ANZCTR search results

This study aims to assess the effect co-administration of pre- and probiotics has on cardiovascular risk in patients with chronic kidney disease, and, whether this is a potential treatment strategy targeting the deleterious side effects of uraemic toxins.

Obesity is a global health problem that is reaching epidemic proportions. Since the 1970’s the rates of overweight and obesity in reproductive-age men has nearly tripled such that 70% of Australian adult men (>18 years) are now overweight or obese. Male obesity alters the physical and molecular structure of sperm which both reduces fertility and increases obesity risk of the next generation. There is emerging evidence from work in mice that that these effects might be reversible for example in response to an antioxidant rich high quality diet and diet and exercise but also that some interventions, for example weight loss with a nutritionally insufficient diet, may be deleterious. Bariatric surgery is increasingly used to treat obesity. The 2 most commonly used procedures: sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB), differ in regards to the magnitude of weight loss, resolution of co-morbidities and impacts on nutrient intake and absorption. For example RYGB is associated more immediate and more patients with resolution of type II diabetes and control of metabolic syndrome with a greater reduction in triglyceride levels, greater improvements to LDL levels and lower HOMA index compared with SG. Poor diet quality is a common outcome after SG as patients experience difficulties in eating certain foods which may contribute to these reduced outcomes. In terms of fertility, following RYGB, hormone profiles (testosterone, inhibin B, SHBG and estrogens) and erectile dysfunction improve in obese men. However less is known about the effects of SG. The effects of surgical weight loss procedures on sperm structure and function really remain unclear, and it cannot be assumed that these procedures necessarily result in beneficial or even similar effects on reproductive potential and outcomes. Therefore, we aim to determine the effect of these procedures (SG and RYGB) on the structure and function of sperm.

Bronchopulmonary dysplasia (BPD) is a chronic inflammatory lung disease characterised by disordered alveolar and vascular development, most commonly affecting extremely preterm infants exposed to mechanical ventilation and oxygen therapy for respiratory distress syndrome (RDS). BPD is associated with mortality, and adverse long-term pulmonary and neurodevelopmental outcomes. Despite advances in neonatal care including antenatal corticosteroids, exogenous surfactant, and the increasing use of ‘non-invasive’ ventilation, the incidence of BPD is not decreasing. BPD remains the most important pulmonary complication in extremely preterm infants occurring in about 50% of survivors to 36 weeks post menstrual age, with no new therapies shown to prevent it. Laboratory and clinical studies suggest a crucial role for lung inflammation (pre- and post-natal) and host immune response in the pathogenesis of BPD. A subcommittee of perinatal experts of the National Health, Lung, Blood Institute summarised the current state of knowledge regarding BPD and identified potential points in its pathogenesis susceptible to therapeutic interventions. One recommendation was to study the use of selective anti-inflammatory therapies, to attenuate the inflammatory response in the developing lung to potentially prevent BPD. As inflammation is a primary mediator of injury in the pathogenesis of BPD, anti-inflammatory agents such as postnatal corticosteroids have long been the focus of preventive interventions. Whilst systemic (intravenous or oral) corticosteroids reduce inflammation and improve respiratory function, their early use may be associated with many side effects. Given the serious adverse effects of systemic corticosteroid administration, safer alternatives are sought.Inhaled or nebulised corticosteroids are technically challenging to deliver with conflicting results from trials as the dose, optimal timing of initiating treatment and the duration are unknown. Local administration of corticosteroids to the lung via the intra-tracheal route has the potential to maximise anti-inflammatory effects on the distal airway, minimise systemic absorption and decrease the risk of adverse effects. Exogenous surfactant is a proven effective therapy for RDS in preterm infants. Combining budesonide with surfactant is a simple intervention that may prevent BPD in the high-risk population of extremely preterm infants. The aim of the PLUSS trial is to evaluate the safety and efficacy of early intratracheal corticosteroid (budesonide) combined with exogenous surfactant as the vehicle for distribution compared with exogenous surfactant alone to increase survival without BPD at 36 weeks’ PMA in extremely preterm infants born <28 weeks’ gestation. This is a multicentre, double-blind, two-arm, parallel 1:1 placebo-controlled randomised trial. Families, healthcare providers, outcome assessors and data analysts will be blinded to the randomisation group. Infants enrolled in the study will be randomised to receive intratracheal surfactant and budesonide or surfactant alone.

The aim of this research project is to test the preliminary feasibility, effectiveness and possible mechanisms of change of a CPT-C treatment program that is tailored to incorporate cultural differences in self-concept and trauma related appraisals for use among South East Asian trauma survivors. The primary aim of the research project is to (1) determine the efficacy of a group culturally-modified CPT (cm-CPT) protocol for the treatment of individuals from a South East Asian Background with moderate-high levels of PTSD symptomatology (2) assess feasibility, treatment adherence and client satisfaction of cm-CPT (3) examine moderators, mediators, and mechanisms of change.

