ANZCTR search results

Dexamphetamine and methylphenidate are used in the treatment of attention deficit hyperactivity disorder (ADHD) but few studies directly compare their efficacy. This randomised study has been designed to compare the efficacy and side effects of dexamphetamine and methylphenidate during initial dose titration for treating ADHD. The dose titration schedule will be allocated by weight (maximum dose 1 tablet twice daily for children up to 25kg body weight, 1.5 tablets twice daily for those 25-35kg and 2 tablets twice daily for those weighing more than 35kg: tablets containing 5mg dexamphetamine or 10mg methylphenidate are conventionally considered equipotent). The dose will be increased weekly (as tolerated) over 4 weeks, aiming to establish the lowest dose that gives maximum improvement in functioning. A rating scale will be requested from the child's teacher describing the child's functioning before starting medication and on each dose. Side effects will be monitored with rating scale and measurement of weight and blood pressure. Cognitive functioning using a simple computer-based test will be assessed unmedicated and on each dose used during titration. After dose titration, routine clinic data on the participants will be collected (height, weight, side effects, medication, reasons for medication change) until the completion of 12 months on treatment.

Chronic fatigue syndrome (CFS) is a prolonged multisystem illness, characterised by very poor stamina, delayed post-exertional fatigue, which adversely affects one’s functioning across numerous physical and mental domains. Current treatments for CFS include pharmacological (e.g. fluoxetine, rintatolimod, galantamine), psychological (e.g. cognitive behaviour therapy (CBT), adaptive pacing therapy), and lifestyle interventions. For many who remain in treatment, they continue to experience significant social, occupational, and functional impairment. Thus new treatment approaches are urgently needed. While significant fatigue remains a common complaint across numerous disorders, it is posited that CFS is related to metabolic dysfunction, mitochondrial dysfunction and impaired biogenesis, in turn related to oxidative stress and systemic inflammation. Mitochondria are structures within cells primarily responsible for energy generation, and are particularly active in oxygen-rich and highly energy dependent tissues, such as the brain. Recent research suggests that patients suffering from CFS may improve with the supplementation of mitochondrial nutrients and antioxidants. This supplementation may be associated with the reduction to mitochondrial membranes, restoring mitochondrial energy production, protecting cellular structures and enzymes from oxidative damage, and decreasing fatigue. Given that CFS is largely a heterogeneous illness associated with a complex and multifactorial aetiology, combined with the present state of available treatments, it is plausible that the introduction of a combination of metabolic therapies may have positive effects on mitochondrial dysfunction and lead to symptom improvement for CFS sufferers.

Background: Physiotherapists perceive the provision of physical activity advice as part of their role, and there is some evidence that physiotherapists can counsel effectively for physical activity behaviour change. In addition, simply measuring physical activity levels, without any other intervention, can cause people to change their physical activity behaviours, resulting in more physical activity being undertaken in the daily lives of adults. Considering this, objective measurement of physical activity by physiotherapists may result in favourable increases in their patients’ physical activity levels. This novel ‘measurement as intervention’ approach could prove to be a very efficient yet effective way to incorporate health promoting physical activity changes into physiotherapy consultations, in a number of different settings. The number of physiotherapy consultations per year in Australia has been estimated to be greater than 23 million. With the ever increasing access to objective activity monitoring devices (accelerometers in smartphones, wrist, shoe or arm worn devices etc.) combined with the broad reach of physiotherapy interventions, even a modest effect of a ‘measurement as intervention’ approach, with accountability to their physiotherapist, may prove to be an efficient approach to increase the populations’ physical activity levels in a meaningful way. However, preliminary work is required to determine the effects of potential measurement intensity (in terms of the frequency of measurement). Methodology: A pilot (two parallel arm) randomized control study conducted over 18-weeks at the University of Canberra will inform a larger study to determine if regular measurement of physical activity by physiotherapists increases physical activity levels in Australian adults (18 – 64 years old).

This randomised controlled trial will evaluate the effectiveness of training family to help with physiotherapy for older people. It will formalise ad hoc arrangements of involving family in physiotherapy, and identify whether this approach is safe and effective for frail older people who have been in hospital, have become weak, and need time and support to get back on their feet. We will measure improvements in physical activity levels, as well as confidence with walking, and quality of life.

