ANZCTR search results

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

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31306 results sorted by trial registration date.
  • The development and implementation of Fit for Play, A program designed to develop the physical literacy and physical activity levels of children with a mental health disorder

    A mental health disorder (MHD) affects how a person thinks, behaves and interacts with others. People diagnosed with MHDs have poorer health than the general population, which is concerning as MHDs affect approximately one in seven children/adolescents each year. Physical activity (PA) participation is fundamental to good health, with benefits including increases in strength, plus improved bone, heart and mental health. Developing good PA habits throughout childhood is important, as active children are more likely to become active adults. This project therefore aims to develop, implement and evaluate an exercise program designed to improve the PA levels of children with a MHD through developing their physical literacy. Physical literacy is a concept surrounding the motivation, confidence, physical ability, knowledge, and understanding required to value PA and take individual responsibility for PA throughout life. Physically literate individuals are more likely to be physically active because they enjoy movement, and have a positive attitude towards PA. Children diagnosed with a MHD often have many barriers to being physically active including poor movement skills, and low strength and fitness compared to their peers. These barriers can negatively impact PA therefore, improving a child’s physical literacy, may assist them in becoming more physically active, resulting in a positive effect on their overall health. This exercise intervention, will be implemented into the Pathways therapeutic day program, a specialist unit within the Child and Adolescent Mental Health Service (CAMHS). The Pathways day program is for primary school-aged students with anxiety, behavioural and mood MHDs. Children will be allocated to one of two groups; Group 1 will continue the normal Pathways program; and Group 2 will participate in a 10-week exercise intervention in addition to their normal Pathways program. The exercise intervention will include 20 group sessions, with a focus on physical competence, knowledge, understanding and motivation for PA. Family involvement will be encouraged through education sessions and ‘homework’ exercise sessions. The primary outcomes include PA levels and physical literacy (physical competence; motivation and confidence for PA; knowledge and understanding). Using a knowledge translation plan the outcomes of this research will be implemented into clinical practice across CAMHS. Project partners (patients/families, the public, clinicians, policy makers, mangers) will be engaged through all stages of the research process. The outcomes of this study will assist in improving the PA levels of children with MHDs.

  • The Healthy Active Peaceful Playgrounds for Youth (HAPPY) Study. An inclusive and evidence-based approach to primary school physical activity environments.

    This HAPPY Study aims to examine the relationship between physical activity and on-task behaviour in primary school students, and to understand the environmental and societal factors that encourage physical activity in primary school students. To do this, an intervention will be developed and implemented, to increase physical activity, and enhance the social support provided to student, encouraging them to be physically active in schools. This study will aim to address physical activity levels in students, behavioural and psychological well-being in students, and how effective the intervention used is. In order to demonstrate how increased physical activity during school time can lead to improved on-task behaviour in primary school students, a study is required that measures both physical activity levels in students, and their behaviour in classes following this physical activity. Physical activity data will be collected before, during, and after the intervention to measure the impact that environmental modifications, social support and teacher training has on physical activity levels. This data will be analysed in relation to behavioural and on-task behaviour, collected through a survey and direct observations in class time following breaks. Comparison of these data sets should allow for any trends between physical activity, and psychological well-being in students identified and explored. This study will provide unique insight in how schools might address the educative and public health nexus of physical activity is a cost effective and sustainable way. The study will measure the effectiveness of an intervention, it's efficacy and scalability.

  • High-intensity interval training and hypoglycaemia minimisation in adults with type 1 diabetes

