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These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32856 results sorted by trial registration date.
  • Physical activity education in community rehabilitation

    Clients attend Alfred Health Community Rehabilitation Program for goal-oriented rehabilitation following a change in their health status (i.e. stroke, joint replacement, falls). Many of these clients are elderly and/or suffer from one or more chronic health conditions (i.e. osteoarthritis, diabetes, heart disease). Rehabilitation is targeted to address current goals and concerns, however no formal education is given about the benefit of adherence to a long-term physical activity program. This study will assess the feasibility of delivering a single session intervention of physical activity education and counselling, geared towards encouraging long-term physical activity. The intervention will be delivered at the end of the client’s community rehabilitation program encounter. On completion of baseline measures, clients will be allocated to either the intervention or usual care group. Usual care group clients will receive standard care with the addition of being provided with written physical activity educational material. The intervention group will receive one additional session to their usual therapy regimen, for the provision of physical activity education and counselling. They will also be provided with written educational material and a personalised written walking program. The intervention will be tailored to the participant's stage of change and self efficacy in relation to exercise. These items will be assessed using questionnaires, completed both at baseline and at three-month follow up. The primary outcome will be assessing the feasibility of this intervention, considering the rate of recruitment, completion of the intervention, and follow up rates. Physical activity levels will be assessed using an activity monitor at baseline and three-month follow-up. Participants will need to wear the activity monitor armband for one week at each assessment point. This will collect data about energy expenditure, sedentary time and time spent in moderate and vigorous physical activity. Quality of Life will also be assessed, using a questionnaire.

  • Effects of a physiotherapy technique on shoulder joint position using diagnostic ultrasound

    Amendment to the effects of a stretching programme on anterior humeral head translation and acromio-humeral distance, this study aims to evaluate the effects of a manual therapy technique - Mulligan's glenohumeral mobilisation-with movement on humeral head translation and glenohumeral translation in healthy subjects using diagnostic ultrasound

  • Assessing mucosal inflammation in ulcerative colitis patients using the new Optical Enhancement Magnification Colonoscope

    Optical enhancement with magnification is a new modality of colonoscopy offered by Pentax Medical (Pentax EPK i-series). It uses optical filters that limit light of certain wavelengths to increase resolution and image contrast of mucosa and underlying blood vessels seen at endoscopy, similar to narrow band imaging technology. The concept is to use pre-image processing by means of filters whilst retaining post-image processing to digitally enhance the image. This dual enhancement (optical and digital) allows for better clarity of the endoscopic image. The technology has also improved on the major barrier encountered in previous iterations of optical filters (reduced illumination), by connecting the peaks of the haemoglobin absorption spectrum (415, 540 and 570mm) allowing a continuous wavelength spectrum. This achieves a higher overall transmittance of the optical filter and an increased level of illumination. Using the optical filter increases the ability to assess microvascular patterns and surface structures, which is vital in assessing mucosal healing in ulcerative colitis patients Study type Prospective, interventional study investigating the ability of a new optical enhancement endoscopic technology to accurately assess mucosal inflammation and develop predictors of disease relapse. Study population and recruitment This study will prospectively recruit patients, aged 18 years and older, with ulcerative colitis to investigate their risk of relapse using a new optical enhancement technology from Pentax Medical. This will be done by scoring a patient’s degree of rectal mucosal inflammation using this optical enhancement technology and correlating it with the current gold standard- histopathologic examination of biopsy specimens. If the patient is to be included in the study, a thorough endoscopic examination of the rectum will be performed. This will be done using the optical enhancement feature of the Pentax endoscope. The rectal mucosa will be examined and the pit pattern of the rectal mucosa will be recorded. Details of the vascular pattern and surface structures will be recorded. The area with the most severe mucosal changes will be biopsied for histology. Biopsies will be examined by a pathologist who is blinded to the patient’s clinical history and endoscopic pit pattern grade. The biopsies will be analysed according to the Robarts index, which is a validated score for assessing the degree of mucosal inflammation in ulcerative colitis based on histologic features including architectural change, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction, and erosion or ulceration.

