ANZCTR search results

Vitamin supplement use is prevalent in Australia. B-vitamin supplements have been shown to reduce symptoms associated with stress and anxiety, and new 'activated' B vitamins are claimed to achieve this clinical outcome with greater efficiency. However, despite the increased costs, there are no clinical data to support this health claim. Tertiary students are at high risk of increased stress. This randomised control trial will compare the effectiveness of activated B-complex vitamins against standard-B-complex vitamins on stress, fatigue and anxiety outcomes in tertiary students. Participants will be recruited from the Sydney campus of Endeavour College of Natural Health and randomly assigned to one of two groups; 1.Activated-B or 2.Standard-B. The study duration will be four weeks, including a pre-treatment week and baseline data collection and treatment for three weeks. The primary outcome measure will be the validated instrument DASS 21; secondary outcomes will include the Fatigue Severity Scale and feasbility markers; recruitment, retention and adherence of participants.

Conventional PTB transtibial prosthetic sockets are widely-used throughout the developing world, however, the manufacture of PTB sockets is still highly dependent on the skill and experience of the attending prosthetist. A PCAST technique for the manufacture of transtibial sockets has been shown to be a potential alternative to PTB sockets, with similar initial patient outcomes recorded for the two sockets. The PTB socket is formed by deliberately creating regions of loading corresponding with the perceived pressure tolerant and intolerant areas of the residual limb. Although, pressure cast sockets aim to load the residual limb more uniformly, eliminating regions of high pressure; previous studies have shown this does not occur. In the PTB socket, the anterior aspect of the socket is shaped closely around either side of the tibial ridge providing rotational stability of the limb. Given the PCAST does not feature this shaping, it is hypothesised that the wearer makes a number of musculo-skeletal adaptations in order to walk stably. Previous comparisons of the PCAST and PTB sockets have explored the space and time characteristics of gait and subjective comfort levels of the wearers. All previously performed tests have involved level walking at self-selected comfortable or fast pace. No studies to date have examined the musculoskeletal gait adaptations of wearers of pressure-cast sockets, or the relationships between the gait biomechanics and the resultant loading patterns in the socket. Thus, further research is required to investigate through what mechanisms or biomechanical adaptations these fundamentally different sockets achieve similar patient outcomes, and how these adaptations change when walking on a non-level surface. Historically, load bearing hydrocasting techniques have been performed with the patient standing with either with 50% of their body weight supported by the pressurised liquid, or during full weight bearing. Intuitively, the rationale for each of these loading conditions is that the loading condition during casting reflects the limb loading during stance and the single support phase of gait respectively. However, there is no empirical data to suggest the either method leads to superior fit, gait biomechanics or comfort. Nor is there any data to quantify the volume, geometry or alignment requirements of the sockets manufactured using the differing hydrocast loading conditions. An understanding of the aforementioned will allow the refinement and potentially improved consistency of hydrocasting techniques among researchers.

The following study will be a comparative open label randomised human pilot study for patients utilising a novel therapeutic modality technology- virtual reality (VR) - to assess its utility as an analgesic in acute pain post laparoscopy. The following pilot study is aimed at efficacy and will assess: • The effect of VR on pain scores after laparoscopy • The effect of VR on opiate analgesia requirements after laparoscopy • Patient feedback on device experience This will be achieved by comparing VR to routine care post laparoscopy. As such, the following study will aid in formulating evidence for utilising VR technology as an analgesia option post laparoscopy and potentially lay the foundations for a larger scale randomised controlled trial (RCT).

Emerging evidence indicates that elective cardiac surgery patients may benefit from inspiratory muscle training (targeted strengthening of the respiratory muscles) to reduce the incidence of post-operative pulmonary complications (PPCs). However, little is known about the baseline (pre-operative) inspiratory muscle strength of patients undergoing elective cardiac surgery. It is unlikely that every patient requires inspiratory muscle training,and it would be helpful to clarify the proportion of patients who are likely to benefit from such training. This can be easily done through measuring their inspiratory muscle strength pre-operatively as part of their preparation for surgery. However, such measurement is not yet standard practice. We hypothesise that the prevalence of inspiratory muscle weakness may be 30% or greater in a cohort of patients preparing for elective cardiac surgery.

