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Anterior cruciate ligament reconstruction with the peroneous longus tendon
Several types of material are commonly used in anterior cruciate reconstruction (ACLR) with the majority of these coming from around the knee. Harvesting tendons may, however in itself cause pain and dysfunction. It is therefore desirable to identifly a harvesting method which does not lead to additional injury and possible dysfunction of the already injured knee while at the same time minimising such problems in other areas of the body. In recent years a small number of studies have been published regarding the use of peroneus longus (a tendon on the outside of the leg) autograft (PLA). These studies suggests PLA is a safe graft choice for ligament reconstruction and causes minimal dysfunction at the harvest site (the ankle). Our hypothesis is that PLA will perform as well as a hamstring tendon in ACLR while not causing pain and loss of strength in the knee nor significant dysfunction at the ankle . The project may potentially lead to the identification of peroneus longus as a suitable graft choice for ACLR. After the pilot study is completed we plan to conduct a randomised trial of peroneus longus versus standard graft (hamstring) to identify whether peroneus longus is superior to standard technique. These studies may lead to an improvement in the standard of care for patients with ACL rupture.
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Mums on the Move Study: a pilot randomised controlled trial to evaluate the effectiveness of a physical activity program for women at risk of post-natal depression.
The Mums on the Move study aims to explore the feasibility of a multi-component 12-week home-environment pilot intervention delivered to first-time mothers at risk of PND for increasing physical activity, with the view to inform the development of a larger intervention trial in future. The study also aims to examine changes in depressive symptoms as a result of participating in the intervention.
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The effect of a beta-3 adrenergic receptor agonist on metabolic disease in humans.
This proposal will determine whether a beta-adrenoceptor agonist can reduce hepatic fat content and improve metabolic control in obese humans. Accumulation of hepatic fat is an early onset and causative factor in liver and obesity-related metabolic diseases and reversal can delay or prevent sequelae. However there are currently no drugs available on-label to treat fatty liver. Increasing daily energy expenditure decreases liver fat independent of weight loss in rodents. Beta-adrenoceptor activation increases energy expenditure in rodents and humans. This proposal will therefore employ a randomised, placebo-controlled, parallel study design in combination with clinically relevant metabolic endpoints to test whether chronic treatment with a beta-adrenoceptor agonist can decrease liver fat in humans.
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The PATHway trial: health motivational strategies and tracking devices for post-surgical rehabilitation following knee replacement or spinal decompression
It is estimated that 6.9 million Australians have chronic musculoskeletal conditions. More than 550,000 elective surgical procedures are performed each year in Australia for all musculoskeletal conditions and one in seven of these operations is for osteoarthritis of the knee or low back pain. The rising prevalence of these conditions and the ensuing surgical costs mean the quality of care and pricing have been identified for review. Moreover, post-surgical care, including inpatient rehabilitation for the knee and lumbar spine, is currently not standardised, sustainable or evidence-based. This contributes to substantial clinical variation and a wide range of outcomes. The PATHway is a randomised controlled trial designed to evaluate a post-surgical rehabilitation program using disruptive technologies to increase function and physical activity for patients following inpatient rehabilitation after their total knee replacement and lumbar spinal decompression surgeries. The intervention is a post-surgical clinical pathway (standardised, evidence-based, multidisciplinary rehabilitation program) supplemented by a 6-month disruptive technology package composed of 4 components: • an exercise program delivered via a health and fitness app (PhysiApp®) • wearable physical activity tracker (Fitbit®) built-in with motivational reminders and used in combination with the Fitbit app • health-coaching delivered via video calls using the Zoom app and through motivational messages delivered via iMessage • knee joint range of motion (ROM) measuring app (Goniometer Pro®) for total knee replacement participants. The proposed program will be compared to a control group which is akin to usual care. The primary outcome is a change in patient-reported average pain intensity (0-10 on a Numerical Rating Scale, NRS) over the last week from baseline to 3-months. The major secondary outcomes include change of NRS from baseline to 6 and 12 months, change in patient-reported pain-related disability, change in physical activity participation (subjective and objective measures) and physical function from baseline to 3, 6 and 12 months. The study aims to recruit a total of 204 participants (102 participants per arm) of whom 50% will have undergone knee replacement and 50% spinal surgery. Patients will be recruited from multiple study sites (hospitals and private clinics) across Australia.
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Efficacy of InferrinTM and lactoferrin on symptoms of Irritable Bowel Syndrome. A randomized double-blind placebo-controlled study.
Approximately 120 adult male and female participants aged over 18 will be recruited from databases and public media outlets. Following preliminary screening via telephone, if eligible, potential participants will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a health assessment including lifestyle, current medications, weight and height assessment, blood pressure, heart rate, IBS questionnaires and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. A blood test will also be carried out. Participants will take the allocated product daily for 56 days attend the study site at day 28 for a progress assessment. At this assessment, all baseline tests will be administered including the blood test. On day 56, the participants will attend the study site and all baseline tests will be administered and blood samples will be collected. A final exit interview will also be undertaken.
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Testing the use of an app intervention to improve behavioural sleep problems in children.
