ANZCTR search results

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

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32114 results sorted by trial registration date.
  • Investigating the effect of French bark extract, Pycnogenol, as a supplement to improve exercise performance in a population of AFL footballers.

    Nutritional supplements are routinely ingested throughout a training period to maximise exercise-based adaptations. While the mechanisms for adaptations can be varied and can include increased energy expenditure, reduced catabolism, and increased protein synthesis, the intended outcome is an increase in the intended adaptations to training. Pycnogenol, a herbal dietary supplement extracted from French maritime pine bark, is widely marketed for its antioxidant effects. Health benefits purported for Pycnogenol include improved cognitive function, endothelial function, and blood pressure regulation. However, the effect of Pycnogenol on exercise performance, or exercise-induced oxidative stress and inflammatory responses is less clear. Consumption of Pycnogenol has been shown to increase serum NAD+ levels and more recently a study demonstrated that French maritime pine bark extract reduced markers of oxidative stress 48 hours post exercise. Substantially more investigation into the influence of Pycnogenol on exercise performance is required to confirm these results, to examine the optimal timing and dose amount of this supplement, as well as to establish the physiological mechanisms that explain the increased time to exhaustion during intense endurance exercise. Therefore, we hypothesize that Pycnogenol, could be a supplement that increases endurance and with greater adaptations when consumed in addition to training. Here we propose a study designed to establish whether Pycnogenol can improve endurance in highly trained AFL footballers.

  • The effects of running gait retraining using wearable sensors in healthy runners

    Providing feedback to runners outside of laboratory settings may be more advantageous than traditional laboratory-based feedback due to reduced associated costs and improved accessibility. With advancements in wearable technology, it is now possible to use small wireless sensors, called inertial measurement units (IMU), to provide runners with real-time feedback on variables associated with injury in their usual running environment. This project will determine the effects of field-based gait retraining using real-time biofeedback from wearable sensors in high impact runners and assess whether any biomechanical effects are retained at 1-month post retraining. To assess our project aims we plan to recruit 30 healthy runners with high landing impacts. Participants will be randomised into an intervention group that will receive real-time feedback to lower their landing impacts or a control group that be provided with a sham IMU and not receive any feedback during field-based running sessions. Groups will be compared post-training and at 1-month post-training. The expected findings may provide an IMU-based method of running gait retraining and allow for large-scale translation of the results to field settings and reduce the reliance on laboratory-based gait retraining.

  • Change in health outcomes for Aboriginal children with chronic wet cough: a multi-centre implementation study

    Overview: Chronic wet cough in children can be a sign of underlying lung disease such as protracted bacterial bronchitis (PBB) or bronchiectasis. In the absence of pointers to alternative diagnoses, chronic (>4 weeks duration) wet cough that responds to antibiotic treatment typically indicates a diagnosis of PBB. Timely recognition and management of PBB can potentially prevent progression of disease to irreversible bronchiectasis with lifelong consequences3. However, detection and management requires both timely health seeking by parents/families and optimal management by clinicians. Our study’s overall aim is to improve (a) parent/family health seeking for chronic wet cough in their children and (b) clinician management of chronic wet cough in First Nations children. We hypothesize that implementation of a culturally integrated strategy, which is informed by barriers and facilitators identified by parents and health care providers, will improve respiratory health of First Nations children and thereby reduce the burden of bronchiectasis by preventing the progression of protracted bacterial bronchitis to bronchiectasis in First Nations children. Methods The trial is a multi-center, pseudorandomized stepped wedge design where the implementation of the intervention (a strategy) is adapted to each site through a combined Participatory Action Research and Implementation Science approach informed by the Consolidated Framework of Implementation Research. Outcome measures will consist of three categories related to (i) health (ii) economics and (iii) implementation. Health seeking will be measured as the proportion of parents seeking help for their child in a 6-month period before and the same 6-month period after the intervention. The Cough-specific Quality of Life (PC-QoL) will be the primary health related outcome measure. Discussion We hypothesise that tailored intervention based on identified barriers and facilitators identified through engagement with parents and health service providers will result in improved health seeking for parents of children with chronic wet cough and improved clinician management of chronic wet cough. We expect this will result in improve lung health outcomes for children with chronic wet cough.