  • Aussie Fans in Training (Aussie-FIT): A weight loss program in sport settings

    Overweight and obesity represent major health problems facing middle-aged men in Australia. In WA, four out of five men risk the quality and length of their lives by being overweight or obese. Middle-aged men are less likely than women to recognise that they are overweight or obese, less likely to know about the links between diet and health, and appear reluctant to participate in weight loss programs. This may be because such programs are typically marketed toward women and are often considered ‘female territory’. A new project led by researchers at Curtin University and Glasgow University offers a promising solution to the problem of how to engage men in weight loss and physical activity programs in WA. Building on the highly successful ‘Football Fans in Training’ (FFIT) program delivered in premier league soccer clubs in Scotland, a new, adapted, Aussie version (Aussie-FIT) will capitalise on men’s passion for AFL as a ‘hook’ to engage them in a physical activity and weight loss program based on sound scientific evidence. The research team will recruit 120 overweight and obese AFL fans to join a 12- week program which will be delivered at the ground of their favourite WA AFL team. The program will be delivered by club coaches trained by the project’s researchers. The men will be put through their paces on the hallowed turf of their favourite team and in the classroom, discuss important issues such as healthy eating and cutting back on drinking. A key part of the program is to educate and support the men to make sustainable changes that will improve their physical activity, eating and drinking habits for the better, and for the long term. The researchers will take a range of measures before and after the program, including physical activity levels, diet, mental health and weight, to assess the program’s effectiveness. When delivered in Scotland, FFIT was highly popular with middle-aged males from all walks of life, and very successful in helping them lose weight. In the future, the Aussie-FIT team aim to customise this program for other sports and groups of fans (e.g., females, families).

  • Real-time video counselling for smoking cessation in regional and remote areas

    Objective: To examine the effectiveness and cost-effectiveness of real-time video counselling compared to: proactive telephone counselling; and self-help materials (control) in achieving smoking abstinence among smokers living in regional and remote areas. Design: A three-arm, parallel, randomised controlled trial will be conducted with 1,842 smokers residing in regional and remote areas of NSW. Participants will be randomised into one of three conditions: 1) real-time video counselling delivered by smoking cessation advisors; 2) proactive telephone counselling delivered by smoking cessation advisors; or 3) written self-help materials (control). Online assessments will occur at baseline and 4-months, 7-months and 13-months post-baseline to measure smoking cessation. Methods: Smokers will be recruited via traditional and online ads and other promotions. The Accessibility and Remoteness Index of Australia (ARIA+) will be used to recruit smokers living in regional and remote areas of NSW. Eligibility criteria are: 1) daily tobacco use; 2) aged 18 years or older; 3) access to a mode of video-communication (e.g. Skype, Face Time); 4) telephone access; 5) internet access; 6) a current e-mail address; and 7) reside in a regional or remote area of NSW. Potential participants will be asked to complete an online screening survey and those who meet eligibility criteria will be automatically redirected to the online baseline survey. At the end of the baseline survey, a random number generator will randomly allocate the participant to one of the three conditions. The hyperlink to online follow-up surveys will be e-mailed to participants, 4-, 7- and 13-months post-baseline. Real time video-counselling condition: Participants in the video counselling condition will be contacted via video communication (e.g. Skype or Face Time). Smokers in the video counselling condition will receive from a smoking cessation advisor up to six video counselling sessions to assist smokers to quit. Proactive telephone counselling condition: Smokers allocated to the proactive telephone counselling condition will receive from a smoking cessation advisor up to six telephone counselling sessions to assist smokers to quit. Control condition: Participants allocated to the control condition will be mailed self-help materials (i.e. a quit kit). Measures: Point prevalence abstinence (primary outcome): The primary outcome will be self-reported 7-day point prevalence abstinence and will be measured at 4-, 7- and 13-months post-baseline. Prolonged abstinence (secondary outcome): Prolonged abstinence will be measured from a 1-month post-recruitment grace period (to give smokers opportunity to quit) to each follow-up and between surveys, resulting in 3-, 6-, 9- and 12-months prolonged abstinence. Quit attempts (secondary outcome): Participants will be asked if they quit for one day or longer since the last survey.

  • Cognitive and Lifestyle interventions to Understand the impact on the Elderly of anaesthesia and Surgery (The CLUES trial)

