ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31349 results sorted by trial registration date.
  • Evaluate changes in physical activity levels in the weeks following left ventricular assist device implantation

    Left ventricular assist devices (LVAD) are pump that are implanted into the heart of patients with impaired heart function (heart failure) to assist in the pumping of blood around the body. An important objective of LVADs is to enable patients to achieve a more active lifestyle. Furthermore, physical activity and exercise are important components of the rehabilitation of patients with LVADs. The aim of this study is to compare the physical activity levels of stable patients with LVAD support (intervention group) compared with patients with advanced heart failure receiving optimal pharmaceutical management, but without LVAD support (control group).

  • Hip Osteoarthritis: effect of combining Pain coping skills training with Exercise and education - HOPE trial

    Persistent hip pain in individuals over 50 years of age is most often due to underlying hip osteoarthritis (OA). Hip osteoarthritis (OA) is a chronic musculoskeletal condition causing pain, physical dysfunction, psychological impairments and reduced quality-of-life. There is currently no cure, thus hip OA is a major public health problem contributing to substantial patient morbidity, health care costs and lengthy surgical waiting lists. Although exercise is recommended by all clinical guidelines for managing hip OA, clinical trials have shown that exercise is either not effective or has only modest benefits. Exercise, typically aimed at addressing muscle strength deficits and restricted joint range of motion, does not directly address psychological factors that are significantly increased in people with hip OA and are associated with higher pain levels and poorer function. Pain coping skills training (PCST), a form of cognitive behavioural therapy, is effective but its clinical application is limited because of poor access to appropriately-trained health professionals and high treatment costs. There is an urgent need to evaluate alternate delivery methods of PCST as an adjunctive treatment to exercise in OA. There are no studies in hip OA that have evaluated the efficacy of PCST (or any other behavioural intervention) either alone, or combined with biomedical treatments such as exercise. This study has two main aims comparing two interventions; Intervention A = Online general education and online PCST, followed by exercise, compared to Intervention B = online education, followed by exercise. In both interventions exercise commences in week 8, on completion of the online educational component. Both interventions are assessed at two separate time points, week 24 and week 8. The first aim is to assess and compare at 24 weeks the effect of the two interventions on pain and physical function. The second aim is to assess and compare the effect of Intervention A and B on pain and physical function prior to the commencement of exercise which is introduced in week 8 in both groups.

  • Evaluating the feasibility and utility of a Quality of Life instrument as a clinical aid in cancer and palliative care

    The study is evaluating the feasibility and utility of the Quality of Life at the End of Life (QUAL-E) instrument in helping staff care for and understand the concerns of people with advanced cancer. Who is it for? You may be eligible to join this study if you are aged over 18 years, have a diagnosis of advanced cancer and receiving inpatient palliative care or outpatient cancer care at the study hospital. Trial details All participants in this study will complete an interview with the QUAL-E used as an interview tool. The QUAL-E instrument explores four domains: symptom impact, relationship with healthcare providers, life completion and preparation for end of life, which have been found to influence patients’ quality of life. This study will use mixed methods to conduct a qualitative content analysis of patients’ responses to the QUAL-E when administered by a research nurse, and a quantitative assessment of feasibility and the possible association between QUAL-E and Distress Thermometer scores.

  • A safety and tolerability study in humans for chemically attenuated malaria parasites

    This study is examining the safety, tolerability, persistence and immunogenicity of chemically attenuated P. falciparum 7G8 infected red blood cells. Participants will receive a single inoculum of malaria parasites attenuated with either 50nM, 100nM or 200nM of Tafuramycin-A. Following administration of the inoculum, we will measure the level of malaria parasites in the blood-stream and then administer anti-malarial treatment (Riamet) at D28. We will also be assessing the safety of the inoculum and the way the immune system responds to it. Determining the safety, persistence and immunogenicity of the Tafuramycin-A malaria parasites is important as they form the basis of a novel malaria vaccine approach.

  • Investigation of the effects of anaesthetic choice on ventilation-perfusion scatter and lung gas exchange.

    The relative effects on V/Q matching in the lung of modern inhalational anaesthetics such as sevoflurane have not been compared with those of the intravenous agent propofol. There are potentially important implications for the management of patients with reduced lung function undergoing surgery.

  • Sedation Practice in Intensive Care: A randomised controlled pilot study

    This pilot study aims to evaluate the feasibility of conducting a large scale multicentre RCT in paediatric intensive care, comparing current sedation practice with a dexmedetomidine based sedation regimen that minimizes benzodiazepines.

  • A randomised trial to evaluate the effect of an education program on fall prevention knowledge and the prescription of exercises shown to prevent falls in older people.