  • Using oxytocin in individuals with body dysmorphic disorder (BDD)

    BDD is one of the most debilitating chronic mental health conditions, with impacts across multiple domains of functioning. Approximately 2% of the Australian population live with this serious disorder. Reappropriated pharmacological and psychological treatments (developed for mental health disorders with some similar symptoms, i.e. social anxiety disorder (SAD)) have efficacy for some people with BDD; however, most patients remain symptomatic and impaired, and many fail to respond at all. Thus, there is an urgent and immediate need for new BDD-targeted treatments given this significant clinical gap. There are only a few researchers worldwide attempting to improve the knowledge gaps in our understanding of BDD in a bid to develop novel interventions. Our CI team represents one of these groups. We have pilot data using a single dose of intranasal oxytocin (OXT) that restored activity in the ‘social brain’ (i.e. amygdala) in a double-blind placebo-controlled trial of BDD patients (d=0.78). This study seeks funding to extend and expand this world-leading work. Patients with BDD have a chronic illness course that has a major negative impact on social engagement, leading to social isolation and a quality of life that is worse than that associated with many chronic physical illnesses, let alone other psychiatric disorders (e.g. SAD). People with BDD are socially anxious, fear negative evaluations, hide their perceived appearance “flaws” from others, disconnect from family and friends, become depressed and are often suicidal. Despite these prominent social impacts, no treatments for BDD address social affiliation directly. We postulate (supported by our pilot data) that treatments which directly address social aspects of BDD, that is intranasal OXT, will have the potential to achieve symptom reduction/remission as well as substantially improve social functioning (i.e. reduced isolation and a better quality of life). Thus, we are proposing to conduct an innovative phase II randomised-controlled trial (RCT) to investigate whether daily intranasal OXT compared to placebo is an effective intervention for the treatment of BDD symptoms as well as related social impairments.

  • A Phase I Clinical Trial comparing Pharmacokinetics of EMD-RX5 Cannabidiol (CBD) capsules to Epidyolex CBD oil in Healthy Volunteers.

    This is a study of EMD-RX5, an experimental new treatment for stress. EMD-RX5 is a cannabidiol (CBD) capsule which is hoped to be absorbed more effectively than other approved CBD products. Some research indicates that CBD affects receptors (a group of cells that control the movement of chemicals and molecules) in the brain, that may alter a key hormone (serotonin) relating to mood, happiness and feelings of well-being. In this study, we are investigating whether EMD-RX5 capsules are safe and how the body breaks down and absorbs the new drug in comparison to approved CBD (Epidyolex).

  • A smartphone-based real time and adaptive intervention to encourage people with type 2 diabetes sit less and move more

    Reducing sedentary behaviour (SB) is recommended for adults with type 2 diabetes (T2D) and is not a replacement for exercising. Breaking sitting time by light activity is suggested as a management tool in T2D that can provide a medium for further behaviour change towards more active lifestyle. Smartphones are widely being used by people. Smartphones have functionalities such as computational power, internet connectivity and ability to install apps that altogether provide opportunities to conduct real-time, adaptive and interactive health behaviour change interventions. Therefore, we will be able to test what behavioural components (e.g., motivational messages) are most effective in improving behaviour, at what contexts (e.g., location) and how the behaviour changes over time. The overall aim of this research is to evaluate a mobile app-based intervention to help people with T2D Sit Less and Move More. Sedentary participants will be randomized to Sit Less intervention, Move More intervention, or waitlist control condition five times a day. Intervention participants will receive appropriate messages via the app, and their changing activity states will be evaluated within 1 hour from sending a notification message. Moreover, overall time spent sedentary or active during course of the intervention will be measured.

  • Motor Improvement in Neurological Conditions: Stroke telerehabilitation feasibility study

    Stroke is a major cause of disability. Loss of movement is a major part of this. Studies show that high doses of rehabilitation therapy can reduce disability, but many patients do not receive this, e.g., due to obstacles such as difficulty accessing care. Our collaborator (Dr. Steven C. Cramer at the University of California at Cal. Rehab) has previously found that telerehabilitation is an effective way to deliver care and improve outcomes. These prior studies were performed after hospital discharge when patients were already back at home. The current study aims to extend this work by introducing telerehabilitation to the bedside of patients admitted to an inpatient rehabilitation facility (Osborne Park Hospital). In this study, we will measure issues and effects of telerehabilitation that is started during the rehab admission. We hypothesize that telerehabilitation started early after stroke is feasible and that participants will experience an improvement in their function.

