ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Feasibility and potential benefits of high-intensity interval cycling for knee osteoarthritic patients: a randomised control feasibility trial?

    Osteoarthritis (OA) is a degenerative joint disease affecting many middle-aged and older adults. As osteoarthritic symptoms typically involve joint pain and stiffness, individuals with OA of the knee are insufficiently physically active, have low levels of physical function and are at increased risk of other comorbidities, falls and reduced quality of life. While continuous moderate intensity cycling is often recommended for individuals with knee OA, little is known about the potential benefits and risks of high intensity interval training (HIIT) cycling for this population, even though this form of exercise is becoming more commonly utilised by a range of other chronic disease groups. This randomised controlled feasibility trial sought to gain some insight into the feasibility, safety and effectiveness of home-based HIIT compared to continuous cycling in middle-aged and older adults with knee OA. Methods: Middle-aged and older adults with knee OA were randomly allocated to either continuous (MICT) or HIIT home-based cycle training programs; with both programs requiring the performance of four cycling sessions (~25 minutes per session) each week. Participants were measured at baseline and post-intervention (8 weeks). Feasibility was assessed by withdrawal rate, adherence rate and number of adverse effects. Efficacy was assessed by the WOMAC, Lequesne index of severity for osteoarthritis of the knee, Timed Up-and-go (TUG) test; Sit-to-stand (STS), preferred gait speed and body composition.

  • Natural history and properties of naevi in advanced melanoma patients receiving treatment

    This study aims to identify genetic differences and dermatological characteristics that pose greater risk for development of skin cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more and are either undergoing targeted therapies and/or immunotherapies at the Cancer Services (PA Hospital) for stage III or IV melanoma OR if you are considered to be at a high risk of melanoma. Study details: This is an observational prospective study (no additional treatment) on the natural history of naevi in advanced melanoma patients receiving treatment. This will include observations of molecular and genetic differences associated with changing naevi and melanoma risk. Patients will be followed up every 4 months for 1 year (4 visits in total) with 3D whole body photography and dermoscopy of all naevi larger than 3mm. The germline genotype is determined by collecting saliva together with baseline demographic data along with images. During follow up visits, naevi which show clinical and dermoscopic changes in pigmentation are sampled using a microbiopsy device. DNA and RNA can be isoalted from these samples for somatic genotyping. The same naevus can be sampled several times over the course of its growth and following visits. Additional shave biopsies (up to 3) will also be taken for comparative purposes. It is hoped that this study will lead to better understanding of genetic and phenotypic characteristics that lead to high risk of melanoma development and that may then assist in early diagnosis and preventative behaviours of skin cancer.

  • Randomised comparison of how different terminologies for papillary thyroid cancer affect decision making about treatment among an Australian community sample

    Purpose of the study: This study aims to explore how adults with no history of thyroid cancer would make decisions about treatments based on the terminology used to describe a hypothetical diagnosis of papillary thyroid cancer. Who is it for?: You may be eligible to join this study if you are aged 18 years or more, have no history of thyroid cancer. Study details: All participants in this study will be presented with three hypothetical scenarios that describe the diagnosis of papillary thyroid cancer using various terminology with and without the "cancer" term. The order in which these scenarios will be provided is random (by chance). Each hypothetical scenario and the treatment options presented to participants will be identical with the only difference being the terminology used. Following presentation with these scenarios participants will be assessed on treatment preferences and psycho-social outcomes. This research study will contribute to a new body of research aimed at understanding how different terminology for precancerous conditions or early stage cancer affect patient’s decision making about treatment.

  • Impact of a Berry Extract on Vascular Function

    Polyphenols are bioactive compounds found in plants. These compounds have been found to have beneficial effects on vascular function. Arguably the most well-established vascular benefits are attributed to flavanols from cacao beans. Berry fruits are another rich source of polyphenols that have vasoactive properties, and there is a growing body of research exploring these effects in various berries (blueberries, cranberries, strawberries) and other fruit products with similar polyphenol composition. A key polyphenol in berries and other fruits believed to provide much of the benefit is anthocyanin. When given as an isolated extract 320mg anthocyanin has been found to improve blood vessel function both acutely and in response to chronic consumption over 12 weeks. Thus the primary focus of this project is to evaluate the effects of berry extracts of differing polyphenol dose on vascular endothelial function.

  • Does an individualised performance-focused swimming training program improve health, fitness and function in individuals following megaprosthesis bone replacement surgery?

    The aim of this project is to evaluate the effectiveness of an individualised, moderate intensity health focused training program, and a swimming performance focused training program at improving health, fitness and function in people with a megaprosthesis. Who is it for? You may be eligible to join this study if you are aged between 15 to 30 years, have had a lower limb megaprosthesis inserted at least 1 year ago, and are insufficiently active for health but are interested in participating in competitive sport. Study details: All participants in this study will partake in a four phase, 14 month (60 week) intervention, consisting of 15 weeks baseline, 30 weeks exercise training and 15 weeks of maintenance/off season monitoring. The study will be administered by a combination of swimming coaches, exercise scientists and physiotherapists. Training will include land and pool based sessions. Exercise choice will promote strength, aerobic capacity, neuromotor function, flexibility and swim performance. Frequency, intensity, duration and activities included in each training session will be individually prescribed and progressed based on each participants individual exercise tolerance. Regular testing will be conducted throughout the study to evaluate health, physical fitness and function.. We hope that information gained from this research will help to inform discussion as to whether individuals that have had a lower limb megaprosthesis should be eligible for participation in Paralympic sport within the current classification system or whether changes are warranted.

