ANZCTR search results

The primary purpose of this trial is to evaluate the efficacy of an exercise and balance training intervention in patients with chemotherapy-induced peripheral neuropathy (CIPN) on functional, neurophysiological, and quality of life outcomes. Who is it for? Cancer survivors at least 3 months-post treatment, aged 18 or over, and with grade 2 or 3 CIPN. Study details All participants in this study will first complete an 8 week wait period to assess the rate of adaptive improvements occurring 'naturally' (e.g. without an exercise intervention). Participants will then complete an 8 week exercise program involving a combination of supervised and unsupervised exercise sessions, totaling three 45-60 minutes sessions per week. Sessions will include a combination of cardiovascular training, strength training and balance training. Participants will be asked to complete a number of assessments and questionnaires at enrolment, after the 8 week wait period and again after the 8 week exercise program. Assessments will include physical function tests, nerve testing, and quality of life questionnaires. This pilot study is being conducted to provide insight regarding the efficacy of exercise and balance training for the treatment of CIPN.

The primary purpose of this study is to evaluate the efficacy of alternative dressing and securement devices in preventing device failure and infection in peripherally inserted central catheters (PICCs) in cancer patients. You may be eligible to participate in this trial if you are a cancer patient of any age, with a haematological malignancy or solid tumour, and are having a PICC inserted as part of your therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to receive one of four PICC dressing/securement device combinations. These combinations are the standard securement device with a simple polyurethane dressing; the standard securement device with a simple polyurethane dressing and a chlorhexidine impregnated disc; an integrated securement device and simple polyurethane dressing combined into a single device; or an integrated securement device and chlorhexidine impregnated disc. The allocated dressing will be re-applied every 7 days or more frequently if required, until 8 weeks or until the time of device removal if removal is required earlier. Participants will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, device failures and infections. It is hoped that the findings of this trial will provide information on which PICC securement devices and dressings are most effective in preventing PICC failure and infection in cancer patients.

Background: A smoking ban was implemented across all prisons in Queensland, Australia, in May 2014, with the aim of improving the health of prisoners and prison staff. However, post-release relapse to smoking among prisoners is common. The WISE study, conducted in the US by Clarke and colleagues (2013), is the only study that has rigorously evaluated an intervention aiming to assist individuals in remaining abstinent from smoking following release from a smoke-free prison. This intervention resulted in significantly higher abstinence rates for the intervention group compared to the control group three months post-release (11.5% and 2.4% respectively). Methods: This paper describes the design and rationale of a randomised controlled trial that aims to replicate an adapted version of the WISE intervention in Queensland prisons, with the goal of extending smoking abstinence among a population of incarcerated men due to be released from smoke-free prisons. Prisoners in the intervention group will receive four weekly sessions of a brief intervention involving group sessions of motivational interviewing and cognitive behavioural therapy, initiated in the four weeks prior to release. The control group will receive a pamphlet and brief verbal intervention at the time of baseline assessment. Assessment of post-release smoking status will be conducted by parole officers at weekly parole meetings for a maximum of three months post-release, allowing for smoking rates among the intervention and control groups to be compared. Discussion: Effective interventions that result in long-term smoking cessation are needed so as to reduce existing health disparities in this vulnerable group of Australians.

Quinoa (Chenopodium quinoa) seed is catalogued as a pseudocereal due to the similarity with the cereal family but with a different nutrient composition. Quinoa is a crop related to beetroot and spinach, grown primarily for its edible seeds. Cultivated in the Andean region between Bolivia and Peru, recent interest in this plant has been due to the nutritional value of the seeds in comparison to other cereals. Comparative to other cereals, quinoa is high in protein and rich in antioxidants (Vega-Galvez et al., 2010; Gorinstein et al., 2007). The quinoa seeds are highly nutritious and contain 60% starch and 15% protein. In addition, quinoa is a rich source of anti-oxidants including flavonoids, phenolic acids and squalene. Research has shown a potential role for quinoa in reducing oxidative stress which is increased in response to a high sugar diet (Pasko et al., 2010), and has also been reported to reduce adiposity in response to a high fat diet (Foucault et al., 2012). We have recently shown quinoa, contributing to 25% of the diet, to significantly increase adiponectin levels in C57BL/6 mouse models of obesity. Several studies have shown the benefits of increased circulating adiponectin particularly in the prevention of cardiovascular diseases, some cases of type 2 diabetes and the Metabolic Syndrome (Hotta et al., 2000; Spranger et al., 2003; Matsuzawa et al., 2004). Whilst body composition did not significantly change, a number of markers of health including lipid profiles were improved. The current study aims to assess the effect of quinoa seeds in varying quantities on adiponectin levels, blood lipid profiles and physical activity and body composition in overweight and obese humans. We hypothesise that inclusion of quinoa in the human diet will increase adiponectin levels and improve blood lipid profile in overweight and obese humans Participants receive either 25, 50, or 100 grams of quinoa per day for 12 weeks and results compared to a control group (0 grams quinoa/day).

