ANZCTR search results

The aim of this randomised controlled trial is to evaluate the preliminary efficacy and feasibility of implementing: 1. Three qualified Exercise Specialist sessions and two sessions with a qualified Psychologist OR two qualified Exercise Specialist sessions and three sessions with a qualified Psychologist (based on individual participant choice); and 2. Three qualified Exercise Specialist sessions and two sessions with a qualified Psychologist OR two qualified Exercise Specialist sessions and three sessions with a qualified psychologist (based on individual participant choice) plus a behaviour change support package (e-health, m-health and help-line) on physical activity levels of school teachers who have type 2 diabetes or are at ‘intermediate/high risk’ of developing type 2 diabetes. Physical activity, HbA1C, fasting blood sugar, blood lipids, Body Mass Index, waist circumference, blood pressure, diet, depression, anxiety, quality of life, social cognitive constructs related to physical activity, teaching self-efficacy related to general teaching and sport/physical activity will be assessed. Assessments will be conducted at baseline, 3-months, 9-months and 18-months post baseline.

Non-contact knee injuries (especially those involving the ligaments of the knee) are prevalent in the female athlete population. The risk of knee injury has been largely correlated with several specific biomechanical patterns including knee valgus and lateral trunk flexion during dynamic tasks, as well as measures of postural control. The research team is interested in whether novel injury prevention strategies could help to reduce these risk factors during dynamic tasks (single leg squat and single leg landing). Specifically, we are interested to see if risk factors for knee injury can be reduced following one of the following three interventions. 1. contracting specific muscles of the trunk, known as trunk motor control retraining, for a few moments at a time over a 5 minute period prior to performing a single leg squat and single leg jump task that will be captured using a force plate and motion analysis software for examination of joint angles. 2. contracting specific muscles of the hip, known as hip motor control retraining, for a few moments at a time over a 5 minute period prior to performing a single leg squat and single leg jump task that will be captured using a force plate and motion analysis software for examination of joint angles. 3. application of a soft, flexible sports tape, called kinesio tape applied to joints of the lower limb prior to performing a single leg squat and single leg jump task that will be captured using a force plate and motion analysis software for examination of joint angles. The research team is also interested in relationships between participant height, body composition, leg dominance, and biomechanics, which will be measured using image capture technology and a force plate. The intervention groups will consist of females aged between 18-35 because this is the population most considered 'high risk' for serious knee injury. The aim of the study is to investigate the effects of trunk motor control retraining, hip motor control retraining and application of kinesio tape on biomechanical risk factors for non-contact knee injury during a single leg squat and a single leg landing in female athletes. Participants will be asked to attend three data collection sessions, spread out over a minimum period of three weeks (in order to include for a washout period). The first session will include completion of a health and activity questionnaire and gathering of participant details, such as height and weight. In each of the three visits, participants will either undergo a control session OR trunk muscle retraining OR hip muscle retraining OR application of sports tape to the lower limb, with analysis of a single leg squat and a single leg landing via motion capture ( the sequence will be randomly allocated)

Global demand for plasma-derived products including intravenous immunoglobulin (IVIg) continues to grow steadily. In contrast, medical advances and improvements in patient blood management have decreased requirements for red cell products. With less collections required to meet red cell inventory, the amount of fractionated plasma available from whole blood donations has been reduced. These factors have shifted donor centre operations from a primary focus on whole blood collections to an increased effort to recruit and retain plasmapheresis donors to meet future demand. Australian Blood Service policy currently requires that blood donors give at least one whole blood donation before entering the plasmapheresis programme. The rationale behind this policy has been to determine donor suitability for apheresis donation (e.g. blood type, vein suitability) and to minimise vasovagal reactions and resulting donor drop-outs and deferrals. Similar policies for recruitment to plasmapheresis donation panels exist overseas with only the United States and the United Kingdom Blood Services permitting first-appointment apheresis donation. Consequently, little data exists regarding tolerability and donor acceptance of first-attendance plasma donation – particularly for voluntary non-remunerated blood donors. With improvements in plasmapheresis safety (e.g. saline compensation), and concern over iron depletion among whole blood donors, a review of Australian plasmapheresis donation policy is warranted. Importantly, there is no regulatory barrier to implementing first appointment plasmapheresis donation. If tolerable and acceptable to donors, first-attendance plasmapheresis donation could help to: 1. Increase the plasmapheresis panel and overall collections of plasma for fractionation 2. Reduce the number of first attendance red cell deferrals 3. Reduce reliance on fractionated whole blood donations for collection of plasma