  • The effect of two concentrations of delta-9 tetrahydrocannabinol (THC, the active ingredient in Cannabis) on saliva-based drug detection systems and driving performance

    This study aims to test the whether legally permissible levels of THC available in foodstuff is detected by a commonly used single-use saliva-based drug test when compared to a placebo and if this differs when given in different concentrations (high and low). We will also be assessing whether there are any changes to driving ability as a result of ingesting hempseed oil.

  • A feasibility study of a text message brief intervention following a suicide attempt

    Suicide is a leading cause of death in Australia, and is the leading cause of death for young people. A previous suicide attempt is a strong predictor of death by suicide, and hospital-treated deliberate self-harm (DSH) is the single strongest risk factor for subsequent suicide. The one-year repetition rate for hospital-treated DSH is 16%, which increases to 30% for those with a history of previous suicidal behaviour. Following a suicide attempt, the first days after discharge from hospital is a particularly high-risk period. Continuity of care is critical, yet this is a time where individuals often lose contact with healthcare services. There is considerable uncertainty about the most effective post-discharge interventions to reduce repetition, with non-significant reductions attained using a variety of techniques. Brief contact interventions, including post-discharge letters, green cards, telephone calls, and postcards, have reduced the number of repeat events, but digital delivery of brief contact interventions, such as SMS, email or social media, has not yet been evaluated. The RAFT project is a single group, pre-post pilot study of a digitally-delivered brief intervention aimed at reducing repeat suicide attempts. RAFT will deliver text messages containing links to information and therapeutic content via mobile telephone, at specified intervals. To pilot this intervention, individuals aged 18 years or older who present to a participating hospital following a suicide attempt will be offered this intervention. After informed consent, baseline measures will be administered online. Follow-up measures will assess suicidal ideation and behaviour, and social connectedness. In addition, feasibility and acceptability of the intervention will be assessed by examining participants' use of the intervention materials and through semi-structured interviews.

  • A proactive Inpatient Diabetes Service to improve diabetes care in hospitalised patients.

    Background: The prevalence of diabetes in hospitalised patients is 25-30% in Australian hospitals. During hospitalisation for surgery or acute medical illness, diabetes management becomes more difficult. Resultantly, hypoglycaemia (low blood glucose) and hyperglycaemia (high blood glucose) frequently occur with associated complications including infections, longer length of stay and mortality. The management of inpatient diabetes remains suboptimal due to multiple factors, including altered physiology, dynamic hospital processes and medication changes. There is inattention and clinical inertia to inpatient diabetes management due to numerous pressures on hospital beds, expediting acute care and the increasing prevalence of diabetes. This study seeks to investigate a novel, proactive model of inpatient diabetes care. Methods: This study is a cluster-randomised controlled trial of a proactive Inpatient Diabetes Service (IDS) model of care. The IDS will identify inpatients with known diabetes and inpatients with new-onset hyperglycaemia using connectivity blood glucose meters and a "glucose alert pathway". The IDS will deliver a proactive consult service to these patients without referral from the treating teams, early in their admission. The IDS will manage inpatient diabetes care and facilitate discharge for these patients with the aim of increasing safety, reducing adverse glycaemia and reducing diabetes related complications. Consecutive inpatients with known diabetes or new-onset hyperglycaemia, admitted to the 8 participating wards will be included. The participating 8 wards will be cluster-randomised to 4 intervention and 4 control wards. The trial consists of a 3-months baseline period followed by a 3-months intervention period. It is hypothesised that the proactive IDS will reduce adverse glycaemia (unsafe blood glucose levels), adverse clinical outcomes and reduce length of stay in hospitalised patients with diabetes.

  • Benefits of Exercise Physiology Services for Type II Diabetes: The BEST Study

    Currently, there is very little collective evidence on the efficacy of AEP-led exercise interventions “in practice” for people with chronic disease. This project aims to determine the effectiveness of services provided by Accredited Exercise Physiologists (AEP) for clients with type 2 diabetes on sustained participation on physical activity and clinical markers. Clients with type 2 diabetes who are referred by their General Practitioner to one of the participating Exercise Physiology clinics will be recruited for this study. Their outcomes will be compared to those of a control group that do not receive a referral but who are willing to undergo the same battery of assessments on two occasions.

  • Training restraint to increase healthy food consumption

    The project aims to investigate the efficacy of computerised inhibitory control training on unhealthy food consumption in obese adolescents and adults. Outcome measures will include consumption of various food types, attitudes towards food, and electrophysiological indices of approach/avoidance during exposure to food stimuli. Training will involve daily sessions playing an iOS app designed to reduce responses to unhealthy food, while encouraging responses to healthy foods. Using a waitlist control design the study will test both the efficacy of the app, and the viability of the intense training schedule.

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