ANZCTR search results

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

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33036 results sorted by trial registration date.
  • Strong for Oesophago-gastric Cancer Surgery - prehabilitation program for people with stomach cancer.

    The majority of patients undergoing oesophageal/stomach cancer surgery have reduced fitness. This means they are at greater risk for, and struggle to overcome post-surgical complications, which leads to further morbidity and mortality. This study aims to assess whether a prehabilitation exercise and nutrition program administered to participants prior to surgery has any impact on their physical, nutritional and psychological wellbeing after surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with gastric, gastroesophageal junction or oesophageal cancer, you are scheduled to receive or are currently undergoing chemotherapy, radiotherapy or both and you are going to undergo elective surgery to treat your cancer after completing these therapies. Study details All participants who choose to enrol in this study will be given a personalised diet and exercise program to follow for 3 months prior to their elective surgery. During the initial visit, participants will undergo a series of physical assessments to determine their current fitness levels and will be asked to provide a diet history to assess their nutrition status. It is anticipated that this initial assessment will take 60 minutes. After the initial assessment, participants will be given a personalised exercise plan to follow, this will include 2x 45-60 minute one-on-one sessions with a physiotherapist each week for 3 months. Participants will also be asked to undertake additional moderate exercise, e.g. walking, for at least one hour per week for the 3 months. Participants will also be given nutritional advice including suggested meal plans to address target areas (e.g. reducing carbohydrates or increasing protein or vitamin intakes) to follow over the 3 months prior to their surgery. For the 5 days prior to and 5 days after their surgery, participants will also be provided with an immune-modulating supplement (drink) to consume. Participants who are assessed as at risk for anxiety and depression, and those participants who are struggling to comply with their exercise plan will also be offered one-on-one psychological counselling. Data collected from participants who are undergoing these interventions will be compared to historical patients who received standard of care prior to their surgery. It is hoped this research will demonstrate whether a targeted prehabilitation program has a positive effect on the physical, nutritional and mental wellbeing of patients who are undergoing treatment for gastric and oesophageal cancers. If this study does show a positive effect, the prehabilitation program may be expanded to a greater number of cancer patients.

  • Assessing the impact of walking with inflatable cuffs on fitness and function of older people

    Age-related declines in muscle mass and cardiovascular fitness have debilitating effects on tasks of daily living for older people. Exercise helps to maintain physical abilities, but many older individuals cannot tolerate the recommended high-intensities of training. This research will assess an innovative form of exercise to increase fitness for older people, combining low-intensity walking with wearing inflatable cuffs on the limbs to restrict blood flow, in a 24-week walking exercise intervention. The aims of this project are to determine the effects of BFR walking training on physical fitness, functional abilities, and cognitive function, in older people.

  • Examining the impact of sleep restriction on reward learning

    A disruption in reward processing is suggested to underpin a number of mental health disorders. Current evidence indicates alterations in brain regions during the anticipation and receipt of reward characterise individuals with eating-related disorders (e.g., obesity, binge-eating), non-substance addictions and substance use disorders. These alterations may facilitate compulsive behaviours and potentiate craving. Current evidence suggests reward processing is also impaired in conditions of sleep disruption, with a number of studies indicating impaired ability to discriminate between reward and punishment and increased reward-driven approach behaviour following sleep deprivation. Given an increasing number of individuals in today’s society function without adequate sleep this may indicate a role for sleep disruption in the development and maintenance of disorders characterised by disrupted reward-processing. This study aims to assess the mechanisms through which reward learning and appetitive behaviour could be impacting on clinical populations via sleep. We hypothesise adults who undergo sleep restriction (prescribed a 5 hour sleep opportunity), relative to well rested adults (prescribed an 9 hour sleep opportunity), will have disrupted reward learning. Furthermore, we hypothesise key sleep stages, particularly REM sleep parameters (e.g., percentage, duration, onset latency, etc.), will mediate the relationship between sleep restriction and poor reward learning.

