Trials最新文献

{"title":"Multicentre, open-label, phase IV, randomised trial testing superiority of individualised targeted antibiotic prophylaxis over empiric prophylaxis at ureteral stent removal following cystectomy: study protocol for the REINFORCE trial.","authors":"Maja Vejlgaard, Hein Vincent Stroomberg, Mie Skjøttgaard Ynddal, Claus Moser, Ulla Nordström Joensen, Andreas Røder","doi":"10.1186/s13063-025-08981-w","DOIUrl":"https://doi.org/10.1186/s13063-025-08981-w","url":null,"abstract":"<p><strong>Background: </strong>In the first months after cystectomy, the most frequent cause of readmission is infection from the urinary tract. Nonetheless, current guidelines are unable to provide evidence-based recommendations on preventative measures and, as a result, antibiotic prophylaxis varies across surgical centres. Most centres in Denmark administer empiric antibiotic prophylaxis at ureteral stent removal after cystectomy, where infection rates peak. However, data indicates that the postoperative urinary microbiota is composed of a wide range of bacteria, suggesting that the patients may benefit from an individualised approach. This trial aims to test whether targeted postoperative antibiotic prophylaxis can reduce infection-related readmissions after cystectomy compared to the current empiric approach.</p><p><strong>Methods: </strong>We present a multicentre, open-label, superiority, randomised clinical trial using a group-sequential design. Participants will be randomly assigned with a 1:1 allocation ratio to receive one of two orally administered single-day antibiotic treatments on the day of ureteral stent removal: (a) standard-of-care pivmecillinam 400 mg morning, noon, and evening or (b) antibiotics targeted to the microbiota identified in a postoperative urine sample. The primary endpoint is the infection-related readmission rate after 90 postoperative days. Secondary endpoints include complication and readmission rates, days alive and out of hospital, quality of life, and microbiological isolates in the urine and blood and antimicrobial susceptibility analyses. A total of 248 patients are planned to be enrolled. The sample size is based on a hypothesised absolute risk reduction in the infection-related readmission rate from 29 to 14%, corresponding to a number needed to treat of six to reduce one hospital readmission. A group-sequential design is proposed to allow for early stopping at interim analysis after 50% enrolment based on predefined rules.</p><p><strong>Discussion: </strong>Responsible use of antibiotics is gaining increasing importance globally, and proper prophylactic strategies amongst high-risk patients are essential to avoid hospital admissions with administration of broad-spectrum agents. In this protocol, we present the first randomised clinical trial testing whether individualised targeted antibiotics can reduce the risk of infections after cystectomy. Results of the trial may improve recovery for this vulnerable patient group, while also potentially improving antibiotic stewardship.</p><p><strong>Trial registration: </strong>EU trial number 2024-514312-27-00. Registered on December 10, 2024.</p><p><strong>Clinicaltrials: </strong>gov NCT06709196. Registered on November 27, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"258"},"PeriodicalIF":2.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733472","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":"ENHANCE-D: protocol for a pragmatic, 3-arm, randomised controlled trial comparing the impact of enhanced smoking cessation interventions to very brief advice for adult smokers in dental care settings.","authors":"Richard Holliday, Nina Wilson, Vicky Ryan, Chrissie Butcher, Tara Homer, Philippa Watts, Dorcas Kareithi, Paul Blaylock, Laura Ternent, Roland Finch, Susan M Bissett, Adam Todd, Helen Hancock, Fiona Ellwood, David I Conway, Nicholas S Jakubovics, Ralf Kist, Richard D Holmes, Linda Bauld, Philip M Preshaw, Elaine McColl","doi":"10.1186/s13063-025-08954-z","DOIUrl":"https://doi.org/10.1186/s13063-025-08954-z","url":null,"abstract":"<p><strong>Background: </strong>Smoking is a key contributor to health inequalities, particularly impacting oral health. Periodontal (gum) health is significantly affected by smoking. With their extensive reach, regular and frequent patient contact, and potential teachable moments, dental teams are well placed to support patients to stop smoking. This is currently mainly provided through Very Brief Advice (VBA) interventions and so there is scope to enhance the cessation support offered. A large definitive trial is needed to confirm whether this would lead to improved smoking quit rates, improved oral health, and be good value for money.