ANZCTR search results

Children with Cerebral Palsy (CP) have decreased fitness compared to their typically developing peers. Land based exercise training in children with CP has demonstrated improvements in fitness, but there are barriers to ongoing exercise participation such as pain and movement difficulties. Exercising in water, using a novel high intensity interval training method (HIIT), may allow children with CP to exercise at high intensities, improving aerobic capacity, without pain. This pilot RCT will investigate the feasibility of water HIIT over ten weeks in 20 adolescents with CP who are ambulant. Measures will be collected around fitness, muscle mass, pain and health related quality of life.

Children of women depressed in pregnancy are likely to have an increased risk of behavioural problems such as anxiety, depression and attention deficit/hyperactivity, with effects on mental health lasting at least to adolescence. This study is a fully powered RCT (n=230 women and their infants) which will evaluate medium-term change in child outcomes following cognitive-behavioural therapy (CBT) for depression in pregnancy. We hypothesise that children in the intervention group will have fewer Internalising behavioural problems at the age of 24 months than children in the control group. Pregnant women (30 weeks or below) diagnosed with depression will be allocated to CBT intervention or to treatment as usual. During eight weekly CBT sessions, women will be provided with behavioural and cognitive strategies to help them recover from depression. Other child behavioural, motor and cognitive outcomes will also be assessed.

This is a randomised controlled trial of 40 consecutive patients undergoing elective total hip arthroplasty. The aim is evaluate the use of a tissue adhesive (Glubran 2, Matrix Surgical) for subcutaneous fat closure. Participants will be randomised to have their fat layer closed with either a tissue adhesive or dissolvable sutures. The participants will undergo an ultrasound at day 10 to 20 post-operatively to assess the degree of fluid accumulation in the fat layer. Outcomes will include the incidence and magnitude of superficial seroma, participant reported pain scores, blood loss and incidence of wound complications. We hypothesise that subcutaneous fat closed with the glue will have less fluid accumulation which may be a precursor to infection.

The purpose of this study is to evaluate the safety and feasibility of the Shockwave Medical Lithotplasty System for patients with severe calcified aortic stenosis, Who is it for? You may be eligible for this study if you are aged 18 or older and have severe calcified aortic stenosis. Study details All participants will receive TAVL treatment during a procedure under general anaesthesia in a cardiac catheterisation laboratory. All participants will be followed-up according to the protocol specific endpoints. Patients will undergo diagnostic tests such as CT scan, echocardiography (both transthoracic and oesophageal) , laboratory (blood tests) and undertake several questionnaires as a part of the clinical trial. It is hoped that this research will provide information into the non-surgical treatments of severe aortic stenosis thereby providing future non-surgery related options for the disease.

The primary aim of this pilot is to improve understanding of acceptability and benefits of an online and a face-to-face mindfulness-based cognitive therapy (MBCT) program for people with MS, and to generate preliminary data to inform the development of a larger multi-centre, randomised controlled trial (RCT) in order to promote wellness and quality of life of people with MS. This study aims to: 1) evaluate acceptability of an online and a face-to-face MBCT program against a yoga intervention, its overall effect on mental health and quality of life, and enablers and barriers to incorporating the mindfulness practice at home sustainably; 2) assess if there is improvement in mental health and quality of life in participants from baseline and immediately after the an online or a face-to-face MBCT program or against a yoga intervention and over a six-month follow-up after the program; and 3) evaluate economic data on the cost-effectiveness of the online and face-to-face MBCT program against the yoga intervention.

This is a single centre, first in human, SAD, randomized, double-blind, placebo-controlled clinical trial of PLG0206, an engineered cationic antibiotic peptide (eCAP) or matching placebo, administered to healthy subjects. There will be a total of up to 56 subjects, divided into up to 7 sequential groups. Subjects who are eligible for enrolment after screening testing will return to the study centre on Day -2 for confinement at the study site. Subjects will be discharged on Day 3 (48 hours post dose), after recording vital signs and the 12-lead ECG and obtaining safety bloods (haematology and chemistries). Serial blood samples for PK evaluations will be obtained. For each subject, the total duration of the study will be 1 week after dosing. A Safety Review Committee (SRC) comprising of relevant site investigators, the medical monitor and sponsor representative will oversee safety, Cohort evaluation and dose-escalation for the study. A formal charter will be established to include the rules, meeting frequency and scope of responsibilities of the SRC for the conduct of the SRC.

The aim of this randomised control trial is to evaluate the efficacy of a lunchbox program on the nutritional content of student lunchboxes. The program will run for approximately 15 weeks. 36 primary schools in the Hunter New England region will be randomly allocated to one of two intervention arms, or a waitlist control group. The program aims to support parents/carers to swap what is packed in lunchboxes from sometimes to everyday food, through the use of weekly support messages delivered through a school communication app and resources for parents, with or without the development of school lunchbox guidelines.

Aging is associated with loss of muscle mass and this accelerates after 60 years of age, even in healthy individuals. This is undesirable, as loss of muscle mass is strongly associated with sarcopenia, increased morbidity and mortality and lower quality of life. Sarcopenia is the age related degenerative loss of skeletal muscle mass, quality, and strength. The cause of sarcopenia with aging is multifactorial, with declines in physical activity and poor nutrition, neuromuscular decline, hormonal changes, systemic inflammation and chronic illness, all being implicated. Interventions to enhance and maintain muscle mass are urgently needed. This study is a 16 week, randomised controlled trial for adults aged 65 years and over, who are at risk of sarcopenia due to a low protein intake and sedentary lifestyle. Participants complete a home based resistance exercise training programme as well as consume either a high or low dose protein based nutritional drink. The aim of this study is to determine the efficacy of the combined nutritional and exercise approach in improving: • Body composition • Bone mineral density • Muscle strength and function • Muscle protein synthesis markers • Systemic protein markers • Systemic inflammation • Systemic gene expression of inflammatory/ muscle protein synthesis pathways We hypothesise that In an older population at risk of sarcopenia, greater improvements in fat free mass, bone mineral content, muscle strength and function can be achieved when a resistance exercise programme is combined with a high dose versus low dose protein based nutritional supplement drink.

The purpose of this study is to determine the risk factors related to progression of myopia in children aged 4 - 15 years by evaluating hereditary and environmental factors. The possible role of these newly found and existing factors in predicting the onset and progression of myopia in non-myopic eyes will also be determined. To achieve this, participants will be followed up for 2 years with 6 months interval. There will be a total of 5 to 6 visits for each participant. The null hypotheses of this study are; (i) Annual rate of myopia progression is age dependent. (ii) Onset and progression of myopia is dependent on the magnitude and intensity of near and outdoor activities

We hypothesize that engagement in yoga and mindfulness will lead to significant improvements in quality of life and other important clinical outcomes including activity and psychological status in individuals diagnosed with severe asthma. A total of 54 adults (>=18yrs) that have stable severe asthma and will be recruited and randomly allocated to the NAMASTE yoga intervention group or control group. Participants randomised to the intervention group will participate in two supervised classes of yoga and mindfulness per week for 16 weeks. Participants randomised to the control group will receive written information about physical activity, mindfulness and goal-setting after their baseline assessment, in addition to usual care. All participants will also receive an activity tracker and be encouraged to increase their daily steps each day.