ANZCTR search results

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

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31239 results sorted by trial registration date.
  • Targeted gluteal exercise program versus sham exercise program for people with hip osteoarthritis (the GHOST trial (Gluteal exercise for Hip OSTeoarthritis): A randomized controlled trial

    Osteoarthritis (OA) is a common condition affecting many people. The number of people affected with hip OA is expected to rise exponentially over the coming years due to the ageing population and growing obesity rates. Conservative, targeted interventions (including exercise) are theoretically considered important in order to negate the economic cost and potential adverse events related to the typical intervention for end-stage hip OA; total hip replacement. However, recent studies conclude that current rehabilitation programs are limited in terms of improving hip function and reducing pain. It is suggested that current programs are ineffective due to their inability to target the right muscles, and they don't align with progressive resistance strength and conditioning principles, limiting their scope to cause effective change in muscle function over time. Our research team has devised an innovative exercise program that targets the hip muscles that are most affected in people with hip OA. Using these techniques, in combination with contemporary strength and conditioning principles, we wish to investigate whether this program has better success in improving function, pain and quality of life than a standard exercise program. This study is being conducted jointly by La Trobe University, University of Queensland and University of Otago and will recruit 90 participants over 4 sites (Bendigo, Melbourne, Brisbane and Dunedin). This research is funded by Arthritis Australia and La Trobe University.

  • A prospective randomised study on outcomes of a single-session combined balloon and capsule enteroscopies against capsule endoscopy alone in the management of obscure overt gastrointestinal bleeding

    The purpose of this study is to determine the best approach to investigate and treat the source of bleeding from your small intestine, which may have attributed to your low blood count (ie. anemia). Currently, the source of bleeding in the small intestine can be visualized by two endoscopic techniques. The first is called capsule endoscopy (CE), where the camera is miniaturized into a small capsule with a dimension of 20x8mm. Once swallowed, the CE is able to take pictures of gastrointestinal lining as it is spontaneously moves though the gastrointestinal tract. Whilst the pictures taken from the CE can reveal the potential causes of the gastrointestinal bleeding, it is not able to provide a tissue diagnosis or interventions to stop the bleeding. Furthermore, the locations of the potential bleeding spots are poorly located by estimation of the time taken from ingestion to the time at which the CE reaches the bleeding point. Push-pull enteroscopy is the second established technique used to visualize the small intestine by using a very long endoscope pushing its way along the intestinal tract. To improve the depth of insertion, various types of overtube with balloon(s) attached at the end of the tube are used. We used a single balloon overtube-enteroscope system at our centre. In addition to identify the bleeding focus, the major advantages of push-pull enteroscopy are the ability to obtain biopsy for diagnosis and provide endoscopic treatment to stop the bleeding. The disadvantage of this technique, however, is the inability to visualize the whole small intestine. At best, push-pull enteroscopy can only visualize half of the small intestinal tract.

  • Physical and Affective Wellbeing Study of dog owners (PAWS)

    In this pilot study, we will test the feasibility of the recruitment mechanism, participant group allocation, and proposed measurement methods of a flexible design semi-randomised controlled trial examining the effects of dog ownership on adult physical activity, cardiovascular and metabolic health, and psychosocial wellbeing. Results from this pilot will inform the methods of the main Physical and Affective Wellbeing Study of dog owners (PAWS) trial that will be internationally the first controlled trial to examine the health effect of “real world” dog ownership.

  • Dog-Walking, Health and the Human-Dog Bond

    The primary aim of this research is to investigate the oxytocin response to owner-led dog-walking and human-dog interactions, in both humans and dogs, and to examine if variations in this response are influenced by the chronic strength of the human-dog bond. Secondly, this study aims to examine changes in human autonomic nervous system activity as a result of dog-walking and human-dog interactions, and to associate with any variations in the oxytocin response.

