ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Does a hand strength exercise program improve grip strength in elderly patients with wrist fractures?

    Wrist fractures are amongst the most common fractures suffered by elderly patients. There is limited data regarding grip strength of elderly patients who have suffered a distal radius fracture at the 2 and 6 week mark post injury. We performed a pilot study in the last year investigating grip strength in patients with distal radius fractures at 2 and 6 weeks post injury to determine whether they could drive. One major finding was that patients over the age of 60 who suffered a distal radius fracture had around 0-5kg of grip strength when measured at 2 and 6 weeks post injury. We also found that most patients were given a physiotherapy handout of range of motion exercises which they could perform. There was no strict guideline or recommendation of how often to perform the exercises and there were no grip strength exercises recommended. Grip strength in elderly patients has been noted to be a good indicator of function. Maintenance of function in the elderly patient is of great importance to a patient’s independence in mobility and activities of daily living. We hypothesize that a grip strength focused exercise program given to elderly patients with distal radius fractures will significantly improve patients’ grip strength and therefore function. This study would be of clinical significance to the elderly patient who suffers a wrist fracture. If we can improve a person’s grip strength and function, we may also improve their quality of life. Aim/Objective: To determine whether an exercise program will improve grip strength in elderly patients with distal radius fractures treated nonoperatively. Secondary objective 1. Determine whether an exercise program will improve pain in elderly patients with distal radius fractures 2. To determine whether an exercise program will improve function and reduce complex regional pain syndrome Hypothesis We hypothesize that adherence to a grip strength focused exercise program for a month between 2 weeks and 6 weeks post injury will improve grip strength in elderly patients who suffer a distal radius fracture.

  • Effects of 12-week dairy-derived nutritional supplementation combined with physical activity on health and physical function in healthy middle aged women after a 2-week period of reduced activity

    After the age of approximately 40 years there is a progressive decline in physical function as well as bone, muscle and general health. Recent evidence indicates that some of these changes might be slowed or reversed with appropriate intake of nutrients such as proteins, calcium and vitamin D. However, whilst the effects of these nutrients have been quantified in older individuals (e.g. >65 years of age), no research has determined whether effects are present in younger (e.g. 40 - 60 years of age) individuals. Dairy foods such as milk contain these essential nutrients, and the processing of milk allows for the development of nutritional supplements with higher levels of them. Our hypothesis is that a dairy-derived supplement (fortified milk product, FMP) that is high in protein, calcium and vitamin D will improve physical function as well as bone, muscle and general health in 40 - 60 year-old women. Because the combination of dietary supplements with exercise, which normally forms part of a healthy lifestyle, has been shown to improve health outcomes after supplementation, we will compare the effects of the FMP supplement to a placebo powder (PLA) when taken twice daily during a 12-week period while completing prescribed exercise sessions four times a week. Additionally, because periods of physical inactivity are common in this age group (e.g. due to work and family commitments or short-term illness), we will first impose a 2-week period of reduced physical activity before introducing the exercise (i.e. healthy lifestyle) program and supplementation or placebo.

  • Randomised placebo controlled trial of inhaled corticosteroids for treatment of chronic cough in children.

    This study will help us answer the question: should children with chronic cough be given inhaled corticosteroids to promote faster recovery and improve ability for children to return to their normal daily routines? This study will also evaluate whether fractional exhaled nitric oxide levels can predict short term response to inhaled corticosteroids in children with chronic cough. We hypothesise that a short (two week) course of inhaled corticosteroids will reduce cough severity in children with chronic cough, and that FeNO measurements can be used to predict this response.

  • A Study of Viagra and XCalibur in Healthy Volunteers.

    iX Biopharma Pty Ltd is developing a new capsule formulation of sildenafil for treating erectile dysfunction. Sildenafil as a drug has been approved by the Therapeutic Goods Administration (TGA) in Australia, but the capsule formulation of sildenfil has not been approved by the TGA Therapeutic Goods Administration in Australia or in any other country. This particular formulation of sildenafil, XCalibur (the study drug), and its use in this study are experimental. The study drug will be compared to the pre-existing tablet formulation Viagra.

  • Online Health Psycho-Education and Cognitive-Behavioural Intervention Program (step-up) for Young People to Combat Cyberbullying

    The aim of the trial is to establish if the use of an online psycho-education and cognitive-behavioural intervention will decrease the likelihood that a young person will experience being cyber bullied, and also reduce the impact of any bullying experienced. The program is designed to decrease vulnerability to bullying by building coping responses over time. We hypothesise that young people who complete the on-line intervention will experience decreased bullying (particularly cyber bullying), increased self-compassion, and decreased emotional and behavioural symptoms from pre-test to post-test, and these changes will either be maintained or improved over the 1-month follow-up..