</p><p><strong>Methods: </strong>The ENHANCE-D trial is a multi-centre, pragmatic, definitive, 3-arm, parallel group, individually randomised controlled superiority trial, including an internal pilot, conducted in NHS dental settings. In total, 1215 patients who are current regular smokers will be randomly allocated using a 1:2:2 ratio to the following: (i) VBA; (ii) the offer of a standard course of Nicotine Replacement Therapy (NRT); (iii) or the offer of an e-cigarette starter kit. A subgroup of patients with periodontitis (gum disease) will have additional oral examinations and samples collected. The primary outcome is biochemically verified smoking abstinence at 6 months. A key secondary outcome is the percentage of periodontal sites with probing pocket depths (PPDs) ≥ 5 mm at 6 months in the periodontitis subgroup. Participants will be blinded to the purpose of the trial and not be aware of the treatment packages. Periodontal health outcomes will be recorded by trained and aligned assessors, blinded to intervention arm. Participant recruitment started in July 2022 with an internal pilot progressing to the main trial in May 2023. A qualitative process evaluation will explore participants' experiences of receiving the study interventions, alongside the views of dental teams, NHS commissioners, service managers, and policymakers. An economic evaluation will include a cost-effectiveness analysis and a cost-benefit analysis.</p><p><strong>Discussion: </strong>This will be the largest contemporary randomised trial of smoking cessation interventions in dental settings and one of the first to evaluate enhanced interventions. E-cigarettes were included as an intervention due to growing evidence of their effectiveness. They will be compared to VBA and NRT, and oral health outcomes assessed. The multi-centre, pragmatic design of this trial supports the external validity and potential for impacting clinical practice.</p><p><strong>Trial registration: </strong>ISRCTN 13158982. Registered on 10 May 2022. https://www.isrctn.com/ISRCTNISRCTN13158982.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"261"},"PeriodicalIF":2.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733470","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":"High-intensity resistance and impact training for patients with hormone-sensitive prostate cancer and bone metastases-study protocol of a randomized clinical trial.","authors":"Anne-Mette Ragle, Marta Kramer Mikkelsen, Anders Vinther, Bo Zerahn, Carsten Bogh Juhl, Susann Theile, Kasper Madsen, Dorte Lisbet Nielsen, Peter Busch Østergren","doi":"10.1186/s13063-025-08937-0","DOIUrl":"https://doi.org/10.1186/s13063-025-08937-0","url":null,"abstract":"<p><strong>Background: </strong>Men with metastatic prostate cancer are at an increased risk of metabolic syndrome, cardiovascular disease, and pathological fracture. The latter is both attributed to the cancer itself, bones are the most common site of metastases in prostate cancer, as well as the treatment with androgen deprivation therapy. Exercise therapy has been shown to be beneficial, but with uncertainty about its safety, applicability, and suitability for patients with prostate cancer and bone metastases. In these patients, we aim to investigate the safety and efficacy of exercise therapy that specifically targets bone in terms of bone density in the legs.</p><p><strong>Methods/design: </strong>This blinded, randomized, controlled trial will include 102 patients with prostate cancer and bone metastases. Participants will be assigned to a supervised 32-week high-intensity progressive resistance and impact training program (intervention group) or standard treatment including a municipal 12-week standard training program, if desired (control group). Primary outcomes are changes in physical capacity and lower extremity strength measured by the 30-s Chair Stand Test. Secondary outcomes include bone mineral density and body composition, physical function, quality of life, safety (i.e., adverse events and pain), hospitalizations, physical activity, falls, feasibility, and patient experiences. Data will be collected at baseline, midway intervention (16 weeks), post-intervention (32 weeks), and follow-up (44 weeks).</p><p><strong>Discussion: </strong>This study is the first to examine a long-term high-intensity progressive resistance and impact training in patients with prostate cancer and bone metastases. While exercise recommendations for these patients have typically been cautious, high-intensity progressive resistance and impact training has demonstrated safety and benefit in patients with osteoporosis. This research will shed light on the efficacy and safety of progressive resistance and impact training in patients with prostate cancer and bone metastases, potentially improving treatment-related side effects and quality of life.</p><p><strong>Trial registration: </strong>This trial is approved by the Regional Ethics Committee for the Capital Region of Denmark (J.nr.:H-23015286) and by the Danish Data Protection Agency (j.nr.: P-2023-2018). The study was prospectively registered at ClinicalTrials.gov on February 24, 2024 (ID: NCT06259279).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"259"},"PeriodicalIF":2.