Sleep problems are reported by Australian parents in up to 30% of infants and up to 40% of children during the early school years. The most common sleep problems are behavioural in nature and include difficulties going to bed, difficulties sleeping alone and waking during the night. Persistent sleep problems in children have significant adverse consequences for both child and parent. Cross-sectional studies show that impaired child sleep is associated with poorer child emotional and behavioural functioning, increased injury and obesity, and poorer parental mental health and health-related quality of life. Fortunately, there are brief, parent-oriented behavioural interventions that are effective in addressing numerous sleep problems. The current study will build on the many years of sleep intervention research carried out by MCRI. MCRI has successfully trialled the sleep strategies via face-to-face consultations delivered by clinicians and by written parent education materials only, The latter were effective in reducing child sleep problems and the need for hospital sleep clinic appointments, Families who participated in one of the trials suggested that access to information through a mobile phone-based application (app) would improve the intervention. In light of this suggestion and an increasingly digitised and patient centric healthcare environment, implementing the behavioural sleep intervention via a mobile app is an appropriate next step. The current study aims to investigate whether a sleep intervention provided to primary caregivers by a phone application (App) leads to better child sleep, reduced need to stay on a sleep clinic waitlist, and improved psychosocial outcomes for caregivers and children when compared to treatment as usual.
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BreastScreen Anxiety (BSAnx) Feasibility Study
This study aims to test the viability of implementing two novel consumer-friendly delivery methods of information into the BreastScreen ACT screening program in order to reduce anxiety levels in women recalled for further testing. Who is it for? All women aged over 40 who are eligible for a free screening mammogram with BreastScreen ACT and literate in English will be invited to participate in this feasibility study. Study details Participants will be allocated to one of two groups depending on when they present for their follow up tests, after being recalled for further tests following the screening mammogram. Participants in one group will be given a combination of verbal and written information regarding the proportion of women recalled for further testing who subsequently receive a normal result and those that are diagnosed with breast cancer. Participants in the other group will receive current standard practice of BreastScreen ACT, which involves notifying women of the need for further tests via a phone call from a trained Nurse Counsellor only. All women will be asked to rate their anxiety levels on a questionnaire immediately prior to the screening mammogram and immediately prior to the recall for further tests appointment. This study will inform recruitment and retention strategies, as well as methodology, sample size and budgetary assumptions for a large scale study to determine which consumer-friendly delivery method is most effective in reducing levels of anxiety.
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Genomic sequencing for Refractory EPilepsy (GREP)
GREP is a clinical trial that will study if performing a comprehensive genetic test called whole genome sequencing (WGS) will find out the genetic cause of drug-resistant epilepsy in more patients than usual investigations. It will also look at other ways whole genome sequencing may influence patients' life and healthcare needs, and whether it is good value for money. We plan to enrol children and adults who suffer from drug-resistant epilepsy and are likely to have a genetic cause of their illness. Suitable patients who agree to take part in the trial will have their blood collected. Whole genome sequencing will be performed immediately in half of the patients and delayed by 12 months in the other half. We will compare how earlier genetic testing results influence diagnosis, care and well-being of the patients, and overall cost-effectiveness.
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Health and economic impacts associated with prescribing by expanded scope physiotherapists for patients with spinal pain?
There has been minimal research investigating outpatient clinic physiotherapist prescribing in Australia. The Queensland Health (Allied Health Professions' Office Queensland)/ Queensland University of Technology prescribing course was developed in response to the 2013 Federal, State and Territory Health Ministers endorsed non-medical health prescribing pathway (Health Workforce Australia, 2013). The aim of this study is to examine the potential influence of implementing prescribing by physiotherapists on patient’s healthcare resource usage (including medication use) as well as estimate broader benefits. This trial will also extend the field by describing the safety and appropriateness of extended scope prescribing by physiotherapists for patients with spinal pain. It is anticipated that this information will be valuable for guiding policy and resource allocation decision making regarding future expanded scope prescribing by allied health professions and provide an empirical foundation for further research and clinical service developments in the field.
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A bedside ultrasound in general medicine patients with cardiopulmonary diagnosis.
The project investigates the clinical impact of adding a basic bedside ultrasound examination to the standard clinical evaluation of patients admitted to a General Medicine wards with symptoms reflecting a cardiac or respiratory problem. It is a randomised trial. Randomisation means that patients will be assigned in one of the groups by a method similar to flipping a coin, uncontrolled by the researcher. In this study participants will be randomised and allocated into two groups. One group will receive a focused ultrasound examination of the heart, lung and lower extremity veins, performed by a general physician during the first 24 hours at the unit. This test takes around 20 minutes to be completed and it does not add any risk to the patient. The result of the ultrasound will be given to the treating physician, who will decide the treatment and further investigations. The second group will receive standard care, in which a bedside ultrasound examination is not part of usual practice. We will compare the length of stay at the hospital in both groups. We are expecting that this focused ultrasound will improve the work-flow by helping physician narrow down the possible diagnoses faster and guiding management. This may result in reduced length of stay. We aim to see if length of stay at the hospital can be reduced by 24 hours.