ANZCTR search results

Over 40% of older people living in the community fall each year. In clinical practice, recent guidelines recommend that older people be regularly asked about falls and their circumstances. Ascertaining falls is also important to measure the success of any intervention. In research settings previous studies have found that asking about falls 3- or 12-monthly results in under reporting of falls compared with a daily calendar returned monthly with telephone or paper-based questionnaire follow-up to determine the circumstances of falls. This method of a daily falls calendar and monthly follow-up by questionnaire or telephone call has been well validated and is now considered to be the gold standard in falls ascertainment. However, this method is labour and cost intensive as every month there are postage costs, need to manually check that the calendar has been returned (previous studies have reported 30% need follow-up), telephoning to determine circumstances of falls and data or medical file entry by a research assistant or clinician. Therefore there is an important need to improve the way falls ascertainment is conducted. We aim to undertake the world first testing of a novel emailed electronic falls ascertainment tool (TASeFALL) that reminds participants to complete the electronic questionnaire, with responses automatically fed into a database or clinicians email.

This project aims to assess the effectiveness and feasibility of a program to increase physical activity in individuals with the most common inherited heart disease, Hypertrophic Cardiomyopathy (HCM). A sample of 22 patients will be recruited from the HCM and Genetic Heart Disease clinics at the Royal Prince Alfred Hospital. They will undertake a survey to establish baseline measurements of moderate-vigorous physical activity (MVPA, measured by IPAQ-Long), mental and physical health (SF-36v2), and self-efficacy and barriers to physical activity; and wear an accelerometer for 7 days. A motivational interview, including discussion of barriers and goal setting, will be conducted with a member of the research team. Participants will also be provided with a FitBit Charge device to self-monitor their physical activity. Over the following study period of 12 weeks, participants will receive phone calls (weeks 2, 4, 8 and 12) and weekly text messages from the research team to encourage them to meet their goals and to offer support that is personalised and consistent with Control Theory principles. At the completion of the intervention, participants will undergo the same evaluation as at baseline, and also provide process evaluation feedback regarding the intervention.

Research Plan This research will examine the benefits of HIIT on IR metabolic syndrome and polycystic ovarian syndrome women. A controlled trial was conducted in Armidale for 12 weeks. Metabolic syndrome women with or without PCOS aged between 18 to 70 years were recruited to the high intensity interval training group (HIIT G) or the control group (CG). The primary purpose of this study is to examine the benefits of HIIT on insulin resistance in men and women with metabolic syndrome. Research Hypothesis HIIT induces metabolic changes and improves IR, glucose homeostasis and lipid metabolism HIIT induced regulation of insulin will reduce androgen production HIIT enhances skeletal muscle oxidative capacity Aims To accomplish the primary purpose of this study the following assessments will be conducted:- 1. Evaluate the percentage of change in body composition parameters. 2. Assess the level of change in hormonal parameters. 3. Assess the level of change in blood glycaemic parameters 4. Evaluate the level of change in blood lipid profile 5. Evaluate the percentage of improvement in parameters of cardiovascular fitness, heart rate variability and telomere length. Research Plan This research will examine the benefits of HIIT on IR metabolic syndrome and polycystic ovarian syndrome women. A controlled trial was conducted in Armidale for 12 weeks. Metabolic syndrome women with or without PCOS aged between 18 to 70 years were recruited to the high intensity interval training group (HIIT G) or the control group (CG). Two information and screening sessions will be conducted for participants before the intervention. Information regarding HIIT, exercise testing procedures, blood tests and the intervention study will be discussed. Participants will be asked to complete a health questionnaire. Based on the information provided by the participant and the health questionnaire, decision will be made on eligibility for participation. During the screening session consent forms will be signed. HIIT G participants will undergo supervised high intensity exercise training on bicycle ergometers 3 times/week. A HIIT session will be a 5 min warm up, 3 sets of HIIT for 20 seconds (3×20), 2 minutes of low intensity exercise after each HIIT set, 5 min cool down period and stretching. Participants assigned to the control group will continue with their usual care and will not participate in supervised exercise sessions. Both intervention groups will be provided with an activity journal to record their daily physical activity. Pre training assessment for peak VO2 will be done using an incremental exercise test on an exercise bike. Heart rate will be monitored during each exercise session. Measurements for body composition, blood essays for glycaemic markers, hormones and lipids will be conducted at baseline, 6 weeks, 12 weeks and 6 week post intervention completion.

