ANZCTR search results

Children with cystic fibrosis (CF) need to spend a lot of time on physiotherapy. Families have very busy lives, and using telehealth may reduce the burden of management, and contribute to improved quality of life. Telehealth offers home management with reduced travel requirements, saving time and money for families, and reducing the risk of hospital-acquired infections. Standards of care recommend that there are no interactions between people with CF due to cross infection risks. Telehealth allows young people with CF to connect with each other, and safely do physiotherapy in a fun & socially supportive environment. Aim: to investigate the clinical effectiveness & impact of a purpose-designed telehealth service (CyFiT) in physiotherapy management of CF. Our proposed research will investigate the comparison between CyFiT Intervention Group and standard outpatient physiotherapy for CF. We hypothesise that there will be no difference in functional activity capacity, hospitalisation rate, or increased cost to health providers between the two groups, but there will be significant differences in quality of life and patient satisfaction measures. Research Design: Randomised controlled trial comparing CyFiT Intervention Group and standard outpatient physiotherapy. Balanced block design; 110 participants. All participants will receive the same physiotherapy care, at the same time that would otherwise occur. The difference is that participants will be randomly assigned to physiotherapy delivered face to face (standard outpatient physiotherapy), or at home through telehealth consultations and online group exercise classes (CyFiT Intervention Group). Participants allocated to the CyFiT Intervention Group will be provided with a Garmin activity tracker. The tracked information will guide clinicians during individual and group sessions, and help identify deteriorations. The trial period will continue for 12 months, after which children will return to standard outpatient physiotherapy care. Methods: All participants in this study will receive 4x1 hour reassessment sessions (at 0, 6, 12, and 18 months post commencing the trial). Appoints will align with their regular multi-disciplinary clinics every three monthly to minimise inconvenience for families. Any additional follow-up physiotherapy will be delivered according to allocation to telehealth or control group. Outcome measures are: - Functional Exercise Capacity - Quality of Life - Quality & Quantity of Social Participation - Adherence to physiotherapy - Hospitalisation Rate - Cost Effectiveness/utility - Perception of Service Previous researchers have commented on the efficacy of telehealth in managing CF. No researchers have directly replaced face to face physiotherapy with a comprehensive telehealth equivalent in an operating CF clinic. Through this trial, researchers will investigate the effectiveness of CyFiT Telehealth to integrate into a contemporary and family centred clinic.

This is a two arm crossover study investigating the effects of a high fat, high carbohydrate meal on endotoxin levels and its effect on reproductive hormones in overweight and obese males. The study involves male participants aged between 18-50 with a BMI over 25 engaging in two clinical sessions. The first session requires the participant to be completely fasted. Blood endotoxin, testosterone, inflammatory markers and gut permeability markers are tested over a 5 hour period. Saliva testosterone is also measured over the 5 hours. The second session the participant consumes a designated high fat, high carbohydrate meal immediately to determine whether the meal has an effect on endotoxin in circulation and whether this is reflected in changes in reproductive hormone levels and inflammation.

Purpose of this Study: To investigate the safety and efficacy of oral forms of folate supplements in healthy individuals. The aim of this study is to see if there is a difference between the different forms for absorption and utilisation by the body and to see if there is a difference in efficacy between the different forms. This is an important study as it will help clinicians and the general public make informed choices. Procedure: One capsule per day of 500mcg of either L-5-methyltetrahydrofolate (5-MTHF), folinic acid or folic acid or a control group with no supplementation for four weeks. Visit 1- Baseline and Beginning of Treatment (Week 1) Blood pathology tests for MTHFR, serum folate and vitamin B12. A case report and food diary. Visit 2 - Mid Treatment (Week 2) Serum folate blood testing and food diary End of Treatment – Visit 3 (Week 4) Serum folate blood testing and food diary Discomforts and Risks Folate is generally considered safe and is essentially non-toxic. More than 15mg can cause abdominal distention, hyperactivity, nausea, sleep disturbances and vivid dreams. There are some concerns that folate supplements can mask a B12 deficiency so this will be measured at baseline. Benefits The information you provide during the study will help to guide further research which will inform clinicians and the general public about the effectiveness of different oral forms of folate supplements. Participant Protection and Voluntary Participation Participation in the trial is voluntary. Information that is supplied for the study will be maintained in strict confidence and will be de-identified to protect the participant’s privacy. You are entitled to withdraw from the study at any time. Findings Findings from the study will be published in the form of reports, journal articles and conferences or local presentations. Published results will not include your name or any information that could identify you.

There has been an increasing concern on the possible negative effects of excessive sugar intake, particularly added sugar, on the quality of diet and health status. Added sugar was found to be associated with poorer nutrient intake. A similar impact on micronutrient dilution was expected from free sugar as an estimation of approximately 10 g difference between added sugar and free sugar intake was found in the Australian population. The hypotheses of the current analysis include: a) the WHO cut-offs were not suitable for assessing micronutrient dilution; and b) micronutrient dilution is not evident until %energy from free sugars reaches 25% or above.

The primary aim of this study is to explore the impact of antenatal pelvic floor muscle exercises (PFME) on sexual dysfunction and quality of life in women during pregnancy and in the first three months following birth. A secondary aim is to determine the effect of antenatal PFMT on labour and birth outcomes, urinary and faecal incontinence and specific quality of life three months following birth. This is a randomised controlled trial and the primary hypothesis of this study is that: women who perform antenatal PFMT have better sexual function during pregnancy and three months following birth compared with women who receive antenatal standard care alone. The secondary hypothesis is that; women who perform antenatal PFMT have improved childbirth outcomes, less urinary and faecal incontinence symptoms and also better specific quality of life compared with women who receive antenatal standard care alone. Findings from this study will help to establish an evidence base for the use and effectiveness of antenatal pelvic floor muscle exercise to improve primiparous women’s quality of life, sexual function, childbirth outcome and urinary and faecal incontinence symptoms.

