ANZCTR search results

Participants will be randomly allocated in a 1:1:1 ratio to receive either i) control (usual care); ii) a prescribed home program with one strength exercise or; iii) a prescribed home program with multiple (five) exercises. The control group will not receive any intervention and will continue with their usual care. Participants in the exercise groups will have three video-conferencing consultations with a physiotherapist (week 1-, 2- and 6-weeks post-randomisation, 30 minutes each) for prescription, monitoring and progression of their exercise program, which will be performed independently at home for 3 months. Participants in the exercise groups will be encouraged to continue with exercises beyond the intervention period. Primary time-point for re-assessment will be 3 months, with a secondary time-point of 9 months, after randomisation. The primary outcome measure will be change in average walking pain over the past week on NRS. Secondary outcome measures will include WOMAC pain and function subscales, quality-of-life; arthritis and exercise self-efficacy; fear of movement; global rating of change; muscle strength; willingness for joint replacement.

This study aims to investigate the risk of thrombosis associated with central venous access devices (CVADs) in neonates and infants undergoing cardiac surgery for congenital heart disease. CVADs are essential for delivering medications and fluids during and after surgery, providing stable access to the central venous system. However, their use in infants with complex cardiac conditions may lead to thrombotic complications, potentially compromising both short- and long-term health outcomes. Infants undergoing cardiac surgery are at particularly high risk of thrombosis due to the use of cardiopulmonary bypass and the inflammatory response to surgery. Thromboses can obstruct critical blood vessels, impacting future cardiac interventions and contributing to complications such as pulmonary hypertension. Although previous studies report a wide range of thrombosis incidence rates, from 11% to 61%, there is limited data on long-term outcomes in this population. This study will prospectively observe neonates and infants requiring CVAD insertion during cardiac surgery, assessing the incidence of thrombosis, identifying modifiable and non-modifiable risk factors, and evaluating long-term effects on health. The hypothesis is that factors such as CVAD type, insertion location, and surgical variables may influence the likelihood of thrombosis, and early detection and intervention could mitigate associated risks. By improving understanding of CVAD-associated thrombosis, this research aims to optimize patient care and enhance surgical outcomes for this vulnerable population.

To assess the effectiveness of Biofeedback Assisted Relaxation Training (delivered via the BrightHearts iOS App) plus routine non-pharmacological care compared to routine non-pharmacological care alone for managing pain for procedures following lower limb orthopaedic surgery in children with physical disabilities. It is hypothesized that BrightHearts will assist with decreasing pain levels during procedures performed during the inpatient admission following lower limb orthopaedic surgery.

The surgical ward round is a chaotic environment but is often the only encounter that a patient has with their treating team. There are often external demands that impact the amount of time that the treating team can spend with the patient. To address this we propose conducting a Randomised Controlled Trial (RCT) evaluating the impact of an intervention initially designed for the surgical outpatient department – the POWER form. The form is a 5 point prompt sheet/checklist given to the patient prior to the ward round. It is designed to encourage patients to engage with their team and understand their clinical issues. We hypothesise that use of a POWER form will improve patient engagement and communication on the surgical ward round.

This study aims to determine if blood flow restriction (BFR) during rehabilitation improves muscle strength in the quadriceps and hamstrings more effectively than standard recovery methods following ACL reconstruction surgery. It is a randomised controlled pilot trial where participants will receive either BFR or a sham treatment in addition to standard rehabilitation. Strength in the operated leg will be measured at 6, 12, and 24 weeks post-surgery using specialised equipment. The results will help decide if a larger study is needed to further explore BFR’s benefits. Participants will be recruited from private practices in Northern Tasmania and will be fully informed about the study and their options. We believe that using BFR during rehabilitation after ACL reconstruction surgery will lead to greater improvements in muscle strength in the quadriceps and hamstrings compared to standard recovery methods. This means that patients who undergo BFR will likely recover more effectively and regain strength in their legs more quickly after surgery.

This is a Phase 1 study to evaluate the effect of food on the PK of SION-719, and the bioequivalence of a solid oral formulation compared to the oral suspension.

The iSISTAQUIT Ngurrajili project aims to determine the best method of implementation for iSISTAQUIT smoking cessation training for health providers to address smoking in Aboriginal and/or Torres Strait Islander pregnant women. It will determine the process of implementation that is sustainable and cost-effective in Aboriginal and mainstream health services in Australia.

The present clinical investigation aims to investigate the safety and feasibility of a novel bioscaffold in patients requiring defect repair and restoration of anatomic contour in non-critical sized, non-load bearing portions of the craniofacial skeleton following routine craniofacial operations. This is a first-in-human pilot study for this bioscaffold. It is hypothesised that there are no serious adverse events associated with the actv-graft bioscaffold.

This study aims to evaluate the impact and effectiveness of a new AR education package used in conjunction with daily INCS/INAH in reducing AR symptomatology and improving quality of life, in comparison to the standard of care education that is currently provided via treating healthcare professionals. Ultimately, it is hoped the results of this study will improve education management of those living with the burden of AR. This flows on to benefit families, carers, the healthcare system and the wider community.

Poor dietary patterns such as a high-calorie, high-fat (HCHF) diet can contribute to insulin resistance (IR), which is a condition where body does not respond to insulin as it should, and eventually lead to type 2 diabetes (T2D). Several human studies have confirmed that even 3-7 days of a HCHF diet impairs glucose metabolism, that is it impairs the ability of the body to remove glucose from the blood stream for energy storage and/or energy production. Our team has recently completed a human study (funded by Diabetes Australia, Ethics No: 2019-014) that showed 7-days of a HCHF diet in 14 healthy individuals led to increased meal-induced insulin concentrations within 3 days, followed by reduced meal-induced blood flow in the smallest capillaries of the muscle, also known as muscle microvascular blood flow after 7 days, compared to pre-intervention. However, the above-mentioned studies focused on saturated fat as their main source of fat. Whether the incorporation of high omega-3 polyunsaturated fats into a HCHF diet may protect against HCHF diet-induced hyperinsulinemia and impairments in skeletal muscle microvascular blood flow in healthy humans is not known and is the aim of the current study. We hypothesise that increasing omega-3 fat content in diet will protects against high fat diet-induced ‘early’ vascular impairments.