  • Impact and usability of a digital health intervention designed in the workplace

    BodyGuide’s education and exercise programs are delivered via smart algorithms, based on the user's responses to a series of questions relating to their discomfort. The algorithms also detect risk and encourage users to engage with traditional care where appropriate. BodyGuide programs are 100% self-service, allowing users to access curated, trusted information promoting self-care health literacy. As an evidence-based foundation, we will conduct a research study that will: • Develop an effective framework for evaluating patient outcomes in combination with assessing the usability of BodyGuide as a digital health solution • Systematically validate BodyGuide for efficacy (patient outcomes) and usability • Validate asynchronous support coupled with group learning (through webinars, telehealth and coaching) • Identify user defined barriers/facilitators to the digital health BodyGuide program Aims Objective 1: Create an appropriate framework to measure the efficacy and usability of BodyGuide Objective 2: Systematically validate the BodyGuide App for efficacy (based on patient outcomes) and usability – this is the basic BodyGuide model with no telehealth or coaching Objective 3: Assess the impact of adding asynchronous support coupled with group learning (through webinars, telehealth and coaching) on patient outcomes Objective 4: Identify user defined barriers/facilitators to the digital health BodyGuide program

  • The Veg4Me feasibility study: investigating the effect of digitally-delivered personalised support on vegetable intake in young adults living in rural Australia

    Australians living in rural and regional communities are more likely to die early and experience higher rates of preventable disease than those living in the cities, resulting in higher rates of risk factors for chronic diseases, such as high blood pressure and obesity, and higher burden on health care systems. Rural communities also have reduced access to nutrition professionals than metropolitan communities, mostly due to health care workforce challenges and geographical barriers. Diets low in vegetables are a main contributor to the health burden experienced by rural Australians, which is further compounded by unhealthful rural food environments, and socioeconomic inequities. Yet, only 8% of Australians meet recommended intakes, and this is as few as 3% in young adults living in rural areas. Digital health solutions, such as mobile and web-applications, offer an accessible, scalable and inexpensive delivery model for rapid translation of interventions into rural communities that can be personalised to meet the needs of the user. As most adults own a digital device, such as a smartphone, digital health interventions provide an suitable solution for interventions to increase vegetable consumption, However, digital health solutions will have limited success without addressing the needs of rural communities. An increasing body of literature is engaging with the community for the design of digital interventions, rather than for the community, to ensure it meets the need of the target population and there is evidence that co-designed interventions can result in improved engagement and experience of the user, as well as improved dietary intake. This feasibility randomised controlled trial will investigate the feasibility and acceptability of a co-designed and personalised web application (Veg4Me) compared with a non-personalised web application, to address unique barriers to vegetable intake experienced by young adults living in rural areas of Victoria. If feasible, this intervention will be examined for effectiveness for increasing vegetable intake and to understand context for implementation in rural communities.

  • The effect of ingesting carbohydrate drink on stomach size and cardiac flow in healthy volunteers

    ERAS (enhanced recovery after surgery) protocols have been demonstrated to improve certain surgical outcomes. St Vincent’s Hospital Melbourne employs an ERAS protocol for colorectal surgical candidates. Among many measures, is the provision for ingestion of 400ml of carbohydrate fluid 2 hours before surgery. This intervention aims to reduce patient length of stay at no increased risk of aspiration events. Contemporary literature includes several studies that aim to investigate the transit of preoperative carbohydrate ingestion via non-invasive gastric ultrasound, specifically utilising gastric antrum cross sectional area (CSA). These studies find that the transit of carbohydrate oral drinks, ingested at least 2 hours before surgery, do not remain in the stomach upon intubation: the pre-operative ingestion does not appear to increase the risk of pulmonary aspiration caused by an ‘at risk’ stomach. Any potential changes to a patient's haemodynamic state caused by ingestion of this fluid however, have not been investigated to date. Understanding the haemodynamic effect of this intervention would aid the clinician (i.e., the anaesthetist) in their attempt to provide patient-centred, safe, peri-operative fluid management. This is important, as failure to safely manage a patient's fluid status could precipitate deleterious states such as fluid overload (too much fluid) or hypovolemia (too little fluid).

