ANZCTR search results

Aim: To determine the minimum dose of exercise required to elicit a positive clinically meaningful improvement in cardiorespiratory fitness in stroke survivors. Eligible participants are independently- ambulant, community dwelling stroke survivors who have met the screening criteria. Fitness will be assessed pre, during and after an 8-week exercise intervention. Habitual activity (over a 7-day period) will also be assessed at these time points. Baseline measures include demographics (age, gender, living arrangements), stroke-specific variables (stroke type and severity, time since stroke, side affected, level of disability, anthropometric measures (height, weight, girths), cognitive function and exercise preference. Intervention Participants will participate an 8-week 3 day/week home-based individually prescribed exercise program and will be monitored remotely via tele-rehabilitation.. Exercise sessions will consist of 5 minute intervals at alternating higher/lower intensities (55-85% HR max), progressing from 30s/30s to 2min/2min by week 8 as tolerated. Programs will take into account initial fitness level, degree of disability and participant preference. The starting dose duration will be 30 min/week, progressing 15min/week per dose. The primary outcome will be the smallest dose of exercise required to increase cardiorespiratory fitness by 2ml.kg-1.min-1 in 8 weeks where dose is defined as the total number of minutes of exercise prescribed per week at a moderate to vigorous intensity (55 to 85% HR max). Secondary measures include blood pressure, weight, girths, cycle GXT peak power output, peak HR, lactate, walking ability, mood (anxiety and depression), physical activity level and health-related quality of life factors (HRQoL).

Reducing the prevalence of obesity remains a major public health challenge, demanding effective, broad-scale interventions to support weight management and health behaviour change. The intensive approach seen within academic lifestyle intervention programs is effective, but requires considerable resources, including time, money and the availability of multiple health professionals with expertise in the behavioural treatment of obesity. It may therefore be considered too burdensome and expensive to be sustainable in a community environment. In order to translate the success of academic lifestyle interventions into community settings, we must explore innovative ways to adapt these approaches, while still maintaining the key features that led to their success. Offering patient-provider support via mobile technology offers a potential way to reduce face-to-face contact, thereby lowering the cost, time and burden of obesity management programs. Emerging evidence supports the efficacy of providing technology-delivered extended contact interventions to support weight maintenance after the completion of a lifestyle intervention program. However to the best of our knowledge this is the first study to explore the use of technology as an adjunctive tool to support a community-based obesity management program. This 12-month randomised controlled trial is designed to determine if the addition of telephone and text message support to a community based obesity management program improves lifestyle intervention adherence and clinical outcomes when compared to standard care. Participants within the intervention group will receive monthly telephone calls and individualised text message support for a period of six months in addition to standard care within a community based obesity management program. The additional support will be grounded in behaviour change theory, with a range of behavioural treatment strategies targeted, including: goal setting, self-monitoring, motivational interviewing, problem solving, relapse prevention, stimulus control, cognitive restructuring and self-reinforcement. Outcome measures include diet and physical activity adherence, program attendance/attrition, weight loss, diet and physical activity self-efficacy and motivational readiness.

This research project is being conducted to look at the safety, tolerability, pharmacokinetics (PK, how the human body processes a substance) and pharmacodynamics (PD, the measure of what a substance does to the human body), of different dosages of IONIS-TMPRSS6-Lrx when given to healthy participants as either a single subcutaneous (SC, an injection just under the skin) dose, or as multiple SC doses over a course of 6 weeks.

Background: Lifespan is the systems approach to suicide prevention developed by Black Dog Institute (BDI) and the NHMRC Centre for Research Excellence in Suicide Prevention. BDI is undertaking an evaluation of the LifeSpan approach in four sites across NSW, funded by the Paul Ramsay Foundation and with the support of the NSW Government and the NSW Mental Health Commission. LifeSpan includes nine evidence-based interventions implemented simultaneously within a localised region. Recognising that multiple strategies implemented at the same time are likely to generate bigger effects than just the sum of its parts (i.e., due to synergistic effects), LifeSpan offers a data driven, evidence-based approach, setting it apart from current practise and raising the bar in suicide prevention. Based on the most up-to-date evidence available and drawing from positive results of similar suicide prevention programs overseas, this integrated systems approach is expected to prevent 20% of suicide deaths, and 30% of suicide attempts. Design: LifeSpan involves a stepped-wedge, randomised design whereby the intervention will be sequentially rolled-out in each of the four sites at three month intervals. This design will avoid the effect of the intervention being confounded with any underlying temporal trend. Once rolled-out, the intervention will be active in each site for two years. Methods: LifeSpan will involve implementing nine intervention strategies. The individual-based strategies include: aftercare and crisis care, psychosocial and pharmacotherapy treatments, GP capacity building and support, frontline staff training, and gatekeeper training. The universal strategies include: school programs, community campaigns, media guidelines and means restriction. Furthermore, the project will include a community, professionals, and key stakeholder self-report measures. The project will incorporate and be measured against an Implementation Science framework, to ensure maximum engagement and fidelity to the model.

