ANZCTR search results

This pilot study aims to investigate the effects of a maintenance Tai Chi intervention on exercise capacity and quality of life in people with chronic obstructive pulmonary disease (COPD). This will be a prospective cohort study where people with COPD will be recruited from two sites in Sydney, Concord Repatriation General Hospital and Mona Vale Community Health Centre. All participants will be asked to undertake an eight-week, twice weekly, supervised Tai Chi exercise program using Sun- style Tai Chi at one of the sites. On completion of the supervised program, participants will then be asked to continue with a home-based, unsupervised maintenance Tai Chi exercise program five times weekly for a six-month period. Outcomes will be measured at baseline, at eight weeks following the supervised Tai Chi program and again at three and six months into the maintenance Tai Chi program. Outcomes will include exercise capacity, quality of life, physical activity, balance, participants’ attitudes to management of their health care, compliance with short and long-term Tai Chi training, and satisfaction with the maintenance Tai Chi training.

Approximately half of all survivors of stroke experience memory impairment, which can significantly impact functional independence and quality of life. Two different approaches have typically been implemented in an effort to rehabilitate memory: restoration (computer based training) and compensation (group based training). Overall, there is no clear consensus as to whether either computer-based training or compensatory approaches to memory rehabilitation are effective or efficient for stroke patients. As a result, many survivors of stroke are purchasing costly computer training programs with unknown effectiveness. At Monash University, we are currently running a randomised controlled trial to explore the efficacy and cost efficiency of different approaches to memory rehabilitation post stroke. Eligible participants will be randomised into a waitlist control,memory group or computer training group and will receive free memory rehabilitation over a six week period. In doing so we aim to explore the most cost-efficient and effective way in which memory can be rehabilitated post stroke, thereby addressing a clear gap in service provision.

The project aims to determine if the two commonly used drug regimens for soft food impactions in the oesophagus are better than placebo for passage of the obstructing bolus. Retrospective data from small and poorly-designed studies have led to the recommendations for the trial of glucagon, glyceryl trinitrate (GTN) or a combination of both in soft food bolus impactions as first line management prior to endoscopy. Retrospective data from a recent audit carried out at Freemantle has demonstrated that the rate of clinical resolution was not appreciably different between patients treated with drugs and patients not treated with drugs and that a strategy of proceeding straight to endoscopy might be preferable In order to definitively answer the question, we propose to prospectively assign patients to either a drug regimen of a) glucagon and GTN or b) placebo and observe the outcomes after 30 minutes after which the pharmacological properties of the drugs excludes a drug effect.

The objectives of this study are to determine if leucoreduction is effective in reducing the incidence of transfusion associated microchimerism in major trauma patients and analyse the immune response and cytokine profiles to determine if immunosuppressive conditions enhance the formation of TAM.

Falls are common among people with multiple sclerosis (MS). About 60% of people with MS (PwMS) experience at least one fall each 6 months and about 30% have multiple falls. Increased fall risk and fear of falls have been shown to significantly affect quality of life and curtail activities among people with MS. Therefore, effective interventions to reduce fall risk in PwMS are urgently needed. Fall prevention and treatment strategies in MS are still at an early stage. Studies on falls in MS reveal important balance, coordination and cognitive determinants of falls. Based on these results, we propose a randomised single-blind controlled trial (RCT) to evaluate a step training intervention designed to prevent falls in PwMS. The proposed trial will enrol approximately 500 PwMS over a period of 36 months. Recruitment will initially take place in NSW and will be extended to other Australian states if required. It is expected that if the research confirms effectiveness of treatment strategies, implementation of clinical interventions will contribute to reduced fall rates in PwMS and associated injury-associated costs, reduced fear of falls and improved quality of life for PwMS.

The complex ecosystem of the adult intestinal microflora is estimated to harbour at least 500 different anaerobic bacterial species. Several reports have indicated that five genera account for most of the viable forms of anaerobic bacteria: Bacteroides, Eubacterium, Bifidobacterium, Peptostreptococcus, and Fusobacterium. Some of these species are considered potentially harmful because of their capacity to produce toxins, invade mucosal cells and activate carcinogens and inflammatory responses. There are, however, known strains with health-promoting properties, principally Bifidobacteria and Lactobacilli. This study will examine the capacity of a human-isolated probiotic strain of bacteria to influence the composition of the gut microbiome in healthy adult human volunteers and to examine what health benefits may be associated with daily consumption of the strain in the form of freeze-dried powder in capsules. The strain that will be tested in this study is Lactobacillus fermentum VRI-003, referred to as “PCC(Registered Trademark)”. PCC(Registered Trademark) has been sold as a dietary supplement in capsule and powder form for over ten years worldwide with no reported adverse effect. The study is a proof of concept, single centre, randomised, double-blind placebo controlled, parallel group study. A total of 60 healthy adult subjects (no diagnosed GI disease) will be randomised in a 1:1 ratio to receive either PCC(Registered Trademark) or placebo over a 6 month treatment period. Each active capsule contains a minimum of two billion live organisms. There will be 4 study visits in total. Subjects will provide three faecal samples: at Visit 2 (baseline, Day 1), Visit 3 (day 90) and Visit 4 (day 180). The samples will be analysed by 16S RNA analysis to monitor the composition of the gut microbiome. Subjects will be asked to complete a daily diary regarding their bowel habits. Subjects will also be asked to complete a general health questionnaire (SF-36) on three occasions. Weight will also be recorded.

