ANZCTR search results

There is evidence that engaging in physical activity improves the physical health of prostate cancer survivors. Despite this evidence, men who survive prostate cancer do not engage in recommended levels of physical activity. The aim of this study is to investigate the potential influence clinicians could have on increasing physical activity levels among prostate cancer survivors, by referring cancer survivors to a physical activity program, with expert involvement from exercise physiologists. The participants will be 220 survivors of prostate cancer, defined as men who have completed active treatment (hormone treatment exempt) for prostate cancer three-12 months prior. The study has been designed as a randomised controlled trial to test the efficacy of an intervention (i.e., a clinician’s referral to a physical activity program) to generate a) behaviour change by increasing physical activity levels that is sustained over time and b) improve psychosocial and quality of life outcomes among prostate cancer survivors. The patients’ treating clinicians will be randomised to either the intervention arm or control arm of the trial. The intervention will involve clinicians referring participants to an Active Exercise Program, which comprises 12 weeks of small group sessions and individual home-based physical activity. Patients of clinicians assigned to the control arm will receive usual advice regarding physical activity, given the information and consent form, and invited to be involved in the study by the clinician. The main outcomes that will be measured in this trial are participation in physical activity, cancer-specific quality of life, anxiety relating to prostate cancer, depressed mood, and objective physical functioning. Measurements of these outcomes will be made using standard questionnaires. The questionnaires will be administered baseline (T1), on completion of the intervention (T2), and at six-(T3) and 12-months post-recruitment (T4). Objective physical functioning will be measures at baseline (T1) and on completion of intervention (T2). This study will inform the development of a physical activity program for prostate cancer survivors which could become available across Victorian YMCA facilities and ultimately across Australia.

It is well established that parents of primary school aged children substantially influence the food and physical activity home environment through behaviours, attitudes, feeding styles and role modelling. However, the contribution of fathers’ influence on children’s physical activity and eating behaviour is often overlooked.The Healthy Dads Healthy Kids (HDHK) project is based on research that shows the eating habits and exercise routine of fathers and father figures influence the ways in which the whole family approaches their health. The program was developed and successfully trialled at the University of Newcastle, with trial results showing that the major aims of HDHK were achieved. These were (i) to help overweight/obese fathers achieve a healthy weight, and (ii) to improve the activity and eating behaviours of their children (using fathers as the key agents of behaviour change). The intention of the current project is to research the effectivenss of the HDHK program in a community setting.

Being born too early is a leading cause of perinatal death and morbidity. This trial seeks to determine whether screening for and treating asymptomatic candidiasis in pregnancy reduces the risk of this serious health problem. The trial will discover whether a simple treatment in pregnancy can reduce preterm birth. If positive, the results will be relevant to the management of every pregnancy.

Anxiety disorders in children are prevalent, understudied, and underreported phenomena. Despite well-documented efficacy of treatments for child anxiety, research into the prevention of these disorders remains comparatively limited. An inhibited temperament style has been identified as an early life predictor of the anxiety disorders. Behavioural Inhibition (BI) is defined in terms of reactions of withdrawal, wariness, avoidance and shyness in novel, unfamiliar situations. The findings from our research suggests that inhibited children are significantly more likely than uninhibited children to have an anxiety disorder at baseline and also more likely to develop an anxiety disorder over time. Other factors, such as parenting style, maternal anxiety and interpretation bias also increase the risk for anxiety in this population. In this study we will examine the efficacy of an intervention program aimed at reducing anxiety and risk for future anxiety in BI preschool children by focusing on BI and family environment risk factors.

