ANZCTR search results

Increasing evidence suggests that sleep apnoea is an important factor driving CVD risk. Beyond worsening blood pressure and diabetes, sleep apnoea has direct adverse effects on blood vessels. In this study, we propose to employ a molecular imaging approach to investigate the impact of OSA on plaque activity. This study is a cross-sectional, observational study with the objective to ascertain the presence and extent of inflammatory activity of atherosclerotic plaque in patients with sleep apnoea. We will enroll 50 adults with obstructive sleep apnoea (OSA), 25 with mild OSA and 25 with moderate to severe OSA commencing continuous positive airways pressure (CPAP) therapy with either established atherosclerotic cardiovascular disease (ASCVD) or risk factors for ASCVD. A combined computed tomography (CT) and positron emission tomography (PET) scan will be performed following intravenous administration of is 18F-fluorodeoxyglucose (18F-FDG) which will enable measurement of inflammatory plaque activity. The findings will provide important information that may lead to the development of an important new marker to monitor reductions in CVD risk in sleep apnoea.

Fifth metacarpal neck fracture is a condition commonly referred to hand therapists for management. The method of treatment provided, as well as the frequency and duration of treatment vary widely, due to a lack of conclusive research evidence. This project will determine which of two treatment methods commonly employed by hand therapists is the most effective for the management of fifth metacarpal neck fracture. The findings of this project will enable therapists to decide with confidence which treatment method will produce the most satisfactory functional outcome and is preferred by patients. The results are expected to have implications for decision making about the resources allocated to this condition in the future, both in terms of therapist’s time and expertise, as well as materials used.

For many diseases, researchers have been able to find ‘biomarkers’ that are in the blood and that can predict whether or not someone is at risk of getting the disease. Biomarkers are naturally occurring molecules, genes, or other characteristics that help us to identify diseases and disease processes. The purpose of the research project is to use blood and tissue from people with susceptibility or resilience to cardiovascular disease (CVD), and to try and find new biomarkers that can identify risk of CVD at an early stage. In addition, we will investigate the use of biomarkers that we have already identified, and their ability to predict events and outcomes. We hope that by doing this, we will be able to: 1. Find out more about how and why CVD occurs 2. Find out more about the way that CVD progresses and affects different people 3. Find new biomarkers that will help us to work out if someone is at risk of CVD earlier 4. Find new treatments for CVD

This is a randomised control trial to compare platelet-rich plasma (PRP) against placebo (normal saline) as a treatment for women with symptomatic vulval lichen sclerosus (LS). LS is an acute and often chronic inflammatory dermatosis with autoimmune pathogenesis (Neill et al., 2010). It is a debilitating condition with serious consequences for the patient’s physical, emotional and sexual health (Newman et al., 2015). The management of LS is aimed at controlling symptoms, mainly severe vulvo-vaginal pruritus. Some women with LS are either unresponsive to corticosteroids or hesitate to use them. There are small studies to demonstrate PRP can improve vulvar LS. Therefore, this study is to assess the efficacy of PRP for treatment of vulvar LS.

The OPtimisation of Perioperative Cardiovascular Management to Improve Surgical outcomE II trial (Optimise II) is a large multi-centre randomised trial, which seeks to establish whether increasing blood flow from the heart during major abdominal surgery reduces the risk of infection. Within this large study, blood samples from 200 patients will be collected. All samples will be analysed for evidence of heart injury and 50 samples will be analysed also for circulation injury. This blood sample analysis will try to identify patients who are at higher risk of complications after surgery.

Informed medical consent is often poorly done; it can be time consuming, there is no clear standard between different medical practitioners, and overwhelmingly, the literature provides support for standardised animations or video consent. Video animations have been shown to improve patient comprehension, take the same amount of time, or can even save time and in most cases there is an improvement in patient satisfaction and comprehension. Videos have been successfully used to consent for colonoscopy, knee arthroscopy, laparoscopic urological procedures, cataract surgery, intravenous fluorescent angiography, vascular procedures, coronary angiography, cardiac electrophysiology, urogynaecological surgery as well as for clinical trials. There are no studies evaluating video informed consent for orthopaedic procedures in Australia. Given the literature shows improvements in patient understanding and satisfaction, it is anticipated that the video informed consent will lead to enhanced clinical practice, including enhanced knowledge retention by patients, improved patient and physician satisfaction, improved recall of the procedure, as well as saving minutes per consultation. We aim to compare traditional doctor-patient informed consent to a video animation when consenting for orthopaedic procedures (e.g. total hip replacement, total knee replacement, shoulder reconstruction, joint arthroscopy, hallux valgus deformity and other procedures). We propose that the video consent will be superior to traditional doctor patient consent – patients will have better retention of information, comprehension and understanding and higher satisfaction.

