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.
  • Can N-acetylcysteine (NAC) supplementation enhance exposure to altitude in well-trained cyclists?

    Athletes regularly incorporate living and training at altitude into their programs to enhance physiological and performance adaptations. It can be logistically difficult and expensive for Australian athletes to gain the benefits of altitude training. Current options available in Australia are limited to relatively low levels of natural altitude or the use of artificial hypoxic environments. Preliminary data suggests that supplementation with the antioxidant n­acetylcysteine (NAC) may boost the erythropoeitic response (i.e. increase red blood cell production) to hypoxia and support the immune system during strenuous training blocks. However, to date, the efficacy of NAC to enhance these physiologic systems has not been determined in an applied sports setting. This investigation forms part of a series of studies will be the first to comprehensively examine the acute effects of NAC supplementation to augment the physiological adaptations to hypoxic exposure in elite athletes. It will also contribute to the existing knowledge regarding the ergogenic effect of NAC on repeat sprint cycle performance in well trained cyclists and add further real-­world data to the debate regarding the potential blunting of cellular adaptations with antioxidant supplementation. Importantly, it will also provide valuable information to physiologists, coaches and athletes regarding the prescription and periodisation of NAC supplementation and the optimal integration of hypoxic interventions to produce peak performance during targeted competitions.

  • The Efficacy of Ajapa Japa Meditation on Symptoms of Anxiety Disorder

    This research proposal makes four hypotheses: 1. The practice of Ajapa Japa meditation will reduce the levels of anxiety symptoms experienced by participants; 2. The practice of Ajapa Japa meditation will improve the quality of sleep experienced by participants; 3. The practice of Ajapa Japa meditation will improve the participants’ quality of life; & 4. The practice of Ajapa Japa will increase the participants’ trait mindfulness.

  • A 3-week diet intervention to improve mood and inflammation in young adults with depressive symptoms

    There has been a rapid global shift in dietary composition, from diets high in complex carbohydrate and fibre, to the Western diet, high in saturated fat, sugar and processed foods. This was highlighted recently by Australia’s largest ever diet survey, the CSIRO Healthy Diet Score, 2016, which showed of 86,611 respondents, only 20% were compliant with Australian Diet Guidelines (Hendrie et al, 2016). Consumption of Western diet has been accompanied by considerable adverse health consequences, with the effects on the brain now increasingly recognised. Unhealthy diet patterns are associated with increased risk of depression e.g. a meta-analysis of 20 observational studies showed healthy diet was associated with reduced odds of depression (Lai et al, 2014). But these studies were carried out in community populations so reverse causality cannot be ruled out. Experimental manipulation of diet is the next step in determining a cause-effect relationship. Given diet is one of the few modifiable risk factors for depression, this would offer a low-cost, low-risk, evidence based therapeutic and preventative strategy. However, treatment studies investigating diet as an effective adjunct treatment for depression are scarce. This study aims to investigate whether a 3-week diet intervention can improve depressed mood in young adults. Eighty four participants will be allocated to receive a diet intervention or maintain their diet as usual. Participants in the diet intervention group will be instructed to increase intake of fish, fruits, vegetables, nuts, seeds, natural diary and wholegrain cereals, and decrease refined carbohydrate, sugar, fatty or processed meats and soft-drinks. Recommendations are based on the Australian Guide to Healthy Eating , personalised feedback from CSIRO diet score, incorporate BeyondBlue behavioural tips for eating well, and administered by a registered dietician face-to-face and on video to re-watch as needed. They will be provided a sample meal plan and recipes. Those in the diet as usual group will be instructed to continue their diet as usual. Participants will attend the laboratory at baseline and after 3 weeks to complete measures of mood, memory, food questionnaires, body measurements, photospectrometry, and a urine sample. If shown to be effective, this type of intervention could provide an adjunct treatment strategy for improving depressed mood in an at risk population - young adults.

  • Evaluating the effectiveness of practicing yoga during haemodialysis for fatigue in patients with end stage kidney disease.

