ANZCTR search results

Obesity continues to be a major public health concern in Australia and overseas. In particular, obesity contributes to changes in the heart’s blood flow in the form of increased circulating blood volume, cardiac output, systolic blood pressure and pulmonary pressures. Long-term, these lead to the development of heart failure, atrial fibrillation and ischaemia. Furthermore, fat deposited around the heart is associated with the development of a specific type of heart failure common in individuals with obesity. Hence, obesity is considered an important risk factor for cardiovascular disease. However, there is growing evidence that effective management of obesity also improves cardiovascular outcomes for patients. Bariatric surgery, an established treatment for weight loss, has been shown to reduce the incidence of cardiovascular risk factors and heart attacks. In this study, we seek to assess the impact of bariatric surgery on the heart’s structures and blood flow using cardiac magnetic resonance imaging (CMR). Although ultrasound technology or echocardiography is widely used for assessing such features, challenges remain when acquiring accurate images in those with obesity. CMR offers an opportunity to overcome some of these imaging challenges. CMR is less user dependent compared to echocardiography and has demonstrated excellent feasibility in this population. We hypothesize that bariatric surgery will lead to a decrease in cardiac output, and reductions in the degree of fibrosis of the heart muscle and the volume of fat around the heart as measured by pre- and post-surgery CMR, thus reducing cardiovascular disease risk. Eighty participants will be recruited for this study. Assessments will include cardiac imaging scans, measurement of exercise capacity, blood tests, and quality of life questionnaires. These will be performed before and 12 months after their bariatric surgery.

In this study, we plan to compare two techniques of supplying oxygen to patients during general anaesthetic induction for surgery. The usual way of doing this procedure involves patient breathing about 10L/min oxygen through a standard facemask before being induced. Once the patient is asleep, the anaesthetist helps bag-mask ventilate the patient via the facemask while waiting for complete muscle relaxation for the intubation. During intubation, the facemask is removed. In this study, a computer program will randomly allocate patients to receive oxygen via one of the two devices: 1) Optiflow Switch or 2) standard facemask. The Optiflow Switch is a relatively new device, which can deliver oxygen at a very high flow rate (up to 70L/min) via two prongs in the nose. It also allows seamless transition to facemask ventilation by diverting nasal oxygen flow away from the patient when a facemask is applied on top of the nasal apparatus. Therefore, for the Optiflow Switch group, patients will receive high flow oxygen through the nasal prongs before going to sleep and during intubation, but bag-mask ventilation in between while waiting for complete muscle paralysis. The study aims to test if the Optiflow Switch provides a higher oxygen level compared to standard facemask when used during anaesthesia induction.

Chronic post-surgical pain is an increasingly recognised condition which can have great impact on a child's quality of life. Appendicectomy is one of the most common surgeries performed on children, yet it is not well known how many children develop chronic pain as a result. This is a prospective cohort study using a questionnaire following paediatric appendicectomy at 3 and 12 weeks to determine the presence of chronic post-surgical pain. Where this is detected, further questionnaires and assessment by pain physician will be used to investigate the impact of and risk factors for chronic pain following paediatric appendicectomy.

This study aims to determine the effectiveness and cost-effectiveness of a four-month home-based cognitive-motor step training intervention versus usual care in cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN). Who is it for? You may be eligible for this study if you are aged 18 years or over and have completed greater or equal to 6 months and less than 5 years post-completion of neurotoxic chemotherapy treatment for cancer, with CIPN symptoms impacting lower limbs function. You should also be able to walk 10 metres without the use of a walking aid. Study details Participants will be randomly allocated to either receive the home-based cognitive-motor step exergame training, or usual care with the option to receive the training program following completion of the study period. The exergame training will involve stepping/balance exercises and concurrent cognitive training on a wireless floor step mat, delivered over a few sessions per week with a target range of 80 to 120 minutes total training per week for 16 weeks. Participants will be asked to complete questionnaires about their symptoms' burden, quality of life and health service use, as well as to undertake assessments of balance and cognition at several timepoints throughout this study. Participants' daily physical activity will also be recorded at several time points, using a wrist-worn sensor. It is hoped that findings from this study will help develop management strategies to address the ever-increasing burden of CIPN-related disability in cancer survivors.

The aim of this study is to conduct a preliminary assessment of the acceptability, useability and usefulness of, and engagement with, a new psychoeducation website, Depression Assist, to assist adult family/friends of adults with major depressive disorder (MDD) to carry out their vital supportive role and maintain their wellbeing. In this formative evaluation, we aim to ask 30 family/friends participants to access the website over 3 months and respond to an initial screening and baseline survey and monthly online follow-up surveys (over the three months). The results of this formative evaluation will guide the refinement of Depression Assist and a dedicated rural version that is aimed at benefiting members of the public who care for a person with major depressive disorder.

