ANZCTR search results

This Phase 1 trial is designed to assess the safety, reactogenicity, and immunogenicity of a single IM booster dose of PVX-001 across three ascending dose levels in previously vaccinated healthy adults, in a controlled clinical setting with staged sentinel dosing and an independent Safety Review Committee. This study will be conducted in healthy women aged 18 to 64 years and healthy men aged 30 to 64 years of age.

The Chronic Conditions Course for Young Adults (CCC-YA) is an internet-delivered psychological program adapted specifically for young adults aged 18 to 29 who are living with a chronic physical health condition. This course is a modified version of the Chronic Conditions Course, and is based on cognitive behaviour therapy (CBT) principles. It is designed to help young adults understand and manage symptoms and the impacts of their condition on daily functioning and emotional wellbeing. The course includes 5 lessons, delivered over 8 weeks. The lessons are all delivered via the internet, and provide information and skills for improving emotional wellbeing and daily functioning. Participants have the option of support from a psychologist throughout the course. The primary aim is to evaluate the efficacy of this online psychological program in improving symptoms of anxiety, depression, and disability when specifically adapted for young adults with chronic health conditions. We hypothesise that the program will result in significant improvements in anxiety, depression, and disability at the completion of treatment.

Brief description of the study purpose This study aims to investigate whether self-guided use of sensory massage balls is a feasible, safe and effective way to reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN), such as numbness, tingling, pain and weakness, and to improve quality of life for people affected by CIPN. Who is it for? You may be eligible for this study if you are male or female aged 18 years or older who are receiving chemotherapy or have completed chemotherapy within the previous month, are receiving care through Tweed Valley Hospital, and have symptoms consistent with chemotherapy-induced peripheral neuropathy. Study details Eligible participants will be randomly assigned to one of two groups. One group will receive a set of sensory massage balls and instructions for daily self-guided use at home for 8 weeks, while the other group will receive usual care in the form of publicly available physical activity guidance. After completing Week 8 assessments, participants in the usual care group will also receive the massage ball set if no intervention-related safety concerns are identified. Participants will attend study assessments at baseline, Week 8 and Week 16. During the intervention period, participants using the massage balls will record their usage and symptoms in a daily logbook and receive an initial face-to-face training session. Study assessments will evaluate neuropathy severity, quality of life, balance, strength and hand dexterity. It is hoped that the results of this pilot study will inform larger future clinical trials and contribute to the development of supportive care strategies for people experiencing chemotherapy-induced peripheral neuropathy.

Hip pain is common and can make it difficult for people to participate in physical activity and everyday activities. This study aims to determine whether a 12-week physiotherapist-led graded activity modification program is feasible for adults with hip-related pain. Participants will complete two face-to-face clinical assessments and participate in five individual physiotherapy consultations delivered via telehealth. The program will gradually modify and progress physical activity based on each participant's symptoms and goals. Throughout the study, participants will complete online questionnaires and provide information about their symptoms, physical activity, and study experience. The findings will determine whether a larger randomised controlled trial should be undertaken to evaluate the effectiveness of this intervention for people with hip-related pain.

Many people who have shoulder stabilisation surgery do not return to their previous level of sport or activity, and current rehabilitation programs may be overly conservative. This pilot randomised controlled trial compares two physiotherapy rehabilitation programs in adults aged 16–40 following arthroscopic Bankart repair surgery: a standard time-based program (the American Society of Shoulder and Elbow Therapists, or ASSET, guideline) and a new criterion-based program called RISE (Rehabilitation for Instability with Structured Elements), which progresses based on individual recovery milestones rather than fixed timeframes. Participants will be randomly assigned to one of the two programs and followed up for six months, with shoulder function, strength, range of motion, pain, and psychological readiness assessed by an independent assessor. We hypothesise that the RISE program will result in greater shoulder function at six months without compromising safety. The findings will assess the feasibility of a larger trial and inform the design of a future definitive randomised controlled trial comparing the two approaches.

The aim of this study is to test if Physta® can improve hormone profiles, body composition and muscular strength in middle-aged men. It is hypothesised Physta® will increase total testosterone (and associated hormones), muscular strength, fat free mass and decrease fat mass in middle-age men compared to men who use a placebo.

The main aim of this study is to find out whether starting a specialised pain relief treatment early,using a local anaesthetic delivered continuously through a small catheter near the nerves around the ribs,provides better pain control and improves recovery for people aged 65 years and older who have multiple rib fractures on one side of the chest. The study will compare these patients with a similar group who receive standard pain management using medications alone (such as tablets or injections), without any nerve-blocking procedures. The results will help identify the most effective way to manage pain in older patients with rib fractures. The goal is to reduce side effects from pain medications, improve recovery and overall health outcomes, and guide healthcare professionals in choosing the best pain management approach for this patient group.

This study will evaluate the effectiveness and cost-effectiveness of Partners in Parenting Plus – Education (PiP-Ed+), a clinician-supported online parenting intervention designed to support parents of adolescents experiencing emotionally based school avoidance. This study is a prospective, parallel-group, waitlist controlled, randomised controlled trial. Eligible participants are parents of adolescents (aged 12-15) experiencing emotionally based school avoidance. Participants will be randomly allocated to either the PiP-Ed+ intervention or a 7-month waitlist control condition. The intervention includes a web-based parenting program and structured clinician-delivered coaching sessions, both of which target modifiable parenting behaviours and parental self-efficacy, with the aim of improving adolescent school engagement and mental health outcomes. Outcomes will be measured via parent and adolescent online surveys at baseline and follow-ups. The primary outcomes are parental self-efficacy to respond to adolescent school refusal and adolescent school attendance. Secondary outcomes include adolescent anxiety and depression, adolescent self-efficacy for school situations, parental mental health, parent and adolescent quality of life, parent satisfaction with PiP-Ed+, and cost-effectiveness of the intervention.

This study aims to compare two 8-week resistance training programs to see which better improves daily activities, strength, and well-being in healthy older adults aged 60 to 85. Participants will be randomly assigned to one of two training groups. The first group will use Velocity-Based Training (VBT), a method that adjusts training loads based on real-time movement speed. The second group will follow traditional strength training guidelines recommended by the American College of Sports Medicine (ACSM). We hypothesise that the VBT method will be more effective in enhancing neuromuscular qualities and daily functioning compared to the traditional ACSM approach.

This RCT aims to evaluate the feasibility and acceptability of daily consumption of a multi-ingredient high-protein beverage combined with a resistance exercise intervention in inactive older adults. Muscle function indicators, dietary intake and quality of life are also outcomes of interest. Research questions: (1) Is an intervention of 250mL high-protein beverage daily + resistance exercise twice weekly for 12 weeks feasible to older adults? (2) Is an intervention of 250mL high-protein beverage + resistance exercise twice weekly for 12 weeks acceptable to older adults? (3) Does an intervention of 250mL of low-protein beverage + resistance exercise twice weekly for 12 weeks improve muscle function parameters in healthy, physically inactive older adults? (4) Does an intervention of 250mL of high-protein beverage + resistance exercise twice weekly for 12 weeks result in a greater improvement in muscle function parameters in healthy, physically inactive older adults, compared to a low-protein beverage + resistance exercise intervention?