  • Prostate Cancer Vitamin D Clinical Trial

    The primary purpose of this trial is to evaluate the efficacy of vitamin D supplementation for the prevention of progression in men with prostate cancer who have an immediate risk of progression. Who is it for? Men are eligible to participate in this trial if they are aged 50 to <80 and have been diagnosed with localised prostate cancer with intermediate risk of progression, for which they have chosen to go on active surveillance. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either vitamin D tablets, or to receive inactive sham tablets. Tablets in both groups will be taken orally, once per month, for two years. Participants will be followed up at the end of this period to assess for incidence of disease progression and commencement of active therapy. It is hoped that the findings from this trial will provide information on whether vitamin D supplementation is effective for preventing disease progression in men with prostate cancer.

  • In individuals undergoing simultaneous bilateral total knee replacement, does making a lateral skin incision affect skin sensation, ability to kneel and patient satisfaction?

    The initial skin incision performed to expose the knee during total knee arthroplasty (TKA) is centred over the patella for ease of access to the joint. This places the scar directly over the bony points of the knee that bear load when kneeling, leaving the skin on the lateral side (outside) of the scar with reduced sensation and sometimes the skin on the medial side (inside) of the scar with painfully altered sensation (dysaesthesiae / neuromata). Placing the skin incision lateral to the edge of the patella (kneecap) avoids the necessity of kneeling on a scar and has been shown to reduced dysaesthesiae and neuromata in other knee procedures. Primary Aim: To prove that lateral skin incisions improve the ability to kneel in patients following bilateral total knee arthroplasty Secondary Aim: 1.Investigate whether lateral skin incision has improved retention of skin sensation. 2.Investigate the ability to kneel after TKA. 3.Investigate if there is improved deep flexion. 4.Investigate whether there is decreased pain and better satisfaction as per patient reported outcome measures (PROM) Research Design: Prospective, Randomized Controlled Trial. Patient Demographic: Eligible patients aged between 40-90 years of age with bilateral, tri-compartmental osteoarthritis (OA),undergoing simultaneous bilateral TKA. Patients with previous knee arthrotomy (cut to the joint capsule) will be excluded. Patients' limbs will be randomized for surgery into two groups; (1) Midline Incision Group and (2) Lateral Incision Group. Outcomes:measured at, six months, and 12 months post-operatively. - Knee flexion and extension. - Kneeling Grade Assessment- a novel grading system has been developed that Grades the ability to kneel from 1-5 depending on how far down the patient can knee. - Area of skin dysaesthesia (uncomfortable change in skin sensation) will be mapped and analyzed using imaging software. - Neuroma formation. - PROMs (patient reported outcome measures).

  • Does the use of the Verasense pressure sensor device and alignment method produce a more balanced knee in patients undergoing total knee arthroplasty

    The primary aim of this project is to determine the influence of two different prosthesis alignment techniques in total knee arthroplasty (TKA) on the soft tissue balance of the knee by using a novel pressure sensor device. Our hypothesis is, that the kinematic alignment of a total knee prosthesis creates a more balanced knee without the need for soft tissue releases. The secondary aim of the project is to determine what relationship prosthesis alignment technique has on patient satisfaction and on patient reported outcome measures (PROMs). The proposed research design is a multi-site, single blinded, prospective randomized controlled trial involving four consultant orthopaedic surgeons at the Mater Health Services North Queensland Ltd, Cairns Base Hospital and the Cairns Private Hospital. Participants will be randomized to either mechanical or kinematic alignment. All participants will undergo the same peri-operative and post-operative protocol process for TKA. All procedures will be planned and performed with the use of patient specific instrumentation (PSI) custom cutting guides based on a pre-operative MRI. These allow the surgeon to make pre-planned bone resections specific to the participant's anatomy. All participants will receive the same total knee prosthesis. The surgical technique will be standardized with respect to the resection of bone, ligament tension assessment and the use of Verasense instrumentation. The Verasense insert will be used intra-operatively to measure pressures across the knee joint during the prosthesis trialing phase, before any soft tissue releases are performed. If the knee is not balanced, then measured steps will be undertaken to achieve balance. All intra-operative surgical data will be recorded. Post-operative patient review will be conducted at two weeks, six weeks, six months, and then yearly. Standard TKA post-operative radiologic assessment will be undertaken to determine the final prosthesis alignment. Outcome measures will include validated clinical pain and function scores such as the WOMAC score, EQ5D, Knee Society Score, the Oxford Knee Score, and the Forgotten Joint Score. Data collected will be analysed using statistical methods in order to find any statistically significant difference in results between the two alignment strategies. Once collected, data will be de-identified (non-identifiable) and sent to an external statistician to perform statistical analysis. All participants will receive PSI Zimmer Nexgen CR Flex TKA prosthesis.

