ANZCTR search results

The aim of this randomised controlled trial is to investigate whether milk fortified with calcium and vitamin D3 combined with high intensity resistance training and weight-bearing impact exercise can lead to a greater effect on BMD at loaded sites than the sum of each factor alone in community-dwelling men aged over 50 years. It is hypothesized that the combination of exercise + calcium-vitamin D fortified milk will lead to greater gains in bone density at the hip than either exercise or calcium-vitamin D alone. This is an 18-month factorial design intervention with a 12-month follow up in which men will be randomised to one of four groups: (1) exercise + fortified milk; (2) exercise alone; (3) fortified milk alone; or (4) a usual control group. The primary outcome is femoral neck bone mineral density. Secondary aims (outcomes) are to: 1) evaluate the effects of the intervention on DXA total hip and lumbar spine BMD, QCT bone density, structure and strength at the spine, femur and tibia, body composition (lean and fat mass and muscle size), muscle strength and function, blood pressure and blood lipids, inflammatory and bone turnover markers, health related quality of life and mood, and 2) evaluate the long-term residual effects (12 months post intervention). The results from this trial will provide important information as to whether food-based nutritional supplementation (calcium-vitamin D enriched milk) can enhance the effects of exercise on musculoskeletal health and function in older men with normal to low bone density.

A primary purpose of this study is to evaluate Safety, Tolerability and Efficacy of Topical AKP-11 Administration to Participants with Arthritis. AKP-11 is a Sphingosine-1-phosphate receptor 1 (S1P1) agonist developed to treat multiple pathological events common in arthritis. The study consists of 2 parts: PART A investigates two doses of AKP-11 over 7 days in 20 participants (2 cohorts of 10 participants each) with arthritis. Each cohort will have 8 participants on AKP-11 and 2 participants on placebo. PART B will select the dose identified in PART A and will be conducted with treatment over 21 days in 80 participants with arthritis, The dose of AKP-11 will be selected after the safety profile and efficacy of AKP-11 has been determined. The participants will be randomized to receive AKP-11 or Placebo in a ratio of 1:1.

In the face of the progressive disease burden associated with an ageing population, public hospitals must face the challenge of providing cost-effective, accessible, and timely care for patients with chronic disorders, especially so that the need for inpatient care is reduced. Within the eye health care sector, shared care models are increasingly utilized to facilitate comprehensive care for all patients. These models integrate optometrists in the care of patients with chronic stable conditions, or in need of long-term at-risk disease monitoring, thus effectively focusing specialist and hospital care for patients with urgent or complicated conditions. Establishing effective triage and collaborative care schemes, however, requires careful validation to ensure that implemented alternative care pathways improve patient management. The Centre for Eye Health (CFEH) in Sydney has already established active collaboration with the Prince of Wales Hospital (PoWH) eye clinic resulting in a shared-care glaucoma management clinic. The knowledge and expertise gained from this collaboration provide the foundation to initiate the current project aiming at an expansion of the current eye health care model to patients waiting for over 12 months to be seen at the PoWH eye clinic. Successful outcomes will result in significantly reduced wait times for patients leading to timely implementation of patient care plans and improved efficiency with regard to eye health care specialist appointments within the public health system.

Variability in oocyte quality is a major contributor to pregnancy rates during IVF . We wish to measure the concentration of various steroid and hormones including vitamin D in the follicle fluid and serum of IVF pateints during oocyte recovery and relate this to patient factors, stimulation and ovulation protocols to provide a better indication of their impact on oocyte and embryo quality and on pregnancy and implantation and live birth delivery rates.

The objective of the current study is to develop and evaluate an emotion regulation (ER) child and parental treatment program for children and adolescents (aged 6 to 14 years) who are experiencing ER difficulties as evidenced by recurring emotional/anger outbursts and impulsive maladaptive behaviours. Specifically, the objective is to conduct a proof-of-concept, pilot ER intervention study for at-risk youth of developing chronic internalising and/or externalising disorders. Primary Aim: To develop and test the efficacy of an individual, 6-session, ER child and parental program using an A-B design with a one-month follow-up. The manualized intervention will comprise a) parental training specific components (initial/ session 1 and final/booster Session 6) and child/ adolescent with active parental dyadic intervention phase (4 sessions; conducted weeks 2 to 5).

This study will investigate the safety and tolerability of sodium selenate in patients with behavioural variant frontotemporal dementia. All participants will be given sodium selenate for 52 weeks, and assessed regularly to investigate any negative reactions to the drug, as well as any positive effects on the symptoms of their dementia, as measured by biological samples, cognitive tests and brain scans.

