ANZCTR search results

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

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32867 results sorted by trial registration date.
  • Prescribing the maximum tolerated dose of walking for people with severe knee osteoarthritis: A Phase II, Randomised Controlled Trial

    Low physical activity levels and poor cardiovascular health are big problems for people with severe knee osteoarthritis. This study is the first in the world to find out if a walking program can make a difference to their knee pain and cardiovascular health.

  • Motivational interviewing for people undergoing home dialysis to improve treatment adherence: A randomised controlled trial.

    Psycho-educational support is recommended as essential for patients undertaking self-management of their dialysis treatment An intervention such as motivational interviewing (MI), the use of the 5 As model and information giving from nurses may promote behavioural change to enhance adherence to prescribed treatments and to reduce risk factors associated with severe life threatening medical complications. This randomized controlled trial will examine the effectiveness of this intervention for people with ESKD and who live at home, undergoing either automated peritoneal dialysis or haemodialysis. This intervention may improve adherence to dialysis session times; fluid and dietary intake, diet and taking prescribed medications.

  • A Randomized, Double-Blind, Crossover, Phase IIa Study Comparing a Single-Application TPM (registered trademark)/Oxycodone Patch versus Vehicle Patch on pain intensity in the Topical Treatment of Patients with Postherpetic Neuralgia

    This is a research study to see if the TPM (registered trademark)/Oxycodone Patch (“study drug patch”) is safe and effective in treating participants with PHN compared to a patch which contains no Oxycodone but includes all of the other non-active components of the TPM (registered trademark)/Oxycodone Patch (“placebo patch” or “vehicle patch”). Oxycodone is an analgesic (pain reliever) which has been used, in tablet form, for the treatment of longstanding (chronic) moderate to severe pain, for many years. In tablet form it acts via the blood system. The patch also contains a form of vitamin E, called Tocopheryl Phosphate Mix (TPM), which can help some medications absorb across the skin. The purpose of this study is to find out whether the study drug patch provides pain relief when applied to an affected painful area in participants with PHN when compared to a vehicle patch. The study drug patch is designed to treat the area of reported pain ‘locally’ (at the site of pain in the skin) rather than ‘systemically’ (via the blood system). This TPM helps the drug to enter through the skin. Study participants will be required to wear a patch containing oxycodone (study drug patch) on one occasion and a vehicle patch on another occasion. Participants will be required to wear each patch for 3 days (approx. 72 hours) at the site of worst PHN pain. In addition, this study will determine how safe the patch is: 1. measuring the level of oxycodone that enters into blood (this is expected to be low and thus avoiding issues associated with euphoria, sedation and addiction) 2. monitoring symptoms that may be experienced while wearing the patch 3. observing results from assessments carried out during the course of the study

  • Trial of the effect of incentives and support to increase leisure centre usage by inactive people in Frankston

    Physical inactivity is prevalent in Australia and is a significant contributor to the nation’s burden of chronic disease. Increasing the availability of recreational infrastructure could, however, positively influence levels of physical activity. This study, conducted in partnership with Frankston City Council, will investigate the impact that establishing a major recreational and aquatic centre has upon physical activity and measures of well being in the community. It will test the additional impacts of using marketing strategies to boost centre usage, and thereby inform future action to multiply the health benefits of public investments in recreational infrastructure.

  • The effect of Trauma release exercises (TRE) on symptoms of restless legs syndrome (RLS): A randomised controlled trial

    The purpose of the study is to determine the effect of Tension and Trauma Release exercises (TRE) on the severity of symptoms of Restless Legs Syndrome (RLS). This treatment is currently offered to sufferers but no data supports its effectiveness.

  • Mechanisms of an education intervention to remediate cognitive dysfunction associated with cancer and its treatment

    This study builds on and extends a previous project that tested a group intervention for cancer survivors who have experienced problems with cognitive functions such as attention and memory. The study uses a more rigorous research design (random allocation to treatment or waitlist) and also tests potential reasons that the treatment may be effective. It was hypothesised that participants in the treatment group would show bigger improvements in objective cognitive function, subjective cognitive function and other self-report measures than participants on a waitlist or healthy control participants. It was also predicted that better cognitive function would be associated with higher self-efficacy and more favourable illness perceptions

  • A pairwise randomised control trial of a peer-to-peer play-based intervention for children with Autism Spectrum Disorder to improve social play skills and pragmatic language.

