Trials最新文献

{"title":"Cooperation across healthcare service levels for medication reviews in older people with polypharmacy admitted to a municipal in-patient acute care unit (The COOP II Study): study protocol for a randomized controlled trial","authors":"Leonor Roa Santervas, Torgeir Bruun Wyller, Eva Skovlund, Janicke Liaaen Jensen, Katrine Gahre Fjeld, Lene Hystad Hove, Ingrid Beate Ringstad, Lena Bugge Nordberg, Kristin Mæland Mellingen, Espen Saxhaug Kristoffersen, Rita Romskaug","doi":"10.1186/s13063-024-08442-w","DOIUrl":"https://doi.org/10.1186/s13063-024-08442-w","url":null,"abstract":"Polypharmacy and inappropriate drug use are associated with adverse health outcomes in older people. Collaborative interventions between geriatricians and general practitioners have demonstrated effectiveness in improving clinical outcomes for complex medication regimens in home-dwelling patients. Since 2012, Norwegian municipalities have established municipal in-patient acute care (MipAC) units, designed to contribute towards reducing the number of hospital admissions. These units predominantly serve older people who typically benefit from multidisciplinary approaches. The primary objective of this study is to evaluate the effect of cooperative medication reviews conducted by MipAC physicians, supervised by geriatricians, and in collaboration with general practitioners, on health-related quality of life and clinical outcomes in MipAC patients ≥ 70 years with polypharmacy. Additionally, the study aims to assess the carbon footprint of the intervention. This is a randomized, single-blind, controlled superiority trial with 16 weeks follow-up. Participants will be randomly assigned to either the control group, receiving usual care at the MipAC unit, or to the intervention group which in addition receive clinical medication reviews that go beyond what is considered usual care. The medication reviews will evaluate medication appropriateness using a structured but individualized framework, and the physicians will receive supervision from geriatricians. Following the clinical medication reviews, the MipAC physicians will arrange telephone meetings with the participants’ general practitioners to combine their assessments in a joint medication review. The primary outcome is health-related quality of life as measured by the 15D instrument. Secondary outcomes include physical and cognitive functioning, oral health, falls, admissions to healthcare facilities, and mortality. This study aims to identify potential clinical benefits of collaborative, clinical medication reviews within community-level MipAC units for older patients with polypharmacy. The results may offer valuable insights into optimizing patient care in comparable municipal healthcare settings. The study was registered prospectively on ClinicalTrials.gov 30.08.2023 with identifier NCT06020391.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142187941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of the Better Research Interactions for Every Family (BRIEF) intervention to support recruitment for neonatal clinical trials: an intervention mapping guided approach","authors":"Elliott Mark Weiss, Megan M. Gray, Linda K. Ko, Devan M. Duenas, Ellie Oslin, Stephanie A. Kraft","doi":"10.1186/s13063-024-08446-6","DOIUrl":"https://doi.org/10.1186/s13063-024-08446-6","url":null,"abstract":"Recruitment for neonatal clinical trials can be particularly challenging. Low enrollment rates bias the research population and decrease generalizability of findings. We identified a critical need for an intervention to improve how researchers recruit for neonatal clinical trials. Working within the US neonatal research context, we developed the Better Research Interactions for Every Family (BRIEF) Intervention, which had two overarching goals: to improve the recruitment experience for all parents, focusing on minoritized populations, and to increase participation, focusing on decreasing disparities in research participation. We used intervention mapping (IM) to guide all steps of intervention development. IM is a planning framework that provides a systematic process and detailed protocol for step-by-step decision-making for intervention development, implementation, and evaluation. We performed IM’s six steps. In step 1, we convened two stakeholder groups, a parent panel and an expert panel, who provided guidance through development of all BRIEF components. Through a recent systematic review, empirical data collected by our team, and consultations with the panels, we identified key determinants (barriers and facilitators) of low enrollment rates and research team members as change agents. In step 2, we iteratively refined our list of key factors to include and linked determinants of behavior changes to these performance objectives. In step 3, we chose three theories (social cognitive theory, theory of information processing, and the trans-theoretical model), methods from identified practical applications suitable for the population (research team members) and the context (busy research NICU teams). In step 4, we developed and refined the intervention components, including self-guided pre-work and a single in-person session. In step 5, we identified the Darbepoetin plus slow-release intravenous iron trial as our partner study in which to pilot BRIEF. In step 6, we developed a multi-stage evaluation plan that included five distinct levels of outcomes. This manuscript shares our rationale and processes for the creation of a research team member-facing intervention aiming to improve recruitment processes for neonatal clinical trials. Our approach can inform those aiming to improve recruitment for neonatal clinical trials and those who may be considering use of IM within similar contexts.