Osteoarthritis (OA) is the leading cause of musculoskeletal pain and disability in older adults. The prevalence of knee OA is as high as 50-90% a decade after anterior cruciate ligament injury, irrespective of conservative or surgical management (ACL reconstruction). Our recent magnetic resonance imaging (MRI) data has revealed evidence of OA as early as one year post-ACLR in up to one-third of younger adults – “young people with old knees.” This early-onset OA is frequently associated with pain, reduced physical function, and ultimately, decreased quality of life (QoL) in people aged less than 50 years.Therefore, interventions with potential to reduce pain, improve function and optimise QoL in this population are urgently required. It is known that individuals most at risk of persistent and worsening knee symptoms after ACLR were those with poor knee function 12 months post-and these individuals are more likely to have deteriorating quality of life over the following two years. Post-operative ACLR rehabilitation programs typically aim to decrease pain and improve function to ultimately facilitate a return to competitive sport during the first 12 months post-surgery. There is strong evidence that rehabilitation programs, including progressive resistance and neuromuscular training, have beneficial effects on pain and knee function in patients following rupture of the ACL. However, optimal function and return to sport is not restored in many individuals at 12 months post ACLR, potentially reflecting inadequate rehabilitation participation, and/or insufficient strength/neuromuscular exercise progression. The 12-months post-surgical milestone provides an ideal window to identify those with functional impairments who are at risk of symptomatic deterioration and for interventions that target this group to be implemented. No studies have examined either the feasibility or effectiveness of physiotherapy treatment that aims to enhance self-reported outcomes by targeting specific dysfunction in patients who have persistent functional impairments following ACLR. We hypothesise that a targeted physiotherapy program will improve outcomes in those that are at risk of deteriorating symptoms and early OA following ACLR compared to a control group, who do not receive targeted physiotherapy. The outcomes that we are interested in improving are self reported symptoms, function/return to sport, and quality of life. We will also be assessing whether gains can be made in strength and neuromuscular control at this 12-month post ACLR stage, and whether this is related to improvements in the self reported outcomes. We hypothesise that both groups will improve, however the targeted physiotherapy group will have significantly more gains.

This pilot, double-blind, placebo controlled randomised controlled trial entitled “Vitamin D supplementation and exercise for improving physical function overweight and obese older adults with low vitamin D” is supported by research funding from Monash University’s School of Clinical Sciences “NearMiss” Grant Scheme. Mobility limitation and insulin resistance are common in overweight and obese older adults, and infiltration of adipose tissue into skeletal muscles, known as inter and intramuscular adipose tissue (IMAT) is implicated in the pathogenesis of these conditions, potentially due to proinflammatory effects. Exercise reduces IMAT and so may be important for improving health in older adults, but individuals with high initial IMAT levels may experience attenuated functional and metabolic gains in response to exercise. Adjunctive therapies may therefore be beneficial in overweight and obese older adults to potentiate effects of exercise by reducing IMAT and improving physical function and cardiometabolic health. We hypothesise that correction of low vitamin D status, which is common in overweight and obese older adults, may be effective in reducing IMAT levels, improving physical function,cardiometabolic health and bone health. We will conduct a pilot randomised controlled trial (RCT) of vitamin D supplementation or placebo plus exercise in 50 overweight and obese older adults for 24 weeks.. Primary outcome measures will be changes in physical function IMAT, insulin sensitivity, bone health and arterial stiffness. The findings from this pilot RCT will increase our understanding of the role of vitamin D in muscle function and cardiometabolic health, and contribute to the development of nationally competitive grant applications for further research into exercise and vitamin D supplementation in older adults.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a minimally invasive management option available to select patients suffering from severe aortic stenosis (AS). However, the incidence of cerebrovascular events (CVEs), such as stroke, have raised concern and have the potential to dramatically mitigate any benefits associated with the procedure. We have identified two promising physiological neuroprotective strategies that warrant investigation in this setting: 1) remote ischemic preconditioning (RIPC); and, 2) targeted temperature management (TTM). RATIONALE: (1) RIPC is a protective mechanism whereby a non-lethal ischemic insult, occurring at a site remote from the target organ, activates adaptive mechanisms that blunt tissue injury on subsequent challenge. Laboratory and animal studies have demonstrated this to be one of the most powerful anti-ischaemic strategies known; and yet translation from theory to clinical practice remains a largely unmet medical need. One reason for this has been the unpredictable nature of the timing of stroke, precluding pre-treatment. Cardiovascular procedures, such as TAVI, provide a unique opportunity to apply this technique to a setting of predictably high risk for cerebrovascular events. (2) TTM relies on the reduction in metabolic (e.g. oxygen and glucose) requirements of the brain that occurs with hypothermia. In addition to affecting oxygen consumption and glucose utilisation, hypothermia has other potential benefits including reducing waste products, inflammation, and preventing cell death. HYPOTHESIS: TTM and RIPC offer feasible neuroprotective strategies during TAVI and warrant further investigation. METHODS: This is a prospective, randomised, controlled pilot study. All patients planned to undergo TAVI at The Prince Charles Hospital and St. Andrew’s War Memorial Hospital will be considered. TAVI can be delivered in a number of ways including via blood vessels in the groin (transfemoral or TF approach) or directly through the chest wall (transaortic or TAo approach). Consecutive eligible participants undergoing implantation via a TAo approach will be randomised (1:1) to either control or TTM. Those for whom a Transfemoral (TF) approach is to be used will be randomised (1:1) to either control or RIPC. ASSESSMENT & DATA COLLECTION: A multi-disciplinary approach has been adopted to ensure that relevant experts address each assessment domain. Assessors will be blinded to treatment allocation.