    The present study will utilise the new diagnostic criteria for perioperative cognitive disorders. Together with current best practice guidelines of multidomain interventions to test whether, when offered as a packaged intervention, these interventions reduce the incidence of disability occurring as a result of perioperative cognitive decline in older adults undergoing anaesthesia and surgery. This has the capacity to reduce healthcare costs, delay decline, improve outcomes and reduce the loss of quality-adjusted life years as a result of disability from cognitive impairment. Seven key modifiable risk-factors have been identified (diabetes, hypertension, obesity, smoking, depression, cognitive inactivity and physical inactivity) which account for approximately 50% of all Alzheimer's Disease (AD) and a 10-25% reduction in these could prevent 1.3 million cases of AD worldwide. Several proof-of-concept randomised controlled studies have been undertaken to develop population-level interventions with positive results. Five intervention components have been identified (nutrition, physical exercise, cognitive training, management of vascular and metabolic risk factors and stimulation of social engagement) demonstrating a significant effect on overall cognition. The preoperative education package will include these five intervention components: 1. Physical exercise 2. Cognitive training 3. Nutrition 4. Management of Risk Factors 5. Stimulation of Social Engagement Hypothesis: Preoperative implementation of proven risk reduction interventions for cognitive impairment will reduce the incidence of disability as a result of perioperative cognitive disorders and reduce associated social, healthcare and community costs. The current pilot study will assess feasibility of study design and intervention components prior to undertaking the complete study.

  • Continuous glucose monitoring system used to establish medication management protocol for the safe use of a 2-day intermittent energy restriction (5:2 diet) in type 2 diabetes mellitus.

    The purpose of this study is to further our knowledge on how to manage medication changes and to establish a safe and effective medication management plan for people with type 2 diabetes following the 5:2 diet and using medications like sulphonylureas (i.e. Diamicron) and/or insulin.

  • A study of a clear dental aligner system for orthodontic treatment

    The purpose of the study is to measure how well the clear aligner system moves teeth into the desired position over approximately 12 months.

  • The effect of intermittent energy restriction on the way blood vessels work

    The vascular endothelium plays an important role in the regulation in several important bodily processes, including arterial tone, thrombosis, and inflammation. Dysfunction in the endothelium can lead to the development of atherosclerotic lesions, a pathophysiological link to acute cardiovascular disorders. A common condition associated with endothelial dysfunction is obesity. Current research suggests that the mechanism of obesity-induced endothelial dysfunction may be multifactorial, as excess adipose tissues has been shown to induce several metabolic changes which have the potential to interfere with normal endothelial function. A recent meta-analysis (Joris, P J et al. 2015) of human studies on the effects of weight loss on FMD of the brachial artery reported that weight loss increased FMD vs. control by 3.29%. It also estimated that each 10kg decrease in body weight increased fasting FMD by 1.11%. Researchers highlighted that effects may depend on subject characteristics, type of weight-loss treatment, and dietary composition. Within the studies included in the meta-analysis, increases in FMD were larger in the higher weight-loss group when subjects consumed low-fat diets compared with low-carbohydrate diets. What has not been investigated however, in this meta-analysis or indeed in any RCT to date, is whether the impact of changed dietary composition (and resulting hypocaloric conditions) through intermittent energy restriction results in a change in FMD. Accordingly, the current study is designed to investigate the effect of intermittent energy restriction on endothelial function, relative to habitual intakes. This research will add value to the scientific field by adding to the existing literature targeting intermittent energy restriction and its potential health benefits. primary aim of this study is to investigate the effect of two fasting days compared to two ad libitum eating days on blood vessel function. Secondary aim is to determine changes in, serum lipids, plasma glucose and insulin. We hypothesize that individuals will have similar endothelial function following two fasting days compared to two ad libitum eating days.

  • Uptake of levonorgestrel releasing intrauterine system (LNG-IUS, Mirena 'Registered Trademark') at caesarean section

