ANZCTR search results

This study is to investigate which strategy is best in terms of preserving physical function in older adults (greater than 65 years) who are obese. The interventions are a very low energy diet (VLED - Optifast) plus exercise, diet plus exercise or exercise alone. The trial will last for 12 weeks. We will also look at the effects of these measures on body composition, blood pressure, glucose, cholesterol and memory/thinking.

This project will assess the effect of progesterone therapy on pregnancy outcomes in women presenting with threatened miscarriage. It is hypothesised that progesterone supplementation for early threatened pregnancy increases the live birth rate.

Individually and as the constituents of proteins, amino acids perform numerous and often essential functions. The current researchers have previously demonstrated clearly defined population subgroups based upon urinary amino acid profiles in chronic fatigue and pain patients, each group with specific nutritional requirements for amino acids. The same subgroups were also identified in healthy individuals with profiles differing from the patient groups only in the degree of excess or depletion of amino acids. The current project aims to determine whether distinct subgroups can be identified in healthy individuals reporting sub-health on the basis of urinary amino acid patterns. Sub-health is typically seen as a reduction in energy levels, change in sleeping patterns, increased incidence of viral infections and a loss of vitality with no defined disease being diagnosed. It can be defined as a chronic condition of deteriorated physiological function between health and illness. The project also aims to assess the ability of amino acid supplementation to improve the general well-being of individuals experiencing sub-health based upon membership of the subgroups identified in stage one. The current researchers have developed a nutritional formulation to alleviate fatigue containing a complex range of amino acids. The study will trial the amino acid supplement in subgroups of healthy individuals reporting sub-health. The study will involve a large group of adults reporting fatigue and sub-health but who are free from any significant medical or mental illness. Prior to supplementation all participants will be required to provide a urine sample and to complete general health and fatigue questionnaires. Urinary amino acid excretion patterns will be assessed with the aim of identifying subgroups based upon differential amino acid homeostasis. Once the subgroups have been differentiated, smaller groups of twenty individuals from each subgroup will trial the supplement for 30 days. At the completion of the trial participants will provide another urine sample and again complete the general health and fatigue questionnaires. General health, fatigue and urinary amino acid levels will be analysed to determine whether supplementation can bring about changes at both a symptom and biological level. It is believed that participants will derive significant benefits such as reduced fatigue but that the response to supplementation will be influenced by amino acid profile subgroup membership. This study will determine whether readily identifiable amino acid profile subgroups exist, each with specific amino acid requirements, allowing for the development of more effective dietary supplements in the future. The project’s hypotheses are as follows: 1. It is possible to identify major subtypes of amino acid homeostasis in a population. 2. Amino acid supplementation is capable of alleviating symptoms of sub-health and the symptoms and degree of alleviation will be determined by membership of subgroups based upon amino acid homeostasis.

This project will assess the effect of progesterone therapy on pregnancy outcomes in women previously diagnosed with subfertility. It is hypothesised that progesterone supplementation in early pregnancy decreases the likelihood of miscarriage, and potentially late pregnancy complications in women with previous subfertility.

Background A healthy start to life requires adequate motor development and physical activity participation. Currently 5-15% of children have impaired motor development without any obvious disorder. These children are at greater risk of obesity, musculoskeletal disorders, low social confidence and poor mental health. Traditional electronic game use may impact on motor development and physical activity creating a vicious cycle. However new virtual reality (VR) game interfaces may provide motor experiences that enhance motor development and lead to an increase in motor coordination and better physical activity and mental health outcomes. VR games are beginning to be used for rehabilitation, however there is no reported trial of the impact of these games on motor coordination in children with developmental coordination disorder. Methods This cross-over randomised and controlled trial will examine whether motor coordination is enhanced by access to active electronic games and whether daily activity, attitudes to physical activity and mental health are also enhanced. Thirty children aged 10-12 years with poor motor coordination (below 15th percentile) will be recruited and randomised to a balanced ordering of ‘no active electronic games’ and ‘active’ electronic games. Each child will participate in both conditions for 16 weeks, and be assessed prior to participation and at the end of each condition. The primary outcome is motor coordination, assessed by kinematic and kinetic motion analysis laboratory measures. Physical activity and sedentariness will be assessed by accelerometry, coordination in daily life by parent report questionnaire and attitudes to physical activity, self-confidence, anxiety and depressed mood will be assessed by self report questionnaire. Discussion This is the first trial to examine the impact of new virtual reality games on motor coordination in children with developmental coordination disorder. The findings will provide critical information to understand whether these electronic games can be used to have a positive impact on the physical and mental health of these children. Given the importance of adequate motor coordination, physical activity and mental health in childhood, this project can inform interventions which could have a profound impact on the long term health of this group of children.