The purpose of this study is to examine the effects of a brief 2-hour Compassionate Mind Training intervention on self-compassion levels of parents of autistic children from 3 to 17 years of age. The intervention incorporates physical and mental skills that cultivate compassion, such as grounding, rhythmic breathing, mindfulness, and developing more compassionate ways of relating to the self and others. It is predicted that parents in the treatment group will report higher levels of self-compassion, better mental well-being and emotion regulation, and fewer negative emotions.

Adult survivors of child sexual abuse and other gendered violence are at heighten risk of both mental and physical health conditions. We seek to evaluate a peer-led program, Left Write Hook, which incorporates boxing and expressive writing, to empower survivors. This Type II Hybrid effectiveness-implementation randomised control trial aims to (1) evaluate effects of Left Write Hook in improving self-efficacy (primary effectiveness outcome), and subsequently, modifiable indicators for chronic disease (secondary effectiveness outcomes), in adult survivors of child sexual abuse and other gendered/family violence, and to (2) determine the fidelity of the train-the-champion implementation strategy for intervention training and delivery (primary implementation outcome). Compared to boxing-only, we expect Left Write Hook to meaningfully improve both mental and physical health outcomes.

Title: The Impact of an interprofessional exercise program on improving glycaemic management in children and adolescents with type 1 diabetes Short Title: T1DM & Exercise Study Sites: Tweed Valley hospital SCU gymnasium, Bilinga NSW 4225 Study Aims/Objectives/Hypothesis: The aim of this research is to answer the following two research questions. 1. Does participation in an interprofessional exercise program reduce the incidence of exercise induced hypoglycaemia and nocturnal hypoglycaemia? 2. Does participation in an interprofessional exercise program, improve the confidence of individuals and families to manage T1DM? Study Design: Pre/post intervention trial Study Outcome Measures: Problem Areas In Diabetes (PAID) (Welch, 1997) Diabetes Distress Scale (DSS) (Fenwick, 2018) Physical Activity Questionnaire for Children and Young People (Kowalski, 2004) Incidence of exercise induced hypo/hyperglycaemia Nocturnal hypoglycaemia. Study Population: children and young people between the age of 12 to 18 with T1DM, who are current clients of our Paediatric and Young Adult Diabetes Outpatient clinics Number of participants: Due to the focus of this study, recruitment will target 12- to 18-year-olds, who attend the Tweed hospital for management of T1DM. We currently see 70 children/young people for T1DM management. On average, over the last two years, 10 children/young people are new to the service each year. We estimate a convenient sample size of approximately 20 to 25 participants from our paediatric and young person’s diabetes service will be eligible to participate. Translation to Clinical Practice: Development of protocol for exercise physiologists to support children and young people with T1DM to maintain physical activity through the life span. Key Ethical and Safety Considerations: Management of hypo/hyperglycaemia, trips/slips and falls and developing their confidence in maintaining lifelong exercise. Working with children and young people and ensuring that consent is informed and appropriate based on age.

Follicular lymphoma (FL) is a common type of slow-growing blood cancer. In Australia, the standard treatment for FL is a combination of drugs and immunotherapy. However, this treatment can have side effects, and the cancer can come back without clear options for further treatment. Researchers are now focusing on finding better options to treat FL with fewer side effects and better outcomes for patients. Who is it for? You may be eligible for this study if you are aged 18 and have been diagnosed with follicular lymphoma. Study details LS25 will operate as a sub-study of an AbbVie-sponsored clinical trial called EPCORE-FL2, with the aim to closely monitor how the immune system responds to treatment for FL over time. EPCORE-FL2 patients can choose to participate in LS25, where they will provide extra blood samples, biopsy sample and collect gastrointestinal microbiota sampling. These samples will help researchers understand how the immune system is working inside the tumor and in the bloodstream during treatment. The hope is that by studying these samples, treatments can be tailored more effectively for people with FL, potentially leading to better outcomes.

Schools have been an ideal setting for intervention studies to take place. In PE settings, interventions targeting the psychomotor domain have been the most dominant. With amendments to educational policy, a gap has emerged where interventions targeting ‘other’ outcomes has promoted research into the cognitive, affective and social domains. This intervention study is aimed at evaluating the effect of social domains on high school students. This will be done through the Teaching Personal and Social Responsibility framework, developed by Don Hellison which was initially designed to re-engage students from low socio-economic status backgrounds in PE classes. Whilst TPSR studies have been scattered throughout the world with positive outcomes (academic and otherwise). TPSR has not yet been featured in high schools in Australia.