    Initiating long acting reversible contraception at the time of delivery has several advantages that include high patient motivation, convenience, access to trained professionals, no need for an outpatient insertion (which may be uncomfortable) and immediate contraception prior to the resumption of ovulation(1, 2) . Levonorgestrel releasing intrauterine system (LNGIUS, Mirena, Bayer Healthcare), is an intrauterine long acting reversible contraceptive that provides contraception for 5 years(3). In Australia its use almost always involves insertion through the vagina 6 weeks or more after childbirth (standard insertion). The 2016 Australian contraception guidelines rate immediate insertion of LNGIUS at delivery including caesarean section as category 1 (that is no restrictions placed on use) (4). Mwalwanda and Black (2013) note that, “No studies have specifically examined the uptake rate, long term continuation rates, acceptability or effectiveness” (of LNG-IUS in the immediate postpartum period) (2). Intrauterine device (IUD) insertion has low rates of adverse events such as pain and infection, regardless of timing or route of insertion(1, 5). Expulsion rates following device insertion at the time of caesarean may be higher than following standard insertion but more research is required to quantify the risk. Expulsion of IUDs including LNG-IUS following standard insertion is reported to occur in approximately 1 in 20 women(2). Three studies have been examined expulsion rates of LNG-IUS inserted at caesarean section. Expulsion rates were 0%(6, 7) and 20% (8). IUDs including LNGIUS have nylon strings attached. The strings are useful because they can be seen or felt to check that the device is still present, and they can be pulled to remove the device when this is desired. When devices are inserted through the vagina into the uterus the strings are always visible in the vagina initially, and the chance of strings not being visible in the cervix at follow up visits is 5%(9). When IUDs are inserted at caesarean section the chance of the strings not being in the vagina at followup is 8%(10). Patient satisfaction with LNG-IUS insertion at caesarean section has been found to be high, and not different to standard insertion(7). Continued use of LNGIUS inserted at caesarean for 12 months after delivery has been found to be higher than following standard insertion but this difference was not statistically significant (60.0% vs 40.9%, p=0.35)(8). LNG-IUS contains the hormone levonorgestrel, which is a progestogen. Studies of use of various types of progestogen containing contraceptives early in the neonatal period have not show a consistent adverse effect on breastfeeding initiation or continuation, or on neonatal outcomes such as growth and development(11). LNGIUS insertion at the time of caesarean section is associated with reduced postpartum bleeding compared with insertion of copper-containing IUD at caesarean section or no device insertion at caesarean section(12). There is some evidence that the theoretical advantages of LNGIUS insertion at caesarean encourage higher patient uptake. Two studies of immediate LNGIUS insertion at the time of caesarean section compared to standard insertion showed that more women had the procedure done in the immediate insertion group (19/20 vs 18/22)(8) and 25/25 vs 19/23(7) . This trial aims to offer LNGIUS insertion at elective caesarean section. Uptake rate is the primary endpoint. Device expulsion, string visibility, patient satisfaction, continuing use and bleeding pattern will also be recorded. REFERENCES 1. Lopez LM. Immediate postpartum insertion of intrauterine device for contraception. Cochrane Database of Systematic Reviews [Internet]. 2015; (6). Available from: http://search.ebscohost.com/login.aspx?direct=true&AuthType=ip,athens&db=edschh&AN=edschh.CD003036&site=eds-live. 2. Mwalwanda C, Black K. Immediate post-partum initiation of intrauterine contraception and implants: a review of the safety and guidelines for use. The Australian & New Zealand Journal Of Obstetrics & Gynaecology. 2013;53(4):331-7. 3. Heinemann K, Reed S, Moehner S, Do Minh T. Original research article: Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European Active Surveillance Study for Intrauterine Devices. Contraception. 2015;91:280-3. 4. Family Planning New South Wales FPV, True Relationships and Reproductive Health. Contraception: An Australian Clinical Practice Handbook. Fourth Edition ed. Australia: Family Planning NSW,Family Planning Victoria and True Relationships and Reproductive Health; 2016. 5. Kapp N, Curtis K. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009;80(4):327-36. 6. Puzey M. Mirena at caesarean section. The European Journal Of Contraception & Reproductive Health Care: The Official Journal Of The European Society Of Contraception. 2005;10(3):164-7. 7. Braniff K, Gomez E, Muller R. A randomised clinical trial to assess satisfaction with the levonorgestrel- releasing intrauterine system inserted at caesarean section compared to postpartum placement. The Australian & New Zealand Journal Of Obstetrics & Gynaecology. 2015;55(3):279-83. 8. Whitaker AK, Endres LK, Mistretta SQ, Gilliam ML. Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial. Contraception. 2014;89(6):534-9. 9. Marchi N, Castro S, Hidalgo M, Hidalgo C, Monteiro-Dantas C, Villarroeal M, et al. Management of missing strings in users of intrauterine contraceptives. Contraception. 2012;86(4):354-8. 10. Bhutta S, Butt I, Bano K. Insertion of intrauterine contraceptive device at caesarean section. Journal Of The College Of Physicians And Surgeons Pakistan. 2011;21(9):527-30. 11. FSRH. Clinical Effectiveness Unit Guidance Intrauterine Contraception April 2015 2015 [updated October 2015]. Available from: https://www.fsrh.org/documents/ceuguidanceintrauterinecontraception/. 12. Elsedeek M. Puerperal and menstrual bleeding patterns with different types of contraceptive device fitted during elective cesarean delivery. International Journal Of Gynaecology And Obstetrics. 2012;116(1):31-4.

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