ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Effects of exercise on menstrual pain in women with primary dysmenorrhea: A feasibility study

    The main purpose of this study is to examine the feasibility, of a promising intervention (exercise) that never became a standard treatment but with widespread acceptance with the evidence being mainly anecdotal. This study has been designed to optimise the training, content, and delivery of exercises to participants with menstrual pain. The specific objectives for this study are to: 1.To assess recruitment processes and study uptake to inform the feasibility of running a full study 2. To evaluate the retention rate of participants 3. To evaluate the study protocol 4. To determine the feasibility of the proposed outcome measures 5. To estimate the effect size of the intervention The experimental hypothesis is that a treatment program consisting of aerobic training, strengthening and stretching exercises would be effective in reducing the menstrual pain and severity among women with Primary dysmenorrhea

  • The effect of weight cycling on iron status, inflammation and immune function in young, overweight and obese women

    This study examines the effect of weight cycling on iron status, inflammation and immune function. The objective is to measure iron levels, inflammation and the immune systems of young women and then investigate how weight cycling can affect these factors. This research study is part of larger trial that is comparing the effectiveness of a red meat based, low fat diet and a white meat based, low fat diet on weight loss, immune function, blood fats, glucose, insulin and iron levels.

  • Saline Versus Albumin Fluid Evaulation study - Extrapolation to Paediatric Intensive Care

    Almost a decade ago, the SAFE study provided information on the effect of saline and albumin resuscitation fluids in adult patients in intensive care. Despite further studies, there remains a paucity of data on the most appropriate resuscitation fluid in infants and children in intensive care. The SAFE Extrapolation to Paediatric Intensive Care (SAFE-EPIC) study is an international point prevalence study of fluid resuscitation practice in paediatric patients in intensive care. The SAFE-EPIC study aims to describe the type of fluid used and the patient and intensive care unit factors associated with the use of this fluid in paediatric patients (0 – 16 years) in registered intensive care sites in countries throughout the world on two study dates (one in December 2012, and one in July 2013).

  • Vitamin D in critically ill patients with sepsis in Central Australia

    Indigenous Australians comprise a major proportion of the Central Australia population and there are a number of issues relating to those requiring critical care for sepsis, including higher rates of bacteraemia and poorer socio-economic status compared with non-indigenous populations in Australia. Despite high sunlight exposure in this region, it is thought that a combination of factors is likely to contribute to lower vitamin D levels among this population. The study will aim to establish baseline vitamin D levels in critically ill patients with sepsis in a Central Australian population. Our hypothesis is that there will be a significant degree of vitamin D deficiency in the critically ill, particularly among the septic cohort, and that it may be so prevalent as to justify routine supplementation in all critically ill patients without prior screening, further down the track

  • Effectiveness of a Facebook-delivered Physical Activity Intervention for Post-partum Women

    Background: Physical activity is reduced during the post-partum period. Facebook is frequently used by Australian mothers, and offers flexibility, high levels of engagement and the ability to disseminate information and advice via social contacts. The Mums Step it Up Program is a newly developed 50 day team-based physical activity intervention delivered via a Facebook app. The program involves post-partum women working in teams of 4-8 friends aiming to achieve 10,000 steps per day measured by a pedometer. Women are encouraged to use the app to log their daily steps and undertake social and supportive interactions with their friends and other participants. This study aims to determine the effectiveness of the Mums Step it Up Program. Method/Design: A sample of 126 women up to 12 months post-partum will be recruited through community-based health and family services. Participants will be randomly allocated into one of three groups: control, pedometer only and the Mums Step it Up Program. Assessments will be completed at baseline, 6 weeks and 6 months. The primary outcome (objective physical activity) and the secondary outcomes (sleep quality and quantity, depressive symptoms, weight and quality of life) will be used to determine the effectiveness of the Mums Step it Up Program compared with the control and pedometer only groups. Analyses will be undertaken on an intention to treat basis using random effects mixed modeling. The effect of theorized mediators (physical activity attitudes, subjective norms and perceived behavioral control) will also be examined. Discussion: This study will provide information about the potential of a Facebook app for the delivery of health behavior interventions. If this intervention proves to be effective it will be released on a mass scale and promoted to the general public.

