ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31130 results sorted by trial registration date.
  • Internet-based management of rotator cuff disease: a pilot and feasibility randomised controlled trial

    A recent Australia-wide survey found that many general practitioners recommend unnecessary imaging and surgical referrals for a common type of shoulder pain (rotator cuff tendinopathy). We hypothesise that educating patients with rotator cuff tendinopathy directly about their condition and recommended care has the potential to reduce nappropriate imaging and surgery, increase adherence to recommended care and ultimately improve healthcare outcomes. The proposed study is a three-arm, parallel group, pilot and feasibility randomised controlled trial. Participants will be randomised to one of three trial arms; Group (i) standard advice and exercise via online pamphlet; group (ii) pamphlet in (i) + video delivery; group (iii) pamphlet in (i) & videos in (ii) and individualised daily feedback.

  • The effect of the Nutrition-Care Gluco-Metabolism Formula on glucose levels in pre-diabetic adults: The Gluco-Metabolism Trial

    Prevention and early diagnosis of diabetes is key to avoid diabetes-related complications. In 2018, 2 million Australians are estimated to have pre-diabetes and are at high-risk of developing type 2 diabetes. The Nutrition-Care Gluco-Metabolism Formula contains a mixture of herbs and nutrients, which have been shown to be beneficial for balancing blood glucose levels in the blood. In this randomised double-blind placebo-controlled 12-week trial we aim to assess the tolerability and efficacy of the Gluco-Metabolism Formula for glucose control in pre-diabetics.

  • Go Kids: Evaluation of a school-based therapy prescription app

    Mobile health technology may assist children with disabilities in completing school therapy programs prescribed by their physiotherapist, occupational therapist, or speech pathologist. We have developed an iOS (iPad/ iPhone) app, designed specifically for children with disabilities, that employs electronic gaming elements and other features to maximise children’s motivation to practice therapy activities at school. The feasibility of using this app, with 6-12 years old children with disabilities, for completing individualised therapy programs in a classroom environment will be investigated in this study.

  • Albumin infusion for kidney protection after heart surgery

    Acute Kidney Injury (AKI) following cardiac surgery is a significant cause of morbidity and mortality, affecting up to 30% of patients. It is unclear if 20% albumin infusion is useful in reducing the incidence of AKI in these patients. We hypothesise that an infusion of 20% albumin will reduce the incidence of perioperative AKI after high-risk cardiac surgery, compared with standard care.

  • How nutrition supplements may improve exercise capacity in people with Chronic Obstructive Pulmonary Disease attending outpatient pulmonary rehabilitation program.

    The primary objective of this study is to determine if nutritional supplementation improves exercise capacity in patients with Chronic Obstructive Pulmonary Disease (COPD) attending pulmonary rehabilitation. Secondary aims of this study are to evaluate if nutritional supplementation results in greater improvements in hand grip strength, body weight, body mass index (BMI), nutritional status (MNA), health related quality of life and lower limb strength in people with COPD participating in pulmonary rehabilitation. Participants will attend an 8 week (16 session) pulmonary exercise rehabilitation program which consists of two 1.5 hour exercise sessions per week. Participants that consent to take the nutritional supplement will be assigned to the intervention group and will be asked to take a nutritional supplement daily for the period of their 8-week exercise rehabilitation program. Participants who decline to take the nutritional supplement will be invited to also take part in the study and will be assigned to the Control Group (non-randomised) and asked to complete baseline and follow up outcome measures only. Overseas studies have shown that nutritonal supplements improve exercise outcomes for patients with COPD attending pulmonary rehabilitation and we aim to see if this can be replicated in the Australian population.

  • Prevention of Diabetes Progression in Primary Care through Shared Medical Appointments

    12 groups of 8-12 subjects will be chosen from 6 volunteer Western Sydney Medical Centres to attend 6 x fortnightly experiential learning sessions conducted as Programmed Shared Medical Appointments (pSMAs) in diabetes risk factor management. Participants will be selected from pre-diabetes and early diagnosed (3 years) Type 2 diabetes patients who are not on diabetic medications. The intervention will include a structured audio-visual presentation (12-15 minutes) before a discussion session with a trained facilitator (usually trained nurse or allied health professional), followed individual clinical consultations with a GP with all participants contributing. End-point outcomes (HbA1C, body weight) will be compared with standard treatment controls after 12 months. Patient and provider satisfaction with the process are secondary outcomes.

  • The relationship between cardiorespiratory parameters during physical activity following cardiac surgery

    Exercise is undertaken as part of usual physiotherapy care following heart surgery. While it is considered safe, the exact effects of exercise which is commony prescribed following heart surgery by physiotherapists on heart function, breathing rates and oxygen levels are unknown. Establishing this information will further inform exercise prescription guidelines for physiotherapists who care for people following heart surgery. The aim of this study is to determine the relationship between heart rate, respiratory rate and oxygen saturation and measures of physical function and exercise intensity following heart surgery. People who have undergone heart surgery and require physiotherapy following surgery will be recruited for this study. During the usual physiotherapy tasks which involves exercise, and tests of balance and leg strength, measurements of heart function, breathing rate and oxygen levels will be extracted from the continuous monitoring system of which all people following cardiac surgery are connected to. Participants will be asked to rate their level of breathlessness and exertion following exercise. The relationship between exercise intensity and measures of heart function, breathing rate and oxygen saturations will be assessed.

  • The safety and disposition of metformin in people with liver disease and diabetes already treated with metformin

    Metformin is the first drug chosen to treat type 2 diabetes mellitus. However, the regulatory label warns against it use in people who also have chronic liver disease (CLD) but there is little published data to support this warning. Despite this, metformin is used in patients with CLD. This study will investigate the safety and pharmacokinetics of metformin in patients with CLD who are already prescribed metformin to treat their type II diabetes mellitus (T2DM) . We hypothesis that metformin, at doses adjusted based on renal function, can be safely administered to patients with CLD. Further, the pharmacokinetics of metformin in patients with CLD will be similar to those reported in patient with T2DM and no CLD.

  • Orkambi in Patients with Cystic Fibrosis and Severe Liver Disease

    This is a pharmacokinetic study of Lumacaftor/Ivacaftor (Orkambi) in children between 2 years and 18 years of age who are homozygous for Phe508del-CFTR with severe cystic fibrosis related liver disease, in comparison to those without severe liver disease.

  • PLASTIC: Prolonged Laparoscopic and Lower Abdominal Surgery Trial – Incidence of Complications

    Respiratory complications are reportedly very low (<2%) following open incision lower abdominal surgery and simple laparoscopic upper gastrointestinal surgery (e.g. lap choles). Due to a high cost to benefit ratio, prophylactic physiotherapy directed respiratory exercises and assisted early ambulation is not provided to these patients over and above standard ward care in a majority of hospitals in Australia or Europe. However as more complex procedures, such as bowel resections are increasingly being performed, the corresponding operation times are extending well past 3 hours. This may independently increase the risk of a respiratory complication. However, reports on respiratory complications in prolonged (>3r) laparoscopic and open lower abdominal is lacking. This trial aims to measure rates of respiratory complications in this population in the context of standard hospital ward care. Risk prediction modelling of those patients at highest risk will ensure that future prophylactic delivery of respiratory exercises and Physiotherapy is targeted to those patients that most require them.

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