    High-intensity interval training (HIIT) characterises many team and field sports (eg. basketball and soccer) and spontaneous play in children. It involves alternating periods of high-intensity exercise and periods of recovery. Exercise-induced hypoglycaemia and increased glucose variability are barriers to exercise participation in many people with Type 1 diabetes (T1D). Trials of single-session HIIT generally show that blood glucose decreases to a smaller extent during HIIT compared to continuous aerobic exercise, suggesting that HIIT may be a preferred form of exercise for people with T1D. Overnight basal insulin reduction can reduce the risks of nocturnal hypoglycaemia following afternoon continuous moderate-intensity aerobic exercise in children with type 1 diabetes. Guideline recommendations for preventing post-exercise nocturnal hypoglycaemia after HIIT are generally based on those for continuous aerobic exercise, however it is unclear whether these two exercise types can be treated similarly. The effects of a basal insulin rate reduction to prevent nocturnal hypoglycaemia after HIIT has not been systematically studied. To our knowledge, this study will be the first study to investigate the effects of different dose-reductions in basal insulin to reduce the risks of overnight hypoglycaemia after high-intensity interval training in adults with type 1 diabetes, in comparison to non-exercising control day, and continuous moderate-intensity aerobic exercise. This will allow evidence-based recommendations to be developed to allow adults with type 1 diabetes to safely undertake HIIT exercise with reduced hypoglycaemia risk. Primary Objective: To determine appropriate dose-reduction in basal insulin to minimise overnight hypoglycaemia and hyperglycaemia following afternoon HIIT exercise Hypothesis: An evening basal insulin dose reduction of 20% will similarly minimise hypoglycaemia, and result in the greatest % of glucose in target 4-10mmol/L overnight, compared to 10% reduction and 30% reduction. Secondary Objective: To compare glucose response to single-session HIIT compared to single-session continuous moderate-intensity aerobic exercise. Hypothesis: HIIT with 20% basal dose reduction will be associated with a similar duration of overnight hypoglycaemia and glucose nadir compared with continuous moderate-intensity aerobic exercise of similar energy expenditure with 20% basal dose reduction.

  • Impact on writing alphabet symbols using an orthographic handwriting programme (The Secret Code), for children with handwriting difficulties, in year one or two of primary school.

    ‘The Secret Code’ is a novel occupational therapy handwriting programme. It follows the principals of orthographic development, which has been associated with creating significant and lasting change, for children who have challenges learning to write the letters of the alphabet. Handwriting difficulty is the most common reason for referral to occupational therapists who service young school age children. Currently, occupational therapy intervention is most often based on a motor learning perspective, using specific task training, practise and fine motor training. Evidence indicating the successful generalization of handwriting skills learned in therapy is scarce. With 10-34% of children in schools identified as failing to develop proficient handwriting, further research into this area to determine successful ways to help these children, is essential. This study aims to provide evidence to support further research into inclusion of orthographic processing in the traditional handwriting intervention.

  • Appetite hormones in anorexia nervosa

    We hypothesise that people with anorexia requiring hospital admission for treatment will have abnormalities in appetite peptides, and that these may not return to normal even with weight restoration. A secondary hypothesis is that we may be able to identify a predictor of good outcome at 1 year. This study will collect serial blood samples in people admitted to Westmead Hospital for treatment of anorexia nervosa. Blood will be collected prior to refeeding and at the visits closest to 2, 4, 8, 16 weeks, 6 and 12 months.

  • Effect of almond consumption on metabolic and liver function in overweight and obese adults with increased fasting glucose.

    To examine the effects of daily almond intake over a period of 8 weeks in overweight and obese individuals with increased risk of metabolic disease on a comprehensive array of novel markers of metabolic health that share complex interrelationships including: 1. Blood glucose regulation throughout the day/night 2. Liver fat concentration and composition 3. Abdominal (including visceral) fat volume 4. Liver function 5. Gut bacteria profile and functionality 7. Body weight and composition 8. Cardiovascular Disease Risk Markers 9. Systemic Inflammatory Markers The primary hypothesis is that daily almond consumption (56g – consumed as 2 between meal snacks) for 8 weeks will reduce diurnal PPG and GV and hepatic lipid content to a greater extent than an isocaloric control snack. Secondary hypotheses are that daily almond consumption (56g – consumed as 2 between meal snacks) for 8 weeks will improve measures of liver function, gut microbiome and permeability, systemic inflammation and traditional metabolic health markers (i.e. fasting insulin and glucose, HbA1c and lipids including cholesterol and triglyceride) to a greater extent than an isocaloric control snack.

