ANZCTR search results

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

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32704 results sorted by trial registration date.
  • Wii Fit: the new generation tool for improving balance, health and well-being for women?

    By the year 2031 women (and men) who are currently 40 years of age and over will comprise the 25% of the Australian population aged over 65. The projected fall related health costs will have escalated to over $1000 million annually (Moller 2003) and the current rate of falls (1 in 3 older persons falling annually) will continue for those over 65 (Morris et al 2004) unless new initiatives are implemented. Moller (2003) identified a need for more effective prevention of falls and we believe this intervention must start before decline in balance and bone density become established. Current initiatives that aim to reduce falls and fall related injury and are available in the community presently target adults 65 years and over. Over the last eight years our research team has undertaken a number of projects that helped to inform the evidence base regarding the decline in the sensory-motor contribution to balance and the efficacy of specific balance strategy training in counteracting this decline. Our research team has demonstrated that postural stability and functional balance capacity are significantly reduced in women across the menopause transition period (40 to 60 years) and further reduced in the older person (Isles et al 2004, Low Choy et al 2003, Nitz et al 2003). We have found reduced strength and flexibility, reduced sensory acuity, and increased joint position error and higher thresholds of vibration sensitivity negatively contributing to this early change period in balance ability (Low Choy et al 2008; Low Choy et al 2007; Nitz & Low Choy 2004). Similar findings were reported by Lord & Ward (1994) although there was less data for women under 65 with only 20 to 30 subjects in the 40s and 50s decade groups compared to 118 and 116 for our study. A contributing factor associated with reduced strength and flexibility and reduced ability to balance in women, (Nitz & Low Choy 2007) is a lower self-reported activity level where habitual patterns of activity range from sedentary through to walking several times a week at a comfortable pace. Another most important aspect revealed by our studies of women aged 40 to 80 years has been the identification of the prevalence of falls across these decades and the major physiological factors that might have contributed to the falls in these women. Of particular interest are the findings over the 5 year longitudinal assessment study of balance and postural stability in women aged 40-80. Falls were recorded in 8.5% of women in their 40s in the year 1 audit and this rose to 15% in year 5. For those in their 50s, 13.5% had fallen at year 1 audit. This prevalence remained stable over 5 years. 24.5% of women in their 60s had fallen at year 1 audit but this prevalence dropped slightly to 21% by year 5 and 43% in their 70s had fallen at year 1 audit and this prevalence dropped to 31% by year 5. Of interest is the rise in multiple fall episodes in some women in their 40s through to 70s in the 5 year data collection period (Nitz et al, in review). This provides compelling evidence for the need to target women prior to age 64 for pre-emptive balance preserving intervention. Of particular interest for these younger women is what type of exercise might be adopted to address these declines and potential to fall. We propose to investigate three different exercise approaches that theoretically might reduce or delay the decline in balance and sensorimotor function in younger women. The effect of three approaches to slowing the balance, sensorimotor and fitness decline problem through three different exercise programs will be compared. Previously, balance strategy training has been shown and to improve balance (Hourigan et al 2008) as has aerobic exercises (Lui-Ambrose et al 2007). The effect achieve through exercise using a Wii.Fit™ will be evaluated. Then the three exercise approaches will be compared for effect. Primary aims are to: 1. demonstrate the effect of a training program using the Wii.Fit trademarkon balance, sensorimotor function and fitness in women aged 20-70years. 2. compare the effect in women aged 20-70year of Wii.Fit trademark training with balance strategy training (BST) and aerobic training (AT). Secondary aims are to identify whether one training method is better than another in this cohort of women

  • Assessment of free-living physical activity using a multi-sensor armband in people with chronic obstructive pulmonary disease (COPD) with and without co-morbid physical conditions

    Aim is to determine the overall level of activity generated in everyday living by patients with COPD and co-morbidities compared to a COPD population without co-morbidities. The hypothesis is that people with COPD and co-morbid conditions generate less physical activity in every day living compared to people living with COPD with no co-morbid conditions.

  • A Randomised Controlled Trial of a running program for Hospital Neurological Outpatients

    This is a clincial trial running within Shenton Park Rehabilitation Hospital. Recruitment is from the outpatient rehabilitation list.

  • A randomised controlled trial of fish oil for treatment of aggressive behaviour in young people

    Aggressive behaviours are common issues in young people accessing mental health services. Fish oils are popular treatments and are sometimes marketed for behavioural problems. However, no research has specifically examined fish oils for aggressive behaviour in young people. This study will examine whether fish oil is able to reduce the frequency and severity of aggressive behaviour in children and adolescents.

  • International Study to Predict Optimized Treatment - in Depression

  • A comparison study of fish oil capsules and psychological therapy versus placebo capsules and psychological therapy in patients at risk of developing a psychotic disorder.

