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The effectiveness of a telerehabilitation exercise program in people with chronic liver disease
Exercise has been shown to improve the health of people with chronic liver disease. It may improve a person’s strength and endurance and help them manage their weight. Exercise programs for conditions like chronic liver disease are often provided at hospitals or community centres which can be inconvenient for people to attend and incur costs associated with travel and parking. Telerehabilitation is an alternative treatment which involves completing an exercise program at home, with exercise guidance provided through a video call with the exercise supervisor. The aim of this study is to investigate the effects of a telerehabilitation program on the health and fitness of people with chronic liver disease. If shown to be effective, telerehabilitation will make an exercise program much easier to access for people with chronic liver disease. This project is being conducted by a student and will form the basis of a Physiotherapy with Honours degree at Curtin University, under the supervision of an experienced Fiona Stanley Hospital Exercise Physiologist and Gastroenterologist. We hypothesise that participants that complete a telerehabilitation program over 8 weeks will improve their strength, endurance, muscle mass and quality of life, while reducing their body fat content when compared to control participants that receive usual care and do not complete a formal exercise program.
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Evaluating Prevention of Muscle Loss After Menopause Using Testosterone: The PAMELA study
Endogenous testosterone has been associated with increased lean mass and exercise performance in young and elderly women and testosterone therapy increased lean mass in two pilot randomized controlled trials. However, our systematic review and meta-analyses found no effect of exogenous testosterone on muscle strength or performance, as prior studies have been small (<20 participants per group) and of short duration (6-16 weeks). The aim of this two-arm parallel-group randomized placebo-controlled trial is to determine whether testosterone therapy results in significant gains in muscular power over placebo in postmenopausal women. Participants will be randomly allocated to receive either transdermal testosterone or identical placebo for 26 weeks. The primary outcome will be body weight-corrected power (watts/kg) determined from the maximal vertical jump test on a Leonardo Mechanography Ground Reaction Force Platform (Novotec Medical GmbH). This innovative technology allows for measurement of force, velocity and centre of gravity/sway. It is reproducible and appropriate for older women. Secondary outcomes include grip strength, balance, proprioception, coordination, performance, endurance, and fatiguing (all measured using Leonardo Mechanography), body composition, bone mineral density (BMD), and health-related quality of life. This study addresses the conditions highlighted in the National Women’s Health Strategy 2020-2030 as being of the greatest significance and urgency for older women, who are notably underrepresented in research. It will generate new knowledge in testosterone action and therapy in relation to the preservation of muscle mass and function in postmenopausal women, and potentially provide evidence for novel approaches to prolong the morbidity-free life span of Australian women. This study will provide much needed reference data, presently lacking, for the effect of transdermal testosterone on preservation of muscle mass and function, which will inform the design of future studies of testosterone and other potential therapies. The findings will lead to high impact publications, and potentially transformative interventions ensured by Prof Davis’s standing as the world expert on testosterone in women.
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Evaluating Testosterone Therapy to Prevent Heart Failure in Women: The ETHEL study.
This proof-of-concept randomised double-blind placebo-controlled crossover study will determine the effects of transdermal testosterone supplementation in post-menopausal females with stage B heart failure with preserved ejection fraction (HFpEF) on attenuation of heart failure risk. We seek to do this based on the previously demonstrated efficacy of this approach in female patients with chronic HF as our epidemiological evidence that suggests low testosterone in females is associated with increased risk of major cardiovascular events and there is an urgent need to identify effective prevention and treatment strategies for the patients with HFpEF. Our hypothesis is that transdermal testosterone, versus placebo, will result in a clinically meaningful improvement in V02peak, which is a strong prognostic indicator for future HF risk in postmenopausal women with stage B HFpEF. The improvement will be due to improvements in central cardiac function and structure. The study will provide high-quality evidence as to whether testosterone, as a novel intervention, will improve cardiorespiratory fitness in women at risk of HFpEF, and therefore whether testosterone therapy has the potential and feasibility as a treatment for this condition, for which there is currently no known treatment.
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Finger and wrist worn peripheral arterial tonometry (WatchPAT) compared to a home-based sleep study for the diagnosis of obstructive sleep apnoea
Laboratory polysomnography (PSG) is costly and labour intensive and therefore cannot adequately deal with the large burden of Obstructive sleep apnoea (OSA) in the community. With technological developments there has been a global trend to home-based sleep testing, both with full PSG at home and limited channel home sleep apnoea testing (HSAT) devices, in order reduce the cost and increase the access to OSA diagnosis. The WatchPAT is a simplified, wrist and finger worn device, which measures peripheral arterial tonometry (PAT), a marker of autonomic tone. WatchPAT and similar devices can measure oxygen saturation and from the PAT signal derive measures of sleep staging and sleep apnoea severity. The WatchPAT is in common clinical use and has been validated against laboratory PSG, but there is limited validation against home based PSG in a general sleep clinic population. This multicentre study aims to assess the diagnostic accuracy of the WatchPAT compared to home based polysomnography in sleep clinic patients referred for the diagnosis of OSA.
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Things You Do (TYD) Open Trial: the effects of changing the frequency of daily actions on mental health in healthy adults
The primary aim of this study is to understand the associations between "Things You Do" activities and changes in mental health symptoms. In this two-phase project, participants will be encouraged to restrict the frequency of these behaviours for 4-weeks and then increase these behaviours for the next 4-weeks. In Phase 2, all participants will receive access to the "Things You Do Course", a one-lesson course alongside daily text message reminders. We expect that people will report a increase in depression and anxiety symptoms during Phase 1 (restriction) and then a decrease in these symptoms during Phase 2 (treatment).
