic ultrasound (US) in this study, we can accurately assess diaphragm thickness and determine the onset and rate of diaphragm atrophy in the ECMO cohort Aims: This pilot study aims to investigate if diaphragm atrophy occurs and the rate of diaphragm atrophy incurred whilst a patient is receiving ECMO therapy. The research questions are: 1. Does ECMO therapy lead to diaphragm atrophy as measured by diaphragm thickness on ultrasound? 2. What is the rate of diaphragm atrophy for patients receiving ECMO therapy? 3. Is there a difference in the rate of diaphragm atrophy between patients on VV versus patients on VA ECMO? Design: As this is a pilot study, we will recruit all patients that receive ECMO therapy after consent is obtained from the patient’s next of kin. Ultrasound data and other measurements will be collected at the onset of ECMO insertion and every second day until ECMO decannulation to identify the onset and rate of diaphragm atrophy.
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5 year study of 6 children each year with vascular anomalies who have severe complications failing to respond to the usual treatments will be offered a new use of an old medication- sirolimus
Why is this study important? Vascular anomalies comprise a diverse group of diagnoses. The majority of these conditions are quite rare and have not been widely studied. Some of these lesions can impair vital structures, be deforming or even becoming life-threatening. Many children with complicated vascular anomalies have already failed the conventional treatment and are at risk of significant morbidity and mortality. Currently sirolimus is in clinical trials in various centres of Europe and United States of America. Case studies are suggestive of optimistic outcome. By doing this prospective study, we will be able to assess the response and safety of this medication in our own patients which will definitely be a valuable contribution to the wider medical world to shine light on the management of this rare complex conditions . The protocol is designed as a prospective research study. It involves children in the age group of Zero to Eighteen years. We envisage approximately 6 children per year for 5 years who have complex vascular anomalies will be deemed eligible for treatment with sirolimus. This includes children who are ineligible for or refractory to conventional treatments as well as children who are suffering from rare subtypes of vascular anomaly for whom there is no universally accepted standard therapy. BACKGROUND INFORMATION Vascular anomalies include a heterogeneous group of disorders that are categorized as vascular tumors or vascular malformations. The standard treatment options include resection, sclerotherapy and cytostatic chemotherapy. Some of these anomalies can be very complicated causing disfigurement, chronic pain and organ dysfunction with significant morbidity and mortality. These complicated vascular anomalies are quite rare and have not been widely studied. These patients have either failed the conventional treatment or unable to tolerate the available treatment due to life threatening side effects. 4 Supporting References from the review of literature 1) Adrienne M, MarySue W etal. Sirolimus for the treatment of complicated vascular anomalies in children. Paediatr Blood Cancer 2011;57:1018-1024. 2) Denise M, Cameron C etal. Efficacy and safety of sirolimus in the treatment of complicated vascular anomalies. Pediatrics2016Feb 18:137(2):1-10. 3) Lackner H, Karastaneva A etal. Sirolimus for the treatment of children with various complicated vascular anomalies. Eur J Pediatr 2015 Dec; 174(12):1579-84. 4) Laurence M, Jennifer H etal. Rapamycin as novel treatment for refractory to standard care venous malformation. ISSVA 2016 Conference abst
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The effect of exercise on brain volume and function after stroke
There is a link between two major causes of death, disability, and reduced quality of life in our society: stroke and neurodegenerative dementia. We now understand patients who suffer stroke are more likely to experience a long-term decline in thinking ability and a reduction in brain volume. Exercise is a simple, yet effective, method of improving cardiovascular health. We will examine if exercise after stroke can modify risk factors that may lead to post-stroke brain atrophy and cognitive decline. The aim of this project is to determine whether home-based aerobic exercise has a positive impact on preserving brain volume and function, as well as general physical and psychological well-being. We hypothesise that participants who undertake prescribed aerobic exercise (i.e., exercise that increases heart rate and breathing) after a stroke will have preserved brain volume and neurocognitive performance, higher mood levels, and better end-organ disease well-being (i.e., less recurrent strokes, improved blood pressure, reduced cardiovascular disease) compared to participants who do not undertake aerobic exercise. Results from this study will provide unique information on the relationship between stroke, physical activity, brain health, and dementia. Our findings will establish whether post-stroke aerobic physical activity can prevent, or at least minimise, the impact of brain atrophy, cognitive impairment, and end organ disease state. A prescribed and tailored exercise programme could offer a simple and economically viable solution to patient care.
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A randomised control trial of mild opioids versus strong opioids for post-discharge analgesia following orthopaedic fracture surgery
Opioid analgesics (morphine-like pain killers) are the drug of choice for post-operative pain fracture management. Previous research has been found that most, if not all, surgically managed fracture patients are discharge home from hospital with strong opioids (largely Panadiene Forte, Endone and Oxycontin). Despite the overwhelming push for effective postoperative pain control, at present there is no clear consensus on which pain medication is best for pain management after discharge home from hospital following an orthopaedic fracture. We aim to determine whether over the counter paracetamol plus codeine provides adequate pain relief compared to stronger oxycodone based pain killers.
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A Phase II Feasibility study to determine the efficacy and dose-response of a single enteral dose of Ivabradine to reduce participant heart rate in patients admitted to the intensive care unit with sepsis and sinus tachycardia
Severe infection (sepsis) represents a common reason for admission to the ICU, often involving older people with multiple medical problems. These patients often have a prolonged hospital stay, complicated by multi-organ dysfunction leading to greater morbidity and mortality. Typically, patients have a high cardiac output, low resistance circulation, with rapid heart rates and low blood pressures requiring infusions of medications to increase blood pressure. There is an emerging body of evidence that elevated heart rates in sepsis contributes to morbidity in some people and can cause numerous complications including myocardial infarction, stress cardiomyopathy, immunosuppression and insulin resistance. Elevated heart rates may limit the time for the heart to fill between contractions, and at high rates may actually reduce the cardiac output. Controlling heart rate could therefore be beneficial. While the drug class beta-blockers are traditionally used, they have the potential to reduce blood pressure which may worsen the clinical state. Ivabradine is currently used in heart failure patients to prevent elevated heart rates, and acts via a novel receptor to reduce heart rates without impacting on contractility. The use of ivabradine in the septic population is highly novel and previously untested. This study aims to evaluate if a single dose of ivabradine is effective at reducing heart rate in septic patients, without escalation of ICU supports.
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A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Testofen (Trigonella foenum-graecum) on muscle strength, endurance and body composition in men aged between 25 and 45 years.
This is a double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Testofen (Trigonella foenum-graecum) on muscle strength, endurance and body composition in men aged between 25 and 45 years.