ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32850 results sorted by trial registration date.
  • Linking Brain Vascular Function with Neurobehavioral Function in Obstructive Sleep Apnoea

    Obstructive sleep apnoea (OSA) is a condition in which the upper airway collapses during sleep, leading to episodes of sleep fragmentation and hypoxemia. OSA has been linked to a decrease in neurocognitive function in some patients and potentially to the development of dementia, however the mechanisms remain unclear. This clinical study will investigate the link(s) between cerebrovascular response to hypoxemia, arterial stiffness, brain tissue hypoxia and neurocognitive function in OSA patients, before and after 8 weeks of CPAP treatment.

  • The feasibility of prescribing a walking program to improve physical functioning of people living in the community after hip fracture.

    Hip fracture is a common and serious fracture affecting older Australians, with high risk of ongoing disability. After hip fracture many people have very low levels of physical activity. There is evidence that increasing physical activity has many health benefits, but this is challenging for people after hip fracture due to pain, fatigue, psychological factors and co-morbidities. Preliminary studies from our team have investigated the amount of physical activity that people can tolerate after hip fracture without adverse effects. In the community, we determined that people after hip fracture could safely and feasibly complete 100 minutes of moderate intensity walking in a week. This proposed randomised controlled trial will determine whether prescribing this amount of physical activity (100 min/week) in addition to usual care is a feasible and effective intervention for improving health outcomes in this patient group. It is hypothesised that completing 100 min/week of prescribed walking is feasible for people recovering from hip fracture and effective in improving functional independence.

  • Dietary fibres and gut microbiome response in obese subjects

    Obesity and its associated metabolic diseases are closely linked with the gut microbiome which is significantly affected by the amount and type of dietary fibre consumed. Reviews have identified broad effects on the gut microbiome with consumption of dietary fibre, but recognise that differentiation between the effects of individual fibres is required. Although fibre is referred to as a single entity in nutrient reference values and other dietary guidance systems, fibres vary significantly in chemical composition and their physico-chemical properties in turn affect their physiological actions. This research will investigate these fibres individually in order to enhance understanding of their influence in the relationship between obesity and the gut microbiome. This pilot project will be of crossover design with randomised order of dietary intervention in up to 20 obese subjects with anthropometry indicating metabolic risk (BMI >30 kg m-2 and waist circumference indicating metabolic risk). Four separate dietary interventions will occur, each of 3 weeks (including a low fibre control, two moderate fibre cereals- sorghum and oats and a high fibre cereal- oats) and there will be a 3-week washout between test phases. We will measure effects of increased cereal fibre intake and of different cereal types, on the microbiome, body weight, percent body fat and serum levels of short chain fatty acids (SCFA) and lipopolysaccharides (LPS). SCFA levels will be modulated (higher levels of some SCFA modulated by the type of fibre) by changes in dietary fibre intake and previous research demonstrates that SCFA are part of the mechanism by which metabolic outcomes are improved. The LPS will act as a marker of toxicity which we would expect to decrease with improved diet. Using microbiome changes as the primary outcome will provide insight for ongoing studies to determine doses of fibre and types of fibre that may have positive benefits on health outcomes due to a mechanism involving the microbiome. We expect beneficial effect of increased dietary fibre intake and reduction of aversive effects associated with obesity. We propose that positive changes in the gut-microbiome can be detected after relatively short periods of time and that change is related to the type of fibre increased in the diet, not just the amount of dietary fibre. We hypothesise that this mechanism is associated with changes in SCFA and LPS (which has been linked with positive health outcomes).

