ANZCTR search results

This is a study on the benefits of exercise for women with lymphoedema. Who is it for? You can join this study if you have arm swelling following breast cancer treatment, whether this is induced by surgery or radiotherapy. Trial details Participants will be randomly divided into two groups. One group will attend a 60 minutes exercise program three times a week for 10 weeks, aimed at improving upper limb strength The other group will asked to attend for a 30 minute assessment of their lymphoedema each week for 10 weeks (the control group will not have an exercise program). Both groups will have their lymphoedema assessed each week for 10 weeks. The trial looks at any change in upper limb composition measured using a technique known as multifrequency bio-impedance (which is a way to measure tissue density, particularly the amount of fluid in the arm) and arm circumference at 10 weeks and 6 months following completion of treatment. There is no standard intervention recommended for women with arm swelling. The trial will determine the effects of vigorous supervised resistance training on arm lymphoedema. The trial will document whether women with lymphoedema can use their affected arm in vigorous exercise.

To determine how much the melphalan dose used as conditioning for autologous stem cell transplant can be increased when given with Palifermin, and how many more patients can achieve the best response on this increased dose.

The overall aim of this proposal is to demonstrate that blood sugar elevations are minimized through an even consumption of carbohydrates throughout the day. The study aims to clinically evaluate using an energy balanced diet, the effects of an even distribution of carbohydrate across the day in comparison with an uneven distribution on blood sugar elevations and the subsequent degree of hunger. Evaluation will primarily be based on continuous glucose monitoring using a Minimed continuous glucose monitoring system (CGMS) to provide a very detailed picture of the blood glucose profile.

This study addresses the issue of disability among our ageing population. Preservation of function among our older citizens, and their capacity to live independently, is of significant social, public health and economic benefit. The aims of this study are to (1) test the efficacy of Tai Chi in delaying disability among older people, prior to its onset, (2) investigate the mechanisms by which Tai Chi intervenes in the disability pathway, (3) determine the cost-benefits of Tai Chi for older people. The study will recruit 500 people over 70 years of age and randomly assign them to receive either Tai Chi, or a stretching and relaxation program, for a period of 48 weeks. The groups will then be compared to determine if there is any difference in the development of disability as well as a range of functional outcomes such as strength, balance, depression, arthritic symptoms, life satisfaction, and falls.

Open heart surgery involves a sternotomy, where the breast bone is cut through to open up the chest and expose the heart, resulting in significant soft tissue and bony damage of the chest wall during surgery. The current physiotherapy management of patients post open heart surgery includes a walking program in conjunction with a series of trunk and upper limb exercises, globally referred to as thoracic exercises. This study aims to compare two post operative physiotherapy regimens, one with and one without thoracic exercises, in the acute hospital setting to assess the effect of open heart surgery on a patient’s physical function as well as the available movement of the trunk and shoulders. It is hypothesised that a program including thoracic mobilisation exercises will result in a more favourable outcome. Subjects will be assessed on a range of measures before surgery, and several times after surgery, including prior to discharge, four weeks post discharge and three months post surgery.

Randomised trial of two supraglottic airway devices by measuring objective outcomes in spontaneously breathing adult patients. Our hypothesis is that there will be no identifiable difference (null hypothesis).

Brief Synopsis Levobupivacaine, the S(-) enantiomer of racemic bupivacaine, has been shown to be less cardiotoxic than racemic bupivacaine and its R(+) enantiomer while retaining equipotent local anaesthetic properties, and is commonly used by paediatric anaesthetists. The pharmacokinetics of levobupivacaine in children under 2 years of age (1), and of children less than 3 months of age (2) after caudal epidural blockade have been published; pharmacokinetics in children after levobupivacaine administration via lumbar epidural catheter and ilioinguinal nerve block have also been examined (3, 4). Adrenaline is commonly added to local anaesthetic solutions, both to provide a marker of inadvertent intravascular injection of solution, and with the intention to induce vasoconstriction thereby reducing the rate of systemic absorption of local anaesthetic (resulting in both lower peak plasma levels and therefore potential for toxicity, and longer duration of local anaesthetic effect). The pharmacokinetics of levobupivacaine administered with adrenaline have not been examined. We propose a study of the pharmacokinetics of levobupivacaine when administered via the caudal epidural route, with the addition of adrenaline. We plan to enroll 50 subjects up to 18 years of age undergoing elective sub-umbilical surgical procedures for which caudal epidural analgesia is indicated. Subjects will receive 2mg/kg levobupivacaine, as a 0.25% solution with adrenaline 5 mcg/mL (1:200 000), via the caudal route, under general anaesthesia. Peripheral venous blood samples will be taken from a dedicated intravenous catheter inserted at the time of surgery. Up to 5 blood samples per subject will be taken in the period up to six hours post caudal injection. Samples will be assayed for plasma levobupivacaine. Analysis of raw data will use a population, rather than individual, pharmacokinetic model (NONMEM), allowing accurate estimation of population parameters from data taken from a small number of subjects, and allowing inclusion of incomplete sample data from individual subjects (5). Sample timing is not crucial where this form of analysis is used, so proposed sampling times need not be strictly adhered to.

The aim for the proposed study is to evaluate the effectiveness of a case management approach using senior trauma nurses in providing trauma care services to children who have been moderately or severely injured and hospitalised. We aim to determine the effectiveness of such an approach using a randomised control trial with outcomes of improving clinical information gathering, service quality, and clinician-patient-parent communication and thus patients’ satisfaction. It is hypothesised that the case management approach can achieve twice the clinical information gathered in comparison to the controls. It is further hypothesised that the case management approach can improve both patient and family satisfaction significantly.

We aim to assess whether undertaking a structured, non-weightbearing exercise program over 20 weeks will accelerate healing in people with chronic diabetic foot ulcers. We also aim to assess whether this program improves glycaemic control, body mass index, wound bed substrate and quality of life.

The study aims to measure skin oxygen tension of skin adjacent to chronic wounds and assess whether low oxygen tension occurs in wounds that have delayed healing. If there is a relationship, this measurement device may be used as a screening tool to identify those people who require additional therapies in order to improve healing rates.