  • Statins in Metastatic Castration-Resistant Prostate Cancer

    This study aims to aims to test whether treatment with simvastatin during therapy for metastatic castration-resistant prostate cancer can reverse a poor prognostic plasma lipid signature. Who is it for? You may be eligible to join this study if you are a man aged 18 years or above diagnosed with metastatic castration-resistant prostate cancer and starting chemotherapy (docetaxel or cabazitaxel) or novel anti-androgen treatment (abiraterone or enzalutamide) shortly. Study details All study participants will be treated with simvastatin 40mg daily (oral tablet) for 12 weeks, at the same time as starting treatment (docetaxel, cabazitaxel, abiraterone or enzalutamide). All participants will be followed up for 12 weeks to monitor safety and to assess the lipid profile using plasma samples. It is hoped that this study will help answer the question of whether a 12 week course of a lipid-lowering drug called simvastatin (commonly used to treat high cholesterol, heart disease and diabetes) will lower the specific circulating lipids in blood that are associated with a worse prognosis in metastatic castration-resistant prostate cancer.

  • The ARCHER Study - understanding how puberty hormone change affects health, wellbeing and behaviour in Australian adolescents living in regional New South Wales

    The longitudinal Adolescent Rural Cohort study of Hormones, health, Education, environments and Relationships (ARCHER Study) is a prospective cohort study of 342 healthy adolescents that aims to examine how puberty hormone change affects physical health, mental health, wellbeing and behaviour in young people. Adolescents aged 10-12 years and their parent/guardian who live in and around the regional Australian townships of Orange and Dubbo were recruited during June 2011 and August 2013. Data collection includes annual physical measures (height, weight, waist circumference, body fat), questionnaires on various aspects of health, wellbeing and behavior and cognition test. Annual blood collection, and frequent urine collection (three-monthly collections over the first three years, and six-monthly collections over the last three years of the study) are undertaken to accurately measure changes in puberty hormones. Parents/guardians also complete annual questionnaires on demographic, family and environmental data.

  • Let’s get active at North Ward Dialysis Unit, an exercise physiology led exercise program assessing the impact of exercise on dialysis function, Quality of Life, physical function and nutrition in a group of heamodialysis patients.

    This study aims to determine if participation in a progressive combined (resistance and aerobic) exercise program facilitated by Accredited Exercise Physiologists (AEPs) at dialysis is sufficient to show improvements in time to dialysis efficiency, nutritional adequacy, body composition, physical function, and quality of life (QOL). The primary outcome is the time on dialysis to achieve dialysis adequacy with the intervention. This will be shown by improvements in SpKt/V and URR. The secondary outcome measures include: 1) change in nutrition adequacy assessed by a 2 day food recall including one dialysis day and one non dialysis day, Food Frequency Questionnaire (FFQ) (Australian Eating Survey), and Patient Generated Subjective Global Assessment (PG-SGA); 2) change in body composition assessed using Dual-energy X-ray absorptiometry (DEXA); 3) change in physical function assessed by the short physical performance battery, box and block test, 6 minute walk test and 2 minute step test; 5) change in QOL assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF) and EuroQol five dimensions (EQ5D) questionnaire Research design: Prospective cohort study (pre / post study design). This research project is designed for people on dialysis with low functional fitness. Participants must have a medical clearance prior to entering the program but once accepted will be encouraged to undertake an individualised exercise program during haemodialysis therapy. Conducting the exercise program during dialysis provides an opportunity for this population to be physically active at a time they are usually sedentary. Participants will perform a progressive exercise program at dialysis for 17 weeks (i.e. 3 days / week for 17 exercise sessions or until at least 180 minutes of physical activity per week has been achieved). The exercise will be led by an AEP with support from exercise physiology students. All outcome parameters for dialysis patients will be monitored as per usual care during the 17-week program. At completion, participants will be reassessed on the same tests as conducted at the beginning of the study so that pre-post comparisons can be made.