  • The Professor Marie Bashir Centre sleep program: a work-shop and ward-based program for psychiatric in-patients to improve sleep quality

    Disturbances of sleep are prominent and have a fundamental impact on the course of psychiatric disorders . Depending on the severity of illness, sleep disturbance occurs in 30 to 80% of patients with schizophrenia, and is associated with worse psychiatric symptoms, cognitive deficits, poorer outcome, and impaired quality of life. The main aim of this study is to explore the use of Behavioural Therapy to improve sleep. Patients who volunteer in the trial will participate in a number of daytime activities that are aimed increase their exposure to light during daylight hours. There are also a series of ward measures, such as visual cues and relaxation areas designed to enhance sleep hygiene. The aim is to determine whether these measures will patients' body to adjust to a correct sleep cycle, providing better sleep quality, use fewer as-needed sleep medication, and having shorter hospital stays.

  • The Australian Joy of Moving intervention in primary school children.

    This project aims to evaluate the impact of the Australian Joy of Moving program using a range of psychological measures in mainstream primary school aged (4-14 years) children across Victoria. This study aims to: i) pilot the Australian JoM program in Victorian primary school settings ii) evaluate the effectiveness of the program on psychological wellbeing in primary school aged children pre and post intervention. It is hypothesised that, for teachers, the Australian Joy of Moving program will: 1. Be acceptable, feasible and sustainable in regards to delivery 2. Improve classroom behaviour It is also hypothesised that the following child benefits will be observed in children who participate in the Australian Joy of Moving program in comparison to a waitlist control group: 1. Fewer social-communication symptoms 2. Fewer internalising problems (emotional and peer symptoms) 3. Fewer externalising problems (conduct and hyperactivity symptoms) 4. Increased knowledge of the mind-body connection 5. Increased enjoyment of physical activity 6. Increased wellbeing

  • Understanding the impact of the Active Kids program on school-enrolled children in New South Wales

    This evaluation is being led by the University of Sydney, and is delivered in partnership with the NSW Office of Sport through their contractual partnership entitled SPRINTER. The purpose of the study is to investigate the effectiveness of the Active Kids Program in influencing physical activity behaviours, social wellbeing, self-efficacy and interaction with the sport sector, amongst children living in NSW.

  • The Efficacy of a Pragmatic Slow Eye Blinking Treatment for Insomnia

    Insomnia is one of the most common health complaints worldwide and the most prevalent sleep complaint. Insomnia is defined as lack of satisfaction with the quality or duration of sleep, due to persistent difficulty initiating and/or staying asleep and/or early morning waking, despite adequate time in bed. Current therapeutic treatments are suboptimal, with cost, availability, and adverse consequences arising around methodologically sound and practical to administer options. Research shows well established links exist between neurological mechanisms and the mediation of eyelid closure during periods of drowsiness. Therefore, further investigation into slow eye blinking, which is hypothesised to induce sleepiness, may promote sleep onset. Slow eye blinking may provide a treatment that is cost effective, safe and easy to administer for patients with difficulties initiating and staying asleep.

  • Effects of exercises for the low back muscles on disability in people with chronic low back pain

    Chronic low back pain (CLBP) is the leading cause of disability worldwide (Hoy et al., 2014). In 2015, approximately 540 million or 7.3% of the world’s population had activity limiting low back pain (Hartvigsen et al., 2018; Global Burden of Disease, 2016). In Australia, 3.7 million people (16% of the overall population) suffer from CLBP each year (AIHW, 2015). Exercise treatments are common Australian physiotherapy practice for people with CLBP; however, current evidence does not demonstrate that one type of exercise is superior to another (Hayden et al., 2005; Saragiotto et al., 2016; Wang et al., 2012). This is partly attributed to the fact that the mechanism(s) contributing to exercise-related improvements in CLBP are unknown. Therefore, this research is critically important for understanding the effects and underlying mechanisms of exercise interventions for people with CLBP. We are conducting a research study to compare the effects of neuromuscular and strengthening exercises to strengthening exercises alone on CLBP-related disability. To do this we will allocate people via a random process into two different groups. Participants in each group will complete a 12-week strengthening exercise program. Participants in the intervention group will, in addition to strengthening exercises, complete a neuromuscular exercise. Participants will not be disclosed as to which group they are in until the end of the program. There will be an equal number of participants in each group, and participants will not be able to choose which group they are in. The findings of this study will help to determine what effects strengthening and neuromuscular exercises have on CLBP-related disability, and mechanism of improvements. This will provide clinicians with an evidence base for the prescription of strength and neuromuscular exercises when treating CLBP-related disability. The findings of this study will be published in peer-reviewed medical and physiotherapy journals and be presented at national and international conferences.