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A Randomized, Open-Label, Phase 2 Study of Darolutamide as Single Agent or in Combination with EPI-7386 as a Neoadjuvant Treatment for Patients Undergoing Prostatectomy for Localized Prostate Cancer (DaSCENT)
The purpose of this study is to compare the efficacy of administering the drugs, EPI-7386 and Darolutamide, in combination versus Darolutamide alone, as treatment for patients with prostate cancer, before they undergo standard surgery to remove the prostate gland. Who is it for? You may be eligible for this study if you have been diagnosed with localized prostate cancer and have been referred for radical prostatectomy surgery. Study details Participants will be randomly allocated to either doublet therapy consisting of EPI-7386 and Darolutamide (Arm A) or Darolutamide alone (Arm B) for a treatment duration of 12 weeks. Treatment will be in the form of oral tablets. Prostatectomy will occur the day after completing neoadjuvant therapy, and specimens removed during surgery will then be examined to determine treatment efficacy. It is hoped that information collected in this study will help inform treatment options for patients with localized prostate cancer undergoing removal of their prostate.
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ConsumEr experieNce of supplement on mild to modERate symptoms of fatiGue or reduced vitalitY (ENERGY)
This study involves the testing for eight weeks of a regulatory listed supplement targeting fatigue symptoms. This real-world direct-to-participant study aims to understand healthy volunteers’ perspectives and experiences using the TGA-listed and marketed Swisse Body Activator product to generate advertisement claims within the regulatory permitted indications/label. Patients will be recruited via a consumer panel or through social media or other virtual channels via an online screening survey. The Swisse Body Activator product (ARTG ID: 391453, June 2022) is a hard oral capsule with a comprehensive formulation that targets physical fatigue, energy management and inflammation. It has several permitted indications – Maintain/support energy levels and vitality, relieve weariness, tiredness, fatigue and the feeling of weakness and decrease, reduce, and relieve mild joint inflammation, swelling, pain and soreness, among others.
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Assessing the IMpact of Alopecia Areata (AA) on PatIents’ and CaregiverS’ in Australia (MARISSA)
This is a one-time cross-sectional, online study, consisting in a patient survey and a patient caregiver survey. Adult and adolescent patients with AA, and the caregivers of adolescent AA patients (dyadic and non-dyadic caregivers), will be recruited to participate in the survey. The surveys will assess the psychosocial and life impacts and disease burden associated with AA. In order to increase sample size for the caregiver survey, caregivers will be allowed to participate in the survey even if their dependant adolescent with AA refuses or is unable to participate (ie, non-dyadic caregiver). Additional information about the adolescent with AA will be provided by the non-dyadic caregiver compared to the dyadic caregiver. The survey will use online screening questions to verify participants’ eligibility and invite potential participants to take part in the study. After consenting, data will be collected in the patient survey via a bespoke questionnaire on patient/caregiver characteristics (e.g., age, sex, socioeconomic status, race, and ethnicity), self-reported medical and treatment history, satisfaction with treatment, and validated instruments on disease severity and impact, psychosocial disorders, disease specific quality of life, and work and classroom productivity and impairment. IQVIA will collaborate with the Alopecia Areata Australia Foundation (AAAF) to recruit eligible patients with AA and caregivers, defined by inclusion and exclusion criteria below. The AAAF has nationally representative sample of AA patients and caregivers in their network. Participants will be invited to participate online via the AAAF’s closed Facebook page via post and via the AAAF newsletter distributed by email among AAAF registrants. until the sample size is met. AAAF was founded in 2010 with the purpose of improving the lives of people living with AA and their families in Australia. Recruitment is expected to last 8 weeks or until recruitment target is reached.
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Functional and self-reported outcomes of primary total knee arthroplasty in osteoarthritis comparing two variations of the B.Braun prosthesis used in standard care
In this study we are trying to find out whether 2 different types of knee joint prostheses have the same clinical and functional outcomes for patients 60 years or over at the time of surgery. Once patient and surgeon decide that the patient will undergo total knee replacement with a B.Braun knee replacement prosthesis; depending on the structural features of the joint, the patient may be receiving either a B.Braun Enduro if additional stability is required, or a B.Braun Columbus prosthesis. The purpose of this study is to compare the outcomes of these two variations of the B.Braun prosthesis when considering patient related factors and the complexity of surgery. This study will analyse outcomes, satisfaction, survival, complication, and revision rates of patients 60 years or over who receive the B.Braun Enduro hinged prosthesis, as compared to an age-matched standard care group who receive the B.Braun Columbus prosthesis. This study will collect data at baseline, day 3, day 14, 6 weeks, 6 months and 12 months post-operative. These devices are both used as standard care globally and are not experimental. All components of these devices can be found on the Australian Register of Therapeutic Goods (ARTG) under B.Braun Australia Pty Ltd EnduRo or Columbus.
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Deep oropharyngeal air pressure measurements in newborns on non-invasive respiratory support (AIRPREMO Study)
While continuous positive airway pressure (CPAP) and high flow nasal cannulae (HFNC) are commonly used for treatment of infants with respiratory distress, the optimum level of CPAP/HFNC remains somewhat uncertain. Due to leaks occurring at the nostrils, the mouth and into the stomach, not all of the pressure generated by CPAP/HFNC is transmitted to the airway. Real-time information of the patient’s pharyngeal pressure could provide clinicians with important information. The proposed research is a proof-of-concept observational study to measure the pharyngeal pressure in a convenience sample of 50 infants receiving CPAP/HFNC for the purpose of developing a novel airway pressure monitoring device. TGA-approved dual lumen gastric tubes will be modified to allow for airway pressure measurements in the deep oropharynx using a new airway pressure device (under development). The modified gastric tube will be inserted nasally or orally, similar to regular gastric tubes, and pressures recorded over a one-hour period .