ANZCTR search results

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

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32847 results sorted by trial registration date.
  • Breathing Muscle Training in Parkinson's Disease

    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.

  • Enhancing balance and gait in patients with Multiple Sclerosis – combined use of balance training with non-invasive brain stimulation

    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.

  • Robot-assisted arm therapy and brain stimulation to enhance recovery after stroke

    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.

  • Effects of dance for Parkinson’s on gait, cognitive function and dual tasking in Parkinson’s disease

    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.

  • Limit of Detection in the Emergency Department Trial: A trial to rapidly rule out acute myocardial infarction and reduce hospital length of stay in patients presenting to the Emergency Department with chest pain.

    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.

  • Stratifying asthma severity in children using cough sound analytic technology.

    This study is designed to develop an accurate digital diagnostic test, used on a smart device, to measure the severity of asthma. These tests can then be used in resource-poor communities, emergency departments or via telehealth applications. The test would improve asthma action plans, a mainstay of asthma management. The aim is to develop tests that are as accurate as an expert clinical assessment but do not need a clinical examination or other interventions such as bronchodilator (Ventolin) tests.

  • Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) in people with Mycobacteroides abscessus pulmonary disease: a multi-centre, randomised, multi-arm, adaptive platform trial.

    Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria causing infections in humans. While the overall numbers affected is small, the prevalence of infections is increasing. Individuals with cystic fibrosis (CF) and bronchiectasis are at particular risk of MABS becoming established within their lungs, resulting in a clinical spectrum ranging from simple colonisation to severe infection with increased healthcare utilisation and mortality. There is no evidence for either the timing of starting therapy, or for the currently used treatment regimens, which are complex, often poorly tolerated, and involve multiple expensive and toxic drug combinations given for at least 1-2 years. These considerable challenges have resulted in very few clinical trials being performed leaving an urgent clinical management evidence vacuum. Population: Those with MABS positive respiratory samples. Intervention: We aim to build an iterative, experimental clinical trial platform with adaptive properties and an observation arm to enable multiple treatment combinations to be evaluated in patients with and without CF, in those infected with different MABS subspecies, and strains with macrolide resistance. The platform will enable future novel treatments to efficiently enter the trial as they become available. Comparison: The trial platform will include the current standard of care as a comparator arm; as evidence is accumulated new comparators may be incorporated. Outcome: The trial platform will facilitate the evolution of optimal management for MABS lung disease with primary outcome of microbial clearance and include pharmacokinetic and health economic evaluation. Biomarkers will be developed to guide when to initiate treatment, and enable the monitoring of treatment responses. This will reduce unnecessary treatment associated toxicity and costs and enable targeted therapeutic approaches to maximise clinical benefit.

  • Trial of prophylactic GCSF (white cell growth factor) use to prevent low white cell counts in people re-exposed to clozapine

    Background: clozapine is the most effect antipsychotic drug for treatment-refractory schizophrenia. Approximately 3.8% of people prescribed clozapine develop neutropenia which necessitates discontinuation of drug. Cessation of clozapine often results in psychotic rebound symptoms and may deny highly disabled patients the only effective means of psychotic symptom control. Despite this clozapine rechallenge is rarely undertaken due to concerns about the morbidity of recurrent neutropenia and lack of evidence based rechallenge strategies. One option for clozapine rechallenge is the concomitant use of prophylactic granulocyte-colony stimulating factor (G-CSF) to prevent recurrent neutropenia. However, there is limited current literature reporting the safety and efficacy of such an approach. A recent review identified 23 cases of clozapine rechallenge using prophylactic G-CSF in people previously experiencing clozapine associated neutropenia. This review reported a success rate of 70% at follow-up of one year with a favourable safety profile. However, the protocol for rechallenge was not standardised across cases, analysis was retrospective in most cases and there was risk of reporting bias given most data were derived from case series or single case reports. Further prospective evaluation of prophylactic G-CSF use for clozapine rechallenge in people previously experiencing clozapine associated neutropenia would be beneficial to determine the safety and efficacy of such an approach. Principals and rationale of therapeutic strategy: G-CSF has an established evidence base for the prevention of chemotherapy induced neutropenia and is also effective at augmenting neutrophil counts in people with congenital neutropenic syndromes and immunologically mediated neutropenia. Furthermore, G-CSF is beneficial in reducing the duration of clozapine-associated neutropenia following drug cessation. In people previously experiencing clozapine-associated neutropenia who are re-exposed to clozapine, G-CSF could plausibly augment neutrophil counts to prevent recurrent neutropenia. Hypothesis: use of regular G-CSF can be used safely in people previously experiencing clozapine-associated neutropenia during re-initiation of clozapine to prevent recurrent neutropenia and facilitate ongoing use of clozapine.

  • TARGET Protein Feasibility Study: a prospective, blinded, parallel group, randomised controlled trial to assess the feasibility of conducting a phase III trial of protein targets in critically ill adults

    An ICU stay is associated with significant muscle wasting in up to 80% of critically ill patients. This muscle wasting results in ‘ICU-acquired weakness’ that is associated with slower weaning from ventilator support, longer time to discharge alive from ICU and hospital, higher in-hospital costs which persist well after discharge from the acute care setting. Nutrition therapy, usually delivered to ICU patients as liquid feed via a tube into the stomach. The provision of additional protein has the potential to improve at least part of the significant muscle atrophy that occurs, and hence enhance functional recovery from critical illness. A number of observational research studies have reported that a large proportion of ICU patients do not meet prescribed protein targets, with protein delivered closer to prescribed targets associated with reduced mortality, ventilation and ICU and hospital length of stay. Currently guidelines recommend delivery of protein doses of 1.2 - 2.0 g/kg/day or higher, but this is based on very low quality of evidence. Therefore, there is a need for high-quality randomised controlled trials of differing protein doses.

  • The impact on patient outcomes of a five session, tailored nutrition and dietetic intervention for outpatients receiving psychological treatment for an eating disorder: a proof of principle study

    Despite the seriousness and the often poor prognosis of eating disorders, little research has evaluated nutrition and dietetic treatment options. Specifically, no randomised controlled trials have been conducted exploring the impact of dietitian-delivered evidence based nutrition and dietetic treatment for eating disorder patients either alone or as part of a multidisciplinary treatment team. This study aims to evaluate the effectiveness of providing five sessions of tailored nutrition and dietetic intervention on the outcomes of patients aged 16 years or older who are also receiving psychological intervention for an eating disorder. Qualitative research methods will also be utilised to explore participants’ satisfaction and acceptability of the nutrition and dietetic intervention they receive as well as the involved clinical psychologists’ satisfaction of working with a dietitian to provide treatment for patients with an ED.

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