    This study aims to determine if a specific, one-day education program delivered to allied health and exercise professionals in a workshop format and access to internet-based support materials, results in increased prescription of evidence-based exercises designed to prevent falls in older people. Secondary aims are to determine if the education program results in an increase in the proportion of exercise prescription strategies used in the past month that comply with evidence-based fall prevention guidelines and if fall prevention knowledge increases after three months. We hypothesise that the intervention group participants will prescribe evidence-based fall prevention exercise to a higher proportion of their older clients during the follow-up period than the control participants and that they will prescribe a higher number of evidence-based fall prevention exercises and will perform better on an assessment of fall prevention knowledge at three months follow-up compared with control participants.

  • Effects of physical and mental training on cognition and Alzheimer's disease biomarkers

    Evidence is now emerging to suggest that lifestyle factors, namely physical activity and cognitive stimulation could provide a cost-effective and relatively simple means of protecting the brain against age-related cognitive decline and dementia. This hypothesis can generally be described as a “use it or lose it” philosophy. However, it is unclear which forms, intensity and frequency of physical activity provide the most benefit. Similarly, the optimal level and form of cognitive stimulation remains to be determined. To date, very few intervention studies have demonstrated improvement through standardized tests of memory and cognition (neuropsychological tests) and none have used blood biomarkers as part of the assessment criteria. Therefore, this study is specifically designed to determine whether a home-based lifestyle intervention program, involving physical activity or cognitive stimulation alone, or in combination, can provide measurable improvements in cognition and AD-related blood biomarkers amongst the healthy, community-dwelling elderly. 200 male and female participants aged 60 to 85 will be recruited into 4 intervention groups: physical activity alone, cognitive stimulation alone, physical activity and cognitive stimulation combined or a control group. The intervention period for all of the groups will last for 16 weeks. Participants will be monitored closely throughout the intervention period and assessed at baseline (pre-intervention), during the intervention at 8 weeks and at 2 post-intervention time-points (16 and 52 weeks). The assessment criteria include a battery of neuropsychological and clinical tests and measurement of AD-related blood biomarkers. 20% of participants will undergo a brain imaging scan and body composition analysis to assess the effect of the intervention on brain activity and changes in fat and lean body mass. This project will provide greater insight into the mechanisms underlying the protective effect of physical activity and cognitive stimulation on brain function. The project will also directly assess and compare the efficacy of home-based intervention strategies on a wide range of parameters. Should the interventions prove successful, this study could then be expanded to include a greater number of participants and assess multiple strategies with the ultimate aim being the development of a public health strategy for the prevention/delay of cognitive decline.

  • Cognition and Type 2 Diabetes – A pilot randomised controlled trial (RCT) of exercise

    Type 2 Diabetes (T2DM) is a significant risk factor for dementia in older people, and vascular disease may underlie this relationship. Greater physical activity is associated with better brain function and is also recommended for people with T2DM to reduce cardiovascular risk. However, it is currently unknown as to whether an exercise intervention can preserve or improve brain health in people with T2DM. The aim of this project is to examine the efficacy of a six month structured exercise program in preserving brain health in late middle aged people with T2DM, and evaluate whether this occurs by improving vascular health. This will be done by using MRI scans to measure brain perfusion and structure, sophisticated measures of large and small artery health, and cognitive function before and after the intervention.

  • A randomized control trial evaluating the effects of biologic mesh for the prevention of parastomal hernias in patients undergoing colostomy, ileostomy, ileal, colonic or conduits.

    Parastomal hernias represent a significant morbidity for patients who require permanent stomas. Furthermore, they occur in up to 50-80% of these patients, resulting in a significant societal burden. The use of mesh is now standard surgical practice for the repair of all types of hernias, including parastomal hernias. However, repairing parastomal hernias can be very complex, and often carry their own complications such as enterotomies, prolonged ileus, recurrence, mesh infections, and fistula formation. As such, given the high rate of parastomal hernias, there has been increasing interest in using mesh at the time of stoma formation to prevent this complication. Biologic mesh represents a promising solution to this problem. Biologic mesh has been shown to be an effective tool in hernia repair, without the infection and erosion complications associated with synthetic permanent meshes. A single initial study has been promising, demonstrating similarly low hernia rates as with synthetic meshes. However, questions still remain about whether the added costs associated with expensive biologic meshes can be offset by these potential reductions in patient morbidity. This primary aim of this study is to determine the effectiveness of using biologic mesh at the time of formation of a permanent stoma in the prevention of parastomal hernias. The hypothesis is that the Surgisis (Registered Trademark) biologic mesh will reduce rates of parastomal hernia in patients. Secondary aims of this study include the assessment of any complications arising from this technique, as well as to assess the cost effectiveness of using biologic mesh over the study period.

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