ANZCTR search results

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

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31330 results sorted by trial registration date.
  • Impact of a Berry Extract on Vascular Function

    Polyphenols are bioactive compounds found in plants. These compounds have been found to have beneficial effects on vascular function. Arguably the most well-established vascular benefits are attributed to flavanols from cacao beans. Berry fruits are another rich source of polyphenols that have vasoactive properties, and there is a growing body of research exploring these effects in various berries (blueberries, cranberries, strawberries) and other fruit products with similar polyphenol composition. A key polyphenol in berries and other fruits believed to provide much of the benefit is anthocyanin. When given as an isolated extract 320mg anthocyanin has been found to improve blood vessel function both acutely and in response to chronic consumption over 12 weeks. Thus the primary focus of this project is to evaluate the effects of berry extracts of differing polyphenol dose on vascular endothelial function.

  • Does an individualised performance-focused swimming training program improve health, fitness and function in individuals following megaprosthesis bone replacement surgery?

    The aim of this project is to evaluate the effectiveness of an individualised, moderate intensity health focused training program, and a swimming performance focused training program at improving health, fitness and function in people with a megaprosthesis. Who is it for? You may be eligible to join this study if you are aged between 15 to 30 years, have had a lower limb megaprosthesis inserted at least 1 year ago, and are insufficiently active for health but are interested in participating in competitive sport. Study details: All participants in this study will partake in a four phase, 14 month (60 week) intervention, consisting of 15 weeks baseline, 30 weeks exercise training and 15 weeks of maintenance/off season monitoring. The study will be administered by a combination of swimming coaches, exercise scientists and physiotherapists. Training will include land and pool based sessions. Exercise choice will promote strength, aerobic capacity, neuromotor function, flexibility and swim performance. Frequency, intensity, duration and activities included in each training session will be individually prescribed and progressed based on each participants individual exercise tolerance. Regular testing will be conducted throughout the study to evaluate health, physical fitness and function.. We hope that information gained from this research will help to inform discussion as to whether individuals that have had a lower limb megaprosthesis should be eligible for participation in Paralympic sport within the current classification system or whether changes are warranted.

  • The effect of two concentrations of delta-9 tetrahydrocannabinol (THC, the active ingredient in Cannabis) on saliva-based drug detection systems and driving performance

    This study aims to test the whether legally permissible levels of THC available in foodstuff is detected by a commonly used single-use saliva-based drug test when compared to a placebo and if this differs when given in different concentrations (high and low). We will also be assessing whether there are any changes to driving ability as a result of ingesting hempseed oil.

  • A feasibility study of a text message brief intervention following a suicide attempt

    Suicide is a leading cause of death in Australia, and is the leading cause of death for young people. A previous suicide attempt is a strong predictor of death by suicide, and hospital-treated deliberate self-harm (DSH) is the single strongest risk factor for subsequent suicide. The one-year repetition rate for hospital-treated DSH is 16%, which increases to 30% for those with a history of previous suicidal behaviour. Following a suicide attempt, the first days after discharge from hospital is a particularly high-risk period. Continuity of care is critical, yet this is a time where individuals often lose contact with healthcare services. There is considerable uncertainty about the most effective post-discharge interventions to reduce repetition, with non-significant reductions attained using a variety of techniques. Brief contact interventions, including post-discharge letters, green cards, telephone calls, and postcards, have reduced the number of repeat events, but digital delivery of brief contact interventions, such as SMS, email or social media, has not yet been evaluated. The RAFT project is a single group, pre-post pilot study of a digitally-delivered brief intervention aimed at reducing repeat suicide attempts. RAFT will deliver text messages containing links to information and therapeutic content via mobile telephone, at specified intervals. To pilot this intervention, individuals aged 18 years or older who present to a participating hospital following a suicide attempt will be offered this intervention. After informed consent, baseline measures will be administered online. Follow-up measures will assess suicidal ideation and behaviour, and social connectedness. In addition, feasibility and acceptability of the intervention will be assessed by examining participants' use of the intervention materials and through semi-structured interviews.

  • A proactive Inpatient Diabetes Service to improve diabetes care in hospitalised patients.

    Background: The prevalence of diabetes in hospitalised patients is 25-30% in Australian hospitals. During hospitalisation for surgery or acute medical illness, diabetes management becomes more difficult. Resultantly, hypoglycaemia (low blood glucose) and hyperglycaemia (high blood glucose) frequently occur with associated complications including infections, longer length of stay and mortality. The management of inpatient diabetes remains suboptimal due to multiple factors, including altered physiology, dynamic hospital processes and medication changes. There is inattention and clinical inertia to inpatient diabetes management due to numerous pressures on hospital beds, expediting acute care and the increasing prevalence of diabetes. This study seeks to investigate a novel, proactive model of inpatient diabetes care. Methods: This study is a cluster-randomised controlled trial of a proactive Inpatient Diabetes Service (IDS) model of care. The IDS will identify inpatients with known diabetes and inpatients with new-onset hyperglycaemia using connectivity blood glucose meters and a "glucose alert pathway". The IDS will deliver a proactive consult service to these patients without referral from the treating teams, early in their admission. The IDS will manage inpatient diabetes care and facilitate discharge for these patients with the aim of increasing safety, reducing adverse glycaemia and reducing diabetes related complications. Consecutive inpatients with known diabetes or new-onset hyperglycaemia, admitted to the 8 participating wards will be included. The participating 8 wards will be cluster-randomised to 4 intervention and 4 control wards. The trial consists of a 3-months baseline period followed by a 3-months intervention period. It is hypothesised that the proactive IDS will reduce adverse glycaemia (unsafe blood glucose levels), adverse clinical outcomes and reduce length of stay in hospitalised patients with diabetes.

