ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Intrinsic foot muscle morphology and function in tennis players

    The International Tennis Federation’s 2021 Global Tennis Report tells us that a staggering 87 million people play tennis, with competitors from 142 countries competing in the 2020-2021 period (International Tennis Federation Academy, 2021). However, as the number of tennis players increases, so does the number of reported foot and ankle injuries (Kemler et al., 2022). The impact of these injuries has become of particular interest, as they are reported to be the most common severe injury in tennis players (Robison et al., 2021). Further, there is an increasing body of literature surrounding the significance of the intrinsic foot muscles (IFMs) in these injuries. Thus, a critical issue for exploration is the impact of these foot and ankle injuries on the IFMs of tennis players. By understanding this, a more detailed and accurate management plan for performance optimisation, injury prevention and therapy in both recreational and advanced tennis players can be developed (Di Giacomo et al., 2018). Therefore, the purpose of this study is to determine if there is an association between foot muscle morphology and functional performance of selected IFMs in tennis players who have, and have not, experienced previous foot or ankle injuries. Research Questions: The specific research questions this study aims to answer are as follows: 1. What is the relationship between foot and ankle injuries and the size of the IFMs in tennis players using ultrasound measurements? 2. What is the relationship between foot and ankle injuries and the functional performance of the selected IFMs in tennis players using measurements obtained on a novel biofeedback device? 3. What is the difference between the structural and functional performance of the IFMs in tennis players with and without foot and ankle injuries at an advanced and recreational level? Di Giacomo, G., Ellenbecker, T. S., & Kibler, W. B. (2018). Tennis Medicine A Complete Guide to Evaluation, Treatment, and Rehabilitation (1st 2018. ed.). Springer International Publishing. https://doi.org/10.1007/978-3-319-71498-1 ITF Academy. (2021). 2021 ITF Global Tennis Report https://www.itf- academy.com/?view=itfview&academy=103&itemid=1473 Kemler, E., Valkenberg, H., & Verhagen, E. (2022). More People More Active, But There is a Counter Site. Novice Athletes are at Highest Risk of Injury in a Large Population-based Retrospective Cross-sectional Study. BMJ Open Sport & Exercise Medicine, 8(1). https://doi.org/https://doi.org/10.1136/bmjsem-2021-001255 Robison, H. J., Boltz, A. J., Morris, S. N., Collins, C. L., & Chandran, A. (2021). Epidemiology of Injuries in National Collegiate Athletic Association Women's Tennis: 2014–2015 Through 2018–2019. Journal of Athletic Training, 56(7), 766-772. https://doi.org/10.4085/1062-6050-529-20

  • Determining the utility of uraemic toxins in peritoneal dialysis to optimise patient care

    Peritoneal dialysis (PD) removes toxins that rise during kidney failure. Historically, we looked at removal of small water-soluble molecules as a surrogate marker of dialysis effectiveness. However, given its poor relationship with patient outcomes, recent guidelines have moved away from these targets and is now focusing on patient reported outcomes. Moreover, protein-bound uraemic toxins (PBUT), which are poorly removed in dialysis, may have more of a role in patient outcomes. Additionally, studies in haemodialysis and chronic kidney disease have shown that high-fibre diet may help reduce the generation of these PBUTs but studies are lacking in the PD population. We will determine effects of PBUT removal on patient outcomes (quality of life measure using EQ-5D-5L, symptoms and mood score using IPOS-renal and an assessment of physical function including hand-grip strength and timed chair-to-stand test) and preservation of residual kidney function. We will also look at the effects of increased fibre intake on PBUT levels and above-mentioned patient outcomes in a group of PD patients. We hypothesise that a high fibre diet will reduce PBUT generation in the PD population. We hypothesise that this reduction in PBUT levels will correlate with better patient outcomes and preservation of residual kidney function.