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733471","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 articulated laparoscopic total mesorectal excision for rectal cancer (ATOME trial): a single-arm, prospective trial with pre-specified comparison to robotic surgery.","authors":"Kyeong Eui Kim, Sung Uk Bae, Seung Hyun Lee, Dae-Ro Lim, Heon-Kyun Ha, Jin Kim, Hyo Seon Ryu, Soo Yeon Park, Sung Il Kang, Gyung Mo Son, Soo Young Lee, Chang Hyun Kim, Kyung Ha Lee, Gi Won Ha, Hye Jin Kim, Woong Bae Ji, Woo Ram Kim, Sang Hee Kang, Nak Song Sung, Ji Hoon Kim, Taek-Gu Lee, Myung Jo Kim, Woon Kyung Jeong, Seong Kyu Baek","doi":"10.1186/s13063-025-08847-1","DOIUrl":"https://doi.org/10.1186/s13063-025-08847-1","url":null,"abstract":"<p><strong>Background: </strong>Laparoscopic total mesorectal excision (TME) has become the standard surgical treatment for rectal cancers, despite being a technically challenging procedure due to the straight and rigid nature of the laparoscopic instrument within a narrow bony pelvis. A robotic system with multi-joint instruments, three-dimensional vision, and improved ergonomics was introduced, however it is not yet cost-effective. Recently, several articulating laparoscopic instruments have been developed and introduced as substitutes for multi-joint robotic system instruments. The prospective study aims to demonstrate that the positive rate of circumferential resection margin following laparoscopic surgery with articulated laparoscopic instruments is non-inferior to that of robotic surgery in the treatment of rectal cancer.</p><p><strong>Methods/design: </strong>Patients with primary rectal cancer who are treated with low anterior resection using articulated laparoscopic instruments will be included in the study. Participating colorectal surgeons must use articulated laparoscopic instruments at least during TME. We hypothesize that the positive rate of circumferential resection margin after robotic surgery will be 6%, 3 based on the previous studies. A trial with 157 patients contributing to the primary outcome analysis would have 80% power to declare non-inferiority with a 5.2% non-inferiority margin, assuming a 10% dropout rate. To compare laparoscopic TME group and robotic TME group, we adjust for variables such as gender, T stage, N stage, sphincter saving status, and preoperative chemoradiation using propensity score matching. The primary end-point of this study is cicumferential resection margin after surgery.</p><p><strong>Discussion: </strong>Based on this study, we hope to demonstrate the efficacy and viability of articulated laparoscopic instruments in the treatment of rectal cancer at a lower cost than robotic surgery.</p><p><strong>Trial registration: </strong>Clinical Research Information Service KCT0008896. Registered on 15 August 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"260"},"PeriodicalIF":2.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733473","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":"Bringing optimised COVID-19 vaccine schedules to immunocompromised populations: statistical elements and design.","authors":"Michael Dymock, James H McMahon, David Griffin, Michelle Hagenauer, Tom L Snelling, Julie A Marsh","doi":"10.1186/s13063-025-08965-w","DOIUrl":"https://doi.org/10.1186/s13063-025-08965-w","url":null,"abstract":"<p><p>Bringing optimised coronavirus disease 2019 (COVID-19) vaccine schedules to immunocompromised populations (BOOST-IC) is a multi-site, adaptive platform trial designed to assess the effect of different booster vaccination schedules in the Australian immunocompromised population on the immunogenicity, safety and cross-protection against COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its variants. Participants from one of three immunocompromised subpopulations (people living with human immunodeficiency virus, solid organ transplants or haematological malignancies) are randomised to receive a one- or two-dose booster vaccination schedule using one of three COVID-19 vaccine brands (Pfizer, Moderna or Novavax) available in Australia. The primary endpoint is the SARS-CoV-2 anti-spike immunoglobulin G concentration at 28 days after the final dose of study vaccine and is modelled using a Bayesian hierarchical two-part model, anticipating that a significant proportion of responses may be below the limit of assay detection. We describe the structure and objectives of the BOOST-IC trial and how these are mathematically represented, modelled and reported, including specification of the estimands, statistical models and decision criteria for trial adaptations. This paper should be read in conjunction with the BOOST-IC study protocol. BOOST-IC was registered on 27 September 2022 with the Australian and New Zealand Clinical Trials Registry NCT05556720.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"256"},"PeriodicalIF":2.0,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144718746","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":"Effects of isoinertial training on muscle power, endurance, isometric strength, and balance: randomized clinical trial in patients with post-ACL reconstruction.","authors":"Ramesh Chandra Patra, Som Gupta, A Yashudas, Sanjeev Mahajan","doi":"10.1186/s13063-025-08953-0","DOIUrl":"https://doi.org/10.1186/s13063-025-08953-0","url":null,"abstract":"<p><strong>Background: </strong>ACL reconstruction surgery leads to temporary limitations in knee movement due to weakness in the quadriceps, swelling, and stiffness. Effective therapy is necessary to regain strength and functionality. While flywheel resistance training enhances strength and eccentric loading, there is limited knowledge about its effectiveness in conjunction with conventional rehabilitation methods. This study evaluates the impact of both conventional rehabilitation and isoinertial therapy on muscle power, endurance, isometric strength, and balance in patients following ACL repair.