A randomised controlled trial of instructions for taking Polyethylene glycol + electrolytes (PEG+E) in the treatment of faecal impaction in children aged 4 to 18 years presenting to an emergency department (ED). This study aims to compare effectiveness of two different sets of instructions provided with PEG+E for paediatric faecal impaction treatment in an ED. This is a single-centre, prospective, randomised controlled trial of two instructions (standard instructions vs. extended instructions) provided in both written and video for the intake of PEG+E treatment. Primary: Main symptom improvement, remission from the inclusion criteria at day 6 post study treatment initialization as rated by the participant or his/her guardian. Secondary: stool frequency/consistency/ease of stool passage and stool volume (questionnaires)

Anxiety and depression are common in the perinatal period (i.e. during pregnancy and the first year after childbirth). Postnatal depression and anxiety disorders affect around 15% of women, with up to 45% of cases beginning in pregnancy (e.g., Austin et al., 2010). Early evidence shows that iCBT is effective for reducing postnatal depression, anxiety, general distress and parental distress (Danaher et al., 2013; Pugh, Hadjistavropoulos, & Dirkse, in press). Tailored iCBT programs are needed to provide women in the perinatal period with practical coping skills to manage depression and anxiety symptoms, as well as deal with the unique difficulties they may face which can impact on depression and anxiety (e.g. complications during pregnancy and/or delivery, body image, difficulty breastfeeding, an unsettled baby, and unrealistic expectations about motherhood). The primary purpose of this trial is to evaluate the clinical efficacy of a newly developed internet-delivered cognitive behaviour therapy (iCBT) program, the Perinatal MUMentum Program. This iCBT program has been tailored to maternal anxiety and depression experienced during the perinatal period. The MUMentum Program consists of two 3-lesson courses: Pregnancy and Postpartum. The courses can be completed separately or in conjunction with each other and have been designed in consideration of several key issues experienced during the perinatal period when seeking and completing treatment, including a lack of time, fatigue, and stigma. The main hypotheses to be tested for Study 1 (Pregnancy Course) are as follows: 1. Internet cognitive behavioural therapy delivered during pregnancy will significantly reduce symptoms of anxiety, depression, distress and disability. 2. Internet cognitive behavioural therapy delivered during pregnancy will be significantly more effective than the control group at reducing symptoms of anxiety, depression, distress and disability. It is hoped that the findings of this trial will provide further information regarding the efficacy and acceptability of the Perinatal MUMentum Program in reducing maternal anxiety and depression experienced during the perinatal period.

Anxiety and depression are common in the perinatal period (i.e. during pregnancy and the first year after childbirth). Postnatal depression and anxiety disorders affect around 15% of women, with up to 45% of cases beginning in pregnancy (e.g., Austin et al., 2010). Early evidence shows that iCBT is effective for reducing postnatal depression, anxiety, general distress and parental distress (Danaher et al., 2013; Pugh, Hadjistavropoulos, & Dirkse, in press). Tailored iCBT programs are needed to provide women in the perinatal period with practical coping skills to manage depression and anxiety symptoms, as well as deal with the unique difficulties they may face which can impact on depression and anxiety (e.g. complications during pregnancy and/or delivery, body image, difficulty breastfeeding, an unsettled baby, and unrealistic expectations about motherhood). The primary purpose of this trial is to evaluate the clinical efficacy of a newly developed internet-delivered cognitive behaviour therapy (iCBT) program, the Perinatal MUMentum Program. This iCBT program has been tailored to maternal anxiety and depression experienced during the perinatal period. The MUMentum Program consists of two 3-lesson courses: Pregnancy and Postpartum. The courses can be completed separately or in conjunction with each other and have been designed in consideration of several key issues experienced during the perinatal period when seeking and completing treatment, including a lack of time, fatigue, and stigma. The main hypotheses to be tested for Study 2 (Postpartum Course) are as follows: 1. Internet cognitive behavioural therapy delivered during the postpartum period will significantly reduce symptoms of anxiety, depression, distress and disability. 2. Internet cognitive behavioural therapy delivered during the postpartum period will be significantly more effective than the control group at reducing symptoms of anxiety, depression, distress and disability. It is hoped that the findings of this trial will provide further information regarding the efficacy and acceptability of the Perinatal MUMentum Program in reducing maternal anxiety and depression experienced during the perinatal period.