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142187968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reducing pain by improving brain and muscle activity with motor cortical neuromodulation in women with interstitial cystitis/bladder pain syndrome: a study protocol for a randomized controlled trial","authors":"Eileen V. Johnson, Molly Bachmann, Moheb S. Yani, Sandrah P. Eckel, Giselle I. Garcia, Larissa V. Rodriguez, Jason J. Kutch","doi":"10.1186/s13063-024-08450-w","DOIUrl":"https://doi.org/10.1186/s13063-024-08450-w","url":null,"abstract":"Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain condition creating a wide range of urologic and pain symptoms. There is currently limited evidence to understand the mechanisms of IC/BPS. There have been recent studies suggesting that altered function in brain motor areas, particularly the supplementary motor cortex (SMA), relates to altered bladder sensorimotor control and may play an important role in IC/BPS. This study aims to provide evidence that non-invasive stimulation targeting the motor cortex may help reduce IC/BPS pain, as well as better understand the neural mechanism by which this stimulation targets neuromuscular dysfunction. This study is a two-group quadruple-blinded randomized controlled trial (RCT) of active vs. sham repetitive transmagnetic stimulation (rTMS). In addition, our study will also include functional magnetic resonance imaging (fMRI), pelvic floor electromyography (EMG), pelvic exam, and outcome measures and questionnaires to further study outcomes. All aspects of the study were approved by the Institutional Review Board of the University of Southern California (protocol HS-20–01021). All participants provided informed consent by the research coordinator/assistants. The results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. ClinicalTrials.gov NCT04734847. Registered on February 1, 2021.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142187969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design considerations for Factorial Adaptive Multi-Arm Multi-Stage (FAST) clinical trials","authors":"Jonathan Beall, Jordan Elm, Matthew W. Semler, Li Wang, Todd Rice, Hooman Kamel, William Mack, Akshitkumar M. Mistry","doi":"10.1186/s13063-024-08400-6","DOIUrl":"https://doi.org/10.1186/s13063-024-08400-6","url":null,"abstract":"Multi-Arm, Multi-Stage (MAMS) clinical trial designs allow for multiple therapies to be compared across a spectrum of clinical trial phases. MAMS designs fall under several overarching design groups, including adaptive designs (AD) and multi-arm (MA) designs. Factorial clinical trials designs represent a combination of factorial and MAMS trial designs and can provide increased efficiency relative to fixed, traditional designs. We explore design choices associated with Factorial Adaptive Multi-Arm Multi-Stage (FAST) designs, which represent the combination of factorial and MAMS designs. Simulation studies were conducted to assess the impact of the type of analyses, the timing of analyses, and the effect size observed across multiple outcomes on trial operating characteristics for a FAST design. Given multiple outcomes types assessed within the hypothetical trial, the primary analysis approach for each assessment varied depending on data type. The simulation studies demonstrate that the proposed class of FAST trial designs can offer a framework to potentially provide improvements relative to other trial designs, such as a MAMS or factorial trial. Further, we note that the design implementation decisions, such as the timing and type of analyses conducted throughout trial, can have a great impact on trial operating characteristics. Motivated by a trial currently under design, our work shows that the FAST category of trial can potentially offer benefits similar to both MAMS and factorial designs; however, the chosen design aspects which can be included in a FAST trial need to be thoroughly explored during the planning phase.