Little is known about dietary intake at the level of an “eating occasion (EO)”, which includes meals and snacks. Current dietary advice is framed around the amount and types of food populations should consume, rather than a consideration of eating patterns. Eating patterns describe the frequency and temporal distribution of meals and snacks. Eating patterns are likely to be important determinants of adults’ dietary intakes and health; however, the nutritional and health impacts of EO, meal and snack frequency and temporal eating patterns are inconclusive. Further, inconsistent evidence for eating patterns and health may be partly attributed to the lack of consensus on approaches for defining an EO or for assessing temporal eating patterns. The aims of these secondary analyses were to: 1) explore the influence of different definitions of EOs on the characterisation of eating patterns, 2) to examine temporal eating patterns using a novel data-driven analytic approach, and 3) to investigate associations of different eating patterns (e.g. frequency of all EOs, meals and snacks; temporal eating patterns) with nutrient intakes, overall diet quality and measures of adiposity and blood pressure. The Census and Statistics Act 1905 provides ethics approval for the Australian Bureau of Statistics to conduct household interview components of national surveys, including the National Nutrition and Physical Activity Survey (NNPAS). At this is a secondary analysis of the NNPAS data which is de-identified, an exemption for ethics approval was granted by the Deakin University Human Research Ethics Committee on April 16, 2015. (Project number: 2015-073).

What is this study about? The purpose of this study is to investigate how safe and tolerable a single dose (worn for 24 hrs, 3.5 days or 7 days) and repeat doses (worn for 14 days) of ZYN001 transdermal delivery system is in healthy volunteers. The study will look at how the body absorbs, distributes, breaks down and then removes the study drug from your body. This will be done by analysing the levels of ZYN001 in your blood and urine at various times following drug administration. Your skin at the application sites will be checked to see if there is any irritation or reactions present when the ZYN001 patch is removed. The study will also investigate if ZYN001 affects your brain functioning by administering a number of neuropsychological tests. Who is if for? You may be eligible to join this study if you are aged between 18 and 55 years and are in good health. Study details: This study will investigate different formulation of patches containing ZYN001 compared to a placebo patch (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff administering the study treatment will not know whether you are receiving ZYN001 or a placebo patch. What does study participation involve? Initially, the study will investigate four (4) different patches in each study period. All patches will have the same amount of THC drug within a study period but the ingredients in the patches will be different. You will report to the clinic the day before receiving treatment (Day -1). You will participate in either: • Period 1 - one patch worn for 24 hours • Period 2 - one patch worn for 3.5 days • Period 3 - one patch worn for 7 days OR, you will participate in either: Period 4 - one patch applied and worn for 3.5 days, removed and patch #2 applied and worn for 3.5 days, removed and patch #3 applied and worn for 3.5 days, removed and patch #4 applied and removed 3.5 days later Period 5 - one patch applied and worn for 7 days, removed and patch #2 applied and worn for 7 days You will receive application of ZYN001 or a placebo patch. The patch will be applied to either your left or right upper arm. Throughout the study you will have various medical tests (physical examinations, vital signs measured, ECG measured, neuropsychological tests) and will have several blood and urine samples collected for laboratory analysis.

STX-100/Alhydrogel, the study drug being researched in this project, is an experimental vaccine being developed by Sentinext Therapeutics. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. STX-100/Alhydrogel is a vaccine that is intended to prevent hand, foot and mouth disease. The primary objective of this study is to determine the safety and tolerability of STX-100/Alhydrogel vaccine compared to placebo controls when administered to healthy adults.

The aim of the project is to measure the physical activity of participants on the rehabilitation ward over their inpatient hospital admission. The research design is a prospective pre-­post study. Data will be collected on 161 participants (control group) over their inpatient rehabilitation admission. Changes to ward practice will be then be implemented. These changes include, but are not be limited to, increased group therapy (balance, community access, gardening), meals in the dining area and education sessions. Data will then be collected on another 161 participants (treatment group) over their inpatient rehabilitation admission. An activity monitor (ActivPAL micro) will be taped and a waterproof dressing applied to one thigh on each participant's mid­thigh. The activity monitor measures sedentary (lying/sitting), standing, stepping and metabolic equivalent time (MET); as well as step and transition (sit to stand) counts and cadence. The activity monitor will removed weekly, data uploaded to computer and into Sydney Local Health District Targeted Activity and Reporting System (STARS) in the late afternoon, charged and reapplied the following morning. Data from the activity monitors will be matched to participant data from STARS. Specifically, Australian National Subacute and Non­acute Patient (AN­-SNAP) classification, change in motor Functional Independence Measure (m-FIM) and length of stay.

This research study will look at the 'real world' effectiveness of a novel approach to treating overweight/obesity with co-morbid binge eating disorder, bulimia nervosa or other specified feeding and eating disorder by way of the HAPIFED program, which combines behavioural weight loss therapy with enhanced cognitive behaviour therapy. It is hypothesised that the HAPIFED Program will result in an average weight loss of greater than or equal to 5% of body weight in the group overall and in at least 50% of participants. In addition, it will result in a global score on the Eating Disorder Examination Questionnaire (EDE-Q) of less than 1 standard deviation above Australian community norms (i.e. below 2.46) in at least 40% of participants, at 52 weeks after commencement of treatment.