ANZCTR search results

The study aims to see if it is feasible and acceptable to patients, families and carers as well as staff to use pulse oximetry to help keep patients safe while they are in a psychiatric intensive care unit. Pulse oximetry is a proven technology that is widely used in other medical and health settings. This is a new application of the technology. Participation in the study is voluntary and non-participation or withdrawal from the study at a later stage will not affect the treatment received at the unit.

We propose to study the effects of 3 month supplementation of CoQ10 on cognition versus placebo using a randomized controlled trial methodology. Our focus will be on older participants as this may be a sensitive age for cognitive improvement given that normal increasing age is associated with cognitive decline-particularly memory, the levels of CoQ10 decreases with age, there is increased deterioration in the cardiovascular system with age and finally there is increased oxidative stress with age and less anti-oxidant protection with age. All of these indicators suggest that supplementation with CoQ10 could improve cognitive function in the elderly. Apart from our sensitive cognitive battery we will also measure changes in blood levels of CoQ10 and oxidative stress (F2 Isoprostanes and glutathione peroxidase) as well as markers of cardiovascular function (Blood pressure, arterial stiffness and blood flow).

Cellulitis, a spreading skin infection treated with antibitoics, is routinely stratified according to severity and patient risk factors. Moderate-severity cellulitis is commonly treated with short-course intravenous antibitoics followed by oral antibiotics. This is some evidence to suggest moderate-severity cellulitis could be safely treated with oral antibiotics. This prospective, single-blinded trial will assess the efficacy and safety of oral antibiotics for the treatment of moderate-severity cellulitis. Participants will be randomized to treatment with either oral or intravenous antibiotics and assessed for rates of treatment success and complications.

In this study pharmacists trained in health coaching will provide coaching to patients with poorly controlled hypertension. Patients will receive three health coaching sessions with the pharmacist. The aim of this project is to determine if there is an association between health coaching provided by a community pharmacists and an improvement in blood pressure and medication adherence. The project will also look at the change in patients health behaviours through the study through assessing patient’s stage of change from a stages of change chart. The project will also look at the opinions and attitudes of the pharmacist health coaches throughout the study as well as those of the patients. An improvement in patients’ blood pressure is also expected at the end of the study as well as their health behaviours. It is also expected that patients will have an improved understanding of high blood pressure and its management.

A Randomized Open-Label, Phase 1b Study of the Safety of Pirfenidone Solution for Inhalation (AP01) in Patients with Idiopathic Pulmonary Fibrosis (ATLAS Study)

Abnormal lung function is common in Parkinson’s Disease (PD) and contributes to reduced physical activity, fatigue, problems with speech and swallowing, aspiration pneumonia, and functional decline. Lung function tests show evidence of airway obstruction, reduced compliance of the lung and chest wall and decreased ventilatory muscle strength. There is limited information available on interventions that improve ventilatory muscle strength in PD. Some studies suggest that such programs may not only improve exercise capacity but also walking, balance, fatigue and sleep in a non-PD population. This study will examine the effects of inspiratory muscle training (IMT) on improvement of lung function, gait and balance, speech and swallowing on a group of mild to moderately affected patients with PD and a group of normal age matched participants for comparison. Participants will be recruited to undergo 8 weeks of High intensity IMT (H-IMT) or a control group undergoing 8 weeks of Sham IMT (S-IMT). After initial supervised training, participants will perform the 21-minute exercise program 3 times a week at home. Lung function, balance, mobility, speech, swallowing and Quality of Life will be measured before and after the 8-week training program and 6 months after starting the training. Since treatment related gains are lost over time participants will continue the training exercises at least twice a week after 8 weeks (maintenance training). Based on preliminary results we will offer H-IMT and maintenance training to those in the sham treatment group after 6 months. The results of the study have the potential to deliver significant functional benefits from a simple, home based, easily performed exercise program.