Induction of labour is a common obstetric intervention that 1 in 4 women will experience. The ultimate goal of induction of labour is to achieve a vaginal birth, however in almost 40% of first time mothers it fails. The outcome of a failed induction, a caesarean delivery is associated with vast range of adverse effects, both short and long term for the mother and her baby. In this application we propose that a simple and inexpensive intervention will increase the success of induction of labour. Lessons from successful spontaneous births tell us that labour occurs more frequently, and is shorter with less intervention when it occurs at night. The driver of this is thought to be the endogenous hormone, melatonin. Melatonin is synthesised by the placenta. Healthy pregnant women have higher concentrations of melatonin compared to non-pregnant women. Melatonin levels also increase with gestation, peaking during labour and then falling rapidly after delivery. The biological reason for an altered melatonin cycle in pregnancy is unclear. However, the myometrium of the pregnant uterus expresses melatonin receptors and these receptors have been shown to be up-regulated in labouring compared to non-labouring women. Intriguingly, both melatonin and oxytocin activate the same signalling pathway that results in uterine contractions. Specifically, melatonin treatment of myometrium increases it’s sensitivity, enhances oxytocin-induced contractions and improves myometrium cell communication and synchronization. Taken together this suggests an important role of melatonin in the onset and progress of labour. We therefore hypothesise that supplementing women undergoing induction of labour with melatonin will improve the success rate of induction of labour. We will undertake a double-blinded randomised controlled trial of melatonin supplementation to improve the success of induction of labour in healthy first time mothers.

In a crossover study, we aim to determine whether a Mediterranean diet with adequate dairy foods, consumed over 8 weeks, will improve measures of blood pressure, cardiometablic health, wellbeing and cognitive performance, more than a low fat diet in an high risk population of men and women with for cardiovascular disease (CVD). We believe that volunteers consuming a Mediterranean diet enriched with dairy foods (MedDairy diet), to meet the nutrient reference values for calcium in Australia, will have greater improvements in blood pressure than a low fat diet, based on Heart Foundation recommendations. Low fat diets are recommended for treatment of many chronic diseases such as type 2 diabetes mellitus, heart health and secondary prevention of stroke etc. together with regular physical activity. We know that the MedDiet, rich in bioactive foods and nutrients, has significant effects on longevity as well as reduced total death and death from CVD. Furthermore, given the independent reported health benefits of dairy foods on CVD risk factors including blood pressure, blood lipids etc. a diet combing both a Mediterranean diet and dairy foods (MedDairy diet) may in fact improve indices of cardiovascular health more than a low fat diet.

This study is a pilot observational study, conducting a cross-sectional survey on patient attitudes and satisfaction with medical consultations whilst a medical scribe is present during an Emergency Medicine consultation. It will use a convenience sample of all patients attending Cabrini ED between the dates of April 2016 to September 2016 (the period of time there is a study being undertaken on the economics of using medical scribes at Cabrini Emergency Department). It will commence once ethics approval is obtained from Cabrini HREC. It will use a survey developed specifically for the purpose. Items will relate to patient satisfaction with the consultation and patient satisfaction with various components of the consultation. It will also include a net promoter score for the Emergency Department. It will compare consultations with scribes to consultations without scribes during the same time period using the same group of physicians and the same investigation site. Medical scribes are an emerging role in health. Their numbers are rapidly expanding. Research to date has focused on the economics of their use. There is a need for health administrators and emergency doctors to understand their potential impact on the patient during consultations and this exploratory work should assist with directing future work and guiding administrators and doctors on whether and how to utilise scribes in the future.