  • Examining the efficacy of different iron supplements in women

    Iron deficiency is one of the most common health conditions globally, and disproportionally affects women, comparative to men (Pasricha et al., 2021). Specifically, the menstrual cycle can negatively affect iron regulation, with low-estrogen periods of been prohibitive for iron absorption and menstrual blood loss resulting in a direct, and often substantial loss of body iron (McKay et al., 2022). Additionally, high exercise volumes can also be detrimental to iron status, with direct iron losses (via GI bleeding, haemolysis and sweat) and exercise-induced decreases in iron absorption been contributors to the high prevalence of iron deficiency in athletic populations (Peeling et al., 2008). Accordingly, female athletes need to combat both the sex- and exercise-associated challenges to iron regulation, making them a ‘high risk’ cohort for iron deficiency. One approach for correcting an iron deficiency is to use oral iron supplementation. A conventional supplementation regime consists of daily ferrous sulphate dose (~100 mg of elemental iron), usually found in combination with a source of vitamin C which typically increases an athlete’s iron stores by 30-50% over a 6–8-week period (Dawson et al., 2006; Hinton et al., 2000). However, it is not uncommon for individuals to report high levels of gastrointestinal distress from this treatment, especially athletes. Other formulations have been identified which claim to reduce the side effects associated with iron ingestion. One such formulation, is an iron(III)-hydroxide polymaltose complex (Maltofer), which has shown good efficacy and reduced side effects in pregnant women (Ortiz et al., 2011), however it’s use in athlete cohorts has not yet been determined. Accordingly, this study will assess to efficiency of different iron formulations in different cohorts of women with varying exercise loads and menstrual statuses. It is hypothesised that both supplements will be equally effective at increasing iron stores, however Maltofer consumption will be associated with lower GI complaints. Furthermore, we hypothesise that iron stores will be repleted faster in generally active, compared to athlete cohorts, and that menopausal women will have the greatest increase in their iron stores after 12 weeks. Collectively, this work may highlight the need to develop athlete-specific strategies for the treatment iron deficiency. The aims of this project are: 1. To assess the efficacy of two different iron formulations (Ferrograd C and Maltofer) on the treatment of low iron stores in women. 2. To compare the efficacy of oral iron supplementation in different cohorts of women. 3. To assess the relationship between iron status, supplement efficacy and the TMPRSS6 rs855791 (2321 C>T) polymorphism in women.

  • The effects of two doses of alcohol on eye movement behaviour during driving

    This project investigates how low and moderate doses of alcohol affects eye movement patterns during simulated driving. It will also examine how these doses of alcohol affects cognition, visual information processing, and subjective intoxication

  • Optimising Respiratory Support in Rural and Remote Settings for Children

    Respiratory illnesses are the most frequent reason for non-elective hospital admissions in children aged less than 5 years, with a high global health burden. Whilst mortality due to acute respiratory failure (ARF) has improved in high-income countries, mortality remains between 13-20% in less well-resourced settings. In Far North Queensland (Qld), 50% of mostly indigenous children with ARF require transfer to a tertiary hospital due to higher care needs, whereas in South-East Qld only 9-12% of these children require transfer. To address this inequality, we aim to introduce an evaluation of a measured model of care using a comprehensive respiratory care bundle for children with ARF in rural and remote hospitals in Qld. This includes the implementation of nasal high-flow therapy, which is a standard therapy used in regional and urban hospitals in Australia, but yet to be offered in a large number of rural and remote settings. We hypothesis that with the implementation of the respiratory care bundle we can reduce the number of children requiring interhospital transfers.

  • A Randomised Controlled Trial of Cannabidiol (CBD) for the treatment of Cannabis Use Disorder (CUD)

    The study is a parallel group double-blind Phase 3 randomised control trial comparing a 12-week treatment period of oral Cannabidiol (CBD) (400mg daily, Experimental) to Placebo (Control). The research hypothesis is that CBD, compared to placebo, will achieve significant reductions in cannabis use, as measured by number of self-reported cannabis-free days and urinary THC-COOH levels, among treatment-seeking patients with moderate-severe CUD. Participants will be treatment-seeking clients recruited from study sites under conditions of informed consent. Participants will be randomly allocated to either CBD or placebo (1:1 ratio, double blind conditions), and attend every 3 weeks (weeks 1-12) for (a) clinical review with study doctor, (b) dispensing of medication, (c) collection of urine drug screen and (d) a research interview with an independent researcher. Participants will have up to 4 sessions of Cognitive Behavioural Therapy-based counselling over the 12 weeks. Final research interview will occur at week 24, 12 weeks after the study intervention. Additional qualitative research interviews will be conducted with Aboriginal participants in a sub-study examining their perspectives of treatment. Sample size is 250 participants, with approximately 125 randomised to each condition. It is estimated that approximately 20% of participants (n=50) will be Aboriginal. The study will use an intention to treat between-group analysis.

