ANZCTR search results

The broad aim of this multi-site, randomised wait-list controlled trial is to determine the effectiveness of the 8-week program of FES-cycling and functional sit to stand (STS) training (2 x per week) and a home exercise program (1 x per week) of recreational cycling and STS training, to improve gross motor function, perceived performance and satisfaction of transfer-related occupational tasks (COPM) and cycling performance in 40 children with moderate CP (GMFCS levels II-IV). Secondary aims are to determine the effects of the intervention on STS and activity capacity; participation at home, school and in the community; and habitual physical activity levels. A qualitative evaluation will independently examine engagement of children/adolescents and their families in the program. This randomised wait-list controlled trial of 40 children with CP will compare an immediate intervention group, to a waitlist group, who will continue to receive usual care then receive the training program. Children/youth with CP who are/have: aged 8-18 years; functioning at GMFCS levels II, III or IV; goals to improve cycling ability or STS transfers; adequate range of motion (ROM) in the lower limbs to cycle will be recruited. Activate-CP will consist of 3 x 60 minute training sessions per week for 8 weeks (24 hours over 24 sessions). Two sessions will be FES-C and STS training. The third session will be completed at home including the STS training and recreational cycling. All FES-C training will be completed on an RT300-SLSA cycle (Restorative Therapies Inc.) designed for users to cycle while sitting in their own wheelchair. FES-electrodes will be applied to both quadriceps, hamstrings, gluteal, gastrocnemius and tibialis anterior muscles as tolerated, A global starting frequency of 40-50Hz will be applied and pulse-width and amplitude will be adjusted based on participant's tolerance. Participants will undertake STS transfers at home and at school to gain context-specific practice. Adapted and recumbent tricycles will be customized to meet individual needs for use at home and in the community. The primary outcome is the Gross Motor Function Measure where an improvement of more than or equal to 3 points following the 8-week intervention is proposed (T2); along with greater perceived performance and satisfaction ratings (by more than or equal to 2 points) on Canadian Occupational Performance Measure (COPM) and improved cycling performance immediately following the intervention (T2). Secondary outcomes will test their STS transfer capacity (Five times STS test); activity capacity (PEDI-CAT), participation at home, school and in the community (PEM-CY), and 7 day habitual physical activity (HPA) levels.

This study is designed to assess the impact of a six month high- and low-intensity cycle-based exercise intervention on cognitive function, measures of brain volume and connectivity and Alzheimer’s disease (AD)-related blood biomarkers in a cohort of older adults aged 60 - 80 years. Furthermore, we will assess the impact of genetic predisposition on responses to exercise within this population. The effect of the exercise regimen will be assessed using a comprehensive battery of neuropsychological tests to assess cognitive function. To assess the impact of the intervention on AD risk, MRI scans and measurements of blood biomarkers will also be evaluated across the intervention groups.

Purpose The purpose of this study is to investigate how safe and tolerable single and repeat doses of BTX1503 solution are in healthy volunteers. The study will look at whether the body adsorbs cannabidiol (CBD). by analysing the levels of CBD in blood at various times after drug administration. The application site will also be monitored for reactions and irritation. Study participants Healthy adults, aged between 18 and 65 years, inclusive, will participate. Experimental Treatment The study will investigate single and multiple doses of BTX1503 solution applied to the face. The components of BTX1503 have all been used in products that are applied to the skin. There will be four (4) different treatment cohorts with up to six (6) participants in each cohort. Cohort 1: 1 mL of BTX1503 5% Solution will be applied as a single dose in the first part of the study and then, after washout period, a single application will occur each day in the clinic for 14 days during the second part of the study. Cohort 2: 1 mL of BTX1503 5% Solution will be applied twice on Day 1 (12 hours apart) in the first part of the study and then, after washout period, twice daily applications will occur (one in the clinic and one self-applied) for 14 days during the second part of the study. Cohort 3: 3 mL of BTX1503 5% Solution will be applied as a single dose in the first part of the study and then after washout period, a single application will occur each day in the clinic for 14 days during the second part of the study. Cohort 4: 3 mL of BTX1503 5% Solution will be applied twice on Day 1 (12 hours apart) in the first part of the study and then after washout period twice daily applications will occur (one in the clinic and one self-applied) for 14 days during the second part of the study. The study consists of a Screening Visit (up to 14 days before receiving the study treatment), a confinement visit starting on the morning of Day 1 and lasting approximately 24 hours, daily applications at the clinic on Day 8 through Day 20, a second confinement on Day 21 lasting 24 hours and 1 follow up visit on Day 23. The maximum study duration for any participant from screening visit to last clinic visit is 37 days. Tests and procedures which are conducted at some, or all visits during the study include: a brief review of your body systems, vital signs measured, blood and urine sampling.

The aim of this 15-year follow-up study was to determine the influence of environmental, anatomical, metabolic, physiological and genetic determinants on health outcomes in older women. This was a follow-up study of 1500 women aged 70 years and over, recruited from the general population of Perth, Western Australia.

The purpose of this study is to formally follow up and record the effectiveness of autologous (your own) stem cell injections in the treatment of arthritis. A secondary objective is to determine whether stem cell therapy offers disease modifying potential and therefore whether it can limit, prevent or possibly reverse progression of arthritis.