Peripheral neuropathy is one of the most common complications associated with type 2 diabetes and its effects can have major impact on pain, daily activities and quality of life. The primary aim of the project is to non-invasively evaluate nerve function and detect any changes over a one-year period among a group of people who are at high risk of developing diabetes (women with previous gestational diabetes mellitus) or at high risk of developing early and severe nerve complications from diabetes mellitus (people with early-onset type 2 diabetes mellitus). Women with previous gestational diabetes are at least a 7-fold higher risk of developing type 2 diabetes; and people with early onset type 2 diabetes are more likely to develop severe complications of diabetes (e.g. cardiovascular disease) some 15-30 years earlier than those with typical late onset type 2 diabetes. The sensitive nerve tests we propose to use will likely detect any changes in nerve function before they are apparent clinically. Early identification of nerve dysfunction will allow clinicians to proactively initiate early intervention and management in an effort to slow progression of nerve complications. Our proposed study has both quantitative and qualitative aspects. The quantitative aspect of the study will entail a prospective longitudinal evaluation of nerve conduction using established nerve excitability tests . This will comprise motor and sensory nerve excitability tests of the median nerve in the hand and a nerve conduction tests of the peroneal and sural nerves in the lower limb. The participants will be followed up at 6 months and 12 months and all tests will be repeated. We will also obtain information about participants' level of physical activity (using a questionnaire and a lightweight accelerometer), obtain HbA1c and fasting glucose. The qualitative part of the study will involve a 45-minute semi-structured interview, which will focus on the following topics: beliefs and understanding of nerve function in diabetes and what influences nerve complications; knowledge about signs and symptoms of nerve impairment; and knowledge of current exercise recommendations for health.

Current practice guidelines universally recommend ‘reassurance’ as an important component of low back pain (LBP) management. However, despite the recognition that clinicians are able to effectively reassure LBP patients (and with lasting effect), how best to reassure – and its impact on pragmatic outcomes – is poorly understood. Approximately 2000 adults with spinal pain are referred by medical practitioners (annually) for surgical opinion in the spinal outpatient clinics at the Royal Adelaide Hospital (RAH). Surgery, however, is likely to benefit less than 10% of these patients. It has been suggested that the communication of imaging reports may increase fear of re-injury and reduce the likelihood of a good outcome. Indeed, the highly prevalent ‘abnormalities’ detailed in radiology reports are rarely reassuring. Recent evidence suggests that many ‘degenerative’ changes found on spinal imaging are not abnormal and highly likely to be found in asymptomatic individuals. It is also understood that spinal imaging findings are not well associated with pain or prognosis. Our intervention involves a new and standardised method of communicating radiological findings in a manner designed to reassure patients, and promote engagement in an active recovery. This study is a feasibility trial which will be conducted in the spinal outpatient setting at the RAH. It is the crucial first step towards definitive testing of GLITtER (Green Light Imaging Intervention to Enhance Recovery). Aim The aim of this study is to inform feasibility of definitive testing of the GLITtER intervention in a quasi-randomised controlled trial. This trial would ultimately address the question of whether the proposed intervention – integrated into routine practice in a spinal outpatient clinic setting - is a cost-effective strategy for reducing chronic LBP and disability.

The aim of this study is to examine the effectiveness of EMDR when used to treat Indigenous Australian peoples (aged 18+) suffering from trauma related symptoms consistent with PTSD. The efficacy of EMDR for PTSD has been established, therefore this study will examine its cultural acceptability and clinical effectiveness in a remote, Aboriginal Australian community sample. The aim is to treat 20 individuals suffering from PTSD symptoms using a maximum of 10 EMDR sessions provided on alternate days. A second aim is to develop the cultural acceptability of EMDR with Indigenous Australian clients. Findings of effectiveness will be discussed with reference to the utility and cultural appropriateness of EMDR. Implications for clinical practice with Indigenous Australian clients and directions for future research will also be discussed.

The purpose of Queensland Health's Targeted Risk Modification Kids (TRIM Kids) program was to contribute to the reduction of the prevalence of overweight and obesity in Queensland children in two ways. Firstly, it sought to increase the capacity of the families who participate in it to adopt healthy lifestyles related to healthy eating and physical activity in the future. Secondly, it intended to promote healthy weight and weight management through sustainable behaviour change. The intervention delivered by the program was the PEACH program, a six-month parent-focussed positive parenting and healthy lifestyle group program that has demonstrated effectiveness in reducing the degree of overweight in primary school aged children and maintaining this reduction for more than two years after the program ended. The PEACH program is based on the recognised cornerstones of child weight management, namely diet and activity changes through behaviour modification with parental involvement and support. The delivery through parent-only groups (ie parents as the exclusive agents of change) is based on the work of Golan and colleagues who demonstrated better outcomes when parents alone were targeted and children not included in intervention sessions.

Recent evaluation of the FRAT at Peninsula Health identified that use of prompted clinical judgement had higher sensitivity for when to provide falls interventions than the stratification of risk and allocation of score. This led to the development of a new FRAT with just interventions prompts. This stepped wedge cluster randomised control trial seeks to analyse this new method of falls intervention. The design aims to roll out the introduction of the new forms to each cluster over a 9 month period. All inpatient sites and wards of Peninsula Health will be involved in this roll out excluding Women’s Health, Emergency and Paediatrics, due to different documentation requirements. The primary outcome of interest will be falls rates, secondary outcomes will also include rates of change in completions in FRATs, difference in time taken to complete new and old documentation with a potential economic evaluation of the cost of interventions. This research will provide important information about the way in which we both implement falls interventions but also seek to prevent these within the inpatient setting.

Sports Stars is a group physiotherapy program for school-aged children with Cerebral Palsy. It aims to introduce children to a range of sports specific drills, training activities and modified game scenarios to improve fundamental movement skills and provide an avenue to go on to participate in mainstream junior entry level sports programs. This study aims to investigate the feasibility, effectiveness and efficiency of group-based, sports-oriented, movement therapy for school-aged, ambulant children with CP with outcomes anticipated and measured in body structure and function, activity and participation dimensions of the ICF.