Multiple sclerosis (MS) is the most frequent neurological disease in young and middle-aged adults in Australia and has a lifelong impact. Abnormalities in gait and balance are common in patients with MS. A number of different mechanisms are known to contribute to recovery from neural injury and relapses in MS. Functional imaging studies suggest that cortical plasticity and reorganization can promote recovery from brain injury in MS (Reddy et al. 2000; Pantano et al. 2002; Rocca et al. 2010, 2002). Balance training is an important rehabilitation intervention for MS patients, and most studies show a small, but significant, effect of physiotherapy on balance in people with multiple sclerosis who have a mild to moderate level of disability (Lord et al. 1998; Cattaneo et al. 2007a; Paltaama et al. 2012). Non-invasive brain stimulation (NIBS) is being increasingly trialled for enhancing brain plasticity after neural injury and shows promising results in patients with stroke, dystonia and Parkinson's disease (Edwardson et al. 2012; Ridding and Rothwell, 2007). Brain stimulation can be used to excite the brain and promote relearning. This study aims to recruit MS patients who have mild to moderate difficulty with balance and walking. We will evaluate if brain stimulation (transcranial direct current stimulation – tDCS) added to a structured balance training program will provide added benefit in mobility. This will be in addition to their regular outpatient therapy program prescribed by their physicians. This study will recruit patients with MS who have mild to moderate impairment of balance and walking. They will be randomly split into two groups: Both groups will complete a structured balance training program (1 hour sessions, 2 days a week for 6 weeks). Group 1 will also receive brain stimulation (tDCS) prior to each balance therapy session, while Group 2 will receive a sham-tDCS session. A physiotherapist who is not involved in the treatment will test each patient's balance and walking, as well as administering some questionnaires and a cognitive test. These assessments will be done before the treatment commences, immediately after the 6 week program and 6 months, 12 months and 24 months after the initial assessment date.

This randomised, double blind, sham-controlled trial aims to investigate whether non-invasive brain stimulation in the form of transcranial direct current stimulation (tDCS) can alter cortical neuro-excitability and thus enhance the effects of physical therapies in people with stroke. We hope to recruit 75 subjects who have had their first-ever ischemic stroke within the previous 12 months who have mild to moderate upper limb impairments. Subjects undergo 20 minutes of tDCS followed by 1 hour of robot-assisted arm therapy 2-3 times/week for 6-9 weeks (total 18 interventions). Outcome measures include neurophysiological, impairment, functional, psychological and subjective measures.

Individuals with Parkinson disease (PD) often demonstrate postural instability, gait difficulties, and reduced functional mobility that can lead to decreased quality of life. While there is accumulating evidence supporting dance as an effective management option in alleviating the symptoms of PD, there is a limited number of studies that have objectively assessed the effects of dance, particularly related to the Dance for Parkinson’s Disease® (DfPD®) programme. Therefore this study aimed to explore the impact of dance classes based on the DfPD® model, on gait during normal walking and dual-tasking, cognition, functional mobility, fine manual dexterity, anxiety, depression, quality of life and caregiver burden in people with Parkinson’s disease (PD). We hypothesised that improvements in the above outcomes would be noted in the dance group while no improvements would be noted in the untreated control group.

Over 450,000 patients present to an Australian Emergency Department with chest pain every year. The current processes used to rule out heart attack for these patients are lengthy and costly, taking a median of 26 hours at a cost of $2,127 per patient. This contributes to overcrowding in the Emergency Department, and is not sustainable within a healthcare system that has growing demand and finite resources. This project will implement and evaluate a new chest pain assessment strategy to be used on presentation to the Emergency Department. The strategy incorporates results from blood tests with shared decision-making to identify low-risk patients who can rapidly be discharged with no further testing. The goal is to realise a safe, efficient, and patient-focussed method for the assessment of chest pain. The new strategy will be termed LEGEND (Limit of detection in the EmergENcy Department). In the first instance, this will be implemented at seven Queensland hospitals. Data collected before and after the implementation of LEGEND will be used to assess 1) whether LEGEND reduces hospital length of stay, 2) whether LEGEND is safe for identifying heart attack, and 3) whether LEGEND reduces healthcare utilisation and healthcare costs. It is anticipated that this strategy will reduce the need for healthcare resources and will place patient needs at the centre of clinical decision making.