  • Pre-Hospital Lung Ultrasound in Infants Presenting with Respiratory Illness: A Feasibility Study

    Respiratory illness is a common presentation among the paediatric population and many will have multiple presentations during their lifetime. Bronchiolitis is one of the common viral-induced lower respiratory tract infections (LRTI), particularly during Winter, and can often result in hospital admission. This project proposes to demonstrate the use of pre-hospital point-of-care lung ultrasound is practical in the diagnosis of bronchiolitis and the ultrasound images can be reliably interpreted by Retrieval Doctors.

  • Fibre supplementation to decrease hunger, improve chronic disease risk factors and weight loss in overweight and obese children.

    Aims: The aim of this study is to examine the effect of PolyGlycopleX® (PGX®) supplementation on metabolic risk factors in overweight and obese children. Background: The number of overweight children in Australia, Canada and the US has doubled in recent years, with a third considered either overweight or obese. There is considerable evidence childhood obesity can result in orthopaedic complications, sleep apnoea and hepatic steatosis, cardiovascular disease risk factors, type 2 diabetes and psychosocial problems, including low self-esteem and depression. Childhood obesity usually progresses into adulthood, leading to earlier development of chronic diseases such as type 2 diabetes. As a consequence, early interventions in overweight children are required urgently. High-fibre intake has been shown to reduce the risk of metabolic syndrome, cardiovascular disease and type 2 diabetes in adults. Studies in adults have demonstrated that fibre supplementation can benefit many components of the metabolic syndrome (MS) such as glucose levels and insulin response, blood pressure, as well as lipid profile, thereby reducing chronic disease. However, the effect of fibre supplementation on MS components in children is currently unknown. Supplementation with the novel viscous polysaccharide PGX® (a listed medicine with the TGA, with the active ingredient known as Alginate-konjac-xanthan polysaccharide complex) in adults has shown beneficial effects on weight gain, satiety, lipids, glycaemic response and insulin sensitivity but there have been no studies on the effects in children. Therefore, the aim of this study is to investigate the role of 5g PGX® supplementation (plain powder added to 250 mL milk and one spoon of sugar-free chocolate powder) compared to a placebo, for 16 weeks on fasting glucose, HbA1c, lipids, BMI for age percentile, body composition and satiety in overweight/obese children aged 9-13 years. Collectively, PGX® supplementation could be promoted to overweight and obese children as an aid to weight loss and management by increasing satiety and suppressing excess food intake. Therefore, a simple strategy of PGX® supplementation may offer an easy solution to improvements in metabolic syndrome in children without the need for other nutrient modification. Study Proposal: Seventy overweight and obese children will consume 10g PGX® or placebo supplement (as a divided dose of 5g) for 16 weeks. Fasting measurements of various metabolic risk factors such as glucose, glycated haemoglobin (HbA1c) and lipids will be taken at 0 and 16 weeks. Height, body weight, body composition, waist, hip, blood pressure, body water and satiety will be measured at 0, 8 and 16 weeks.

  • Active Minds, Happy Families: healthy lifestyles for preschoolers and their mums - a program targeting healthy levels of physical activity and sedentary behaviours in preschool children and their mums, and improvements in social skills and cognitive development in children

    The aim of this project is to test the efficacy of a low-cost, stealth intervention utilising novel approaches to improve health behaviours in preschoolers (3-5yrs) and their mothers. This project targets improvements in physical activity and sedentary behaviours in preschoolers and their mothers. The proposed program directly engages mothers, targets early childhood settings and utilises a stealth approach. Mothers identify little need and multiple barriers to changing their and their children’s behaviours but programs targeting inter-generational behaviour change may be effective. A stealth approach, focusing on outcomes or characteristics valued by participants without appearing to be directly related to the targeted behaviour itself, is a novel and necessary approach to take in addressing physical activity and sedentary behaviours in preschoolers and their mothers. This project includes a focus on children's social skills and cognitive development as previous research has identified that these are outcomes of particular relevance to mothers of preschool children. The researchers hypothesise that by targeting improvements in children's physical activity and sedentary behaviours, particularly screen time, children's social skills and cognitive functioning will also improve.

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