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142187971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"MultiSCRIPT-Cycle 1—a pragmatic trial embedded within the Swiss Multiple Sclerosis Cohort (SMSC) on neurofilament light chain monitoring to inform personalized treatment decisions in multiple sclerosis: a study protocol for a randomized clinical trial","authors":"Perrine Janiaud, Chiara Zecca, Anke Salmen, Pascal Benkert, Sabine Schädelin, Annette Orleth, Lilian Demuth, Aleksandra Maleska Maceski, Cristina Granziera, Johanna Oechtering, David Leppert, Tobias Derfuss, Lutz Achtnichts, Oliver Findling, Patrick Roth, Patrice Lalive, Marjolaine Uginet, Stefanie Müller, Caroline Pot, Robert Hoepner, Giulio Disanto, Claudio Gobbi, Leila Rooshenas, Matthias Schwenkglenks, Mark J. Lambiris, Ludwig Kappos, Jens Kuhle, Özgür Yaldizli, Lars G. Hemkens","doi":"10.1186/s13063-024-08454-6","DOIUrl":"https://doi.org/10.1186/s13063-024-08454-6","url":null,"abstract":"Treatment decisions for persons with relapsing–remitting multiple sclerosis (RRMS) rely on clinical and radiological disease activity, the benefit-harm profile of drug therapy, and preferences of patients and physicians. However, there is limited evidence to support evidence-based personalized decision-making on how to adapt disease-modifying therapy treatments targeting no evidence of disease activity, while achieving better patient-relevant outcomes, fewer adverse events, and improved care. Serum neurofilament light chain (sNfL) is a sensitive measure of disease activity that captures and prognosticates disease worsening in RRMS. sNfL might therefore be instrumental for a patient-tailored treatment adaptation. We aim to assess whether 6-monthly sNfL monitoring in addition to usual care improves patient-relevant outcomes compared to usual care alone. Pragmatic multicenter, 1:1 randomized, platform trial embedded in the Swiss Multiple Sclerosis Cohort (SMSC). All patients with RRMS in the SMSC for ≥ 1 year are eligible. We plan to include 915 patients with RRMS, randomly allocated to two groups with different care strategies, one of them new (group A) and one of them usual care (group B). In group A, 6-monthly monitoring of sNfL will together with information on relapses, disability, and magnetic resonance imaging (MRI) inform personalized treatment decisions (e.g., escalation or de-escalation) supported by pre-specified algorithms. In group B, patients will receive usual care with their usual 6- or 12-monthly visits. Two primary outcomes will be used: (1) evidence of disease activity (EDA3: occurrence of relapses, disability worsening, or MRI activity) and (2) quality of life (MQoL-54) using 24-month follow-up. The new treatment strategy with sNfL will be considered superior to usual care if either more patients have no EDA3, or their health-related quality of life increases. Data collection will be embedded within the SMSC using established trial-level quality procedures. MultiSCRIPT aims to be a platform where research and care are optimally combined to generate evidence to inform personalized decision-making in usual care. This approach aims to foster better personalized treatment and care strategies, at low cost and with rapid translation to clinical practice. ClinicalTrials.gov NCT06095271. Registered on October 23, 2023","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142187972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mothers and Babies Virtual Group (MBVG) for perinatal Latina women: study protocol for a hybrid type-1 effectiveness-implementation randomized controlled trial","authors":"Rheanna Platt, Sarah Polk, Alinne Z. Barrera, Sandraluz Lara-Cinisomo, Lisa R. Hirschhorn, Andrea K. Graham, Rashelle J. Musci, Jaime Hamil, Diane Echavarria, Lindsay Cooper, S. Darius Tandon","doi":"10.1186/s13063-024-08423-z","DOIUrl":"https://doi.org/10.1186/s13063-024-08423-z","url":null,"abstract":"Immigrant Latinas (who are foreign-born but now reside in the USA) are at greater risk for developing postpartum depression than the general perinatal population, but many face barriers to treatment. To address these barriers, we adapted the Mothers and Babies Course—an evidence-based intervention for postpartum depression prevention—to a virtual group format. Additional adaptations are inclusion of tailored supplemental child health content and nutrition benefit assistance. We are partnering with Early Learning Centers (ELC) across the state of Maryland to deliver and test the adapted intervention. The design is a Hybrid Type I Effectiveness-Implementation Trial. A total of 300 participants will be individually randomized to immediate (N = 150) versus delayed (N = 150) receipt of the intervention, Mothers and Babies Virtual Group (MB-VG). The intervention will be delivered by trained Early Learning Center staff. The primary outcomes are depressive symptoms (measured via the Center for Epidemiologic Studies-Depression Scale), parenting self-efficacy (measured via the Parental Cognition and Conduct Towards the Infant Scale (PACOTIS) Parenting Self-Efficacy subscale), and parenting responsiveness (measured via the Maternal Infant Responsiveness Instrument) at 1-week, 3-month, and 6-month post-intervention. Depressive episodes (Structured Clinical Interview for DSM-V- Disorders Research Version) at 3-month and 6-month post-intervention will also be assessed. Secondary outcomes include social support, mood management, anxiety symptoms, perceived stress, food insecurity, and mental health stigma at 1-week, 3-month, and 6-month post-intervention. Exploratory child outcomes are dysregulation