We are investigating how a high diary diet (compared to a low dairy diet) will affect insulin sensitivity in normal weight, and overweight/obese people with normal/impaired glucose tolerance. There is evidence that dairy may affect insulin sensitivity, but currently the studies that perform dairy interventions in a diet are conflicted. There is therefore a need to design and perform dairy study that may help argue the case for our population eating more dairy in order to prevent developing type II diabetes. Hypothesis: eating higher amounts of dairy each day for four weeks will improve insulin sensitivity.

Nalu Medical (the sponsor) is developing an implantable medical device that is designed as an adjunctive therapy to medical management of patients with chronic pain in the trunk and/or limbs. To support the design and development of this implantable device, Nalu Medical has developed an External Trial Stimulator (ETS) for use during a trial of Spinal Cord Stimulation (SCS) prior to implanting the permanent device. All commercial devices are trialed in a similar manner, through the use of a proprietary ETS, prior to permanent implant. This study is intended to evaluate the Nalu ETS.

The ageing population and the success of treating previously fatal acute cardiac disease has led to an ongoing epidemic of heart failure. Given the status of this diagnosis as a component of overall health costs, controlling HF readmission represents a significant component of controlling hospital expenditure in the coming years. Furthermore, the lessons learned from a successful partnership approach to integration of hospital and community services will inform similar approaches to other chronic diseases including chronic lung disease and diabetes. In the current context, success of this program will have wide reaching implications for service delivery nationally and internationally. This randomized trial will provide the information with which to make evidence-based decisions about improved transfer of HF to community care and improved systems of community maintenance. This Partnership seeks to provide the necessary steps in system re-design to overcome identified problems. Specifically, the research-specific outcomes from this project will be to define where best to invest community resources for the management of heart failure, how to improve hospital and primary care integration in the management of this condition, how to identify early deteriorations and keep patients at home, reduce hospitalisations and save money.

One of the most effective treatments for PTSD is prolonged exposure (PE). In this treatment, the person is helped to gradually address the difficult memories and avoided situations in a supportive and controlled fashion. PE is delivered by qualified therapists in sessions that are held once a week for 10 weeks. For some people, this can pose a barrier – it may be difficult to get time off work or to make other arrangements for family commitments. Allocating 10 weeks for treatment can also be difficult for serving members. There is now some early evidence that we may be able to get equivalent results by providing the same number of sessions on a daily basis in just two weeks. In this study we seek to test whether the intensive approach is as effective as the 10-week model. If so, it has the potential to increase how accessible and acceptable this evidence based treatment is to veterans, serving members, civilians and their families. Using a randomised controlled trial design, we will therefore compare the effectiveness of the standard and intensive versions of PE in the treatment of PTSD in veterans and serving members. Eligible veterans and currently serving Defence members who meet criteria for PTSD will be randomly allocated to either standard PE (SPE; 10 weekly 90-minute sessions or intensive PE (IPE; 10 daily 90-minute sessions). Participants will be assess pre-treatment and at 4 weeks, 12 weeks and 12 months post-treatment commencement. We hypothesise that IPE will be as effective as SPE in reducing the severity of PTSD symptoms at post-treatment and 12 month follow-up.