Tranexamic acid is a medication that can help reduce bleeding by stopping the breakdown of blood clots. It has been shown to reduce bleeding from many types of surgeries (such as heart, knee, hip, trauma and some gynaecological surgeries). When it has been used to reduce bleeding in surgery, tranexamic acid has not caused an increase in bad outcomes (adverse events). No one has yet done a study to see if tranexamic acid also helps to reduce bleeding in keyhole surgery for severe endometriosis. If less bleeding occurs using tranexamic acid during these surgeries it may also help to make operations shorter and less likely to have complications. We predict that tranexamic acid will reduce blood loss in keyhole surgery for severe endometriosis. This study is a randomized controlled research project where we randomly put people who are going to have endometriosis surgery into two groups. One group will get the treatment (tranexamic acid) during the surgery and the other group will get a placebo (a medication with no active ingredients). This is a double-blinded study which means both the participants and their doctors do not know which treatment the participants are receiving. We will weigh the blood loss from the surgeries to compare between the two groups if the tranexamic acid does indeed reduce blood loss in this type of surgery. We will also see if there are other differences between the groups such as the time it takes to finish the surgery, the rates of complications and how long the participants need to stay in hospital.

In this study, we investigate the effects of strength training of the non-affected arm on the affected arm after stroke. It has previously been shown that training of one arm can increase the strength in the trained and the untrained arm. We will test the strength in both arms before, during and after the training program. As a secondary outcome measure, we will test sensorimotor performance with the KinArm exoskeleton and test if our program has an effect on activities of daily living with the stroke-impact-scale.

This study aims to investigate whether an exercise program (TASK), with a self-management approach is feasible in terms of assisting people living in the community with stroke to exercise on an ongoing basis. Self-management in a complex condition like stroke is difficult. For self-management to be successful, an individual requires knowledge and skills, as well as the self-efficacy to be able to manage their exercise over the long term. We propose applying a more structured approach to self-management that includes training, resources and ongoing support – the TASK program. The proposed study includes two stages. In the first stage, participants will undertake the TASK program as physiotherapist-supervised practice. This practice is institution-based, supervised by physiotherapists and designed to progressively build knowledge and skills, and empower the person to exercise independently at home. In the second stage, participants will undertake TASK as self-directed practice, in which participants complete TASK independently at home. Throughout this stage participants will be provided with equipment, resources and ongoing remote support to complete the exercises. We anticipate the TASK program will remove barriers for people with stroke to self-manage their exercise upon discharge from formal rehabilitation and enhance their confidence to be more physically active in daily life. If the TASK program proves to be successful, physiotherapists will have an engaging, accessible and easy to deliver tool to a population where ongoing intervention is lacking – therefore enabling ongoing exercise.

Objectives: To determine the feasibility of conducting a future definitive randomised trial to assess the efficacy of specific load-intensity and time-under-tension exercise interventions for reducing pain in mid-portion Achilles tendinopathy. Design: Single-centre, outcome assessor-blind, feasibility factorial randomised pilot trial. Setting: Interventions provided in a university/ gym setting. Participants: Total number of 48 male participants with Achilles tendinopathy, recruited from the community. Interventions: Participants will be randomised into one of the four factorial arms that include high (6 repetitions to failure) or low (18 repetitions to failure) load-intensity calf exercise, and each will be performed with high (6 second per repetition) or low (2 seconds per repetition) time under tension. Exercise will be home-based and performed 3 times per week over 12 weeks. One exercise session per week will be monitored via telerehabilitation (videoconference). Main outcome measure: The primary outcomes will be study processes used to determine feasibility of a future definitive randomised trial. Process outcomes will include recruitment and retention rates, adherence to interventions, response rates to self-reported questionnaire outcomes, adverse events, and participants’ and telerehabilitation observers’ experiences with the interventions. Clinical outcomes including patient rated pain, function, global satisfaction, health-related quality of life, physical activity, kinesiophobia, pain catastrophic thinking as well as measures of plantarflexion motor function will be collected to explore the rate of change over 6 and 12 weeks in patients while completing a loading protocol with varying parameters for mid-portion Achilles tendinopathy. Discussion: This study will determine the feasibility of a future definitive randomised trial examining the efficacy of specific load-intensity and time-under-tension exercise interventions for Achilles tendinopathy.