ANZCTR search results

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

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31058 results sorted by trial registration date.
  • Feasibility of a Musculoskeletal-targeted Exercise and nutrition TElehealth program for Older women following bariatRIC surgery (METEORIC Trial)

    Despite its overwhelming benefits, a negative outcome of bariatric surgery is severe loss of bone and muscle mass. Postmenopausal women experience over two-fold greater bone microarchitecture deterioration than premenopausal women and men following bariatric surgery, and as such are at greatest risk for incident fractures. We have previously identified that supervised 30 minute, twice weekly functional impact training (FIT) in postmenopausal women with low bone mass resulted in significant improvements in lumbar spine and femoral neck bone mineral density (BMD) compared to control. No study has investigated the role of FIT in postmenopausal women following bariatric surgery using telehealth applications. We hypothesise that an 8-month functional and impact training (FIT) program combined with nutritional education, delivered via a mobile application, will be acceptable, safe, and well-adhered to in postmenopausal women following bariatric surgery. It is anticipated that the outcomes of the bariatric trial will inform the design of innovative future randomised controlled trials exploring this program as a potentially effective, safe, and feasible treatment strategy for maintaining musculoskeletal health after bariatric surgery.

  • KPJ (kidney protective jacket) Feasibility Study

    This is a feasilibility study to determine if use of KPJ™ (Kidney Protective Jacket) during renal transplantation is feasible and implementable in the Australian kidney transplant setting. In addition, it shall also assess whether the KPJ™ improves transplantation outcomes from ‘marginal’ or higher risk grafts currently used for transplantation.

  • The impact of endovascular therapy on clinical, physiological and imaging parameters in patients with ilio-caval occlusive disease

    The aim of this research is to establish how well stent treatment works at improving the condition of legs affected by narrowing of the veins that drain blood from the leg. It also aims to identify which diagnostic tests are best at determining which veins should be treated. Although we know that stenting can improve the condition of legs by improving the drainage of blood in legs affected by vein disease it is not clear when stenting should be offered as a treatment. In particular there are few studies that have looked at a wide range of ways of assessing the condition of the legs. There are a range of ways of assessing how severe an area of vein narrowing is, but it is not clear which method is best for guiding the surgeon when deciding whether or not to treat with a stent. In this research project we will be assessing the condition of the legs using a wide range of methods. We will also assess the narrowing in the vein with a range of different diagnostic tests prior to treatment at the time of the venogram. We will also follow up participants for one year after the treatment to check on the success of the treatment. From this information we hope to clarify some of the uncertainties around treatment of vein disease by identifying which assessment methods are best for identifying which patients will benefit the most from treatment.

  • ACTIVE STRIDES-CP: Effect of Intensive rehabilitation for children with moderate to severe cerebral palsy on gross motor skills and physical activity participation

    ACTIVE STRIDES-CP: Effect of Intensive rehabilitation for children with moderate to severe cerebral palsy on gross motor skills and physical activity participation. In Australia, 420 infants are born annually with cerebral palsy (CP), making it the most common physical disability in childhood. Of these infants, 40% will have moderate to severe motor disability which is associated with reduced general health, greater pain and discomfort, reduced independence in daily life skills and participation in physical activity, and poorer vocational outcomes. We have promising data about a new intervention, called Active Strides-CP, which we will test in 150 children with bilateral cerebral palsy and compare results to usual care. Researchers from The University of Queensland, led by A/Professor Leanne Sakzewski in partnership with researchers in Sydney, Melbourne and Perth are testing a new rehabilitation approach for children with moderate to severe cerebral palsy to help improve gross motor abilities, and participation in physically active leisure in the community. This novel approach combines a package of gait training using treadmills, overground walking using assistive devices, cycling and targeted training of gross motor goals with a total of 32 hours of training provided over an eight week period.