  • Evaluation of educational workshops for health professionals in behaviour change

    Interventions used to change behaviour typically rely on providing solely education, however this is usually insufficient for behaviour change. Training of health professionals in effective strategies such as behaviour change techniques can provide positive benefits in both the confidence of health professionals to deliver effective interventions as well as improve primary care. To date, dietitians have received limited training in this area and have expressed a need for professional development on behaviour change. To address this gap, dietitians will be able to participate in two 2-hour workshops in behaviour change. The pre-post trial will allow us to see changes over time over three time points. Outcomes of the study will guide the development of future continuous professional development for health professionals in health-behaviour change to improve client outcomes.

  • Functional outcomes in patients undergoing Primary and Revision Hip Arthroplasty

    Osteoarthritis is the most common joint disorder in the world and occurs most often in hips and knees, with symptoms including pain, stiffness and limited movement of the affected joint. Diagnosis of OA is the principal indication for total hip arthroplasty which is the treatment for individuals with end stage hip osteoarthritis when conservative therapies to manage symptoms have been exhausted . The aim of this study is to investigate how restoration of the native hip anatomy in total hip arthroplasty (THA) affects biomechanical and functional outcomes. Biomechanics (in this context) refers to gait assessment (joint angles and ground reaction forces) and its integration with musculoskeletal modelling techniques to determine joint contact forces.

  • A pilot study of pulmonary artery catheters in low-risk heart surgery.

    Background • Over 2 million people undergo heart surgery every year. • An invasive monitoring device called a ‘pulmonary artery catheter’ can measure how well the heart pumps, and is commonly used in heart surgery patients • Small studies suggest that pulmonary artery catheters may not benefit these patients, and may even lead to harm such as major bleeding and infection • Some experts conclude that pulmonary artery catheters overcomplicate things and lead to unnecessary and risky treatment • There has never been a high quality ‘randomised controlled trial’, so there is still uncertainty amongst doctors Aims • Our ultimate aim is to provide reliable evidence on whether heart surgery patients benefit from pulmonary artery catheters • First, we must test whether a large-scale trial is feasible by starting with a small ‘pilot study’ Methods • 150 patients undergoing low risk heart surgery will be eligible to participate • After providing informed consent and prior to surgery, participants will be allocated at random to receive either a pulmonary artery catheter or a less invasive alternative in a 1-to-1 ratio • We will record how smoothly the pilot study runs by collecting information on the number of patients we recruit, the number of times a person is switched from one strategy to another by their doctor, and how completely we can collect data and follow up patients • We will also assess whether pulmonary artery catheters influence a range of clinical outcomes in the intensive care unit, general ward, and at home after patients are discharged. Impact • If the PUMA Pilot is successful, the research team will conduct a large-scale randomised clinical trial that could change global practice

  • The ASPIRE Trial - understanding the impact of mucositis on cachexia in head and neck cancer

    The main purpose of this study is to better understand how changes in treatment impact muscle wasting (also known as cachexia) in people with head and neck cancer (HNC). In particular, we are interested in understanding the blood marker GDF-15 and swelling/ulceration of the mouth or gut (known as mucositis), and the relationship with cachexia. This study is focused on people diagnosed with head and neck cancer, scheduled to undergo radiotherapy +/- chemotherapy. The study will involve the collection of blood and saliva throughout 7 weeks of radiotherapy, with some additional questionnaires completed by the participant. All assessments will be performed at routine clinic visits to decrease the burden of participating. By understanding the interaction between mucositis and cachexia, we hope to be able to identify people at risk of cachexia and direct them to appropriate care pathways early.

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