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.
  • Investigation of the Impact of Degree of Weight Loss on Physiological Adaptations to Weight Loss

    There is evidence that public health measures aimed at reducing the burden of obesity have not been effective. Whilst there are several possible reasons for this, including a multitude of competing messages, the overabundance of energy dense food and the near absence of obligatory physical activity, it is likely that the more important reason is the fact that weight appears to be physiologically regulated and defended. This means that using public health measures to combat obesity is not likely to work for obese subjects. What is not yet known is if subjects who are overweight (as opposed to obese), defend weight loss, nor is it known if modest (~5%) weight loss is defended. If overweight or modest weight losses are not defended, it would allow the targeting of public health messages towards the overweight and to focus on modest weight loss in the obese. This study aims to investigate if overweight people defend weight loss as vigorously as obese people, and to determine at what degree of weight loss these physiological changes begin. Overweight and obese people will be recruited and placed on a VLED (very low energy diet) for a period of 12 weeks, aiming to decrease body weight by 15%. Measurements in body weight and a number of biomarkers will be taken at proscribed intervals. All participants will be followed up for a period of two years, to observe weight regain (if any). Gut hormone and other biomarker changes over the trial will be compared between the overweight cohort and the obese cohort, to determine any differences. For both cohorts, changes in gut hormones and other biomarkers will be compared at 5%, 10% and 15% baseline body weight lost, to determine when physiological defences increase.

  • Intensive treatment of Pediatric Obsessive Compulsive Disorder (OCD): Improving access and outcomes

    The aim of the study is to examine whether D-Cycloserine can augment graded exposure therapy for children and adolescents with Obsessive Compulsive Disorder. D-Cycloserine is an antibiotic drug traditionally used to treat tuberculosis. D-Cycloserine is a glutamatergic partial N-methyl-D-aspartate (NMDA) agonist, which has recently been shown to facilitate fear extinction in humans and animals and has also demonstrated to improve treatment outcome when combined with exposure therapy in social phobia, acrophobia, or fear of heights and OCD in adult samples. The drug has recently been used to augment exposure therapy for children and adolescents with OCD. A secondary aim of the study is to systematically examine the timing of D-Cycloserine augmentation in a pediatric sample by comparing D-Cycloserine given immediately before or immediately after exposure therapy.

  • Pathways to primary care: Improving the physical health outcomes of people with severe mental illness

    Compare health outcomes of people with a severe mental illness and at least one co-morbid chronic physical health problem who attend the Physical Health Clinic at Fremantle Hospital with a similar group of people who are engaged with a general practitioner in the community.

  • The effectiveness of branched-chain amino acid (BCAA) supplementation in delaying fatigue during prolonged exercise.

    Fatigue is common during exercise, with fatigue being described as sensations of tiredness with associated decrements in muscular performance and function. Exercise-induced fatigue is unique as it presents acutely and both the perception and duration of fatigue may be manipulated. Studies have shown that at the end of prolonged exercise, the concentration of serotonin was ultimately high compared to before exercising. Although we know the consumption of branched-chain amino acid (BCAA)are able to reduce the concentration of serotonin, there are still discrepancies to prove the effectiveness of BCAA in delaying fatigue and improve performance.

  • How Fit is the Stroke Survivor? Can community-dwelling stroke survivors undertaking an individualised program to increase activity levels improve their cardiorespiratory fitness? A pilot study

    Stroke is common in Australia and the number of people experiencing stroke will increase with the ageing population. Currently, rehabilitation therapy after stroke focusses on restoring functions such as walking, swallowing and speech, with a primary goal of enabling people to return home. Improving physical fitness, particularly cardiorespiratory fitness, receives very little or no attention; however, improving fitness has the potential to enhance recovery of function, prevent future stroke or other cardiovascular events such as heart attacks, and improve the quality of life of stroke survivors. Low levels of fitness make everyday activities difficult and fatiguing to perform and may also put the person at greater risk of another stroke. Studies of stroke survivors suggest they are only about half as fit as non-stroke people of a similar age. Unlike heart attack survivors who commonly access cardiac rehabilitation, fitness-training programs are not routinely available for stroke survivors. There have only been a small number of fitness training trials in stroke and most required participants to undergo expensive testing in a large hospital or research centre. The majority used a "one-program-fits-all" training approach and required participants to train at a single centre. Therefore the purpose of this project is to trial a physical activity program that is individualised to the participants' interests, abilities and access to equipment in their home or local community, is low-cost, and could be implemented anywhere in Australia. Participants will be provided with encouragement and support by phone and email, not only for the 12 weeks of the program but for the 12 month study duration. This pilot is a small, controlled trial where 50% participants will commence the program immediately while the other 50% will undergo baseline testing then be retested 12 weeks later before they start the program. We will compare fitness levels between those undergoing immediate and delayed fitness training, and measure changes before and after training as well as at 6 and 12 months.