The primary objective of the study is to examine the safety and efficacy of SATIVEX 'Registered Trademark (R)' in the inpatient management of cannabis withdrawal, in a double blinded randomised trial compared to placebo. Specifically, the study will compare withdrawal severity, detoxification completion and adverse events between the two conditions in an intention-to-treat analysis. Secondary objectives include 1-month post-withdrawal outcomes (including cannabis and other drug use and psychosocial outcomes), and to assess the relationship between the number, severity and duration of cannabis withdrawal symptoms and rates of continuous and point prevalence abstinence from cannabis, time to relapse, levels of cannabis use, and cannabis related problems at one month follow-up. The study will also explore the cognitive impact of withdrawing from cannabis, as well as the impact of SATIVEX on cognitive functioning, with an aim to assessing the real world safety profile of the drug ahead of larger outpatient studies. The study will also explore the pharmacokinetics and metabolites associated with SATIVEX (R) administration to develop a protocol for differentiating between SATIVEX(R) and illicit cannabis in blood or urine among those entering cannabis withdrawal treatment. This pharmacokinetic assay will prove useful for future large scale outpatient trials should the current trial prove successful. A final exploratory objective of the study is to determine whether there is evidence of an interaction with the efficacy of SATIVEX(R) and patient characteristics on admission (including demographics and cannabis and other use and psychosocial factors such as treatment expectancy) on reported severity of cannabis withdrawal and subsequent post-withdrawal outcomes (cannabis use, psychosocial outcomes, sleep disturbances and cannabis-related problems) to be fully tested in a larger community study.

Obesity is a global health epidemic increasing adverse health risks for sufferers. Lifestyle and diet are fundamental to prevention and treatment of obesity-related disorders and attention to the role of staple foods as part of total dietary intake is warranted. Wheat grain is a staple food in Western countries, providing energy, nutrients and fibre, and is commonly consumed as a breakfast cereal. When compared with highly refined cereals, wholegrain cereals are more nutritious beneficial in maintaining healthy weight, blood glucose, cholesterol levels, and reducing cardiovascular and diabetes risks. This study aims to evaluate the effectiveness of consuming 2 types of wholegrain wheat breakfast cereals in overweight and obesity, that have undergone different processing treatments and may differ in chemical composition.

Diastasis recti (also known as abdominal separation or DRAM) is a disorder defined as a separation of the rectus abdominis muscle into right and left halves. In pregnant or post-natal women, the defect is caused by the stretching of the rectus abdominis by the growing uterus and the increased hormones associated with pregnancy that cause flexibility in the body’s tissues. A clinically significant (larger) DRAM is defined as being greater than or equal to three fingers wide. Although these larger DRAMs are treated by physiotherapists at Southern Health, there is limited evidence into the physical/psychological problems suffered by women in association with a larger DRAM. The aim of this study is to investigate the incidence of back and pelvic pain, incontinence and body image in post-natal women, immediately post birth (incontinence only), six weeks (whether there is a clinically significant DRAM or other problems) and then six months after child birth. The incidence of any dysfunction as mentioned will be compared between women with either a) no DRAM (healthy age-matched women who have never been pregnant); b) a clinically insignificant DRAM (less than three fingers width) and c) a clinically significant DRAM (three fingers or greater wide). The study will also aim to determine the factors associated with back or pelvic pain, incontinence and body image in post-natal women. The findings of this study will inform the development of a randomized, controlled trial of physiotherapy intervention in women at risk of morbidity following DRAM.

This study aims to test if acupuncture is effective in treating hot flushes after the menopause.

This study evaluates an innovative supportive care intervention to improve the well-being of men diagnosed with prostate cancer. Who is it for? This study is for men who have recently been diagnosed with localised prostate cancer in Queensland. Trial details In this study participants are randomly (by chance) divided into two groups. One group will receive usual care, i.e. currently available resource and support materials. The other group will receive the Living with Prostate Cancer supportive care intervention. This includes the provision of self-management resources in both print and web-based form, as well as access to a study website where participants can interact in group discussions and forums. The intervention also includes group peer support phone calls for participants led by trained peer support volunteers and a specialist prostate cancer nurse counsellor. The duration of this intervention is 6 months. Participants will complete questionnaires at 3, 6 and 12 months after enrolling in the study to evaluate their psychological well-being and quality of life.