    In recent years, researchers of psychotic disorders, a group of mental disorders that involve a loss of contact with reality and symptoms such as hallucinations and delusions, have focused their attention on studying the early phase of psychotic disorders, referred to as the prodromal phase. The prodromal phase is the period of a psychotic disorder where individuals experience the types of symptoms that are indicative of a psychotic disorder but are not yet of the severity or frequency that constitute a psychotic disorder. Much of the disability associated with psychotic disorders can develop during this phase, and such disability is difficult to reverse once a full psychotic disorder has developed. Hence, researchers are keen to learn more about the prodromal phase of psychotic disorders and investigate treatment strategies that can be applied during this phase with the hope of preventing, delaying or reducing the severity of psychotic disorders. As yet, a clear treatment strategy for this phase of disease has not been established. Researchers have established criteria to define individuals who are 'at risk' of developing a psychotic disorder. These are referred to as the 'ultra high risk' (UHR) criteria. Not all patients who are 'at risk' go on to develop a psychotic disorder; however, the use of such criteria allows researchers to further define the prodromal phase and investigate strategies that may prevent the development of a psychotic disorder. In this study, 320 patients who are 'at risk' of developing a psychotic disorder will be treated with omega-3 fatty acids, naturally occurring molecules found in fish oil, or receive a placebo. In addition to receiving one of these two treatments, all patients will receive a psychological treatment known as cognitive behavioural case management, which is based around standard case management and cognitive behavioural therapy that is routinely delivered by doctors and psychologists. The primary aim of the study is to determine whether omega-3 fatty acids, provided on a background of cognitive behavioural case management, can reduce the incidence of the development of a psychotic disorder in patients who are 'at risk' of developing such a disorder.

  • A phase IB/II study of sunitinib in combination with neoadjuvant radiation in patients with resectable soft tissue sarcoma

    Phase 1 and 2 This study looks at the effectiveness and side effects of different dose strengths of the drug sunitinib used in combination with standard pre-operative radiotherapy for soft-tissue sarcoma. Who is it for? You can join this study if you have soft-tissue sarcoma that has been confirmed by microscopic analysis, and is suitable for preventative radiotherapy and surgery and you are aged 16 years or older. Trial details Location: Peter MacCallum Cancer Centre, St Andrews Place, East Melbourne, Victoria, Australia. Participants will receive treatment over seven and a half weeks’ treatment. This involves 14 days of orally administered sunitinib followed by 5 weeks of combination treatment comprising standard pre-operative radiotherapy and oral administered sunitinib, at varying dosage levels. This research is being carried out with the aim of developing a more effective treatment than standard radiotherapy and surgery alone. Although standard treatment is frequently successful, some patients do not respond well to this treatment. Low oxygen levels in tumours, which may be a particular problem with sarcomas, are thought to be one factor that contributes to failure of radiotherapy. Sunitinib is a new drug that is active against cells with low oxygen levels. The combination of sunitinib and radiotherapy has shown promising results in other cancers. The purpose of this study is to find out whether treatment with a new drug, sunitinib, can increase the effectiveness of radiotherapy at killing cancer cells, and to test the safety of the combination of sunitinib and radiotherapy.

  • Effects on environmental, child, maternal and family outcomes for children born to at risk mothers (who have one or more risk factors for poorer parental coping) receiving sustained nurse home visiting compared with usual care

    Home visiting programs comprising intensive and sustained nurse home visits over the entire first two years of life (SNHV) show promise as interventions to promote child health and family functioning, and ameliorate disadvantage. This study is the first Australian randomised trial to determine the impact of a comprehensive SNHV program commencing antenatally in a population group living in an area of known disadvantage. As such this trial is a best-practice demonstration model for professional home visiting in Australia, with significant implications for the development of early childhood policy and strategy throughout Australia.

  • 'Songs for Life': Group music therapy for serious and enduring mental illness (SEMI) - a randomised control trial

    Severe and enduring mental illness (SEMI) impacts detrimentally on the ability to work and form relationships, thus reducing quality of life. People with SEMI living in the community are particularly vulnerable. The importance of psychosocial interventions, in conjunction with medication, to improve quality of life or people with SEMI is increasingly being acknowledged. Music therapy is a recognised psychosocial intervention that can promote social support through musical and personal interaction. A recent Cochrane review analysed four outcome studies of music therapy and mental illness (Gold, Heldal, Dahle & Wigram, 2005). Methods included active music making (mostly improvisation), and listening to music with discussion. A meta-analysis of results concluded that music therapy, when compared with standard care, improved global state, mental state and social functioning. The Songs for Life project aims to extend current knowledge about the benefits of music therapy for chronic psychiatric illness. The study will examine the effect of a music therapy intervention (involving singing, percussive improvisation and writing and recording an original song) on quality of life, self-esteem, social support, and sense of meaning and purpose in people with SEMI living in the community.

  • Does Gabapentin reduce the incidence of chronic pain post thoracotomy?

    Patients undergoing surgery usually experience some sort of pain post operatively. There are many drugs which can be taken to reduce or take away the pain. There are also different types of Anaesthetic procedures to help a patient who is in pain (such as an epidural for pain relief in childbirth). There have been recent advances in medicine which show that using several different types of pain medication is more effective used together and has fewer side effects such as nausea and vomiting, constipation and drowsiness. Also at this time, there is a theory that receiving pain relief just before an operation can help reduce the pain afterwards. Unfortunately for some patients the pain can be hard to control and it may bother them for some time (months or years) after the operation. We call this chronic pain and it is a common and difficult problem to manage. Previous experience has shown that using various pain medications is a useful approach to treating pain as there are many factors that can cause pain. It makes sense to use different medications to target the different pain pathways which are aggravated after surgery. Some pain relieving drugs have been found to have some unacceptable side effects. It has reduced the choice of medication that we can use to treat pain. We are proposing to use a drug that is commonly used for the treatment of chronic pain, Gabapentin. Gabapentin was first used for the treatment of seizures but it was quickly found to be useful in treating chronic pain. Gabapentin is licensed in Australia for treating pain and seizures. There have been some studies recently that have shown that it is helpful in treating immediate post operative pain (acute pain). As well as studying the effects of Gabapentin on post operative pain, we would also like to investigate whether continuing Gabapentin for 3 weeks after a thoracotomy helps prevent or reduces chronic pain.

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