    Children with Autism Spectrum Disorder (ASD) have a number of limitations that contribute to social play and pragmatic language restrictions. Effective social play skills and pragmatic language are necessary for psychosocial development. Well developed social emotional skills and good quality relationships are protective factors that promote resilience and quality of life. The aim of this study is to evaluate the effectiveness of a peer-to-peer play based intervention to improve social play skills and pragmatic language in children with ASD. It is expected that following the intervention children with ASD will have improved social play and communication skills and improved ability to establish and maintain friendships. Findings from this study can be translated into clinical practice.

  • The feasibility and effectiveness of high-intensity boxing training versus moderate-intensity brisk walking in adults with abdominal obesity: A pilot study

    Background: High-intensity interval training (HIIT) performed on exercise cycle or treadmill is considered safe and often more beneficial for fat loss and cardiometabolic health than moderate-intensity continuous training (MICT). The aim of this pilot study was to assess the feasibility and effectiveness of a 12-week boxing training (HIIT) intervention compared with an equivalent dose of brisk walking (MICT) in obese adults. Methods: Men and women with abdominal obesity and body mass index >25kg/m2 were randomized to either a boxing group or a brisk walking (control) group for 12 weeks. Each group engaged in 4 training sessions per week, equated for total physical activity. Feasibility outcomes included recruitment rates, assessment of training intensities, adherence and adverse events. Effectiveness was assessed pre and post intervention via pertinent obesity-, cardiovascular-, and health-related quality of life (HRQoL) outcomes. Results: Nineteen individuals expressed an interest and 63% (n=12) consented. Recruitment was slower than anticipated (1.3 participants/week). The boxing group trained at a significantly higher intensity each week versus the brisk walking group (p<0.05). Two participants in the boxing group experienced an adverse event; both continued to exercise with modifications to the exercise program. No other adverse events were noted. The boxing group attended more exercise sessions (79% vs. 55%) and had a lower attrition rate (n=0 vs. n=2) than the walking group. Analysis of covariance revealed that the boxing group significantly improved body fat percentage (p=0.047), systolic blood pressure (p=0.026), augmentation index (AIx; p<0.001), absolute VO2max (p=0.015), and Physical Functioning (p=0.042) and Vitality (p=0.024) domains of HRQoL over time. The walking group did not improve any clinical outcomes, and experienced a worsening of Vitality (p=0.043). Conclusions: Boxing training (HIIT) in adults with abdominal obesity is feasible and may elicit a better therapeutic effect on obesity, cardiovascular, and HRQoL outcomes than an equivalent dose of brisk walking (MICT). Robustly designed randomized controlled trials are required to confirm these findings and inform clinical guidelines and practice for obesity treatment.

  • Patellofemoral joint osteoarthritis: the effect of foot orthoses on pain, function and bone marrow lesions. A pilot study

    Patellofemoral osteoarthritis is a common condition that results in pain and functional limitations. Custom foot orthoses are effective at improving pain and function in younger people with patellofemoral pain, and thus may also be of benefit in older people with patellofemoral osteoarthritis. This Phase 2 study aims to investigate the feasibility of a Phase 3 randomised controlled trial evaluating the effect of custom foot orthoses and footwear on pain, lower limb function and bone marrow lesions in patellofemoral osteoarthritis.

  • Are endometrial nerve fibres unique to endometriosis? A prospective case control study of endometrial biopsy as a diagnostic test for endometriosis in women with pelvic pain.

    There is currently no non invasive way to diagnose endometriosis. The gold standard is laparoscopy plus directed biopsy. Previous studies have suggested that endometrial nerve fibre detection may function as a less invasive outpatient test of endometriosis. This work suggested that if fine nerve fibres (C type unmyelinated) are present in the functional layer of the endometrium then the patient has endometriosis and if the fibres are not present the patient does not have endometriosis. We wish to recruit women with pelvic pain as we wonder if the nerve fibres relate to the painful condition rather than to endometriosis. We will perform endometrial nerve fibre detection in 20 women with pain and no endometriosis and 20 women with pain who have endometriosis. Our hypothesis is that fine nerve fibres will be found in the functional layer of the endometrium in women both with and without endometriosis who also have pelvic pain. Thus endometrial nerve fibre detection is not a useful way to diagnose endometriosis.

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