  • Pharmacokinetics of Subcutaneous Injection (SC) of Testosterone in an Oil Vehicle: Nandrolone (ND) in Healthy Volunteers

    Although intramuscular injections of androgen's are known to be effective, they result in varying degrees of pain at the injection site that may last for a day or two. These injections need to be given into a precise location of the buttocks and require staff with expert training. Unlike many other injections these cannot be self-injected due to the difficulty of safely injecting into the buttocks. A SC injection, if effective, may be given by yourself in your own home, which would be more convenient to avoid extra medical visits as well as saving GP and hospital resources. Many men who require androgen replacement therapy may have bleeding disorders or are on medications that may intentionally slow the ability of their blood to clot. These men have a theoretical risk of bleeding and a very large bruise deep in an important muscle may later become infected and cause significant disability. As a result men using these anti-clotting drugs are usually prescribed other forms of androgen replacement therapy that are not always optimal. A SC injection, if effective, may be used in these men. Nandrolone decanoate (ND) Subcutaneous (SC) will be trialed in healthy volunteers,with a historical, intramuscular (IM) control data set. This is the first stage of a 2 stage research study

  • The 'Healthy Dads, Healthy Kids' community effectiveness trial: Evaluation of a community-based healthy lifestyle program for overweight fathers and their children

    It is well established that parents of primary school aged children substantially influence the food and physical activity home environment through behaviours, attitudes, feeding styles and role modelling. However, the contribution of fathers’ influence on children’s physical activity and eating behaviour is often overlooked.The Healthy Dads Healthy Kids (HDHK) project is based on research that shows the eating habits and exercise routine of fathers and father figures influence the ways in which the whole family approaches their health. The program was developed and successfully trialled at the University of Newcastle, with trial results showing that the major aims of HDHK were achieved. These were (i) to help overweight/obese fathers achieve a healthy weight, and (ii) to improve the activity and eating behaviours of their children (using fathers as the key agents of behaviour change). Phase 1 of the HDHK community effectiveness trial (http://www.anzctr.org.au/trial_view.aspx?ID=335368 ) was to evaluate the impact of the program in a community setting with trained local facilitators, employing a RCT design. The intention of this current project (Phase 2) is to research the effectivenss of the HDHK program on a larger scale community roll-out using a non-randomized, prospective design.

  • The effect of cognitive training and physical activity on everyday executive function in older adults.

    Normal cognitive ageing is characterised by slowing of information processing and a decline in a range of cognitive abilities that involve problem solving, attention, working memory, episodic memory and executive function. Cognitive ageing only interferes with daily activities when there are complex cognitive demands occurring jointly with sensory and physical demands. In order to improve everyday function in older adults, we aim to develop an intervention targeting both complex cognitive demands and physical demands. As a pilot study, we aim to compare executive function training with a physical activity intervention (Jazzercise), compared with a comparison group receiving no intervention, on everyday function outcomes including a driving simulator task.

  • Effects of aldosterone blockade in hypertrophic cardiomyopathy

    The hypothesis to be tested is that diffuse fibrosis in patients with hypertrophic cardiomyopathy is reduced following eplerenone therapy in a randomised, double-blind placebo controlled study

  • Improving the mental health of carers of stroke patients

    Stroke is a disease with severe consequences for the survivor and the unexpected carer. Carers experience tremendous changes and challenges from role reversal to financial struggle and subsequent increased burden, low mood, and poor overall health. In Australia, there are approximately 60,000 new strokes per year; a decrease in stroke mortality as a result of improvements in medical and surgical management mean people are living longer with the residues of stroke, and that carers increasingly face long-term burden. Eighty percent of individuals who experience stroke return home with varying degrees of neurological, behavioural and psychological symptoms. At home, they often rely on informal carers for their physical and emotional support. Previous psychosocial interventions to support informal carers of stroke survivors have shown promising results; however none have sought to integrate carer interventions with care coordination. To address this, the Australian Care Coordination program (ACCORD) has combined a 12-week individualised Collaborative Therapy with 3-month, 6-month and 12-month follow-up and care coordination in a 4-year study. This research will assess the feasibility and cost-effectiveness of improving the mental and physical health, social connectedness and health service utilisation of the carers of stroke as well as stroke survivors. This model will be designed with the intention of being readily adapted and applied in the context of other physical and also mental diseases. The findings of this randomised control trial will investigate the impact of ACCORD on reducing carer depression, burden and emotional stress.

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