The aims of this research project are to determine how hamstring muscle function and structure change over time during rehabilitation for hamstring strain injury and whether exercising completely pain-free or to a pain-threshold effects the time course of these changes. The research project is split into two parts, part A is a cohort study to determine presence of acute hamstring strain injury and part B is a randomised control trial. We will recruit recreationally active males and females who suspect they have suffered an acute hamstring strain injury for part A of the study until we have recruited forty participants with clinically confirmed acute hamstring strain injury within seven days of initial suspected injury for part B of the study. Part A of the study involves a one off initial clinical assessment including a subjective interview, inspection of the injury site, assessments of muscle structure, strength and flexibility to determine presence of acute hamstring strain injury. If acute hamstring strain injury is confirmed within seven days of initial suspected injury, participants will be eligible to participate in part B of the study and randomised to either a pain-free or pain-threshold exercise group. Both groups in part B of the study will complete identical follow-up clinical assessments and rehabilitation including progressive running and resistance exercise twice per week until pre-determined return to play criteria is met. Participants in the pain-free group must complete all exercises and running within the rehabilitation protocol completely pain-free and if any level of pain in caused during rehabilitation, exercises will be altered appropriately. Participants in the pain-threshold group will be allowed to exercise and run to a pain-threshold of 4/10 on a visual analogue scale (VAS) and if any level of pain greater than this is experienced during rehabilitation, exercises will be adjusted accordingly. Once these criteria have been met, participants will be free to resume their previous level of activity and invited to attend ACU on a weekly basis for follow-up clinical assessment as above for a period of 3 months. During this period and the subsequent 24 months following return to play clearance, participants will be contacted on a weekly basis to enquire whether any suspected re-injury has occurred. In this event participants will be required to attend a follow-up clinical assessment to confirm presence of re-injury and if confirmed they may be eligible for additional rehabilitation services.

Regular aerobic exercise has now been established as an effective therapy for reducing liver fat in patients with non-alcoholic fatty liver disease (NAFLD), even in the absence of weight loss. However the efficacy of regular exercise in progressive liver disease such as non-alcoholic steatohepatitis (NASH) is yet to be established. Recent evidence has suggested that high intensity exercise may be required for benefit and, as such, high intensity interval training (HIIT) may be an effective modality for improving cardiovascular, metabolic and liver health in patients with NASH. A key feature to the success of any exercise intervention is the ability to adhere to the intervention in the long-term. The ability to perform HIIT on a regular basis, in an unsupervised environment has yet to be determined. The aims are to i) examine the efficacy of a 12 week supervised exercise intervention involving high-intensity interval training (HIIT) in patients with biopsy-proven non-alcoholic steatohepatitis (NASH) for improving cardiorespiratory fitness (CRF), and ii) examine the safety and feasibility of regular HIIT in patients with NASH both when performed under supervision and when performed unsupervised (home-based, for 12 weeks). We hypothesise that, compared with control: i) the HIIT intervention will significantly improve CRF, and ii) the HIIT intervention will be safe and feasible for sustaining both supervised and unsupervised exercise adherence in people with NASH. Eligible participants (n=22) will be randomised into 12 weeks of HIIT (n=11) or a control (n=11). The primary analysis will examine the efficacy of 12 weeks of HIIT on changes in cardiorespiratory fitness, body composition, liver fat, liver stiffness, abdominal visceral fat, vascular function, and other cardio-metabolic risk factors, compared with control. The supervised HIIT training will begin with a warm-up for 5 min and at 60% of maximal heart rate (HRmax) followed by 4 x 4 min intervals at 85-95% HRmax interspersed with 3 min ‘recovery’ periods at 60% HRmax, then a 5 min cool down. Participants randomised to the control group will perform 12 weeks of stretching and then be invited to complete the HIIT protocol. On completion of the HIIT intervention, all participants (n=22) will be prescribed an on-going exercise program based on an equivalent type and intensity of exercise, modified for an unsupervised home/gym environment. Feasibility and adherence will be assessed via self-administered questionnaires and focus group after 12 weeks of home based exercise.

Borderline Personality Disorder (BPD) is a severe mental disorder that arises during adolescence and young adulthood. This study investigates the most effective form of psychoeducation for families and friends of young people (15-25 years old) presenting for treatment of BPD for the first time. It is a randomised controlled trial comparing two interventions: the MS-BPD group with online BPD program compared with the individual, self-directed online BPD program alone. The primary outcome is reduction in burden of care. It is expected that post-intervention, participants who receive the MS-BPD group in addition to the online BPD program will have better outcomes than those who receive the online BPD program without the MS-BPD group. The measures to be used assess level of coping, burden, and personality disorders knowledge of participants, along with mood and anxiety symptoms, expressed emotion, and quality of life.