  • Randomised study comparing the effects of the stimulant medications dexamphetamine and methylphenidate for treating attention deficit hyperactivity disorder (ADHD)

    Dexamphetamine and methylphenidate are used in the treatment of attention deficit hyperactivity disorder (ADHD) but few studies directly compare their efficacy. This randomised study has been designed to compare the efficacy and side effects of dexamphetamine and methylphenidate during initial dose titration for treating ADHD. The dose titration schedule will be allocated by weight (maximum dose 1 tablet twice daily for children up to 25kg body weight, 1.5 tablets twice daily for those 25-35kg and 2 tablets twice daily for those weighing more than 35kg: tablets containing 5mg dexamphetamine or 10mg methylphenidate are conventionally considered equipotent). The dose will be increased weekly (as tolerated) over 4 weeks, aiming to establish the lowest dose that gives maximum improvement in functioning. A rating scale will be requested from the child's teacher describing the child's functioning before starting medication and on each dose. Side effects will be monitored with rating scale and measurement of weight and blood pressure. Cognitive functioning using a simple computer-based test will be assessed unmedicated and on each dose used during titration. After dose titration, routine clinic data on the participants will be collected (height, weight, side effects, medication, reasons for medication change) until the completion of 12 months on treatment.

  • Mitochondrial agents in the treatment of chronic fatigue syndrome: a 20-week, open-label, intervention trial

    Chronic fatigue syndrome (CFS) is a prolonged multisystem illness, characterised by very poor stamina, delayed post-exertional fatigue, which adversely affects one’s functioning across numerous physical and mental domains. Current treatments for CFS include pharmacological (e.g. fluoxetine, rintatolimod, galantamine), psychological (e.g. cognitive behaviour therapy (CBT), adaptive pacing therapy), and lifestyle interventions. For many who remain in treatment, they continue to experience significant social, occupational, and functional impairment. Thus new treatment approaches are urgently needed. While significant fatigue remains a common complaint across numerous disorders, it is posited that CFS is related to metabolic dysfunction, mitochondrial dysfunction and impaired biogenesis, in turn related to oxidative stress and systemic inflammation. Mitochondria are structures within cells primarily responsible for energy generation, and are particularly active in oxygen-rich and highly energy dependent tissues, such as the brain. Recent research suggests that patients suffering from CFS may improve with the supplementation of mitochondrial nutrients and antioxidants. This supplementation may be associated with the reduction to mitochondrial membranes, restoring mitochondrial energy production, protecting cellular structures and enzymes from oxidative damage, and decreasing fatigue. Given that CFS is largely a heterogeneous illness associated with a complex and multifactorial aetiology, combined with the present state of available treatments, it is plausible that the introduction of a combination of metabolic therapies may have positive effects on mitochondrial dysfunction and lead to symptom improvement for CFS sufferers.

  • Physiotherapy & Physical Activity Promotion in healthy adults: Is measurement alone enough?: a pilot study.

    Background: Physiotherapists perceive the provision of physical activity advice as part of their role, and there is some evidence that physiotherapists can counsel effectively for physical activity behaviour change. In addition, simply measuring physical activity levels, without any other intervention, can cause people to change their physical activity behaviours, resulting in more physical activity being undertaken in the daily lives of adults. Considering this, objective measurement of physical activity by physiotherapists may result in favourable increases in their patients’ physical activity levels. This novel ‘measurement as intervention’ approach could prove to be a very efficient yet effective way to incorporate health promoting physical activity changes into physiotherapy consultations, in a number of different settings. The number of physiotherapy consultations per year in Australia has been estimated to be greater than 23 million. With the ever increasing access to objective activity monitoring devices (accelerometers in smartphones, wrist, shoe or arm worn devices etc.) combined with the broad reach of physiotherapy interventions, even a modest effect of a ‘measurement as intervention’ approach, with accountability to their physiotherapist, may prove to be an efficient approach to increase the populations’ physical activity levels in a meaningful way. However, preliminary work is required to determine the effects of potential measurement intensity (in terms of the frequency of measurement). Methodology: A pilot (two parallel arm) randomized control study conducted over 18-weeks at the University of Canberra will inform a larger study to determine if regular measurement of physical activity by physiotherapists increases physical activity levels in Australian adults (18 – 64 years old).

  • Does training family to help with physiotherapy improve falls related self efficacy, physical activity and quality of life for older people transitioning from hospital to the community?

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