ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Promoting Independence in Lewy Body Dementia through Exercise

    LBD is an aggressive disease with a prevalence of up to 30.5% of all diagnosed dementia cases. Diagnosed individuals not only display symptoms of dementia such as memory loss, dysfunction in problem solving and decision making, but also display symptoms of Parkinsonism such as slow movement (bradykinesia), resting tremor, and freezing of gait while walking. In addition, Individuals with LBD also experience psychotic symptoms such as visual and auditory hallucinations and delusions, as well as autonomic symptoms such as incontinence, orthostatic hypotension (low blood pressure upon standing), and disrupted sleep patterns. The culmination of this cluster of symptoms is a significant reduction in functional independence and a subsequent increase in reliance on caregivers, increasing stress and burden in both individuals. Exercise research is scarce in this population, with very limited and low quality data available. In similar cohorts though, Like Parkinson's disease and other types of dementia, exercise of a variety of modalities has shown efficacy in improving physical function among other variables. Further to this, increasing incidental physical activity around the home has also been reported to improve function in individuals with Parkinson's disease. Logically, exercise could show similar benefits in Lewy Body dementia cohorts. The PRIDE trial will be a world first trial investigating the magnitude of the risk factors that contribute most to a loss in functional independence in individual with LBD, and then using that information in combination with evidence based best practice to design an 8-week exercise intervention to be trailed in community dwelling participants with LBD. PRIDE will include a cross-sectional baseline study of LBD, followed by a 16-week, fixed-period crossover controlled trial of targeted exercise. Participants will be tested at baseline in a cross-sectional analysis of the most important modifiable factors in LBD mediating functional independence. A subset of the recruited cohort who lives in the community will then be enrolled in an 8- wk usual care control period followed by an 8-wk experimental exercise intervention. Randomisation is not possible due to carry- over effects of exercise. All outcomes will be measured at three timepoint: at baseline just before wait-list control period, after 8 weeks of wait-list control, and after 8 weeks of exercise intervention (Week 16) by the same assessor to minimise issues related to inter-rater reliability.

  • Efficacy of fruit extracts in reducing risk factors of heart disease in obese men

    Aim: This study will investigate the potential of a natural dietary antioxidant extract capsule from blueberries and blackcurrants known as anthocyanin in improving haemostatic function and inflammation under oxidative stress conditions in obese men. It is hypothesized that by virtue of anthocyanin's antioxidant properties, it may help block pathways of blood clot formation, endothelial function and inflammation under conditions of oxidative stress in obese men. Research design: Twenty-three healthy, sedentary, obese (BMI>30) male volunteers will be recruited for this randomised, double blind, placebo controlled crossover design, dietary intervention trial. Participation will involve 5 visits to the Haematology research laboratory. During visit 1, each participant will sign an informed consent and complete screening forms (physical activity, health history, and antioxidant questionnaires). After completion of these forms a member of the research team will determine the height, weight, waist to hip ratio, body fat (using a 3 site skin fold assessment technique) and blood pressure of each participant using standard procedures. Participants will then be asked to complete an incremental exercise test on a cycle ergometer using standard procedures. During the incremental exercise test expired gas will be collected by a metabolic cart (ParvoMedics) using standard procedures. During visit 2, a 25 mL baseline blood sample will be collected from the participant's arm vein using standard venepuncture procedures by a trained phlebotomist, followed by body mass, resting heart rate, resting energy expenditure and blood pressure measurements. A constant load exercise test will then be performed at moderate intensity (70% of aerobic capacity) for 60 min. Each test will be preceded by 3 min of unloaded cycling and with an active cool down for 6 min. Another blood sample (25 mL) will be collected using standard procedures after the exercise test. A non-invasive echo-Doppler to assess the flow mediated dilation of the brachial artery will be performed to assess endothelial function before and after the exercise test. The participant will then consume either 320 mg/day of anthocyanin capsules or placebo capsules for 28 days. After 4 weeks of capsule supplementation, i.e. on the 29th day (visit 3), two blood samples will be collected before and after an exercise test (similar to visit 2). After a 2 week wash out period with no supplement intake, a supplementation cross-over will be performed, and exercise intervention and sample collection procedures repeated on day 43 and day 72.

  • Case Series Study: Treatment of Osteochondral Defects in the Hip Using Microfracture Augmented with CelGro (Trademark) Collagen Matrix

    Articular cartilage is aneural, avascular and has limited capacity for self-repair. Articular cartilage defects pre-dispose patients to developing osteoarthritis, and if left un-treated, damage can become so severe that joint replacement is indicated. Autologous Matrix-Induced Chondrogenesis (AMIC) is an enhanced version of the original microfracture technique, in which a type I/III collagen matrix (Chondro-Gide, Registered Trademark) is placed over the cartilage defect to stabilise the fragile bone marrow cell infiltrate and provide infrastructure for tissue repair and regeneration. Currently, the majority of commercially available collagen membranes are manufactured in Europe or the USA from locally-produced source material. Australian-sourced biological materials are valued due to the historically low rate of zoonotic infectious diseases and absence of transmissible spongiform encephalitis. CelGro (Trademark) is manufactured in Australia, using collagen originating from Australian Government veterinarian-certified animals bred and raised in Western Australia, eliminating disease transmission concerns associated with foreign products. This study will use CelGro (Trademark) as the collagen matrix in AMIC treatment for osteochondral defect in the hip.