  • The STRICT pilot study - Simvastatin Therapy for Reducing Inflammation in Colorectal cancer Trial

    The aim of this study is to assess the safety and feasibility of adding simvastatin to standard first-line chemotherapy regimens in untreated, metastatic colorectal cancer (CRC) patients with elevated inflammatory biomarkers. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with metastatic colorectal cancer with evidence of systemic inflammation. You must also be eligible for standard first-line chemotherapy regimens in accordance with local standards of care and pharmaceutical benefits scheme approvals. Study details All participants in this study will receive standard first line therapy, as chosen by their treating medical oncologist. In addition, participants will be asked to take a daily 40mg dose of simvastatin orally in the evening from the first day of chemotherapy until tumour progression or patient is withdrawn from treatment due to clinician or patient decision. Participants will be monitored for treatment toxicity and inflammation, and will also be asked to complete a questionnaire at 6 months to evaluate quality of life. The feasibility of the trial methods will also be evaluated in order to determine whether they could be used in a larger randomised clinical trial (RCT).

  • Is a low cost electronic measure of balance as valid as a force platform in distinguishing the balance performance of a healthy and a clinical older population?

    Do balance performance measures (both static and dynamic balance) on the low cost HUMAC Balance device have similar classification accuracy for balance impairment as the Neurocom EquiTest (Registered Trademark) System in healthy people over 60 years and people over 60 who have had a stroke

  • A Prospective Randomized Trial of the Direct Anterior Approach versus the Posterior Approach in Primary Total Hip Arthroplasty

    The research is aimed at investigating and comparing two surgical techniques practised for hip replacement surgery. The standard approach used across many health institutions is the posterior approach. This study compares the outcomes between the posterior and the anterior approach. The anterior approach is a well established technique that is widely used in Europe and the USA. There is reportedly a reduced rate of dislocation and quicker recovery time. However it is a technique that requires a higher level of skill and specialized equipment. The study aims to determine if the anterior approach for hip replacement surgery is equal if not better when compared to the standard posterior approach. Participants will be randomly allotted into one of two groups. One group will have surgery via the anterior approach and the other via the posterior approach. Participants will only know which group they are allotted to post operatively.

  • Essential Oils for Agitation Management in Older Adults: A Mixed Method Study

    This study is the first three-phase mixed method sequential design conducted to investigate the effect of Lavender or Lemon Balm on agitation in older people living in residential aged care facilities [RACFs]. This study will investigate the clinical effect of the essential oils on agitation and the situation, RACF setting, in which the clinical investigation is being conducted to identify perceptions or bias which may influence the study and outcomes. This proposed study is guided by the following questions: *What is the effect of Lavender or Lemon Balm aromatherapy on agitation in older people living in RACFs? *Are there differences between the agitation behaviour, frequency or severity experienced relative to no dementia or the degree of dementia? *Is the effectiveness of agitation management with Lavender or Lemon Balm dependent on no dementia or degree of dementia? *Can aromatherapy management affect the quality of life for the older person living in RACFs? *Can a nurse’s pre conceived perception and clinical experiences of aromatherapy effect methods and outcomes in essential oil investigations? This research seeks to answer the research questions by addressing five hypotheses: *Participants when receiving the Lavender or Lemon Balm aromatherapy treatment will experience less agitation than when receiving placebo treatment. *Participants who have dementia will experience greater agitation than participants who have no dementia. *Aromatherapy affects agitation differently in older people with no dementia to those with dementia. *Participant’s quality of life will improve with aromatherapy treatment groups than those receiving the placebo. *Bias in the study will be identified through nurses’ perceptions of aromatherapies effectiveness and practicality in RACFs

  • We Think You Can Dance! A pilot randomised controlled trial for aged care residents with dementia.

    This study is a single-blind randomized controlled pilot of a cognitively-enriched dance intervention called “We Think You can Dance!” for aged care facility residents with dementia. Residents will be randomly assigned to the dance program (n=8) or passive listening to a classical music and socialisation control group (n=8), for three 45-minute sessions a week for 16 weeks. Assessments will be conducted before, immediately and 2 months after the 16 week intervention period. We hypothesise that residents who participate in the dance group will improve in cognition, clinical assessment of change, agitation, physical function and activities of daily living relative to the control group.

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