Aim The aim of this study is to determine the effectiveness of a lymphoedema exercise protocol in individuals recovering from head and neck cancer treatment. Who is it for? You may be eligible to join this study if you are aged 18 years or above, treated for head and neck cancer at the Sir Charles Gardiner Hospital and experiencing head and neck cancer related lymphoedema. Study details Participants in this study are randomly allocated (by chance to one of two groups. Participants in one group will receive a complete decongestive therapy protocol (usual treatment) for 6 weeks, whilst participants in the other group will receive an exercise protocol in addition to usual treatment for 6 weeks. Assessments (stage and amount of lymphoedema; body image; swallowing; health and wellbeing) will administered pre-intervention (0 weeks) and at post intervention (6 weeks). The proposed study will expand the limited knowledge of lymphoedema for people recovering from head and neck cancer and determine the effectiveness of complete decongestive therapy in conjunction with an exercise protocol.

Background and purpose: Attention deficit hyperactivity disorder (ADHD), a neurodevelopmental disorder, which has relatively high prevalence and incidence of comorbidity among children. Medication is usually the first-line treatment for ADHD; however, the adverse effects of medication may cause other medical issues. Healthy lifestyle pattern (diet, physical activities, reducing screening time) may ameliorate disease severity. To discover suitable interventions, comprehensive investigations of lifestyle patterns will be conducted in both western and eastern countries among primary school children with or without ADHD. The aims of present studies are: to compare the lifestyle patterns in children with ADHD and typically developing children, to determine cultural differences of children with ADHD in western and eastern countries, and to develop a suitable lifestyle modification program for children with ADHD. Methods: The first phase of this study will investigate the lifestyle patterns in Australian and Taiwanese children with or without ADHD. All participants and their parents will be given a series of questionnaires to examine: dietary pattern, physical activity, sleep quality, screening time, demographic data, disease severity, and pressure of their caregiver. These data will be using multiple regression methods to determine the best predictors of the symptoms of ADHD.

A cluster randomised controlled trial will be conducted in secondary schools in New South Wales to reduce sugar sweetened beverage (SSB) consumption in students. The aim of this study is to assess the efficacy of a school based nutrition intervention targeting sugar sweetened beverages in reducing daily sugar sweetened beverage consumption and daily percentage energy from sugar sweetened beverages of secondary school students. We hypothesise that a school based nutrition intervention targeting sugar sweetened beverages will be effective in these aims. Convenience sampling methods will be used for recruitment whereby information letters will be sent out to invite principals to participate. A week will be given to the principal to consider the matter and then a phone call will be made to verbally invite the principal to participate their school in the program. A meeting will be arranged to explain the intervention to school staff should the school consent. The trial will run for two school terms and consists of a whole school approach towards encouraging the students to reduce SSB consumption in up to four intervention schools compared to an identical ratio of control schools that will continue with their usual school activities. The intervention is guided by the Health Promoting Schools framework and consists of five evidence-based practices designed to address student barriers to reducing SSB. These practises include nutritional education to students, building peer support, school guidelines, school nutrition environment modifications, and providing information to parents. More specifically, the intervention will involve providing nutritional education and notifications to students, a schoolwide challenge to reduce SSB consumption, implementing school guidelines to limit access to SSB, canteen and vending machine changes in the school, adding water refill stations in each school, and parental involvement through newsletters and notifications. Primary outcomes are daily SSB consumption in students and daily percentage energy contributed from SSB in students' diet. Secondary outcomes include investigating the average daily SSB consumption of students in school, average daily energy intake of students, and changes in mean student BMI. An additional outcome that will be evaluation is the acceptability of the intervention. Data collection involves anthropometric measurements for BMI, a validated online food frequency questionnaire (Australian Child and Adolescent Eating Survey) and online student, parent and staff surveys. Process evaluation: Regular audits will be conducted via observation at intervention schools to ensure the fidelity of the intervention.

The primary objective of this study is to evaluate the impact of a social participation and engagement tool on community participation and quality of life of community aged care clients. It is hypothesised that the implementation of the ACPQ and ICECAP-O (social participation and engagement tools) as part of routine assessment for community aged care services will improve social engagement and quality of life for clients. The aims of this study are: (i) ascertain the levels of social participation and engagement, and quality of life for a sample of community aged care clients; (ii) measure the association between the delivery of community aged care services, social participation and engagement, and quality of life; (iii) utilise the findings to provide recommendations of potential strategies that could be implemented in the future to improve social participation and engagement. A mixed method design will be utilised for this study, involving the collection of both quantitative and qualitative data to achieve the study objectives. The study will be conducted over two years with one of Australia's largest aged care providers.