Osteoarthritis (OA) is a chronic disorder affecting the joints, most commonly involving the hands, knees and hips. In view of the strong association of OA with ageing, major concerns with the disease exist due to the continuous rise in the number of elderly. Pain is the most common symptom in addition to progressive difficulty or incapacity to perform daily activities. Among the different disease phenotypes, OA of the hands is a frequent condition, causing symptoms in up to 15% of the population worldwide. The subtype affecting the base of the thumb, in particular, is probably caused by mechanical factors overloading the joint in addition to genetic predisposition. Debilitating symptoms can occur in this subset of patients, including pain during daily activities such as writing and grasping, loss of hand function and joint stiffness. Due to modest effects, current non-surgical treatment frequently do not meet patients’ demand while surgery is only indicated in cases refractory to conservative therapy due to potential complications. For this reason, the need for novel studies addressing new conservative treatment strategies is emphasized by several reviews. Combination of therapies is often used in clinical practice but little evidence exists about its efficacy. Furthermore, the combination of non-pharmacological and pharmacological rehabilitation interventions has never been studied in the context of patients with thumb base OA. Therefore, the objective of this study is to investigate the effect of a combination of therapies compared to a control group receiving usual care. The new strategy will be delivered over a 6-week period and will consist of education about the disease and joint protection, exercises for the hand, splint for the base of the thumb and use of a topical NSAID. The control group will receive education and instructions on joint protection techniques alone.

The aim of this study is to determine the activity and safety of treating a site of disease with with a single fraction of SABR during immunotherapy with nivolumab in advanced NSCLC progressing after 1 or 2 lines of chemotherapy. Who is it for? Adults with advanced non-small-cell lung cancer (NSCLC) progressing after 1 or 2 lines of chemotherapy and with an asymptomatic metastasis suitable for SABR. Tumour blocks should be available to test for PD-L1 expression. Study details Participants will be randomly allocated in a ratio of 2:1 to either nivolumab 240mg every 2 weeks plus SABR (experimental) or nivolumab 240mg every 2 weeks alone (control). Nivolumab is continued until disease progression or prohibitive toxicity. Participants will be assessed regularly for treatment response and side effects during the treatment and follow up phase. Clinical assessments will be performed before each cycle of nivolumab (2 weekly) and CT scans at baseline, week 6, 12, 18, 24 then 12 weekly until progression. Anticancer treatments and survival will be reviewed every 12 weeks after progression. This will enable us to determine the activity and safety of each treatment option in patients with an asymptomatic metastasis.

Our aim is to design and pilot an innovative, translatable ­by design online parenting support package: Parenting Acceptance and Commitment Therapy (PACT) for families of young children with CP. We will pilot PACT in a randomised controlled trial recruiting 66 families of children with CP (2-6yo). We predict that PACT will be associated with improvements in the parent-child relationship, in child functioning, and in both parent and child  adjustment and quality of life. Outcomes will be assessed immediately post-intervention and at 6 months post-intervention (retention). 

The aim of the research is to evaluate the feasibility and preliminary efficacy of a 3-month healthy lifestyle program (HEYMAN) for young men (aged 18-25 years) delivered using ehealth and weekly face-to-face sessions. HEYMAN is developed based on previous formative research with young men Participants will be randomly allocated to the intervention (HEYMAN) or waiting list control group. After 3-months the waiting list control group will receive access to hEYMAN program tools. Participants in both groups will be asked to have a series of measures taken (e.g. weight, height) and complete online questionnaires at the start of the program (baseline) and post program (3-months). The researchers will also track intervention participants engagement with the program (e.g. session attendance, website use metrics), retention, acceptability and satisfaction with the program.

This research project is being conducted to look at evaluate the Pharmacokinetics (PK) and Safety of Two Formulations of a 7-Day Application of Memantine Transdermal Delivery System (TDS) Compared to Oral Administration of NAMENDA XR and to assess TDS adhesion in Healthy 50-80 year old Volunteers

This research project is being conducted to look at the Pharmacokinetics (PK, how the human body processes a substance), Pharmacodynamics (PD, how body systems are affected by a substance), and Safety of up to Four Formulations of a 7-Day Application of Donepezil Transdermal Delivery System (TDS, a patch) in Healthy Female Volunteers. It is anticipated that Donepezil TDS could be a treatment for Alzheimer's Disease.

Changing the scheduling of existing programs in childcare centres may represent an effective strategy which is suitable to ‘scale-up’ for population-wide implementation. Unstructured outdoor free play (as opposed to structured, staff-guided play) has been consistently associated with greater child physical activity. The study hypothesise when compared to children attending control services, where outdoor play is scheduled within a single continuous period, children attending intervention services will spend an additional 10 minutes in moderate-to-vigorous physical activity per day at childcare. An increase of 10 minutes of moderate-to-vigorous physical activity in preschool-aged children has been found to have clinically important effects on fat mass and peak bone mass.