This project aims to test whether enhanced fluid intake on the morning of a colonoscopy can avoid some of the deleterious effects associated with bowel preparation and prolonged fasting. It will examine whether increased fluid intake of up to 1,200 mls of Gatorade during the morning, up to 2.5 hours before the start of the afternoon list will alter the incidence of fluid depletion and dehydration, and the associated symptoms and clinical signs such as headache, dry moth, thirst, dizziness, postural hypotension and concentrated urine. This will be compared to a control group fasting from 0600 on the day of the procedure.

This study aims to test a primary care intervention that is designed to improve uptake of bowel cancer screening among primary care patients. Who is it for? You may be eligible to join this study if you are aged 50 to 74 years, are presenting for a general practice appointment, and have been identified via a brief baseline assessment as being at average or slightly increased risk of bowel cancer. You will not be eligible if you have been screened for bowel cancer using a faecal occult blood test (FOBT) in the past two years or colonoscopy in the past five years. Study details Clinics will be randomly allocated by day to intervention or usual care, therefore participants will receive the intervention based on the day of the week they attend the practice. Participants in the intervention group will receive: 1) A faecal occult blood test kit 2) A feedback sheet containing screening recommendations for those at average risk of bowel cancer 3) General practitioner endorsement of the importance of faecal occult blood test screening. Participants in the usual care group will receive standard care, and then the feedback sheet once the study is completed. All participants will be asked to complete a telephone interview 6 weeks after their initial appointment. During the interview, participants will be asked whether they have completed a faecal occult blood test within the past 6 weeks and will be asked questions to assess their bowel cancer screening knowledge. It is hoped that this primary care intervention will be an effective way to increase the uptake of bowel cancer screening

Recent evidence suggests that obstructive sleep apnoea (OSA) is a multifactorial disorder and is not only the result of a small, collapsible upper airway anatomy. Several non-anatomical physiological traits have been identified that can also play an important role in causing OSA. These include: (1) an oversensitive ventilatory control system (i.e. ventilatory control instability or high loop gain), (2) poor pharyngeal muscle responsiveness, and (3) a low respiratory arousal threshold. Importantly, the relative contribution of each of these traits varies between patients. Thus patients often have OSA for different reasons. An oversensitive ventilatory control system also referred to as having “high loop gain” has been shown to contribute to OSA severity in at least one third of patients. Loop gain characterises the sensitivity of the control of breathing during sleep. Patients with high loop gain have an overly large compensatory respiratory response to any given disturbance in breathing. In such patients, even a mild disturbance to breathing (i.e. hypopnoea) during sleep can produce a self-sustaining unstable breathing pattern, leading to repetitive airway collapse. While singular therapies targeted towards lowering loop gain have shown promise—including oxygen therapy and respiratory stimulants such as the drug acetazolamide (ACZ),— their effect size on reducing loop gain has not been large enough to resolve OSA in the majority of patients studied. Importantly, physiological studies have shown that oxygen and ACZ manipulate different sub-components of the respiratory control system; oxygen reduces ‘controller gain’ whereas ACZ reduces ‘plant gain’. That is, according to respiratory control theory, both of these treatments should have an independent and additive effect on lowering loop gain. As yet no study has assessed the therapeutic effect of manipulating loop gain with a combination of both agents. Importantly, in a sub-group of OSA patients where loop gain is abnormally high (36%), a large reduction in loop gain, is likely to be sufficient to resolve their OSA. The primary purpose of this clinical trial is to assess, for the first time, the ability of the combination of oxygen therapy and ACZ to reduce loop gain and thereby reduce OSA severity. We expect that this combination of therapeutic agents to have a greater effect on lowering loop gain than either alone. As a secondary objective of this trial, we intend to measure, at baseline, each of the four known traits known to cause OSA (upper airway collapsibility, loop gain, pharyngeal muscle responsiveness and respiratory arousal threshold) so that we can determine the characteristics of individuals that demonstrate that greatest therapeutic benefit from this combination therapy.