  • Real Time Continuous Glucose Monitoring and Everyday Diabetes Care

    Despite rapid advances in the field of technology to monitor blood glucose continuously and prevent hypoglycaemia in type 1 diabetes (T1DM), the majority of patients, particularly young children, fail to achieve recommended HbA1C target of 7.5%. Real-time continuous glucose monitoring (RT CGM) offers the opportunity to improve diabetes control by providing a continuous glucose reading every 5 minutes. The most recent generation of RT CGM systems are more accurate in the hypoglycaemic range and have an added feature which allows transmission of the glucose values via bluetooth to a mobile device and share it with caregivers or health care providers. Little is known of the psychosocial impact of these technological advances on the patients and their caregivers. This study aims to evaluate the impact of RT CGM with the added feature of remote monitoring on psychosocial factors such as fear of hypoglycaemia and quality of life measures in young children with type 1 diabetes mellitus (T1DM) and their parents.

  • Efficacy of motivational, self-regulatory and automatic processes in a computer-tailored physical activity intervention for hospital staff.

    Background: People do not engage in sufficient physical activity (PA), and therefore, do not confer health benefits and reduce risk of chronic diseases. Increasing PA levels reduces this risk and is also linked to better quality of life and reduced stress. Healthcare professionals frequently provide guidance on physical activity; however often do not meet the recommendations themselves. There is a need for large-scale coordinated efforts to promote PA at the population level and, in particular, in healthcare professionals who often experience stressful work patterns. Recent developments in technology have been used to promote PA through tailored interventions. The main objective of this study is to develop and test the feasibility, acceptability and efficacy of tailored interventions in healthcare professionals to increase their PA and quality of life, and to reduce work-related stress and absenteeism. The study will also compare the unique and interactive effects of three forms of the tailored intervention on study outcomes based on different techniques from behavioural theory. Methods/Design: Frontline hospital staff (N = 168) will be recruited from four hospitals in Perth, Western Australia via employer’s mailing list, leaflets and posters. Participants will be randomised to one of the four conditions: motivation, self-regulation, habit, and control. Participants in all conditions will be provided with access to a web-based platform that provides a library of short lay-language articles on promoting PA. All intervention groups will receive a tailored intervention administered via the web-based platform with supporting text messages. Theory-based personalised information will be delivered to participants based on their responses to surveys assessing theory-based cognitions (e.g., motivation, self-efficacy). The content of the tailored messages will adopt specific techniques based on behavioural theory. The primary outcome will be PA measured using activity monitors. Secondary outcomes include: self-reported quality of life, stress, anxiety, sleep, and absenteeism from employee records. All outcomes will be assessed pre- and post-intervention (at 3 months). Website engagement, retention and preferences related to each component of the intervention, and potential mediators and moderators of the intervention will be assessed. Discussion: This is the first study to deliver a tailored, technology-supported intervention aiming to increase PA in frontline healthcare professionals. In addition, the inclusion of different techniques based on behavioural theory in different arms of the trial will assist in providing an evidence base assessing the effectiveness of motivational, self-regulatory and habit-forming strategies in promoting PA. The online platform developed in this study has a potential to deliver efficient, scalable and personally-relevant intervention that can be translated to other occupational settings.

  • Evaluation of the Let's Talk about Children recovery model for parents in Victorian mental health and family services: Phase 3

    This research examines the utility of Let's Talk About Children intervention for its application in Australian mental health services. The objectives of the project are to determine the effectiveness of the Let's Talk program, an innovative, evidence-based program which involves training clinicians in talking to mental health clients about their children. The research will investigate the impact of Let's Talk on parenting confidence and family functioning along with aspects of recovery (e.g. self worth, relationships, independent living) and quality of life, as compared to a control group receiving standard treatment.

  • Is opportunistic screening appropriate for identifying arrhythmias and establishing effective clinical pathways for Aboriginal Australians?

    Background: The leading cause of death for Aboriginal Australians is cardiovascular disease, including stroke and heart attack. Atrial Fibrillation is a precursor to stroke. There are no published studies about the prevalence of Atrial Fibrillation for Aboriginal people. The purpose of the study is twofold: to estimate prevalence of Atrial Fibrillation in Australian Aboriginal people and evaluate the effectiveness of opportunistic screening, and assessment and treatment pathways for Aboriginal people with Atrial Fibrillation or other arrhythmias. Methods: This is a mixed methods study which will screen 1500 Australian Aboriginal people living in New South Wales, Northern Territory or Western Australia to estimate prevalence of Atrial Fibrillation. This data will be analysed statistically to estimate prevalence. In addition, the study will conduct semi-structured interviews with Aboriginal workers who conduct the screens to evaluate qualitatively the effectiveness of opportunistic screening using an iECG to facilitate timely assessment and treatment for Aboriginal people over 45 years. Discussion: The study aims to determine the feasibility of the portable iECG device to diagnose abnormal heart rhythm in Aboriginal people and facilitate access to further assessment and treatment; estimate the prevalence of AF in Aboriginal people in Australia; improve health literacy in Aboriginal people and health workers; and help prevent the effects of untreated AF in Aboriginal people; including ischemic stroke and prevent early deaths or impairment.