Heart surgery using extracorporeal circulation alters how drugs stay and move within the body, which can lead to sub optimal therapy and adverse effects in patients. Although multiple factors potentially contributing to these changes have been identified, there has been minimal research on the impact of extracorporeal circulation on the function of liver enzymes that have a major role in clearing medications from the body. Extracorporeal circulation is associated with an intense inflammatory response which may alter the extent to which liver enzymes breakdown essential drugs leading to sub optimal dosing and adverse effects. Changes in liver enzyme activities may be associated with unpredictable responses seen in patients during and after treatment with extracorporeal circulation, e.g. increased ventilation times or memory impairment. This pilot study aims to identify factors contributing to the altered breakdown of critical medications and estimate the extent to which changes in the activity of liver enzymes in patients undergoing treatment with short-term (surgeries requiring CPB) or long-term (treatment with ECMO) extracorporeal cuircuits , compared with a control group undergoing a different surgery without extracorporeal circulation (laparoscopic cholecystectomy). Hypothesis Extracorporeal circulation, triggers an inflammatory response in patients altering the capability of liver enzymes to breakdown critical drugs. Outcomes and benefits of the completed pilot study include: 1. Understanding the inflammatory response triggered by extracorporeal circulation and how this affects the ability of liver enzymes to breakdown essential medications. 2 .Utilising new approaches to measure the activities of major enzymes in the clinical setting. 3. Informing the design of a future larger clinical study. 4. Developing guidelines to assist clinicians in delivering optimised drug therapy and personalised health care. 5. Minimising adverse effects associated with altered breakdown of medications in patients thereby reducing length of stay in the ICU and costs associated with complications caused by sub optimal drug therapy.

Low back pain (LBP) is a major health problem affecting approximately 60-80% of the adult population at some stage. LBP is the second most common reason for physician visits, and for work disability and is associated with substantial health care costs. The intervertebral disc (IVD) is the most common source of LBP, being the prime source in about 40% of complex chronic LBP presentations. Non-invasive options, such as pharmacological manipulation, exercise, physical therapy and pain management programs have limited evidence. Further, surgical interventions such as discectomy and fusion for disc degeneration have similarly limited success. Cell based therapies may offer possibilities to regenerate the IVD, restore or improve its function, leading to clinical success. Mesenchymal stem cells (MSCs) are a very attractive cell source for use in restoring the normal cellular constitution of the degenerated disc. A recent pre-clinical animal study showed that implantation of bone marrow derived MSCs to degenerative discs inhibits fibrosis/scarring, preserving mechanical properties and overall spinal function. Furthermore, a study of 10 patients with confirmed disc related LBP and injected with autologous MSCs, described rapid improvement in pain and disability at 3 months, followed by a modest improvement within 6 and 12 months after injection. Importantly, based upon current clinical trial outcomes, MSC therapy is low-risk. A recent meta-analysis of trials involving a total of 1012 participants receiving MSC therapy for various conditions , did not identify any significant adverse events other than transient fever. The primary aim of this prospective case series pilot study is to evaluate the safety, tolerability and dose efficacy of autologous mesenchymal stem cells in the treatment of internal disc disruption (IDD) resulting in LBP. A secondary aim is to determine whether MSC therapy offers disease modifying potential through the examination of structural changes using MRI. Follow-up will be conducted over 12-months.

Mental health problems often have first onset during adolescence and when this happens teenagers frequently turn to their peers, rather than adults, for support. The core aim of this proposal is to test the effectiveness of a new public health intervention, ‘teen Mental Health First Aid’ (teen MHFA), designed to improve the quality of peer guidance and support for adolescents with mental health problems. teen MHFA is a new 3 x 75min training course for adolescents in High School years 10-12. The program is evidence-based and developed from a Delphi expert consensus study with youth mental health consumer advocates and MHFA instructors who work with youth, and from research evidence on barriers to help-seeking. An uncontrolled evaluation has been carried out and showed positive effects on knowledge of how to help a peer, confidence in helping, stigma, help-seeking intentions and participant mental health. The current project aims to carry out a rigorous evaluation with a control group and to investigate the longer-term impacts of the training on student experiences of providing support and guidance to peers. Schools will be randomized to receive either teen MHFA or physical first aid training. Ten schools will receive the interventions over a three-year period. Student questionnaires will be completed at four time points: before training begins, immediately after training, 1 year after training and 18 month after. Questionnaires will assess changes in knowledge, attitudes, intentions and behaviour towards peers with mental health problems, as well as reports of support received from peers, and participant mental health. If found to be effective, this public health intervention can be easily disseminated through the existing MHFA Australia Instructor networks nationally and worldwide.

120 Patients referred with chronic low back pain clinically arising from the facet joints were referred and assessed for suitability for diagnostic medial branch blocks. The patients had 2 blocks performed with either bupivacaine then saline or vice versa or bupivacaine on both occasions in a double blind randomly controlled prospective fashion. Any patient with 50% relief to any block was offered a radio frequency neurotomy and their analgesia and function and distress was measured post procedure for 3 months.

This is the first RCT to evaluate the efficacy of sun-protective clothing in reducing the rate of development of melanocytic naevi (pigmented moles: a major risk factor for melanoma) in early childhood. The proposed prospective cluster randomised intervention trial aims to determine whether reducing sun exposure, primarily through the use of sun-protective clothing can delay the development of a significant proportion of the melanocytic naevi which develop in early childhood, and have been shown in numerous case-control studies to be a major risk factor for lifetime melanoma risk. More specifically, we aim to: 1. determine whether regularly wearing sun-protective clothing can reduce the number of new melanocytic naevi developing on the body during 3 years of follow-up; 2. determine whether regularly wearing sun-protective clothing can reduce the rate of acquisition of melanocytic naevi on those body-sites protected by study clothing (i.e. upper arms, posterior neck, trunk and thighs).