ANZCTR search results

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.

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 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.

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.

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.

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.

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.

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.

This study is a multi-site parallel group cluster randomized trial delivering pain education and biopsychosocial care to students attending secondary schools. This school-based intervention aims to provide the opportunity for all adolescents to access accurate and evidence-based information about pain and pain management. This study is a three-arm parallel group cluster randomized trial, with economic evaluation. Participating schools will be randomly allocated to 1) pain education module and parent resources, 2) pain education module and parent resources, plus biopsychosocial care for students reporting problems with pain, or 3) no intervention.

Tonsillectomy is one of the most common childhood surgical procedures, however the postoperative recovery is often long and challenging for children and their families. This study aims to investigate if seven days of oral melatonin is able to improve sleep and pain management in children post-tonsillectomy, without increasing the risk of postoperative complications compared to placebo. We hypothesise that: (1) Melatonin will improve sleep following tonsillectomy; (2) melatonin will decrease post-operative pain and reduce breakthrough opioid requirement; and (3) melatonin will not increase the risk of post-operative complications.