ANZCTR search results

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

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31130 results sorted by trial registration date.
  • Training Intensity Early after Stroke

    This is a novel dose-escalation study to find the maximum tolerable cardiorespiratory fitness (CRF) training intensity in acute stroke survivors. Small consecutive groups of five stroke survivors receive a CRF training program at a certain intensity. In the next cohort of five participants, the intensity can escalate, stay the same or the study will be stopped and will be based on pre-defined rules. The rules are determined by the occurrence of symptoms of over-exercising in each cohort i.e. increase in pain and exhaustion. If the study is stopped the intensity in the previous cohort of 5 will be regarded as the maximum tolerable training intensity.

  • Early Moves: Can babies' early movements predict cognitive impairment?

    Early Moves aims to identify early biomarkers for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life. In the Early Moves study, parents will use a smart-phone app called Baby Moves to video their babies General Movements (GMs), with automated scoring being developed through machine-learning. GMs are spontaneous movements of babies less than 3 months old and provide insight into the function of a baby’s brain. Infants in the study will be assessed cognitive impairment at age two years using a standardised test of toddler development. It is hypothesised that GMs are sufficiently predictive of cognitive impairment at two years to act as a reliable screening tool.

  • Enhancing Type 2 Diabetes Risk Communication with Message Framing and Tailored Risk Feedback: An Online Randomised Controlled Trial

    While health risk communication interventions have proved efficacious in the general population, it has not been adequately tested as a brief online intervention tool. The aim of this study is to assess the feasibility and efficacy of a brief online health risk communication intervention on changing behavioural intentions. Participants will be randomly assigned to receive a health risk communication intervention with either a personalised or generalised T2D risk presentation condition, and subsequently either a gain-framed or loss-framed health message condition (e.g. personalised risk and gain-framed health message, personalised risk and loss-framed health message etc). It is hypothesized that participants who received the personalised gained framed condition will demonstrate a greater change in their behavioural intentions.

  • Integrating Osteoporosis in Primary Care: The Osteoporosis Risk and Management (ORMA) Project

    The ORMA Project is a randomised stepped wedge study aimed to assess the effectiveness of an e-technology (CAT-Osteoporosis) in the detection and improvement of osteoporosis disease management and associated risk factor by general practitioners. Is it hypothesized that with the use of CAT-Osteoporosis the proportion of patients properly identified, tested and diagnosed with osteoporosis increase

  • A foodservice model in a high performance sports team.

    This study will compare data from days that athletes are provided meals from a dietitian led food-service system and days when the food choices are led by the athletes. The methods of data collection will be used to extrapolate and compare player’s dietary (energy and macronutrient) intake, nutrient timing and dietary quality on food service vs athlete led days. Hypothesis: Dietary intake and meal timing will be superior (in relation to guidelines) on days that athletes consume meals provided by the clubs integrated food service model run by a sports dietitian.

  • Endurance training characteristics and Cardiac Arrhythmias in Cycling

    The aim of the proposed research is to identify the influence of endurance exercise training on rates of cardiac arrhythmia, and how the manipulation of training variables can modify this relationship. Competitive and recreational cyclists will undergo monitoring of exercise and periodic screening for cardiac arrhythmia burden. This study will be run as a randomised, counterbalanced crossover trial with four intervention periods, those being: habitual training levels, high intensity, high frequency and high duration of exercise. Participants will attend laboratorial testing sessions at the beginning and end of each intervention period, where they will be tested for cardiac arrhythmia burden, aerobic fitness and for biochemical markers. During each observation/intervention period their daily exercise training and physical activity will be monitored.

  • Trialing a fruit and vegetable intervention to promote a healthy weight and reduce disease risk

    Only 5% of Australian adults meet the recommended intake of fruit & vegetables. Energy from discretionary foods contributes to one third of total energy intake. Together these dietary patterns contribute to the prevalence of overweight and obesity in Australia. This 6 month study will trial two dietary patterns aimed to increase fruit and vegetable consumption and subsequently decrease consumption of discretionary foods. Participants will be randomised to one of two fruit and vegetable eating patterns. All participants will receive 2 weeks worth of fruit and vegetables. The type of fruit and vegetables they receive will depend on the group they have been radomised into. Participants will also be supported via personalised dietary consultations which will be delivered intensively in the first three months and then less intensively (maintenance phase) in the second three months. Aim: Evaluate the effect of two dietary patterns on diet quality, body composition, skin & urinary carotenoids, blood lipids and glucose. 2. To validate the Australian Eating Survey (AES).

  • Evaluation of new exercise guidelines for young people with Type 1 Diabetes

    Exercise has numerous physical and psychological health benefits for people with type 1 diabetes (T1D) however, the varying effects exercise has on blood glucose levels makes it challenging for young people with T1D. The current T1D guidelines available for exercise vary, are challenging to follow and not very accessible. Our research team have developed an app collating the guidelines with data from our previous studies to assist people with T1D to safely participate in a more physically active lifestyle. This project aims to evaluate the acceptability and usability of the app in individuals with T1D aged between 12 to 25 years during physical activity. At the end of the pilot test, these participants will complete an interview and survey. Analysis of pilot results will contribute to amending the features of the App to improve its usability and acceptability before conducting a trial.

  • A DDI Study to Evaluate the Effects of Itraconazole and Fluoxetine on AK0529 in Healthy Volunteers

    This Phase I study will evaluate the drug-drug interaction of the investigational medicinal and substrate product AK0529, when administered with either itraconazole, a strong cytochrome P450 3A4 and P-glycoprotein inhibitor (Cohort 1) or fluoxetine, a strong cytochrome P450 2D6 (Cohort 2) inhibitor in healthy adult subjects. The primary objective of this study is to evaluate the effect of multiple doses of itraconazole and fluoxetine on the pharmacokinetics of a single dose of AK0529. This is a two part, open-label, fixed sequence study to be conducted at a single clinical research centre.

  • Preventing relapse of major depressive disorder in youth: Randomised Controlled Trial of a novel mindfulness-based cognitive online social therapy

    The study aims to evaluate, via a randomised controlled trial (RCT), the effectiveness of Rebound, a moderated online social networking system in preventing relapse of Major Depressive Disorder (MDD) in young people (aged 14-27) with remitted MDD. Rebound includes therapeutic activities and information about mental health, mindfulness, personal strengths, and other topics relevant for young people recovering from MDD. Rebound also includes a social network where participants can communicate via posts and comments in a newsfeed and a problem-solving forum. The social network will be moderated by experienced mental health workers and trained peer workers with lived experience of mental ill-health. Enhanced TAU includes access to a private website with information about depression symptoms, causes and course, the relationship between behaviour and mood, information on diet, exercise, sleep, social support and getting support. Enhanced TAU does not include therapist support or online social networking. The primary hypothesis of the study is that, relative to enhanced TAU, TAU plus Rebound will reduce relapse rates among remitted young people with MDD.

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