ANZCTR search results

Knee osteoarthritis (OA) is a major public health problem. It develops over many years, with progressive loss of articular cartilage. In people over 70, even without radiographic OA, most will have cartilage damage. Loss of cartilage is associated with pain and reduced function. Thus in an older population, it is important to reduce knee cartilage loss, and prevent structural progression. Low dose aspirin, used in the prevention of cardiovascular disease, may also affect cartilage by a variety of mechanisms. We have pilot data in 2 independent studies suggesting that low dose aspirin may reduce cartilage loss by more than 50%. The ASPirin in Reducing Events in the Elderly (ASPREE, ClinicalTrials.gov identifier NCT01038583, website www.aspree.org) study is a current 5 year randomised placebo controlled trial testing whether low dose aspirin in healthy adults > 70 years prevents cardiovascular disease, cancer and functional decline. Within this larger study (ASPREE parent study) we will examine in the ASPREE Knee Sub-study whether the use of low dose aspirin reduces change in knee cartilage volume in older adults.

This project is investigating minimum standards of practice and education for physiotherapists working in Australasian intensive care units. The lack of consistency in professional standards and dedicated training poses a substantial threat to the practice of physiotherapy and the credibility of the profession within the critical care unit. To provide 24 hour, 7 day a week services, many physiotherapy staff are required to contribute to critical care rosters, regardless of their primary discipline or interest (e.g. orthopaedics). Traditionally physiotherapists complete a tailored, in-house intensive care orientation including theory, clinical skills training and clinical practice until deemed competent by another staff physiotherapist. This process is subjective, requires extensive familiarization and additional skills in assessment and treatment. Educational requirements for competency training are not standardized across or within Australia or NZ, and are established by individual networks, with large variability in the content, requirements and duration of the education provided. A panel of participants will be selected to reflect the range of stakeholders who have an interest in the outcomes of the project (Boulkedid, Abdoul, Loustau, Sibony, & Alberti, 2011). Sixty-one participants from across Australia and NZ will be invited on to the panel, including Physiotherapy Specialists/Fellows in critical care, senior physiotherapy critical care clinicians, and physiotherapy academics in cardiorespiratory education. The Delphi survey plan will consist of two or three rounds of surveys.

This study aims to define the role of iron deficiency and iron deficiency anaemia in Paediatric Inflammatory Bowel Disease. Iron deficiency with or without anaemia is prevalent in inflammatory bowel disease (IBD) and an adverse impact on quality of life and cognitive function. These effects are likely to be equally if not more severe in the paediatric population. Correction of iron deficiency in IBD is difficult because of ongoing losses and because oral iron is poorly tolerated and bioavailability is impaired in states of inflammation. Given this, intravenous iron preparations are increasingly being used to correct iron deficiency. Previous preparations were complicated by a high rate of anaphylaxis and of iron toxicity which limited the doses administered leading to incomplete correction. We aim to show that the treatment of iron deficiency and iron deficiency anaemia in children using a newer, safer compound with no reported anaphylaxis nor iron toxicity, Ferric Carboxymaltose, is safe and effective in children and that treatment to correction of iron deficiency improves quality of life. This compound has been safely and effectively given, in corrective doses to over 10,000 patients aged 14 and above and there is no reason to indicate it is not equally safe and efficacious in younger children. We also aim to demonstrate improvements in cognitive function after correction of iron deficiency and that the administration of ferric carboxymaltose does not significantly increase markers of lipid peroxidation in paediatric inflammatory bowel disease. The patients included in this prospective open study will be children (six and older) treated for Inflammatory Bowel disease at the Royal Children's Hospital in Brisbane, with documented iron deficiency or iron deficiency anaemia (as defined by published guidelines). Baseline records of iron status (Ganzoni formula, FBC, IS) and quality of life will be obtained through blood tests and the IMPACT III QOL questionnaire (previously validated). A cognitive assessment will also be recorded by a qualified psychologist using a WISC-R. Treatment with Ferric Carboxymaltose will be undertaken (dose 15mg/kg body weight up to 500mg as per current hospital infusion guidelines for patients aged 14 and over. Following this, repeat iron status and quality of life information will be obtained at 8 weeks, with a repeat assessment of cognitive function. Primary endpoints will be defined as correction of total iron stores and improvement in cognitive function and QOL measures.

Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting one in four people in the adult population. AF is a major cause of admission to hospital and represents a major public health burden. AF is an independent risk factor for stroke, with a near five fold excess of stroke observed in patients with AF. It is of even greater concern that patients living with AF experience a range of physical and psychological symptoms which are distressing and impact negatively on their quality of life. In addition, those with AF have a high prevalence of known cardiovascular risk factors such as being physically inactive, overweight and having hypertension. Despite the evidence that cardiovascular risk factors are poorly controlled in patients with AF, they are typically not included in risk factor reduction programmes. Therefore, in this study, we aim to determine if a simple patient-centred, home-based risk factor management program can improve cardiovascular risk and quality of life in patients with clinically diagnosed AF. The study will be a pilot trial using a pre-post design with 3 month follow-up of clinical outcomes involving 20 people with AF. A mixed methods design comprising both quantitative and qualitative methods will be utilised. Study volunteers will have a baseline assessment and an initial in-person module selection and goal-setting session of approximately one hour. All participants will take part in a 3-month patient-centred intervention with tailored risk factor management and an individually tailored community-based exercise program. This program is based on health coaching and motivational interviewing principles and the extensive experience the researchers have with modular secondary prevention of cardiovascular disease and behaviour modification in high risk patients. Simultaneous, ongoing consultation with their general practitioner and specialist physician will be encouraged as part of standard medical care. Outcome assessments for all participants in the pilot study will be made at three months after baseline assessment.

There is a need to better understand the mechanisms involved in peritoneal membrane deterioration in patients undergoing peritoneal dialysis. We have found that a recently discovered particle (calciprotein particle, CPP) is present at high levels in drained out peritoneal dialysis fluid (PDF). Experimental work suggests that CPP may promote inflammation and calcification in certain situations. This is a pilot study to ascertain whether differences in PDF composition, in particular with respect to fluid glucose and calcium concentration, effect the formation and levels of CPP present in drained PDF. We hypothesise that PDF containing higher glucose and calcium concentrations would be associated with greater intra-peritoneal CPP accumulation, which may predispose to peritoneal inflammation, calcification and ultimately, technique failure.

Our 3-month randomised placebo controlled double-blind trial study aims to investigate the effect of aged garlic extract on blood pressure and other cardiovascular biomarkers including cholesterol, homocysteine and arterial stiffness in a group of adults with uncontrolled hypertension.