Studies have also shown that children with Type 1 diabetes mellitus (T1DM) have much higher rates of problems with behaviour and cognition (learning, understanding, attention, memory etc) which can affect their health and quality of life. In particular, youth who have more problems with behaviours such as aggression and conduct (called ‘externalising’ behaviours) have been shown to have much higher rates of poorer mental health outcomes and poor long-term diabetes control. It is known that despite having regular insulin injections, individuals with T1DM can have large swings in blood glucose levels (from very high to very low or vice versa) over the course of a day. These high and low levels of glucose not only give rise to uncomfortable symptoms, but have also been shown to result in an increase in externalising behaviours and impaired mental functioning. ‘Intensive insulin therapy’ regimens involve either multiple daily injections (MDI) of insulin or continuous subcutaneous insulin infusion (CSII) using an insulin pump. These regimens aim to better mimic the work of the pancreas and therefore to reduce the large swings in glucose found in T1DM. A previous study that followed up 32 youth who commenced use of CSII showed significant improvements in their scores of behaviour & cognition after 6-8 wks. Improvements in behaviour have persisted to 2 years in those using CSII. Of note however, there was no control group in this pilot study and so results can not be generalised. If however, similar results were found when comparing CSII and MDI, then CSII would offer additional health and wellbeing benefits for youth with T1DM. The aim of this randomised controlled trial is to assess whether, in a group of youth already using MDI, commencement and continued use of CSII results in improvements in indices of behaviour and cognition, and if so, whether these changes are as a result of improved glucose profiles. The study will run at both the Royal Children’s Hospital Melbourne (VIC) and the Children’s Hospital Westmead, (NSW). Children and adolescents aged 9-16 years who are on the waiting list to commence CSII (i.e willing to use CSII and assessed by the diabetes team as capable of doing so) will be invited to participate. Assessments performed will include standardised behaviour questionnaires and cognitive tests (supervised and scored by a trained psychologist) as well as 6 days of continuous glucose monitoring (using a probe inserted under the skin which continuously records glucose measurements) and HbA1c (a standard monitoring test of glucose control). Following baseline assessments, 110 youth will be randomly assigned to either continue MDI or to commence and continue CSII. All participants will then have standard diabetes care until assessments are repeated at the end of a 4month period. Differences between outcomes in the 2 study groups at 4 months will be compared. Between group difference in scores of externalising behaviour at 4 months is the primary outcome of interest. Differences in scores of mood, cognition and markers of glucose control at 4 months are secondary outcomes of interest. Since all participants will be recruited from the CSII waiting list, at the end of the 4 month study period, those randomised to continue MDI will be commenced on CSII.

Cognitive brain training, which involves repeated exercise on a range of cognitive problems, may help improve cognitive function and slow age-related mental decline. Previous studies of brain training have mainly focused on clinical populations, and so its effectiveness in healthy, working age individuals is not known. We therefore propose to measure the effectiveness of brain training across a wide range of outcomes with scientific, business and health relevance, including cognition, psychological wellbeing and workplace productivity.

The main rationale for this study is to evaluate the analgesic effect of Quetiapine XR in conjunction with non-opioid analgesic/s and/or nonsteroidal anti-inflammatory drugs (NSAIDs), with or without an antidepressant in treating patients with Chronic Somatoform Pain Disorder (CSPD), who have not responded adequately to their existing pain management therapy alone.

The purpose of the study is to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on glycaemic control, the release of gastrointestinal peptides, gastric emptying and sensations of appetite in patients with type 2 diabetes, when given concurrently with the dipeptidyl dipeptidase IV inhibitor, sitagliptin.

The primary hypothesis is that participants randomised to the 1 month gait training program will reduce KAM and improve symptoms of OA compared to the control group. Osteoarthritis is the most common musculoskeletal disorder affecting Australians and is the leading cause of pain and disability. OA is caused by rapid degeneration of articular cartilage. Knee osteoarthritis reduces physical activity level due to the associated pain, impaired gait and balance and lower-extremity muscle weakness. Osteoarthritis treatment is typically driven by a pharmacologic approach to provide analgesia and reduce inflammation, rather than employment of disease-modifying agents, or risk factor reduction, with knee replacement surgery the only option in advanced cases. Gait retraining and postural control is theoretically far more targeted to the impairments in knee OA. The primary hypothesis that participants randomised in the 1 month gait program will have a significant reduction in the KAM compared to the control group, and have a significant improvement in symptoms of OA such as pain.

Patients with chronic obstructive pulmonary disease (COPD) have previously been shown to complain of poor sleep, daytime fatigue and sleepiness. This has been seen in large studies based on questionnaires, however a US study of over 2,000 participants with mild COPD found little sleep disturbance. This study will measure sleep quality and symptoms of sleep disturbance in a group of participants with moderate to severe COPD and correlate perceived with actual sleep disturbance. Thirty participants with moderate to severe COPD (defined as at least 1 standard deviation below the lower limit of their predicted function) will complete questionnaires measuring quality of life, symptoms of respiratory and sleep disturbance and daytime sleepiness. They will be required to have a stable regimen of treatment for their lung disease and no significant medical or psychological conditions which could prevent them completing the study. Standard clinical spirometry will be performed and an in-laboratory sleep study carried out. This sleep study will monitor sleep, airflow, oxygen and carbon dioxide (CO2) levels during the night, as accumulation of CO2 during the night in these patients may contribute to sleep disruption and fragmentation. Participants will be asked to describe the quality of their sleep and this will be compared to the measured sleep, as sleep perception is thought to be poor in these patients. The outcomes of the study will be a description of sleep architecture, including the number of changes in sleep stage. It is thought that sleep stage transitions are important for daytime sleepiness. The degree of sleep fragmentation will be correlated with the sleep questionnaire outcomes and also with the severity and other measures of the respiratory function.