ANZCTR search results

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

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30806 results sorted by trial registration date.
  • Effectiveness and acceptability of a swimming and education program for low back pain

    This project aims to compare the effect of a swimming and education program compared to education only control. Adults in Australia will be eligible to participate in the program if they have chronic low back pain, are able to demonstrate water competency and are willing to complete an 8-week program. The participants who are allocated to the swimming and education program will receive an individualized swimming program and access to a local swimming pool over 8 weeks. The swimming program will be delivered and adjusted 4 sessions with a physiotherapist, delivered over telehealth. The primary outcome is function related to low back pain, measured at 8 weeks. Participants allocated to the education only group will be provided with a brief education session, with an optional second session, and compensated for their time to complete surveys using e-gift vouchers.

  • Feasibility of prebiotic fibre supplementation during allogeneic stem cell transplantation

    This pilot study is evaluating the feasibility of providing an oral plus enteral prebiotic fibre supplementation and assess tolerance and whether this can improve the microbiome and reduce complications in patients receiving an allogeneic stem cell transplant Who is it for? You may be eligible to join this study if you are aged 18 years and older undergoing allogeneic myeloablative or reduced intensity myeloablative allogeneic stem cell transplantation at the Royal Brisbane and Women’s Hospital (RBWH). Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to the intervention group or the control group. Participants allocated to the intervention will receive an oral prebiotic fibre supplement from a week prior to the start of conditioning therapy and continue it until a month post stem cell transplant (SCT) and prebiotic enteral nutrition (EN) starting day one post SCT until required. The control group will receive a non-fibre EN formula from day one post SCT as per usual care. Participants will then be followed-up and assessed weekly for 4 weeks post SCT to determine feasibility and effectiveness of an oral plus enteral prebiotic fibre supplementation in patients receiving an allogeneic stem cell transplant. It is hoped that this research will support the microbiome and improve health outcomes for participants undergoing allogeneic SCT.

  • Targeting engagement in resistance training in the community using outdoor gyms: A study protocol for 'scaling-up' the ecofit intervention

    ecofit is a multi-component mHealth intervention aimed at increasing resistance and aerobic physical activity using the outdoor built environment (i.e., outdoor gyms) and social support. We have previously demonstrated the efficacy and effectiveness of the ecofit program in insufficiently active people with (or at risk of) type 2 diabetes and community-dwelling adults, respectively. The objective of this trial is to compare the effects of two implementation support models (i.e., ‘Low’ versus ‘Moderate’) on the reach (primary outcome), uptake, dose received, impact and fidelity of the ecofit program. We hypothesis that there will be more people using the outdoor gym equipment to workout in the outdoor gym locations that received the moderate support package.

  • Targeted care for chronic plantar heel pain: Shockwave therapy for bone marrow lesions (the BALSA trial)

    Up to 50% of people with chronic plantar heel pain have a bone marrow lesion (BML) in the calcaneus. Calcaneal bone marrow lesions are high signal lesions on MRI that are associated with having chronic plantar heel pain and with poorer longer-term pain and function outcomes. Shockwave therapy is an approved therapeutic device in Australia for treating musculoskeletal pain, including plantar heel pain. It emits high levels of acoustic energy that has been shown to improve pain and shrink bone marrow lesions at other body sites, but it has never been tested for its effect on pain in people with a bone marrow lesion sub-type of chronic plantar heel pain. The primary aim of this study therefore is to determine whether shockwave therapy is effective at improving pain in a BML-positive subgroup of participants with chronic plantar heel pain. Ninety participants will be randomly allocated to either an active or sham shockwave group (45 per arm), each receiving one treatment per week over three weeks. Pain will be assessed by validated questionnaire at baseline, 4- and 12-months to determine if shockwave is effective at reducing pain. Secondary measures for physical function and quality of life will be assessed at baseline, 4- and 12-months and perception of global rating of change assessed at 4- and 12-months. As an exploratory analysis BML size will be measured by MRI at baseline and 4-months to determine if change in BML is associated with change in pain.

  • The effectiveness of a dietary challenge for improving dietary intake in Australian adults.