  • Baduanjin mind-body exercise for cancer-related fatigue

  • Feasibility, acceptability, and potential efficacy of a staff professional development program for the promotion of healthy eating and physical activity in Out of School Hours Care (OSHC) services.

    This pilot study will assess the feasibility, acceptability and potential efficacy of a staff professional development intervention among Out of School Hours Care (OSHC) services to improve fruit and vegetable provision, child movement behaviours, and staff health promoting behaviours. A cluster parallel-group randomised controlled trial design will be used. The intervention will involve staff attending one three-hour professional development session, followed by four weeks of ongoing support. Investigators of the current project have been conducting a study to co-design an OSHC intervention with key stakeholders from the OSHC sector. Through this study, stakeholders were presented with findings from previously conducted before and after school care observational studies; and contributed to discussions around what support was needed to bring about meaningful change. The intervention to be piloted in this study is being developed through this collaborative process. It is hypothesised that OSHC services who participate in this intervention will increase their provision of fruit in before school care and vegetables in after school care. Children who attend these services will also have increased minutes of moderate-to-vigorous-intensity physical activity.

  • Community-based cardiac rehabilitation for Chinese migrants in Australia

    This is a 24-week pilot randomised controlled trial of a community-based cardiac rehabilitation (CR) program for Chinese migrants in Australia. A total of 24 participants will be randomly allocated in a 1:1 ratio to the intervention or waitlist control group. People in the intervention group will be offered a CR program virtually in entirety for 24 weeks, including health education via text messages, Shared Medical Appointment (SMA), and online live Tai Chi. Participants in the waitlist control group will be given no intervention during their wait period and will be encouraged to keep their normal lifestyle and physical activity. They will receive the same CR program after their wait period. The objectives of this project are: (1) To assess the feasibility of the co-designed community-based CR program for Chinese migrants in Australia of a wider trial by measuring its adoption rate. (2) To examine the effects of the co-designed CR program on improving health outcomes among cardiac patients from Chinese migrants in Australia. (3) To explore the cost effectiveness of the community-based co-designed CR program for Chinese migrants in Australia. The expected outcomes of this pilot randomised controlled trial include: • This pilot randomised controlled trial will quantify the feasibility, cost-effectiveness, and effectiveness of the co-designed, culturally sensitive community-based CR program. • The findings from this pilot trial will be interpreted as indicators of the potential value of a fully powered randomised controlled trial and other implementation and cost-effectiveness studies for CR among Chinese migrants in Australia and other western countries.

  • A Phase Ib/II Study of APG-2449 in Combination with Doxorubicin Hydrochloride Liposome in Patients with Ovarian Cancer

    This study aims to establish the safety and best tolerated dose of a new investigational drug called APG-2449 in participants with ovarian cancer. Who is it for? You may be eligible to join this study if you are aged greater or equal to 18 years and have been diagnosed with ovarian cancer. Study details: All participants in this study will be treated with a new investigational drug called APG-2449 in combination with a chemotherapy called Doxorubicin Hydrochloride Liposome (PLD). APG-2449 capsules will be administered to study participants orally once daily at a 28-day repeated cycles, 1200mg as the starting dose, and the dose level may be escalated to 1500mg or de-escalated to 900mg to determine the optimal dose level based on the safety observations, in combination with PLD 40mg/m2 intravenously infused on Day 1 of each 28-day cycle. More participants will be treated, once the optimal dose level of APG2449 identified, with APG2449 capsules orally daily in combination with PLD 40mg/m2 intravenously infused on Day 1 of each 28-day cycle. Participants will be closely monitored until they reach their study endpoint (disease progression, intolerable toxicity or withdrawal of consent) in order to determine safety, tolerability and preliminary efficacy of treatment. The results from this study will be analysed to see if it is worthwhile for this new drug to be tested in future studies involving larger numbers of cancer participants.

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