  • Positive Behaviour Study - Evaluating Positive Behavioural Supports Intervention for Individuals with Acquired Brain Injury

    Behaviours of concern (BoC) following acquired brain injury (ABI)– including aggression, agitation and sexual inappropriateness – present significant challenges for the person with ABI, their families, service providers and wider society. These behaviours often result in social isolation and dislocation from accommodation, and represent a significant source of stress to caregivers over many years following injury. Over the past 30 years, there has been a gradual shift towards a focus on modifying the antecedents as opposed to the consequences of behaviour in individuals with ABI. This shift has been led by Mark Ylvisaker and Tim Feeney, through their development of a Positive Behaviour Support (PBS) intervention for people with brain injury and BoC (Feeney & Ylvisaker, 1995, 2006; Ylvisaker, et al., 1998; Ylvisaker, et al., 2003; Feeney 2010). Although the principles underlying the PBS framework reflect current standard best practise, there has been no previous controlled evaluation of a PBS intervention in adults with BoC after ABI. This study will be the first controlled trial of a PBS intervention for BoC in adults with ABI. The creation of this evidence will underpin more efficient and effective interventions and better coordinated care for individuals with ABI and BoC. This project aims to develop, implement and evaluate the efficacy of a Positive Behaviour Support (PBS) model of intervention for individuals exhibiting BoC following ABI which reduces or minimises BoC. It is hypothesised that: *participants receiving the 12-month PBS intervention will show a greater reduction in frequency and severity of BoC on the Overt Behaviour Scale (OBS) (Primary outcome) than a treatment as usual waitlist control group monitored over the same period *the reduction in BoC on the OBS will be maintained at 12-month follow-up. * relative to treatment as usual waitlist controls, participants receiving the 12-month PBS intervention will show a greater increase in community participation, and in quality of life, a greater reduction in attendant care support costs, a greater reduction in score on the Care and Needs Scale, in medication use, in alcohol and drug use, in anxiety and depression symptoms and improvement in family functioning. *The improvements on secondary outcomes will be maintained at 12-month post-intervention follow-up.

  • Health Impacts and Dietary Composition of the Paleolithic and Australian Guide to Healthy Eating Diets in Australia

    The study comprises a cross sectional, case-control study comparing the long term health impacts of the Paleolithic diet with a high carbohydrate, low fat diet in healthy volunteers. Primary outcome measures will include faecal short chain fatty acids (SCFA), secondary bile acids, ammonia and phenol concentrations, serum TMAO, SCFA and BCAA concentrations. Pre-study power calculations have been conservatively based on between group differences in faecal butyrate, with medium effect size (d=0.5) and 80% power. Fifty one self-reported long term followers of the Paleolithic diet (greater than 1 year) will be recruited and age and sex matched with 51 controls (total n=102). Once inclusion criteria are met and consent provided, participants will complete a diet history interview, 3-day weighed food record and provide a 48 hour stool and 24 hour urine collection and blood sample for analysis. Faecal biochemistry (SCFA, bile acids, ammonia, phenol, total moisture) will be determined using gas chromatography (GC) and high performance liquid chromatography (HPLC) methods. Serum samples will be analysed for SCFA, TMAO and BCAA. Food group, and dietary fibre intake will be analysed using SPSS v22.0 (IBM Corporation, 2013) with between groups and within groups analysis being performed. Data obtained from experiment three will be analysed using SPSS v22.0 (IBM Corporation, 2013) and PRIMER-7 (Primer-E, 2015). Outcome variables will be compared to macronutrient intake as continuous variables using general linear modelling. Analysis of data in this manner will provide estimations of risk for changes in outcome variables for changing carbohydrate, fat and protein intake. The study will provide significant information to public health educators in relation to Paleolithic and AGHE dietary patterns. The study will provide a significant contribution to the understanding of how total long term dietary patterns, inclusive and exclusive of grains and legumes contribute to the risks of future development of non-infectious bowel disease, diabetes and cardiovascular disease.

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