    The current project involves developing a behaviour change readiness index for predicting health behaviour change in the domain of dietary interventions. This work is heavily evidence-based with the unique conceptualisation that health-related behaviours are the result of an individual’s response to internal cues (e.g., implicit and explicit attitudes, motivation), external environmental cues (e.g., social and physical stimuli) as well as regulating factors such as habit. Previous stage-based health models exist, of which Stages of Change is the most popularised. However, understanding stage of change alone is insufficient given the complex array of attitudinal, experiential, and psychological factors that could underlie an individual’s actual readiness to engage in, and complete a health behaviour. The aim of this study is to further refine and validate a CSIRO behaviour change readiness index (C-BCRI). This will be done by assessing the tool’s utility to predict successful short-term behaviour change in the dietary domain (i.e., reduction in consumption of sweet snacks) but also to better understand the associations and strengths of relevant factors in order to refine this tool into a succinct survey.

  • Exploring how the human body responds to extreme heat as a result of climate change

    Climatologists currently estimate that the environmental threshold for human heat tolerance is 6 hours at a wet-bulb temperature (Twet) of 35 °C. When accounting for human physiological thermoregulatory variables such as metabolic heat production and sweating capacity, however, it is likely that this threshold is severely underestimated. Contrary to the assumptions made by the 35 °C Twet model, in real-world scenarios, people expend anywhere between 1.5 to 5.0 METs to perform activities of daily living, and the ability to cool down through sweating is limited in certain conditions. Specifically, in very humid environments, evaporative capacity is limited by a low vapour pressure gradient between the air and skin; whereas in very dry environments, it is limited by the ability of the body to produce sweat. This is an important distinction because the same Twet can be represented by different combinations of air temperature and relative humidity, which means that the limiting factor to achieving heat balance will be different depending on the environmental conditions being experienced. It is more than likely that the limits to human heat tolerance are not represented by a universal Twet temperature threshold, but rather differ based on the type of heat stress an individual is exposed to (i.e., humid vs. dry). This theory has only ever been modelled and has never been tested in human subjects which is imperative to moving this area of research forward.

  • Recommendations on Hospital Falls Prevention and Management

    The primary purpose of the study is to seek expert advice on the best methods to prevent and manage hospital falls. Using the Delphi technique, We will conduct a series of questionnaires and an online meeting with health professionals until consensus is reached on how best to mitigate and manage falls and associated injuries in hospital settings.

  • The Lumir Mission Medicinal Cannabis for Primary Dysmenorrhoea Study

    This study will determine if there are any changes in period pain, and other symptoms of primary dysmenorrhea as well as looking at the rate of adverse events after using medicinal cannabis. Changes in inflammatory markers in menstrual blood will also be tracked. This study will provide data for future clinical trials if potential benefits are found.

  • Do artificially intelligent chatbots work to increase physical activity?

    Physical inactivity is a leading modifiable cause of death and disease, but less than half of Australian adults are meeting the National Physical Activity Guidelines. Therefore, developing and evaluating new strategies to support people in becoming more active is important. The use of digital assistants is becoming increasingly common and a digital assistant powered by artificial intelligence could potentially offer a cost-effective, scalable solution physical activity program. Therefore, the aim of this study is to conduct a randomised controlled trial to examine the effectiveness of a machine learning and app-based digital assistant to increase physical activity. We hypothesise that participants receiving the intervention will significantly increase their moderate to vigorous physical activity at 3- and 6-month follow-up time-points compared to participants allocated to a no intervention control group.

  • Evaluating the role of Immersive Virtual Reality mindfulness in mitigating acute exercise-induced pain following exercise in chronic low back pain: a feasibility randomized controlled trial

    Management of chronic low back pain is challenging, and current best evidence recommends incorporating physiotherapeutic exercise training. Despite this, physical exercise can lead to flare up in pain immediately following exercise and over the subsequent days in individuals with chronic pain. Virtual reality (VR) is a novel emerging technology that is increasingly being used in pain rehabilitation with demonstrated effectiveness in decreasing pain. One application of VR that has received relatively little attention to date in the management of chronic pain is virtual reality mindfulness/meditation (VRM). VRM offers a novel approach to addressing chronic pain as it can create a calming and relaxing setting that facilitates practicing mindfulness skills, with demonstrated effects. This study investigates if VRM has a positive effect on reducing exacerbation of pain following exercise among individuals with chronic low back pain. We hypothesise that the VRM intervention will reduce immediate and laten pain levels compared to controls undertaking usual post-exercise management as well as the VRM is tolerated with minimal side effects and is feasible and acceptable.

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