and school readiness at 6-month post-intervention. Intervention fidelity, feasibility, acceptability, and appropriateness will also be assessed guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. This study will be one of the first to test the efficacy of a group-based virtual perinatal depression intervention with Latina immigrants, for whom stark disparities exist in access to health services. The hybrid effectiveness-implementation design will allow rigorous examination of barriers and facilitators to delivery of the intervention package (including supplemental components) which will provide important information on factors influencing intervention effectiveness and the scalability of intervention components in Early Learning Centers and other child-serving settings. ClinicalTrials.gov NCT05873569.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142187973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide","authors":"Rayan Taher, Charlotte L. Hall, Aislinn D Gomez Bergin, Neha Gupta, Clare Heaysman, Pamela Jacobsen, Thomas Kabir, Nayan Kalnad, Jeroen Keppens, Che-Wei Hsu, Philip McGuire, Emmanuelle Peters, Sukhi Shergill, Daniel Stahl, Ben Wensley Stock, Jenny Yiend","doi":"10.1186/s13063-024-08421-1","DOIUrl":"https://doi.org/10.1186/s13063-024-08421-1","url":null,"abstract":"The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slowed by several challenges, including a lack of knowledge from researchers regarding how to navigate the pathway for mandatory regulatory approval. This paper details the steps that a team must take to achieve the required approvals to carry out a research study using a novel digital mental health intervention. We used a randomised controlled trial of a digital mental health intervention called STOP (Successful Treatment of Paranoia) as a worked example. The methods section explains the two main objectives that are required to achieve regulatory approval (MHRA Notification of No Objection) and the detailed steps involved within each, as carried out for the STOP trial. First, the existing safety of digital mental health interventions must be demonstrated. This can refer to literature reviews, any feasibility/pilot safety data, and requires a risk management plan. Second, a detailed plan to further evaluate the safety of the digital mental health intervention is needed. As part of this we describe the STOP study’s development of a framework for categorising adverse events and based on this framework, a tool to collect adverse event data. We present literature review results, safety-related feasibility study findings and the full risk management plan for STOP, which addressed 26 possible hazards, and included the 6-point scales developed to quantify the probability and severity of typical risks involved when a psychiatric population receives a digital intervention without the direct support of a therapist. We also present an Adverse Event Category Framework for Digital Therapeutic Devices and the Adverse Events Checklist—which assesses 15 different categories of adverse events—that was constructed from this and used in the STOP trial. The example shared in this paper serves as a guide for academics and professionals working in the field of digital mental health. It provides insights into the safety assessment requirements of regulatory bodies when a clinical investigation of a digital mental health intervention is proposed. Methods, scales and tools that could easily be adapted for use in other similar research are presented, with the expectation that these will assist other researchers in the field seeking regulatory approval for digital mental health products.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142188001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effectiveness of Bio-Min toothpaste in the management of white spot lesions: a randomised control trial","authors":"Ama Johal, Aoife Keogh, Honieh Bolooki","doi":"10.1186/s13063-024-07990-5","DOIUrl":"https://doi.org/10.1186/s13063-024-07990-5","url":null,"abstract":"White spot lesions (WSL) are common side effects of orthodontic treatment with fixed appliances, in which the surface layer of enamel is demineralised. Thus, remineralisation, that is a partial or complete reversal, of these lesions can occur as they affect the surface enamel. Remineralisation with low-dose fluoride, in addition to optimal oral hygiene and diet, has been recommended to manage WSL. The aim of the planned trial is to assess the effectiveness of a fluoride-containing bioactive glass toothpaste (BioMin™) in its ability to remineralise post-orthodontic demineralised WSL. A single-centre, double-blind randomised clinical trial to assess intervention with Bio-Min toothpaste on WSL forming on the teeth of young people completing orthodontic treatment. Remineralisation of WSL can vary depending on the individual and the site of the lesion. There is a range of oral fluoride delivery methods which include toothpastes, oral rinses, and gel preparations, which can aid remineralisation of these lesions. Identifying effective methods of remineralisation to manage this common and