The primary purpose of this study is to compare the efficacy of denosumab treatment with placebo in preventing bone decay in premenopausal women being treated with ovarian suppression and aromatase inhibition for breast cancer. Who is it for? You may be eligible to enrol in this trial if you are a premenopausal woman aged 18 to 55 who has been diagnosed with oestrogen-receptor positive, non-metastatic breast cancer (TxNxM0) for which you are scheduled to begin ovarian suppression and aromatase inhibition therapy which is intended to last for at least 12 months. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either denosumab once every 6 months by subcutaneous injection or to receive placebo once every 6 months for a 12-month study period. Participants will be followed-up at 6 and 12 months after starting the trial drug/placebo with scans, blood tests and questionnaires which will be used to measure bone density and structure, body composition, blood markers of bone health and cardiovascular risk and quality of life. It is hoped that the findings from this trial will provide information on the extent of bone decay which occurs as a result of ovarian suppression and aromatase inhibition therapy, and the efficacy of denosumab in preventing this decay in premenopausal women with oestrogen-receptor positive breast cancer.

In order to investigate the equi-efficacy of DHEA (orally administered via oral strip technology) versus standard troche delivered DHEA. Oral Strip Technology (OST) encompasses a rapid drug releasing product that is presented as a dissolvable strip orally applied. This technology has been used for local action, rapid release products and for bucco-adhesive systems that are retained for longer periods in the oral cavity to release a drug in a controlled fashion. OST offers an alternate platform for molecules that undergo first pass metabolism and for delivery of compounds.

Evidence demonstrates the effectiveness of behaviorally based therapeutic interventions for families where child behavior is of concern. Behaviorally based programs, also known as Behavioural Family Intervention and Parent Management Training commonly identify parents as the potential mechanisms of change in child behaviour. The interventions achieve change through the engagement of parents in one of two distinct modes. They either involve 1. the delivery of parenting information to parent(s) in session in the absence of their children, assessment of which is undertaken session by session via parental self-report 2. the direct coaching of parents as they interact with their children, the assessment of which is undertaken session by session via self-report in conjunction with observational coding during session The current study seeks to trail a combination of both sessional engagement of parents on their own and direct coaching of parents and their children. Drawing on clinic referred children aged between one and three years, and undertaken at UTS: Family Child Behaviour, the current study seeks to assess the potential to increase treatment response by combining these two distinct modes of treatment delivery in a clinic referred population. It is hypothesised that as a result of inclusion in this trrial: Participants will show a decrease in self-reported levels of parental depression, anxiety and stress from baseline to follow up Participants will show an increase in self-reported levels of parenting confidence will be evident from baseline to follow up Participants will show an increase in indices of observed appropriate parental engagement will be evident from baseline to follow up Participants will show a reduction in parent-report levels of child behavioural difficulties evident from baseline to follow up Participants will show a reduction in daycare report of child behavioural difficulties evident from baseline to follow up Methodology: This research will be undertaken as a within subject’s trial, the participants of which will be parents of children aged 1-3 years from NSW Australia. Parents who are referred into the program will be informed about the program, screened for inclusion into it and, if eligible, provided with the option to participate in the research. Parents will then be provided with information about the research and its requirements prior to seeking their informed consent.

The aim of this project is to determine the effect of a Mediterranean diet with lean fresh pork in comparison with a low fat diet on risk factors for CVD and cognitive function, mood and wellbeing in a randomised crossover dietary intervention trial in a population of men and women at risk of CVD. The primary outcome is home measured blood pressure (BP). Secondary outcomes include the Framingham heart risk score, dementia risk score, mood, wellbeing, cognitive performance (memory, executive function, speed of processing visual spatial and attention), blood lipids, insulin, glucose, insulin resistance, C Reactive Protein, erythrocyte fatty acids, apolipoprotein E4, body mass index, abdominal adiposity and body composition, weight, waist:hip ratio, gut microbiome profile, clinic blood pressure, dietary intake data and Mediterranean dietary adherence and low fat dietary adherence. This is a randomised crossover dietary intervention trial with 39 men and women aged 45-75 years at high risk of CVD. They will be included if they have systolic blood pressure greater than 120mmHg PLUS at least two risk factors for CVD including : BMI >25kg/m2 (overweight), abdominal adiposity, impaired glucose tolerance, dyslipidemia, family history of CVD or type 2 diabetes. Half the group will be randomly allocated to commence with either a Mediterranean diet with pork (MedDiet) or a lowfat diet (control current best practice) for 8weeks, then move to a washout diet for 8 weeks (habitual diet) then move to the other diet for the remaining 8weeks. At the start and end of each 8 week dietary phase volunteers will have all outcomes measured. Following an overnight fast, volunteers will attend their clinic visit and will have the following outcomes measured prior to breakfast: Height, weight Waist/hip circumference Blood pressure 40mL blood sample DEXA scan to assess body composition Following a light standard continental breakfast; Cognitive performance will be measured. Volunteers will meet with the dietitian and receive instructions regarding their dietary prescription for the next 8 weeks. They will be issued a diet checklist to ensure they are complying with the diet and receive some food staples. During this appointment volunteers will return items that were issued to them 1 week prior; their blood pressure monitors and 6day readings, together with their 3day weighed food record, faecal specimen and questionnaires. All volunteers will be asked to maintain their usual exercise pattern throughout the study.. Volunteers will be asked to return fortnightly during each diet phase to see the dietitian.