ANZCTR search results

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.

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.

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

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.

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).

The purpose of this research is to examine the feasibility and acceptability of Baduanjin mind-body exercise for the management of cancer-related fatigue (CRF). Cancer-related fatigue is a persistent, subjective sense of physical, emotional and/or cognitive tiredness or exhaustion related to cancer or cancer treatment, and which interferes with a person’s everyday usual functioning in life. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older with cancer who is receiving adjuvant chemotherapy or has recently completed adjuvant chemotherapy who is suffering from moderate cancer-related fatigue. Study details Participants will be randomly allocated to one of two treatments: The intervention group will commence Baduanjin mind-body exercise program for 8 weeks (17-20 mins per session, twice a day for 6 days a week) starting at enrolment. The waitlist control group will continue without modifications to their usual care and undergo no Baduanjin mind-body exercise (however at the end of their waitlist, they are able to participate in the Baduanjin mind-body exercise program but not as a participant). As part of this study, both intervention and waitlist control groups will be asked to complete questionnaires at week 0 (baseline), week 4 (midpoint), week 8 (final week) and week 9 (1 week follow-up). It is hoped that the remote delivery of Badjuanjin mind-body exercise is a feasible home-based program for people with CRF.

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.

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.

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.

Neuropathic eye pain (NEP) is a debilitating pain condition that is difficult to treat. NEP remains minimally responsive to existing pharmacological and non-pharmacological treatments. Although further studies are required to more definitively evaluate its efficacy as a treatment for alleviating NEP, there is growing evidence to suggest that electroencephalography (EEG) neurofeedback has the potential to reduce neuropathic eye pain. We have developed a novel EEG neurofeedback system to reduce NEP using openBCI technology, which incorporates the capturing and recording of EEG, and the delivery of neurofeedback via an interactive gaming interface. To achieve a reduction in NEP, we will use a neuromodulation protocol that targets and suppresses theta (4-8 Hz) and high beta frequency (20-30 Hz) power bands and enhances alpha (9-12 Hz) frequency power bands. A single-case experimental design (SCED) with multiple baselines will be used to examine the efficacy of our self-developed EEG neurofeedback treatment for the alleviation of NEP. Four participants with NEP will be recruited. Each participant will be randomly assigned to a different baseline phase (i.e., 7, 10, 13 or 16 days), which will then be followed by twenty 30-minute EEG neurofeedback sessions over a 4-week period. The Numerical Rating Scale will be used to assess average pain intensity, which will serve as the primary outcome measure. Pain interference will serve as the secondary outcome measure and will be measured using 6 items from the Brief Pain Inventory. Generalisation measures will be used to measure efficacy of the intervention beyond the primary and secondary outcomes and will assess quality of life, sleep quality, symptoms of anxiety and depression, mood and well-being. Satisfaction and feasibility of the intervention will be measured using self-reporting questionnaires and an unstructured interview. SCED trials are considered a viable alternative approach to randomised control trials when identifying evidence-based practices in the field of technology-based health interventions, when recruitment of large samples is not feasible.