ANZCTR search results

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

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31346 results sorted by trial registration date.
  • Effectiveness of physical activity and reduced sitting program on cognitive and physical function in middle-aged and older adults with type 2 diabetes

    Recent studies have shown that physical activity and sitting time reduction may have health and cognitive (memory) benefits for individuals with Type 2 diabetes, however, no such study has looked at the benefits of these two programs in combination. This study aims to investigate whether a physical activity program and a targeted program to reduce sitting time in middle aged and older adults who are not active and who have Type 2 diabetes would be beneficial for physical and cognitive health. The study will run for 12 weeks. Participants will undergo an initial screening visit to determine if they meet criteria for the study. If they meet criteria they will then be invited to participate in the study which will involve: 1) An assessment visit (approx. 4 hours) including a brief cognitive assessment, health questionnaires, physical fitness assessments and a blood test for Hba1c level, electrolytes and liver function to ensure participant safety. 2) Wearing an accelerometer and inclinometer for 7 days after the assessment visit. These are two small electronic devices (about the size of a man’s watch) that are used to measure overall daily activity. 3) An MRI brain scan at the Royal Melbourne Hospital And if they are randomised to either of the treatment groups: 4) A workshop visit to be trained in their intervention program The assessment and MRI visits, and the wearing of the accelerometer and inclinometer will be repeated after the intervention as a 12 week follow up. This project is a clinical trial involving three groups which participants will be randomly assigned to. Two of the groups will be given a home based physical activity program. Participants will be asked to gradually increase their individual activity by 150 minutes of moderate physical activity per week and trying to maintain this level for 12 weeks. In addition to the physical activity program, one of these groups will set goals to reduce the amount of time they spend sitting each day over the course of the program. Both of these groups will attend a workshop of 1-2 hours at the start of the 12 weeks to inform them about the study programs. The third group will be asked to continue with their usual routines for the 12 week period. At the end of their participation in the study this group will be invited to a 2 hour workshop which will cover information about physical activity and sitting time reduction.

  • Effect of Different Fatty Acids on Metabolic Rate in Overweight Women

    The importance of long-chain omega-3 polyunsaturated fatty acids (LCn3PUFA) in fish oil is widely recognised for its ranging health benefits. More recently, studies have looked at metabolic effects of fish oils. An early study indicated that dietary fish oil supplementation reduces body fat mass and stimulates fat oxidation in healthy adults. Whilst associations have been found between LCn3PUFA and body composition, there is inconsistency between studies looking at weight loss. Recent human studies have shown that provision of EPA and DHA from fish oil in a dose-dependent manner correlates strongly with an increase in the omega-3 index. However, no study to date has administered fish oil in a dose-dependent manner based on weight and examined the effects on resting energy expenditure, fat oxidation and body fat. Employing such a method may provide more substantial evidence to support an inverse relationship between fish oil supplementation and weight loss.

  • Central venous Access device SeCurement And Dressing Effectiveness in the ICU: the CASCADE ICU Trial

    About 500,000 Australians need a Central Venous Access Device (CVAD) each year for intravenous administration of medicines, chemotherapy and fluids. Insertion of these devices poses great procedural risk and complications are common during subsequent use. Between 20 and 50% of CVADs fail prior to treatment being complete. This includes CVADs becoming partially or wholly dislodged, occluded, thrombosis of the vein, fractured catheters, severe pain, or a bloodstream infection. These complications are associated with patient suffering, prolonged hospitalisation, more expensive healthcare costs and increased mortality. Two key factors in preventing complications are (i) securement - that CVADs are adequately secured to the skin, and (ii) dressings - that the incision is covered to prevent infection. CVAD securement has traditionally been via sutures, with a simple polyurethane dressing. This approach (sutures plus simple polyurethane) has been dominant since the 1980s, despite significant evidence of increased bloodstream infections. New alternative securement and dressing options have become available that may be superior to suture and simple polyurethane dressings for preventing complications, but these have not yet been adequately tested for efficacy or cost-effectiveness. CVAD securement and dressings cost the Australian health system millions of dollars each year, yet there is currently no high quality evidence from independent trials to guide decision making and practice on this topic. The proposed study is a high quality, pilot randomised controlled trial, designed to assess the feasibility of undertaking a full-scale efficacy randomised controlled trial, and provide preliminary data for an NHMRC project grant application. The full study would aim identify clinically- and cost-effective securement and dressing approaches that prevent CVAD failure. The 4 group trial will test 3 alternatives to standard care, a novel product – tissue adhesive (medical super-glue), and two commercial alternatives. This design will efficiently and rapidly test numerous treatments. The trial will additionally evaluate the acceptability of products to patients and clinicians, and apply an integrated approach to knowledge translation.

  • In people with type 1 diabetes, can an artificial pancreas algorithm improve postprandial glycaemic control following an unannounced meal compared with traditional carbohydrate counting?

    The research team have developed a novel artificial pancreas algorithm named SCENIC. The SCENIC algorithm has been shown to control insulin delivery and maintain good glycaemic control, including following exercise and food, on a diabetes simulator. In order to advance this technology, the next stage is to test the algorithm in people with type 1 diabetes. Therefore, this study aims to compare the SCENIC algorithm with standard insulin. Adults and children with type 1 diabetes will be given a meal and either standard insulin or SCENIC controlled insulin and the blood glucose will be monitored for 4 hours after the meal. To achieve this aim, we will recruit 10 children and adults with type 1 diabetes using insulin pump therapy (a small, programmable device that gives insulin). Participants will attend HMRI on 5 consecutive evenings, during which they will be given a test meal with the insulin dose determined using either standard clinical practice or the SCENIC algorithm. Their blood glucose levels will be monitored for 4 hours following the meal to determine whether the SCENIC algorithm can improve their blood glucose control without causing hypoglycaemia.