</p><p><strong>Methods: </strong>A total of 96 out of 136 patients aged 18 to 45 who had been randomly assigned to groups were included 3 weeks post-procedure. Over 6 weeks, 47 patients in group A (n = 47) participated in both isoinertial training and conventional therapy protocals while in group B (n = 49) followed a conventional rehabilitation protocol for just 30 min daily. To assess the patients' muscle power, endurance, isometric strength, and balance, a flywheel ergometer (D11 Plus; Desmotec, Biella, Italy) was utilized both before and after the 6-week treatment period.</p><p><strong>Results: </strong>Group A had statistically significant increases in eccentric muscular power (p = 0.0001), whereas there was no noticeable difference between the two groups in isometric strength, balance, or concentric power (p = 0.731, p = 0.786, and p = 0.815, respectively).</p><p><strong>Conclusion: </strong>The finding indicates that isometric strength, balance, and both concentric and eccentric muscular power were successfully improved by both 6-week interventions: traditional rehabilitation alone and in conjunction with isoinertial training. But when compared to traditional therapy alone, the isoinertial training group showed better gains in muscular endurance. There were no discernible variations in the groups' isometric strength or balance results. The study also emphasizes how isoinertial training can effectively increase eccentric power.</p><p><strong>Trial registration: </strong>The ethics approval number is LPU/IEC/2018/01/09. Registered in the Clinical Trials Registry of India under CTRI/2019/06/019858 dated 23/09/2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"257"},"PeriodicalIF":2.0,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144718747","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":"RAPTOR: Randomised Controlled Trial of PENTOCLO (pentoxifylline-tocopherol-clodronate) in Mandibular Osteoradionecrosis-study protocol for an open-label phase II randomised controlled superiority trial.","authors":"Richard Shaw, Ruth Knight, Ayten Basoglu, Mandeep Bajwa, Julie Perry, Anastasios Kanatas, Stefano Fedele, Vincent Killen, Rebecca Tangney, Chris Butterworth, James McCaul, Jagtar Dhanda, Vinod Patel, Mererid Evans, Richard Jackson","doi":"10.1186/s13063-025-08966-9","DOIUrl":"10.1186/s13063-025-08966-9","url":null,"abstract":"<p><strong>Background: </strong>Mandibular osteoradionecrosis (ORN) is a severe late radiation toxicity affecting 5-10% of patients who receive radiotherapy as part of treatment for head and neck malignancy. ORN can cause permanent disfigurement, dysfunction, pain and infection. There remains little robust evidence supporting the efficacy of medical or surgical management currently offered in clinical practice. Retrospective case series and meta-analyses of observational studies suggest that a repurposed triple drug combination pentoxifylline-tocopherol-clodronate ('PENTOCLO') may be effective in preventing deterioration, promoting healing and ultimately reducing the need for major reconstructive surgery.</p><p><strong>Methods: </strong>The RAPTOR trial is a phase II, open-label, multicentre, randomised controlled trial with a superiority design. Eligible subjects with mandibular ORN are randomised 1:1 to receive standard of care (Arm A) or PENTOCLO plus standard of care (Arm B) for 12 months. The primary outcome measure is time from randomisation to healing of ORN (without the need for surgery), as measured by clinical examination (confirming completely healed oral mucosa), intra-oral clinical photographs and imaging. RAPTOR has an embedded translational sample collection and a methodological component exploring the use of electronic patient-reported outcome measures (ePROM).</p><p><strong>Discussion: </strong>The RAPTOR trial is the first randomised controlled clinical trial of PENTOCLO in this clinical setting. The results of this phase II trial will provide robust preliminary evidence on its efficacy and inform the feasibility and appropriateness of a subsequent definitive trial.</p><p><strong>Trial registration: </strong>RAPTOR is registered with the ISRCTN registry effective date 11th November 2022: Clinical trial of the non-surgical management of radiotherapy damage to the lower jaw ISRCTN34217298, and also registered with the European Clinical Trials Database (Eudra-CT 2022-000728-39).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"254"},"PeriodicalIF":2.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12291413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144708992","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}