unsightly complication of fixed appliance therapy can improve the health and aesthetics of dentition. ISRCTN.com International Standard Randomised Controlled Trials Number (ISRCTN) 14479893 . Registered on 14 May 2020","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142187974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"SAME day amBulatory c (SAMBA): a multicenter, prospective, randomized clinical trial protocol","authors":"Catherine Arvieux, Fatah Tidadini, Sandrine Barbois, Eric Fontas, Michel Carles, Victor Gridel, Jean-Christophe Orban, Jean-Louis Quesada, Alison Foote, Coralie Cruzel, Sabine Anthony, Julie Bulsei, Céline Hivelin, Damien Massalou","doi":"10.1186/s13063-024-08336-x","DOIUrl":"https://doi.org/10.1186/s13063-024-08336-x","url":null,"abstract":"A recent meta-analysis concluded that outpatient appendectomy appears feasible and safe, but there is a lack of high-quality evidence and a randomized trial is needed. The aim of this trial is to demonstrate that outpatient appendectomy is non-inferior to conventional inpatient appendectomy in terms of overall morbi-mortality on the 30th postoperative day (D30). SAMBA is a prospective, randomized, controlled, multicenter non-inferiority trial. We will include 1400 patients admitted to 15 French hospitals between January 2023 and June 2025. Inclusion criteria are patients aged between 15 and 74 years presenting acute uncomplicated appendicitis suitable to be operated by laparoscopy. Patients will be randomized to receive outpatient care (day-surgery) or conventional inpatient care with overnight hospitalization in the surgery department. The primary outcome is postoperative morbi-mortality at D30. Secondary outcomes include time from diagnosis to appendectomy, length of total hospital stay, re-hospitalization, interventional radiology, re-interventions until D30, conversion from outpatient to inpatient, and quality of life and patient satisfaction using validated questionnaires. The SAMBA trial tests the hypothesis that outpatient surgery (i.e., without an overnight hospital stay) of uncomplicated acute appendicitis is a feasible and reliable procedure in establishments with a technical platform able to support this management strategy. ClinicalTrials.gov NCT05691348. Registered on 20 January 2023.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142188002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The influence of different intensity of Tan Tui exercises on the posture control of students in the Tai Chi Elective Course: protocol for a randomized controlled trial.","authors":"Youhua Li, Zemin Yu, Huaixu Li, Shanyuan Ma, Wenjing Zhang","doi":"10.1186/s13063-024-08447-5","DOIUrl":"10.1186/s13063-024-08447-5","url":null,"abstract":"<p><strong>Background: </strong>Tai Chi (TC) holds a unique and valued place in promoting the physical and mental health of college students. Its significance is underscored by its incorporation as a compulsory physical education course in every university in China. TC, with its rich tradition, places a strong emphasis on posture control as a core sports ability. However, the students in Tai Chi Elective Course (TCEC) have very poor posture control ability. This study protocol investigates the potential of Tan Tui (TT) to address these issues, as TT is a fundamental skill for beginners of traditional Chinese martial arts and has a track record of enhancing lower limb strength and balance, making it a promising choice for improving posture control in TCEC.</p><p><strong>Methods/design: </strong>To investigate the impact of different intensities of TT exercises on posture control in TCEC students, we have designed a randomized, double-blind, parallel-controlled trial. Seventy-six students in the TCEC will be randomly divided into low-intensity Tan Tui (LTT), medium-intensity Tan Tui (MTT), and high-intensity Tan Tui exercises group (HTT) and control group (CON), each with 19 people. The LTT group, MTT group, and HTT group will be given different intensity of TT exercises, and the CON group will be given regular TCEC. The intervention period will be 6 weeks (2 times a week, 20 min each time). At baseline (before), 4 weeks of intervention (middle), and 6 weeks of intervention (after), the Unipedal Stance Test (UST), the Star Excursion Balance Test (SEBT), 60°/s angular velocity knee joint flexion and extension relative peak torque (RPT), and knee joint position perception (KJPP) will be evaluated.</p><p><strong>Discussion: </strong>This is the first randomized controlled trial protocol from the perspective of training intensity to evaluate the effect of different intensity of TT exercises on posture control of students in TCEC. Should our research reveal a significant intervention effect, the results will offer preliminary, higher-quality evidence supporting the positive impact of varying intensities of Tan Tui exercises on posture control in TCEC students.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2000039109. Registered on October 17, 2020.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11382370/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}