The primary purpose of the study was to evaluate whether a bundle of line management measures focused on reducing the risk of contamination of Parenteral Nutrition (PN) lines would reduce the incidence of Late Onset Sepsis (LOS) in Very Low Birth Weight babies. The hypothesis was that the study intervention; comprised of a strict sterile technique for line changes and minimising the administration of other medications or fluids through PN lines would reduce catheter contamination and by minimising breaches would reduce the incidence of LOS when compared to the standard technique routinely used in the Neonatal Intensive Care Unit.

This will be a two group (1) resistance training (RT) in a gymnasium and 2) RT in the home, pre- and post-test feasibility study using a peer (buddy) for encouragement. The aims of this pilot project are to determine whether: 1. Peer (buddy) training is suitable to encourage older people who are not involved in resistance training (RT) currently, but are physically active (e.g. walk regularly) to start participating 2. Peer (buddy) training is suitable to encourage older people who are not involved in any physical activity to meet the recommended Australian physical activity guidelines (150 minutes moderate activity including RT twice a week) 3. The outcome measures proposed for the use in a larger trial planned to follow this feasibility study, are suitable for and acceptable for this population.

The study is to assess the safety and tolerability of PTG300 in normal healthy volunteers. This includes vital signs, safety labs and physical examinations Study drug (a single dose of either PTG-300 or placebo, or two doses a week apart) will be given as a subcutaneous injection. The study will also evaluate the PK of the drug after dose administration, and effects of PTG300 on iron levels. Participants will be entered into standard study cohorts of 10, 8 active:2 placebo for Cohorts 1 to 6, and 6 (5 active: 1 placebo) for Cohort 7

The primary aim of this project is to examine specific inflammatory markers and define the association with coagulopathies in patients undergoing elective total knee arthroplasty (TKA). A total of 20 patients will be observed in the trial; these patients are all undergoing Primary TKA for treatment of osteoarthritis (OA). There are multiple traumatic events that occur over the duration of TKA surgery, all which illicit some form of inflammatory and immune response; it is this response that we are interested in examining. Disruption to the skin, bone and synovial membrane all trigger an inflammatory cytokine cascade. The concentrations in peripheral blood of selected cytokines have been reported to undergo more rapid increases and quicker return to normal values after surgery than either CRP or ESR suggesting they may be better markers for risk of early infection following TKR. There has been limited research to determine whether there is an association between particular inflammatory cytokine markers, coagulopathies and clinical outcomes post-surgery. We aim to examine the changes in concentration of key inflammatory cytokine markers in peripheral blood of elective TKA patients during and after surgery and to define the association with coagulopathies. Patients undergoing unilateral TKA for OA will have blood samples taken at six time-points peri-operative and on the ward at day one and three post-surgery The blood samples will be used for analysis of key inflammatory markers and coagulopathy parameters. Patient-reported health outcomes relating to pain, analgesia, sleep and joint function will be completed pre and post-surgery. Patient rehabilitation post-surgery will be consistent with current standard protocols with the exception of NSAID administration, unless otherwise advised. The use of tranexamic acid during TKA to treat or prevent excessive blood loss during surgery will be recorded. Data collected will be analysed to identify significant changes in both coagulation and inflammatory markers in response to trauma during surgery and in recovery, Correlations between biological markers and patient health outcomes will be explored.

Children with ASD aged 3 to 12 years will take a placebo spray for 3 weeks, followed by being randomised to a course of twice-daily nasally-administered oxytocin or placebo for 12 weeks in a double-blind, placebo-controlled between-subject design. We hope to identify children with ASD who benefit from this treatment and the associated cognitive and neurobiological markers that predict such changes.

A 2-arm randomised waitlist-controlled trial with a primary endpoint at 3 weeks and a 3-month follow-up, testing the effectiveness of a web-based, audio podcast (using computer, smartphone or tablet) program to improve adjustment following an intimate partner relationship separation. The purpose of this intervention is to target individuals who have separated from a romantic relationship in the past six months, and use Brief Interpersonal Psychotherapy (IPT-B) strategies to promote active coping and positive adjustment and decrease suicidal ideation and symptoms of depression. The intervention is a web-based, six-session, online podcast program that can be accessed from any location with internet access. The intervention is free, confidential and easily accessible by people across Australia. Assessments will be conducted at baseline, immediately after intervention (3 weeks) and at 12-week follow-up. Outcome measures will include demographics, mental health status, presence/severity of suicidal ideation, social support, positive adjustment, help seeking and the utility of the program.