  • Neonatal Encephalopathy Brain Outcomes (NEBO): Biomarkers in term born infants to improve accurate and earlier prediction of Cerebral Palsy

    Broad aim of this prospective Observational study is to learn which tests (clinical, MRI and EEG) can be used in the neonatal period, to accurately identify which babies may have problems later in life, so that those babies and their families can be provided with the help they need as early as possible. We aim to determine the risk of adverse neurodevelopment earlier and more accurately than currently possible in a cohort of up to 80 term babies born with HIE and a healthy term reference group between Royal Brisbane and Women's Hospital and Mater Mothers Hospital.. To do this we will use: i) advanced brain MRI to determine the structural wiring diagram of the brain ('brain connectome'), ii) dense array EEG to establish the functional activity or electrical 'traffic' being carried on the main branch of the connectome and iii) structured clinical neurodevelopmental assessments to provide a cutting edge view of the state of brain development. We aim to achieve this in a prospective longitudinal cohort study of up to 80 term infants born >35 weeks GA with HIE, and a reference group of 20 healthy term born infants. Infants greater than 35+ weeks GA will undergo either a clinical MRI at 1.5T or a research brain MRI at 3T at day 1-10 post-delivery (day 5-7 optimal) to develop our understanding of the brain structure and maturation at this time point. A combination of neurological and neuromotor assessments will be performed at less than 7 days post MRI to understand the relationship between brain structure and function. These data will be compared to clinical neurodevelopmental assessments at 3 and 24 months corrected age. HYPOTHESIS 1 In a prospective cohort of infants born at term at risk of CP, we will assess the following aims: Aim 1: Determine the sensitivity and specificity of (i) Structural MRI (sMRI) and Diffusion MRI (dMRI), and (ii) General Movements assessment (GMA) at 41 weeks and at 3 months for CP diagnosis at 24 months corrected age (CA). Hypothesis 1: (i) Absent myelination of the posterior limb of the internal capsule (PLIC) on T1-weighted MRI, and (ii) absent fidgety movements at 3 months will be sensitive and specific for CP at 24 months. SECONDARY HYPOTHESES Aim 2: Determine whether Diffusion MRI (dMRI) and EEG, Functional Connectivity (FC) are associated with severity of CP at age 24 months. Hypothesis 2: (i) Lower fractional anisotropy (FA) of the corticospinal tracts, and (ii) reduced connectivity in the neonatal Connectome will be associated with a higher Gross Motor Function Classification System (GMFCS) classification and poorer function on Neurosensory Motor Developmental Assessment (NSMDA) and Bayley III scales of cognitive and motor development. Aim 3: Determine whether structural MRI can predict the pattern of CP at age 24 months. Hypothesis 3: Location, extent and symmetry of brain injury will be associated with pattern and severity of CP.

  • 'Mapping the area of anaesthesia following an ultrasound guided arm nerve block in health volunteers'

    The primary purpose of this research study is to assess the area of sensory loss that results when a local anaesthetic drug (lignocaine) is injected around a small nerve in the arm called the posterior ante brachial cutaneous nerve. The local anaesthetic will be deposited around the nerve with the aid of ultrasound Ultrasound will help identify the nerve which is surrounded by fat as it become subcutaneous in the arm. This is a novel description of an ultrasound guided block of this nerve. Additionally the location of the nerve in the arm and its size will be measured. Mapping the area of sensory loss that is produced will be helpful to anaesthetists and pain physicians who manage patients with painful lesions of the forearm and elbow.

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