    This study will be a two-group parallel design randomised controlled trial (RCT). The primary aim of this study is to evaluate the effectiveness of practicing yoga during haemodialysis (HD) (i.e. intradialytic yoga) for improving fatigue, physiological and psychological health outcomes in patients with end stage kidney disease (ESKD) receiving treatment in hospital or satellite dialysis facility settings. We hypothesise that patients with ESKD who practice intradialytic yoga for 3 sessions per week over a 12-week period will experience a 23% reduction in symptoms of fatigue by the end of the RCT period compared with usual care alone. We also hypothesise that intradialytic yoga will be associated with: reduced symptoms of post dialysis fatigue; improved quality of life; improved patient engagement in dialysis therapy plans including self care, self-management and adherence; and changes in biochemistry. Data will also be collected on participants’ beliefs about the treatment intervention, the recruitment rate, drop out rate, adherence to the intervention and safety. Participants will be recruited from 2 dialysis facilities in Brisbane Queensland via posters, flyers and site visits by the Chief Investigator. Participation will involve attending an initial intake session during routine dialysis treatment time, followed by being randomly allocated to: 1) intradialytic yoga; or 2) usual care alone. Participants will be asked to provide consent to access confidential data recorded in medical records including medical and renal health history such as blood test results, body weight measurements and routine HD observations such as blood pressure. Participants will also be asked to complete a number of questionnaires and a post dialysis fatigue diary. These will be given at: 1) the start of the study; 2) half way (at 6 weeks); and 3) at the end of the study (week 12). Data collected from medical records and questionnaires will enable the research team to evaluate the effectiveness of the intervention for the needs of ESKD patients. Following the intervention period, participants in the intradialytic yoga group will be invited to participate in an interview to enquire about their experiences of yoga during the study.

  • A Probiotic and Magnesium orotate combination for the treatment of depression.

    The primary purpose is to develop our published pilot work. This study will evaluate the efficacy of a combined supplement combining orotate and probiotics using a placebo controlled randomsied treatment trial for the treatment of depression. The study hypotheses relate to: 1. participants taking the active supplement will have significantly reduced symptom scores compared with the placebo group. (psychiatric assessments). 2. participants taking the active supplement will have reduced dysbiosis and blood inflammatory markers compared with the placebo group. Changes in dysbiosis will be assessed by fecal testing and changes in systemic inflammatory markers will be assessed by by blood tests.

  • Active intervention to treat persistent post-concussion symptoms in children and adolescents

    By age 10, 1 in 5 children (~51,000 Australian children) will sustain a concussion and present with post-concussive symptoms (PCS) requiring medical treatment. Many children and youth recover rapidly from these symptoms and are symptom free and returned to pre-injury activities within 4 weeks. In contrast, ~40% of children suffer ‘persisting PCS’ (PPCS), defined as 2 or more PCS lasting more than 4 weeks. This group of children have limited tolerance for routine academic, sport/leisure and social activities and are unable to return safely to these activities. Despite their debilitating impact, intervention trials addressing PPCS in children are lacking. We propose a randomised trial of a novel multimodal intervention to reduce the burden of debilitating PPCS for the ~40% of children who experience delayed recovery after concussion. Participants with PPCS at 2-3 weeks post-injury will be recruited and randomised to either active (CE) or usual care (UC) interventions, which will be delivered over up to 8 sessions between 4 – 12 weeks post-injury. The primary aim of the CE is to reduce the number and severity of PPCS. We propose the following hypotheses: Hypothesis 1: Compared to the UC, children in the CE will have a clinically significant reduction in number and severity of PPCS by treatment completion Hypothesis 2: Compared to the UC, children in the CE intervention will have a significantly higher proportion of children who, at treatment completion, have: 2.1 Demonstrated reduction in PPCS across all clusters: generic, physical, psychological 2.2 Returned to normal activity (school, sports, leisure activities) 2.3 Improved physical and psychosocial quality of life 2.4 Lower rate of utilisation of health services

  • A Mother’s heart beats for two: to explore the current provision of evidence based practice, outcomes and ‘lived experience’ for women with cardiovascular disease during pregnancy.

    Title: A Mother’s heart beats for two: to explore the current provision of evidence based practice, outcomes and ‘lived experience’ for women with cardiovascular disease during pregnancy. Background: Although cardiac disease complicates approximately 1% to 3% of pregnancies it is responsible for 10% to 15% of maternal mortality. This rate is expected to increase in the current environment of elderly primigravida and increased obesity and diabetes in pregnancy. This study will evaluate the current care and outcomes for women with pre-existent or newly acquired cardiac disease during pregnancy. Methods: The proposed research will include phase 1 :-an analysis of the documented care and outcomes from a retrospective medical record review (MRR) for women with congenital and / or newly acquired heart disease during pregnancy and postnatal follow-up. Aims: 1. Describe the current the clinical course, appropriateness of care, referral and outcomes for these women and babies in relation to evidence based clinical practice guidelines 2. Identify gaps in the clinical management across the course of pregnancy, delivery and on-going care. 3. Elucidate and describe the experience of women with cardiac disease during pregnancy, delivery and on-going care. a. Articulate the difficulties encountered by women with cardiac disease in pregnancy. b. Identify elements that will facilitate improved clinical course and positive outcomes for women with cardiac disease in pregnancy Conclusion: The outcomes of this project will provide baseline data for further research, recommendations for practice change and strategies to improvement the uptake of evidence based guidelines.

