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Exercise-based interventions are well-established in reducing falls and fall-related injuries, but adherence and accessibility remain key challenges, particularly in rural areas. While conventional in-person training is widely used, digital interventions may offer scalable solutions to enhance engagement and reach. However, pragmatic trials evaluating the real-world effectiveness of conventional and digitally supported fall prevention interventions are lacking, limiting the evidence base for their implementation in routine healthcare settings. The SURE-Footed into the Future Fall Intervention Trial (SURE-FIT) aims to compare the effectiveness of two structured fall prevention interventions—a conventional centre-based exercise programme and a hybrid telemedical programme combining in-person and tablet-supported training—against a wait-list control group in reducing falls and fall-related injuries among community-dwelling older adults.
This study is a pragmatic three-arm, parallel-group, randomised controlled superiority trial with a 1:1:1 allocation ratio. Participants (≥65 years, community-dwelling, planned n=2778) will be randomly assigned to (1) conventional centre-based training supplemented with printed materials for home-based continuation (conventional group), (2) a hybrid model integrating centre-based and tablet-supported training for continuation (tablet group) or (3) a wait-list control group. The intervention includes a 9-week supervised phase followed by 43 weeks of independent home-based training. The primary outcomes are the incidence rate of falls and fall-related injuries over 12 months. Secondary outcomes include physical functioning, physical activity, concerns about falling, loneliness and the risk of low protein intake. A process evaluation will assess intervention feasibility and implementation. Additionally, qualitative interviews will be conducted with participants, course instructors and municipal stakeholders to explore experiences, facilitators and challenges related to programme participation and implementation. A health-economic evaluation will be conducted to assess the cost-effectiveness of the structured fall prevention interventions. Data collection will take place at baseline and every 3 months via standardised questionnaires, with a subgroup undergoing physical performance testing and sensor-based activity monitoring. Analyses will follow an intention-to-treat approach.
Ethical approval has been granted by the Ethics Committee of Ulm University (271/23). Written informed consent will be obtained from all participants before enrolment. Study findings will be disseminated through peer-reviewed publications, scientific conferences and national fall prevention initiatives. Additionally, results will be shared with key municipal representatives, and the German National Association of Senior Citizens’ Organisations (BAGSO). A publicly accessible website will provide ongoing access to study information and findings in plain language.
DRKS00032878, German Clinical Trials Register
Patients with chronic somatic diseases such as obesity often develop comorbid depressive symptoms. E-mental health interventions are an innovative and effective treatment option within a stepped care approach. Studies have shown that acceptance and adherence are higher when they are tailored to the specific needs of the target group. This study protocol describes a randomised controlled trial (RCT) of an internet-based self-help intervention, Fit4Mood, to improve mental health in the high-risk group of adults with obesity. The objective of the @ktivPLUS research project is to evaluate the effectiveness, acceptability and cost-effectiveness of the intervention in comparison to an online bibliotherapy.
Eligible individuals will be randomly allocated to an intervention group (access to an internet-based intervention) or to an active control group (access to an online bibliotherapy). Assessments will be conducted before the start of the intervention (baseline (BL)) and 4 months after BL (follow-up (FU)). The primary outcome is the reduction in depressive symptoms (Beck Depression Inventory-II) in n=190 participants. Secondary outcomes are anxiety, quality of life, activity, self-efficacy, resilience, mental and digital health literacy, stress, sleep quality, weight loss, weight management activities and readiness to lose weight, weight self-stigma, uptake, adherence and satisfaction with the intervention, workability and cost-effectiveness at follow-up. Additionally, sociodemographics, health, comorbidities and disabilities, as well as internet-specific information, will be assessed at BL. Intention-to-treat analysis using generalised linear mixed models will be applied.
Approval for this study has been granted by the ethics committee of the University of Leipzig (ID: 140/25-ek). All participants will provide informed consent prior to participation in the study. Results will be disseminated in peer-reviewed journals and presented at national and international conferences. In the case of a successful evaluation, the internet-based self-help intervention Fit4Mood will be provided as freeware, which will be easily accessible and free of charge.
The current RCT study has been registered at the German Clinical Trials Register (Identifier: DRKS00036178, Registered 24 June 2025; https://www.drks.de/search/de/trial/DRKS00036178).
We will recruit 478 paediatric patients with newly diagnosed IgAV across multiple centres. Participants will undergo prospective longitudinal assessment at disease onset and at 1, 3, 6 and 12 months postdiagnosis. Standardised evaluations will include clinical manifestations, physical examinations, laboratory parameters and patient-reported outcomes. The data will be analysed statistically with SPSS software (V.27.0), adopting a significance threshold of p
This study has been approved by the Medical Ethics Committee of the First Affiliated Hospital of Guangxi Medical University (2024-K0480), the Ethics Committee of the First People’s Hospital of Yulin (YLSY-IRB-SR-2025060), the Medical Research Ethics Committee of the Liuzhou Workers’ Hospital (KY2024356) and the Ethics Committee of the Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region (No. (2025–1)003) and written informed consent was obtained from all the parents or guardians of the patients involved. It will be disseminated by publication of peer-reviewed manuscripts and presentation in abstract form at national and international scientific meetings.
ChiCTR2500099716.
Blue light (peak wavelength 442 nm) has been shown to modulate the immune response in preclinical models of intra-abdominal sepsis and pneumonia. In vivo pathways involve optic nerve stimulation with transmission to the central nervous system, activation of parasympathetic pathways terminating at the spleen, and downstream immune effects including decreased inflammatory tissue damage and improved pathogen clearance. Related effects on pain mediators including proinflammatory cytokines (interleukin 6, TNF- α) and autonomic tone (increased parasympathetic outflow) suggest possible analgesic properties that would be highly relevant to a trauma population.
This is a randomised controlled trial in which adult trauma inpatients (
Full ethical approval for this trial has been granted by the University of Pittsburgh Institutional Review Board. On study completion, results will be published in the peer-reviewed literature and at ClinicalTrials.gov.
FreshRSS 