  • The EXTRA Practice Study: the feasibility of an extra practice upper limb protocol for adults after stroke

    Arm and hand training is routinely provided within stroke rehabilitation programs around Australia. Arm and hand training for stroke survivors aims to improve the amount a person can move, the control they have during the movement, and the strength of the muscles in the arm and hand. Research has shown that hospitalised patients get between 30 to 60 minutes of hand and arm practice every day. Other research has shown that doing extra leg practice every day is not harmful and can lead to people being able to walk earlier than those who did not complete the extra practice. What remains unknown is whether it is feasible for an inpatient to do extra arm and hand practice than is currently offered in Australian hospitals, and if an inpatient completes extra arm and hand practice, does this also lead to a person being able to move more or earlier than those who only complete their usual therapy. This study aims to find out if receiving 60 minutes of extra arm and hand practice in addition to usual therapy is safe and feasible after stroke. Participants will be asked to complete a semi-supervised EXTRA practice upper limb therapy package for one hour per day, six days a week for four weeks while an inpatient of Caulfield Hospital.

  • A comparison of three community aphasia groups for people with aphasia and their family members

    The aim of the study is to compare the efficacy of three models of community aphasia groups for participants with aphasia and their nominated family members. Outcomes for people with aphasia will be measured in relation to each domain of the World Health Organisation (WHO) International Classification of Functioning, Disability, and Health (WHO, 2001): impairment, activity & participation, personal factors, and environmental factors. Quality of life and participant experience of the program will be additional outcome areas of interest. Outcomes for family members will relate to caregiving, psychological health, supported conversation skill, and participant experience of the program. Hypotheses: 1) Each of the three community aphasia groups will lead to positive outcomes for all people with aphasia at the end of participation in at least one area of outcome measurement, 2) People with aphasia attending the treatment group (known as multidisciplinary-facilitated community aphasia group, or MD-CAG) will show greater gains than people with aphasia attending either of the two active comparison groups, 3) The gains made by people with aphasia attending MD-CAG will be maintained or will increase further 4-6 weeks after the end of participation, 4) Family members attending MD-CAG and one of the active comparison groups (known as volunteer and peer-facilitated community aphasia group, or VP-CAG), will show gains in at least one area of outcome measurement at the end of participation, 5) Family members of people with aphasia attending MD-CAG will show greater gains than family members of people with aphasia attending either of the two comparison groups, and 6) The gains made by family members will be maintained or will increase further 4-6 weeks after the end of participation. Reference: World Health Organisation. (2001). International Classification of Functioning, Disability, and Health. Geneva, Switzerland: World Health Organisation.

  • Neuromuscular, physiological and perceptual responses to linear vs. multidirectional high intensity running sessions in academy rugby union players.

    This study will examine the neuromuscular, physiological and perceptual responses to two types of modified high intensity running sessions typically used in rugby training environments, i.e. linear (L) vs. shuttle run with multiple changes of direction (COD). Measures of muscle function (i.e. knee flexion, extension, shallow range eccentric hamstrings and adductor squeeze) will be recorded before and immediately after both protocol A (linear) and B (multidirectional). Blood lactate concentration ([La]), rating of perceived effort (RPE), heart rate (HR) and a perceptual measure of fatigue questionnaire will also be measured at each trial. Movement characteristics during running will also be recorded using a 10Hz GPS system. Subjects will run at maximal speed during 30 m shuttles set up in accordance to either protocol A or B. Each 30m of running will be followed by 30 m walking at <1 m/s. Subjects will run a total distance of 1500 m in both protocols. Neuromuscular markers will be reassessed at 48 hours post running.

  • Effects and Feasibility of a Physical Exercise Intervention for Individuals Living with a Dementia in Nursing Homes

    Physical exercises are well established as having a wide range of physical and psychological health and well-being benefits for individuals, including older individuals. However, less is known about the effects of PE interventions for individuals with dementia, specifically in nursing homes. The aim of this PhD study is to implement and evaluate the effectiveness of a physiotherapist-led PE intervention for individuals living with a dementia in nursing homes in Adelaide. The primary outcome will be a measure of agitation levels using the Cohen Mansfield Agitation Inventory, and the secondary outcomes will be physical performance (timed up and go test, six meter walk test, five time sit to stand test, (modified) functional reach test, timed static pedalling and number of falls) and interviews with family and staff.

  • Assessment of state of (under-)nutrition and its relationship with muscle mass and function over 12 months in institutionalized elderly in South Australia.

    This is an observational study which aims to evaluate the nutritional status, muscle mass and function, quality of life, morbidity and mortality in the elderly living in nursing home setting. Measurements will be taken at baseline, 6 months and 12 months. Outcome measured in this study include: nutritional status, muscle mass and function, hospital admission (number and length of hospital stay), level of care quality of life, and mortality.

  • A pilot trial evaluating a new online pain management program (Reboot Online Pain Program) for adults living with chronic pain.

    The project aims to evaluate the acceptability and clinical efficiency of the online Reboot Pain Program. Up to 30 people with chronic pain (experiencing pain for more than 3 months) will be assigned to the active treatment group. The treatment group will commence the Reboot online program immediately. The efficacy of the program will determined by comparing severity of pain levels before and after treatment and at 3-month follow up.

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