Stereotactic body radiotherapy (SBRT) is an new form of cancer treatment involving highly precise radiotherapy. SBRT appears to be very effective in controlling cancer. After the treatment is given, however, with standard scans we have not been able to reliably assess how well the treatment worked. We propose to research SBRT with state-of-the-art scanning tools in patients with cancer spread to the lung. We aim to better understand how cancer responds to this therapy. This is the first step of the research, and is a small ‘pilot’ study. The ‘pilot’ is designed to assess whether the research can be completed. Who is it for? This trial is for patients who have cancer which has spread to the lung. We aim to enrol ten patients in total to participate in the research. These patients will be invited through Peter MacCallum at East Melbourne. Trial details: If you participate in this study you will have two different types of scans as well as a single stereotactic body radiotherapy session (SBRT). The two types of scans we are researching are called a four-dimensional positron emission tomography (4D-PET) scan and a computed tomography (CT) perfusion scan. Both scans are slow and recorded along with your breathing, which allows us to see how much your organs move as you breathe in and out. Each 4D-PET scan is broken down into many separate scans, each showing where your organs and the cancer are at a specific point of your breathing, for example, just as you start breathing in. For us to know whether you are breathing in or out, we will monitor your chest movement using breathing equipment. This will be done by either putting a belt around your chest or abdomen which senses your breathing, or a small lightweight reflective box on your chest and watch this using a special camera in the room. Both devices can tell us at which part of your breathing cycle each CT or PET image was taken, so we can make sets of images from each phase. Either device can be used during your scan, and this will depend on the particular machine on which you have your scan taken. The CT perfusion scan is similar to a standard CT scan, but is taken over a longer period of time with more contrast. This allows us to record the flow of contrast and blood flow into the cancer. Specifically, the research involves: 1. Before treatment, you will have a four-dimensional positron emission tomography (4D-PET) scan and a computed tomography (CT) perfusion scan, as a baseline. 2. After treatment, you will have another 4D-PET scan and a CT perfusion scan at day 14 and day 70. These will be compared with the first scans in order to assess how your cancer responded to the treatment. The stereotactic body radiotherapy (SBRT) treatment itself will routinely involve a third type of scan: a cone-beam CT. This scan is performed on the treatment machine, and is used to make the treatment more precise. Specifically, the stereotactic radiotherapy treatment involves as standard: 3. Prior to treatment whilst being set-up on the treatment machine, a cone-beam CT will be used to check the position of the cancer. This will be repeated immediately before the treatment and again mid-way through the treatment (a total of 3 cone-beam CTs). 4. A single high-precision, high-dose radiotherapy (SBRT) treatment directed against the cancer. Follow-up will involve a visit at approximately 2.5 to 3 months, and then at 6 months, 9 months, and 12 months from treatment. Participation in this study will involve no extra cost due to either having these scans or the treatment.

Stroke is a leading cause of disability amongst Australians. After stroke, activity levels are low, with few people able to exercise at an intensity which will reduce the risk of future cardiovascular events. This project examines the effectiveness of implementing a combined high intensity treadmill training program embedded in a self-management approach to improve activity levels, mobility, cardiovascular risk profile in stroke survivors, increasing their independence and reducing the burden of care.

Vitamin D in your body comes from exposure to the sun or from your diet. Having enough vitamin D in your blood stream is important for maintaining healthy bones, but we don’t really know how much our bones need. Having higher vitamin D levels might also reduce risks of diseases such as diabetes, heart disease, multiple sclerosis and some cancers, but this is uncertain. To fully understand the health effects of vitamin D we need to do studies with very large numbers of people. We are aiming to recruit about 25,000 Australians aged 60-79. The aims are to see if taking a vitamin D tablet changes the risk of a person being diagnosed with health conditions such as cancer, heart disease or infections (like flu). D-Health will give us much-needed information so that we can advise people correctly in the future.

Mindfulness interventions are emerging as a potentially promising intervention to reduce mental health problems in the perinatal period, however there is a need for more robust evidence supporting their efficacy. The current proposal outlines a pilot study with the primary aim of exploring feasibility issues to inform the development of a randomised-controlled trial of a mindfulness-based intervention in pregnancy. We propose to test and evaluate a range of recruitment strategies designed to maximise uptake of a program offered to women booked in to give birth at the Royal Women's Hospital. We aim to recruit around 45 women to this pilot study. Participants in the project will complete study questionnaires at three time-points: pre-intervention, post-intervention, and at a three months postpartum follow-up. Questionnaires will include standardised measures of depression, anxiety, stress, and mindfulness. The postnatal follow-up questionnaire will include items on maternal postnatal quality of life and child outcomes (cry-fuss-sleep behaviour). Analysis will focus on uptake via different recruitment methods and assess rates of ongoing participation, engagement, and acceptability of study instruments. The data collected in this study will be used to inform the development of a large scale randomised controlled trial evaluating a mindfulness-based group intervention in pregnancy for reducing perinatal anxiety and depression. In addition, the pilot study will support and develop collaborative links between staff at The Royal Women's Hospital and researchers in the Healthy Mothers, Healthy Families group at the Murdoch Childrens Research Institute.