  • Benefits of Exercise Physiology Services for Type II Diabetes: The BEST Study

    Currently, there is very little collective evidence on the efficacy of AEP-led exercise interventions “in practice” for people with chronic disease. This project aims to determine the effectiveness of services provided by Accredited Exercise Physiologists (AEP) for clients with type 2 diabetes on sustained participation on physical activity and clinical markers. Clients with type 2 diabetes who are referred by their General Practitioner to one of the participating Exercise Physiology clinics will be recruited for this study. Their outcomes will be compared to those of a control group that do not receive a referral but who are willing to undergo the same battery of assessments on two occasions.

  • Training restraint to increase healthy food consumption

    The project aims to investigate the efficacy of computerised inhibitory control training on unhealthy food consumption in obese adolescents and adults. Outcome measures will include consumption of various food types, attitudes towards food, and electrophysiological indices of approach/avoidance during exposure to food stimuli. Training will involve daily sessions playing an iOS app designed to reduce responses to unhealthy food, while encouraging responses to healthy foods. Using a waitlist control design the study will test both the efficacy of the app, and the viability of the intense training schedule.

  • Impact of obstructive sleep apnea treatment in patients with paroxysmal atrial fibrillation.

    There are multiple small observational studies suggesting that treatment of sleep apnoea has beneficial anti-arrhythmic effects. In this study we want to evaluate the impact of obstructive sleep apnoea treatment with continuous positive airway pressure on AF burden. We hypothesise that treatment of OSA improves AF burden.

  • Efficacy of the SMS4dads text messaging program in reducing depression and anxiety in new fathers, a randomised controlled trial.

    The perinatal period is a risky time for the mental health of fathers and this has important implications for them and their families. Fathers who experience psychological distress in the perinatal period are often isolated, unsupported, and uninformed about the need to seek help and how to go about it. Following previous research demonstrating that message content, and the processes used to operate SMS4dads are acceptable to fathers during their transition to parenthood, this multi-centre randomised controlled trial (RCT) aims to test the efficacy of SMS4dads. In this study the investigators will assess, using validated scales, the influence that SMS4dads has on key indicators of how well a father is coping with the transition to parenthood. These indicators include paternal depression, anxiety and distress, a sense of co-parenting quality, perceptions of parenting confidence, and reported alcohol consumption. Fathers will complete surveys at entry to the study, after 6 months and at 12 months after their child is born. Participants will be randomised into either an intervention arm (where they will receive messages and links, identical to those used in the previous phases of this research from 16 weeks pregnant to 12 months after birth) or to a control – wait list – arm, where they receive generic health messages for six months before being switched to recive intervention messages.. The intervention messages will provide fathers with information, motivation and practical advice on his relationships with his child, his partner and himself. Fathers, in the intervention arm will also be asked to keep track of their mood during the study by submitting information to SMS4dads on how well they are travelling. When fathers submit this information they will receive texts, of encouragement or support, which have been tailored to the response options. If this information indicates that a father is experiencing high levels of psychological distress an escalation system will be activated linking him to perinatal services offering telephone based counseling and support. The aim of this component of the project is to offer appropriate services to those in need but to also test whether fathers who report high levels of distress take the opportunity to access these services. Mothers will also be invited to participate if their partner is enrolled. The project will assess maternal distress at one time point (entry) to determine interactions between the intervention and levels of maternal depression, anxiety, and distress.

  • The effect of video game playing in older adults

    Recent findings on aging, as opposed to older scientific account, argue that the cognitive decline experienced during the later years in life is not inevitable. A stimulating environment is a potent catalyst to facilitate learning among older adults and may contribute to improvement in cognitive functioning and promote successful aging (Greenwood & Parasuraman, 2012). Video game playing is one of the popular interventions aimed to improve cognitive function among older adults. Studies have shown that older adults may benefit from a regular 30 to 60 minutes of gaming per day (Anderson-Hanley et al., 2014; Whitlock, McLaughlin, & Allaire, 2012). Positive changes in cognitive domains such as executive function, processing speed, and memory observed through video game play (e.g. Jaeggi, Buschkuehl, Jonides, & Perrig (2008), Nouchi et al. (2012), Anguera et al. (2013)). Encouraging findings have been shown in an experimental study by Anguera et al. (2013) which revealed older adults who played a multitask simulation game for 4 weeks experienced brain activation exceeding young adults who have not played video games. The benefits of gaming are not limited to cognition, but include physical functions and wellbeing (Y.-Y. Chao, Scherer, & Montgomery, 2015). Exergame is a type of game that requires not only cognitive, but also physical involvement of its players. Therefore, it is no surprise that burgeoning literature on exergaming effect to not only cognitive, but also the physical benefits. For example, Maillot, Perrot and Hartley (2012) revealed a significant improvement in heart rate, muscle strength, and balance after 14 weeks of Nintendo Wii compared to a no-contact control group. Parallel with physical enhancement, cognitive benefits are also observed post-training with significant positive changes in executive functioning and processing speed among older adults. Interestingly, cognition is not the only function that received the beneficial impact of physical activity. A shorter sleep latency and higher sleep efficiency reported among older adults with aquatic exercise (Chen, Fox, Ku, & Chang, 2015). Additionally, gaming also has positive effects towards older adults’ quality of life indicated by a higher well-being score and fewer depressive symptoms after weeks of game playing (Ballesteros et al., 2014; Y. Y. Chao, Scherer, Montgomery, Wu, & Lucke, 2014). The aim of the study is to investigate the effects of video game playing in older adults on cognitive performance, physical performance, sleep quality, and quality of life. Based on the existing literature, the study came to hypothesize that there will be significant differences in cognitive and physical performance between the groups of older adults, as well as in their sleep and quality of life.

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