  • State-wide dissemination of the Internet-based Professional Learning to help teachers to support Activity in Youth (iPLAY) intervention

    Whole-of-school programs are considered one of eight investments that work for physical activity promotion by the International Society for Physical Activity and Health. However, very few whole-of-school interventions progress beyond efficacy testing to implementation at-scale. The ‘Internet-based Professional Learning to help teachers support Activity in Youth’ (iPLAY) program ) is a whole-of-school physical activity intervention, that includes three curricular and three non-curricular components: (i) quality physical education, (ii) classroom energisers, (iii) active homework, (iv) active playgrounds, (v) parental engagement, and (vi) community links. The iPLAY program was designed to improve cardiorespiratory fitness by providing children with opportunities to participate in moderate-to-vigorous physical activity within and beyond the school setting. The iPLAY program was evaluated via a cluster randomised controlled trial (RCT) in 22 New South Wales (NSW) primary schools (ACTRN12616000731493). At 12- and 24-months, students in the iPLAY group had greater increases in cardiorespiratory fitness than students in the control group. The aim of this study was to examine the dissemination of the iPLAY program in NSW primary schools using the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework.

  • Effect of Taking Probiotics and Synbiotics on Physical and Psychological Health and Cognitive Functions in Adults: An Experimental Study

    Depression and anxiety are some of the major mental health problems negatively affecting the physical and mental health of many individuals. Recent research suggests a possible therapeutic impact of taking probiotics as dietary supplements on symptoms of depression and anxiety. This study extends the current knowledge on the beneficial effects of taking dietary supplements on health by comparing the effect of taking probiotics and taking synbiotics and exploring potential mediating factors (e.g., cognitive function, personality, etc.).

  • Effect of Taking Probiotics, Synbiotics and Postbiotics on Physical and Psychological Health and Cognitive Functions in Adults: An Experimental Study

    Depression and anxiety are some of the major mental health problems negatively affecting the physical and mental health of many individuals. Recent research suggests a possible therapeutic impact of taking probiotics as dietary supplements on symptoms of depression and anxiety. This study extends the current knowledge on the beneficial effects of taking dietary supplements on health by comparing the effect of taking probiotics, taking synbiotics, and taking postbiotics and exploring potential mediating factors (e.g., cognitive function, personality, etc.).

  • MindYourHead web-app: a randomized controlled trial of the effect of online personalised mental wellbeing feedback on help-seeking among Chinese international students

    This study will evaluate the impact of a personalised mental wellbeing web-app on help-seeking, mental health literacy, self-stigma, and wellbeing among Chinese international students in a randomised controlled trial. Participants are randomised to the intervention (enhanced MindYourHead app), which provides personalised symptom feedback, tailored psychoeducation on symptoms and interventions, and tailored links to external resources and local mental health services; or the attention-control arm (standard MindYourHead app) with an identical web-app design but without the personalised feedback and tailored psychoeducation. Assessments occur at baseline, 1 week post-intervention and 6 weeks follow up. It is hypothesised that participants receiving the intervention will have higher help-seeking intentions and attitudes than those in the the control group.

  • Randomised hybrid implementation-effectiveness trial of a school-based mental health program in Australian schools

    Implementation of evidence-based programs in school settings can be challenging and these challenges undermine the benefits these programs deliver for children. The primary aim of this study is to assess the potential effectiveness of an implementation intervention designed to enhance the adoption of the PAX Good Behaviour Game in New South Wales (NSW) primary schools. A secondary outcome is to investigate the impact of the PAX Good Behaviour Game on children’s mental health in the Australian context. The study uses a cluster randomised hybrid III effectiveness-implementation design and will involve 60 NSW primary schools. Randomisation will occur at the school level. All NSW public schools trained in the PAX Good Behaviour Game are eligible for participation. The intervention is a multicomponent implementation strategy that has been iteratively co-designed by the research team and local stakeholders. Intervention schools will have access to multi-component implementation support strategy in addition to the coaching received as usual care to assist with implementation challenges. Primary and secondary implementation and effectiveness outcomes using self-report online surveys with teachers, support staff and parents at baseline until 6-months follow up, and where relevant, from baseline to 12-months follow up. Qualitative interviews with teachers, support staff and principals will be used to examine which implementation strategies worked for whom and under what conditions.

  • Cost effectiveness of routine histology for haemorrhoidectomy specimens

    This study aimed to determine the cost-effectiveness of routine histology for haemorrhoidectomy specimens in a regional Australian hospital, as a way of detecting incidental anal cancer. The secondary aim was to determine the proportion of specimens that were sent for histology over the study period and whether individual surgeons had a significant preference for whether to send for histology.

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