  • Suitability of an alternative nutrient bar for assessment of regional gastrointestinal transit using the Atmo gas-sensing capsule

    A novel medical device, the Atmo gas-sensing capsule, has emerged as a technique capable of reliably assessing regional gastrointestinal transit time. In order to standardise assessments made using the Atmo gas-sensing capsule, the meal that is eaten as part of the investigation needs to be consistent across assessments. An alternative nutrient bar has been developed for this purpose to approximate the nutrition profile and form of a predicate nutrient bar. This study aims to compare how the two nutrient bars impact regional gastrointestinal transit time, to determine whether the newly developed, alternative nutrient bar is suitable for future evaluations of transit time using the Atmo gas-sensing capsule.

  • Feasibility of a Stepped-Care Cognitive Behaviour Therapy Program for Cancer Fatigue Management

    Persistent cancer-related fatigue affects many cancer survivors and can have impacts on their physical, psychological and emotional wellbeing. Cognitive Behaviour Therapy (CBT) is a recommended treatment for persistent cancer fatigue in survivors. CBT focuses on changing unhelpful ways of thinking and modifying learned patterns of unhelpful behaviour, but traditional CBT programs are often provided over a long period of time (more than 6 months). This study aims to determine if a stepped-care model of behavioural care that involves patient self-management of fatigue symptoms followed by a shorter course of CBT is feasible and acceptable to cancer patients. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed and finished treatment for any cancer type within 3 months, and you report moderate to severe fatigue based on a series of screening questions (asked prior to enrolment). Additional eligibility criteria may apply to patients with melanoma and/or blood cancers, we recommend you contact the Public queries person listed below to see if you are eligible for this study. Study details All participants who choose to enrol in this study will be given a self-management cognitive behaviour therapy (CBT) work booklet that contains activities and educational materials (Step 1). Participants will be asked to work through the booklet at their own pace over a 5 week period, and will have access to telephone and email support after the first week. Participants who do not have any change in their fatigue levels after completing this 5-week program will then be offered Step 2, which involves an additional 4 x 50 minute face-to-face/Telehealth individual or group CBT sessions with a Clinical Psychologist. It is hoped this research will determine whether it is possible and acceptable to cancer patients to deliver behavioural therapy in a stepped-care manner rather than a standard 12-week program. If this stepped-care model is acceptable to patients, it may be delivered as part of a larger trial that could help future cancer patients with their fatigue as well.

  • Investigating the effect of medicinal cannabis on the symptoms and side effects of chemotherapy in people with cancer.

    The CANCAN trial aims to provide the evidence needed to better inform healthcare professionals in the use of medicinal cannabis in people with cancer. The purpose of this study is to investigate whether medicinal cannabis – a combination of cannabidiol (CBD) and tetrahydrocannabinol (THC) – is effective and safe for the management of chemotherapy symptoms and side effects in people receiving treatment for cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are scheduled to undergo either at least 3 cycles of chemotherapy for treatment of a solid tumour, or autologous stem cell transplantation for treatment of a haemotological cancer. Study details Participants will be randomised (i.e. allocated by chance) to receive either the medicinal cannabis treatment or a placebo. Participants in the medicinal cannabis group will receive 400mg per day of CBD and a starting dose of 2.5mg per day of THC in the form of an oral capsule for the duration of each treatment cycle, while participants in the placebo group will receive a daily glucose capsule. All participants will be monitored for symptoms of gut distress, have blood tests and their body weight taken, and answer a number of questionnaires, to determine if the medicinal cannabis treatment has an effect on chemotherapy symptoms and side effects for up to 6 months after the completion of treatment. Participants will also be monitored over this period for whether they have used supportive care or been hospitalised, for whether they have completed or ceased treatment and why, for their response to chemotherapy, and for any adverse events. It is hoped that this study may show that medicinal cannabis will minimise the intensity of chemotherapy symptoms, and thus have beneficial effects on the outcomes of chemotherapy. Specifically, we anticipate that CBD will minimise gut injury, therefore minimising local symptoms including diarrhea, malabsorption and pain, while THC will promote food intake, improve sleep quality and decrease anxiety. We expect this to have benefits on quality of life, and the ability of participants to receive their intended dose of chemotherapy without interruptions.

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