The main aim of this RCT is to compare the clinical effectiveness and cost-effectiveness of individualised Cognitive Functional Therapy delivered with movement sensor biofeedback versus without movement sensor biofeedback, and also compared with usual care for patients with persistent, disabling LBP.

Intravenous immunoglobulin (IVIg) (a type of antibody) is given after lung transplantation to correct low levels in the blood of individuals. It is safe and thought to help reduce infection and rejection after transplant. This is a pilot randomised clinical trial which compares routine IVIg therapy with placebo in patients following lung transplant. Participants will be randomised in a 1 to 1 manner to receive either IVIg or placebo (Human Albumin) at week 6 post transplant and thereafter monthly for 6 months. Each participant will be followed for 1 year following transplant. Evidence of recruitment and retainment will be collected. Additionally, details of all episodes of infection, rejection, and hospitalisation will be collected. Adverse events related to the study drug and IgG levels will be collected for safety analysis.

To our knowledge, there are no known scientifically evaluated physical activity interventions designed for middle aged Arab-Australian women. While there are a host programs and interventions designed for the general population, these are not applicable to those from culturally and linguistically diverse (CALD) backgrounds and more specifically Arab-Australian women. Due to the unique needs and requirements of each CALD group, it is important to individually tailor and target interventions to suit a specific population of interest. The aim of this study was to test the feasibility and acceptability of a 12-week culturally-tailored physical activity intervention for Arab-Australian women aged 35-64 years.

Previous studies have shown specialized dietary fibre supplements can prevent type 1 diabetes in mice by altering the gut bacteria, reducing inflammation around the body and preventing the autoimmune destruction of the insulin-producing cells in the pancreas. While this fibre supplement has been used to treat other health conditions in humans, it has yet to be determined whether humans with type 1 diabetes will experience the same protection as mice. This pilot research trial therefore aims to determine whether a large clinical trial of this fibre supplement that releases high concentrations of the natural products, acetate and butyrate, is a) feasible, b) safe and c) well-tolerated in adults with established type 1 diabetes, and to (d) determine whether this supplement affects any markers of diabetes, such as changes in the gut microbiota and inflammatory markers, which would indicate the supplement would have a similar effect on type 1 diabetes protection in humans as in mice. To achieve these aims, we will conduct a pilot study in 25 adults with pre-existing type 1 diabetes consuming the dietary fibre supplement twice daily for 6 weeks, with a follow-up at 12 weeks. The supplement is an ordourless, tasteless powder that dissolves easily in cold or hot foods. Eligible participants will attend the study centre on 4 separate occasions (baseline, 3, 6 and 12 weeks) and will receive dietary counselling and an individualised plan for the times of day they take the supplement and the specific foods in their usual diet they incorporate it into. Participants will be monitored closely for changes in their blood, urine and stool pathology, their blood glucose control, insulin requirements, and any side effects or feedback on the supplement. Blood and stool samples will also be taken to at each visit to assess the preliminary efficacy of the dietary supplement and ensure the laboratory experiments are feasible for a future large clinical trial.

This research project is being conducted to investigate the safety, tolerability, and pharmacokinetics of single ascending dose and multiple ascending dose of oral EHP-101 when administered in healthy adult subjects.

This study will involve the creation of a Knowledge Translation Hub and a network of specialist therapy centres in Australia. The translational hub will inform and guide stakeholders in knowledge translation, upskill therapists and establish a community of practice. The specialist therapy centres will deliver SENSe to people with stroke, and provide training to upskill therapists. The study will monitor a range of outcomes including touch sensation, functional use of the hand, and return to personally-important activities for survivors of stroke, therapist confidence to deliver SENSe, and costs to implement the service. The project has been funded by the NHMRC as a partnership grant to implement evidence into practice.