  • Text message program to improve the health of people with type 2 diabetes.

    The aim of this study is to determine the effectiveness of a text message intervention on lifestyle risk factor modification and diabetes self-management for people with type 2 diabetes. A pragmatic randomised controlled trial will be conducted in New South Wales. The intervention group will receive mobile phone text messages for 6 months; the messages will provide information, motivation and support on physical activity, nutrition, weight, smoking cessation and diabetes self-management. The control group will receive usual care. The primary outcome measure will be HbA1c; secondary measures will include physical activity, nutrition, body mass index, blood lipids, and medication adherence. A sample of 340 will be needed in the trial. People will be recruited through various sources such as the Illawarra Shoalhaven Local Health District (Ambulatory and Primary Health Care, hospitals & the Diabetes Service), general practices, local newspapers, pharmacists, podiatrists, and Diabetes NSW. People will be eligible to participate if they: have type 2 diabetes (HbA1c 7.0% or above); have a mobile phone; are 18 years or older; able to read and speak English; and have medical clearance from their doctor. Exclusion criterion will be pregnancy.

  • Exploring the potential of Hybrid Electrical Stimulation Cycling for aerobic exercise in Persons with Advanced Multiple Sclerosis

    Aims: The objective of this project is to advance knowledge on the aerobic exercise options that are available for persons with advanced MS. Currently persons with advanced MS have severely reduced exercise options and little is known about the benefits of those exercises. Much of the information available is anecdotal and persons with MS and practitioners are in need of clearer guidelines and information. The specific aim of this research project is to explore the potential of electrical stimulation exercise to expand the aerobic exercise options available for persons with advanced MS. In this project we will investigate the relative benefits and drawbacks of arm cranking, FES cycling, and hybrid FES exercise in persons with advanced MS. We will measure the cardiorespiratory and cardiovascular responses, the fatigue levels induced, and the effort required. Intervention: Ten persons with advanced multiple sclerosis will participate in three exercise trials using different modes of aerobic exercise. The trials will be performed at the Faculty of Health Sciences, University of Sydney. Prior to the exercise trials participants will complete 1-6 practice sessions to become familiarized with FES cycling and a maximum arm crank test. The three trials are an arm cranking trial, an FES cycling trial and a Hybrid FES cycling trial (which involves simultaneous voluntary arms and FES leg cycling exercise). Each trial will be separated by between 2 days to a week. During each trial routine non-invasive measures of cardiorespiratory metabolism will be performed. Oxygen consumption and other cardiorespiratory metabolism will be measured by a metabolic cart. Heart rate will be monitored with a standard chest strap heart rate monitor. At the end of each exercise trial participants will be asked how hard the exercise felt and how fatigued they feel on a visual analogue scale. Hypothesis: It is predicted that hybrid FES exercise will result in the greatest aerobic exercise response of the three exercise modes. Therefore, the primary hypothesis tested during this project is that: “Hybrid FES exercise elicits greater oxygen consumption than either arm cranking exercise or FES cycling exercise.” We will also examine if there is a difference in the heart rate, tolerance, perceived exertion, and the fatigue response between the three different exercise modes.

  • A randomised trial comparing two new types of nerve repair (Neurawrap and Neuragen) to the conventional type of nerve repair among patients with finger nerve injury.

    Peripheral nerve repair still remains a challenging problem for surgeons. Despite improvements in microsurgical techniques, the sensory recovery remains suboptimal. With the advancement in molecular biology and tissue engineering techniques there has been further development in the realm of nerve repair using various synthetic and biological materials to develop nerve wraps and conduits. It is now vital to be able to compare these newer repair techniques with conventional methods to determine whether they provide an improvement in outcome in the form of sensory recovery. The aim of this study is to compare outcomes between 3 types of digital nerve repair techniques following digital nerve laceration where primary neurorrhaphy is possible. These 3 arms are direct end to end repair of severed nerve ends, direct end to end repair with protection of site using a collagen nerve wrap and short gap neurorrhaphy using a collagen conduit.

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