ANZCTR search results

This will be a pilot trial assessing the feasibility, safety and efficacy of combined high-intensity interval training (C-HIIT) for people with disorders of gut-brain interaction (DGBI). Participants will be recruited from the local Newcastle and Hunter region district (NSW). After consent is provided, participants will undergo testing (including cardiopulmonary exercise testing, body composition, bloods, stool sample, functional strength and a series of questionnaires to capture mental health, gastrointestinal symptoms, overall wellbeing and dietary habits) and then be asked to maintain current dietary and physical activity habits for 8-weeks and then come in to repeat the testing in week 9. Following this, participants will undergo 8- weeks of 3 x weekly, 30-minute C-HIIT sessions, supervised by an accredited exercise physiologist or exercise science student. Participants will then repeat the same testing and will be invited to participate in an interview to better understand their experience with the program.

The primary objective of this project is to determine if balance-enhancing shoes are more acceptable than minimalist shoes in older women. The secondary objective is to determine if balance-enhancing shoes are more effective at improving balance performance and perceived risk of falls than minimalist shoes in older women. This study will utilise a randomised crossover study design. Participants will be women aged 65 years or older who are free from any conditions which may negatively impact their balance or ability to walk independently. Participants will be randomly allocated to two shoe conditions and will be required to wear the shoes from each condition for six weeks before crossing over to the alternate condition. Participants will attend the university for assessments over four sessions. We hypothesize that participants will find the balance-enhancing indoor shoes more acceptable than the minimalist indoor shoes

This study aims to evaluate the acceptability of a coach-supported, individually-tailored online parenting program for parents of adolescents who experience anxious and/or depressive symptoms following a traumatic event. The program aims to increase parental self-efficacy to support their teenage child by providing personalised feedback about their current parenting and equipping them with evidence-based parenting strategies to respond to trauma, anxiety and depression. The intervention is delivered online and comprised of up to 12 parent-led, online modules covering different topics. Online modules are supplemented by up to 8 one-on-one videoconferencing sessions with a therapist-coach to support parents in making changes in their parenting. In this study we aim to understand how acceptable the program was to receive, and how the acceptability of the program could be enhanced. We also aim to gather preliminary indications of how effective the program was in improving 1) parental self-efficacy to respond to trauma, and 2) parenting behaviours to reduce teen anxiety and/or depression. Due to the exploratory and mixed-methods nature of the study, no hypotheses have been specified.

Nurse-led memory clinics have the potential to be complementary models to help address the growing care for those living with dementia and their care partners. However, to date there is limited research evaluating the benefit of nurse-led memory clinics. This research will be a pilot study to evaluate a nurse-led memory clinic, Enhance. Enhance is a nurse-led multidisciplinary clinic with the aim of supporting independence, wellbeing and function of people living with dementia. Both people living with dementia and their care partner will be able to clients at the clinic.

The primary aim of this pilot randomised controlled trial is to examine if smart inhaler use as part of asthma care for children aged 5-9 years is effective in reducing moderate and severe exacerbations over a 12 month period. The secondary aims of the research are to: i) increase children’s adherence to preventer therapy; ii) decrease use of reliever therapy; iii) increase self-reported asthma control; and iv) decrease healthcare use reacted to asthma (GP and specialist visits, ED presentations and hospital admissions). The feasibility and the acceptability of the intervention will also be examined. A total of 40 children aged 5-9 years with asthma along with one parent/carer will be recruited. Each child- parent dyad will be randomly allocated to the intervention (n=20) or usual care condition (n=20). The intervention includes: a) Provision of smart inhaler devices for reliever and preventer inhalers, and education in use; b) FindAir system facilitated prompts and feedback to children/parents (eg daily medication reminders); c) Researcher support in the use of the FindAir smart devices and the FindAir Asthma Diary App; d) FindAir system facilitated feedback to GPs and GP-based nurses; and FindAir facilitated feedback on asthma care flags to parent/carers and GPs (if applicable). The control group will receive usual care. The control group will also receive FindAir smart devices for their child’s preventer and reliever puffers to enable data collection of the child’s inhaler use; the other functions of the smart inhaler (e.g., medication reminders, feedback) will not be accessible to participants in the control group. Outcome data (number of moderate/ severe exacerbations and preventer adherence) will be collected at baseline, during the 12-month intervention, and 2 months after the intervention in both the intervention and control groups. Intervention feasibility will be determined by examining use of the smart inhaler. Acceptability will be determined via semi- structured interviews with child and parent/guardians in the intervention group and participating clinicians.

We are conducting a study testing an online, group intervention for aphasia after stroke. This online intervention is called Multi-Modality Aphasia Therapy Tele, or M-MAT Tele. M-Mat Tele is delivered to a group of three people with aphasia with the aim of improving spoken communication. We hope to learn if M-MAT Tele is feasible and enjoyable compared to usual care, and whether to conduct a large trial that tests how well it works. M-MAT Tele is a new telehealth version of M-MAT (Pierce et al., 2024). Telerehabilitation reduces clinician and client travel and need for treatment space while addressing geographical inequity amongst people who have experience a stroke. We have preliminary evidence that M-MAT may be equally effective at a low-moderate intensity (Pierce et al., 2023). This project explores M-MAT Tele at a clinically implementable low-moderate intensity for people with aphasia of less than one year. Feasibility, acceptability, and preliminary efficacy will be explored. Results of this project will provide crucial data for applications for definitive trials of M-MAT Tele in this setting.

This clinical trial will look at patients who have had an acute ischaemic stroke caused by a blood clot, but where doctors can't find a clear reason for it (this is called Embolic Stroke of Uncertain Source, or ESUS). The study will test whether a type of medication called DOAC (a stronger blood thinner) can help prevent future strokes and improve recovery in patients with atrial myopathy, a condition identified through ultrasound showing reduced heart chamber strain. Additionally, there will be a parallel study to confirm current and new tests for atrial myopathy that can help predict the chances of having another stroke.

This is a pilot feasibility randomized clinical trial comparing the novel intramuscular use of dexmedetomidine, an alpha-2 agonist agent, in preventing delirium and improving sleep in older, non-ventilated intensive care patients, compared with usual care. The main aims are to determine if using the drug in this context is safe, and if further, larger studies would be feasible.

The study aims to evaluate the feasibility and preliminary effectiveness of a machine learning (ML)-based physical activity digital assistant to promote physical activity in older adults 65 years of age or older. The study will use an existing ML-based digital assistant MoveMentor that applies natural language and reinforced learning in an engaging, interactive, and personalised intervention. This study will assess the feasibility (usability, acceptability, and engagement), preliminary effectiveness, and user experience. A feasibility study with non-randomised pre-post measures will be conducted over 14-weeks. At baseline (week 0) participants average step count will be tracked through an activity tracker, then complete a brief online survey to assess participant demographics, self-reported physical activity, and intentions to engage in physical activity. At the end of the intervention (week 13) participants will complete a further online survey to measure changes in self-reported physical activity, intentions to engage in physical activity, and user experience assessed through usability, acceptance and engagement with MoveMentor. The primary outcome is the change in steps recorded from baseline to post-intervention.

The study is a randomised controlled trial investigating the effect of breathwork on mental health outcomes in student paramedics. It involves two groups, with participants randomised to either the breathwork intervention or a control group, over a three-month period. The primary focus is to assess improvements in mental health metrics such as stress, anxiety, depression, insomnia, resilience and overall well-being. We hypothesise that the breathwork group will experience positive improvements in mental health, resilience and well-being, compared to the control group.