  • An Open-Label, Randomised Study of Ortho-ATI (Trademark) Versus Surgery for Treatment of Severe, Chronic, Resistant Lateral Epicondylitis

    Lateral epicondylitis (LE) or "tennis elbow" is the most commonly diagnosed condition of the elbow and occurs mostly in patients whose activities require strong gripping or repetitive movements. 1 in 10 patients with LE who receive standard therapies like coricosteriod injections do not obtain relief from symptoms. In Australia, such patients with severe, chronic non responsive LE for over 6 months are referred for surgical treatment. OrthoATI (Trademark) is a class 3 biological autologous tenocyte implantation (ATI) product manufactured in Australia by Orthocell Ltd, that could potentially prevent or delay the need for surgery in LE patients who don't respond to standard therapies. OrthoATI (Trademark) is indicated for patients with symptoms of degenerative tendon injury who have failed conservative treatment methods. The current research project is a 1 year, single dose, single-centre, randomised, open label, parallel group, comparator controlled, non-inferiority study to assess the efficacy, safety and tolerability of OrthoATI (Trademark) in patients with severe, chronic, treatment resistant lateral epicondylitis compared to surgery.

  • Morning versus evening exercise: Its effect on body composition and weight loss

    Overweight individuals use exercise primarily as a means to reduce body weight. Given the continued rise in the prevalence of overweight and obesity (Hill et al., 2012; Ziauddeen et al., 2015), optimising the benefits of exercise for weight loss is crucial. In recognition of this, evidence-based recommendations for exercise prescription including frequency, intensity, mode, duration, pattern, and volume have been developed (Donnelly et al., 2009; Garber et al., 2011). Similarly, some countries have established guidelines for minimum physical activity levels required for weight maintenance and weight loss (Donnelly et al., 2009; insert OZ ref). However, there is no such recommendation for the optimal time-of-day at which exercise should be performed to maximise its impact on weight loss. Circadian rhythms regulate several physiological processes that influence appetite, sleep/wake cycles and exercise performance (Almoosawi et al., 2013; Drust et al., 2005; Froy, 2007; Thun et al., 2015; Winget et al., 1985; Youngstedt et al., 2002), therefore, it is possible that individuals will respond differently when exercise is performed in the morning, compared to the evening. However, the majority of available exercise-based weight loss research either does not control, or does not report, the time-of-day at which exercise has been prescribed. Therefore, the implications of exercise time-of-day for weight loss are unknown. The aim of this chapter is to present an overview of the available literature including observational and experimental studies in the area of exercise timing and its potential effects on body weight and composition. Additionally, some discussion surrounding the physiological responses to exercise and circadian rhythm of hormones will be presented to provide additional insight to understand the mechanisms behind the time-of-day effect on body weight and composition

  • Management of tooth decay in refugee children: a conservative approach

    Dental caries (tooth decay) in the early childhood, known as Early Childhood Caries (ECC) can be debilitating, significantly impacting on a child’s growth, nutrition, sleep, learning, appearance and quality of life. Children from refugee backgrounds face significant barriers in accessing timely care and therefore continue to experience significant disparities in oral health. The persisting barriers to seek and provide dental care inevitably leads to emergency hospitalisations and dental extractions. Topical fluoride varnish application, specifically 5% sodium fluoride varnish (NaF), has been recommended in the prevention and control of dental caries in children. This forms part of current best practice in caries prevention along with provision of oral hygiene and dietary advice. Silver diamine fluoride (SDF) is another topical fluoride modality that has shown to have greater efficacy than NaF and is non-invasive, easy to apply, and effective treatment modality to arrest dental caries in high-risk children. The aims of this project are to evaluate the: (i) effectiveness of SDF in arresting carious lesions in refugee children (ii) quality of life (QoL) changes in refugee children before and after SDF application Refugee children under the age of 12 years will undergo a dental examination through the RHS, as per current protocols. The option of fluoride treatment will be offered to the parents of children presenting with at least one carious lesion. Eligible children will then undergo simple sequential randomisation and SDF or NaF will be applied to the carious lesions at initial visit, 6 months and 12 months at RHS and final review will be conducted at OHCWA at 18 months. Follow-up QoL surveys, dental charting and intra-oral photographs will be taken to assess changes in the carious lesions. The expected outcome of this study is to develop the use of SDF as an adjunctive treatment modality for refugee children, thereby improving their quality of life and reducing the need for emergency dental treatment.

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