{"title":"The effect of repetitive transcranial magnetic stimulation (rTMS) on perioperative neurocognitive disorders in patients after cardiac surgery: study protocol for a randomized controlled trial.","authors":"Jing Wang, Xuyang Wang, Sijie Li, Jinrong Yang, Xiang Yan, Jie Gao, Xiuqin Jia, Long Zuo, Anshi Wu, Changwei Wei","doi":"10.1186/s13063-025-08988-3","DOIUrl":"10.1186/s13063-025-08988-3","url":null,"abstract":"<p><strong>Introduction: </strong>Perioperative neurocognitive disorders (PND) is one of the most common postoperative complications among elderly patients (above 65 years old) undergoing cardiac surgery. However, thus far, there have not been any effective therapies for managing PND. Recent research has shown that repetitive transcranial magnetic stimulation (rTMS) alters brain plasticity and improves cognitive function in several neurodegenerative disorders and psychiatric disorders. However, the potential benefits of rTMS in reducing PND in patients undergoing cardiac surgery have not been investigated. Therefore, the current protocol is designed to determine whether rTMS can reduce the incidence of PND in patients undergoing cardiac surgery.</p><p><strong>Methods and analysis: </strong>The study will be a single-blinded, randomized controlled trial. Participants undergoing elective cardiac surgery will be randomized to receive either rTMS or sham stimulation with focal figure-of-eight coils over the right dorsolateral prefrontal cortex. A series of neuropsychological tests will be completed to evaluate cognitive function in surgery patients before, on day 7, and on day 30 after cardiac surgery. The primary outcome is the prevalence of PND in cardiac surgery patients. The secondary outcomes will be the incidence of postoperative delirium, pain, sleep quality, depressive symptoms, activities of daily living, length of hospital stay and ICU length of stay, and rate of complication and mortality during the hospital stay.</p><p><strong>Ethics and dissemination: </strong>Beijing Chaoyang Hospital Ethics Committee approved this study and has the number 2022-ke-487. It is registered with Clinical Trials (trial number NCT05668559). Informed consent must be provided by all participants. The study result will be published in a peer-reviewed journal.</p><p><strong>Trial registration: </strong>NCT05668559. Registered on June 6, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"253"},"PeriodicalIF":2.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12291346/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144708993","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}

{"title":"Blended therapy for adolescents with chronic health conditions to increase fatigue-related self-efficacy (Booster): protocol for a single-case multiple baseline study.","authors":"Maartje D Stutvoet, Anouk Vroegindeweij, Jan Houtveen, Raphaële R L van Litsenburg, Elise van de Putte, Remco C Veltkamp, Sanne L Nijhof","doi":"10.1186/s13063-025-08960-1","DOIUrl":"10.1186/s13063-025-08960-1","url":null,"abstract":"<p><strong>Background: </strong>Fatigue is a common symptom in adolescents with a chronic health condition. Persistent fatigue and its impairments may be prevented by early intervention with Booster. Booster is a transdiagnostic blended care intervention that aims to increase fatigue-related self-efficacy (FSE). Through experience sampling methodology (ESM) via the Booster smartphone app, Booster helps users gain personalised insight into the relationship between their thoughts, feelings, activities, and fatigue. Based on this insight and shared-decision making, the participant and executive investigator set personal lifestyle goals, such as more exercise and fewer daytime naps. The previous version of Booster, PROfeel, has already been shown effective in treating persistent fatigue in youth. Booster's value as an early intervention has yet to be studied. To better suit this aim and align with user preferences, the new Booster app includes features like goal attainment assistance, daily outcome tracking, and motivating game mechanics (e.g., rewards and a minigame). This protocol describes a study to examine the effect of Booster on FSE and the other study outcomes fatigue, school participation, life satisfaction, and perceived health. The secondary aim is to explore individual differences regarding (moment of) changes in outcomes during the Booster intervention.</p><p><strong>Methods: </strong>It is a single-centre study with a multiple baseline single-case experimental design (SCED). We aim to include twenty adolescents ages 12 to 18 years with a chronic health condition and fatigue. Booster's effect on outcomes will be measured with a daily survey during Phase A (baseline) and B (intervention). The start of phase B will be randomised across cases. The effect will be assessed with the multiple baseline single-case randomisation test (SCRT) at the group level. Additionally, at the single-case level, we will explore change using permutation distancing tests (PDTs), single-case interrupted time series analysis (ITSA), and change point analyses. Also, we will assess participant characteristics associated with (long-term) improvements.</p><p><strong>Discussion: </strong>Booster uses innovative methods by combining tailored ESM-insight, mHealth and healthcare professional support. Group-level analysis, strengthened by single-case observational analyses, will evaluate the effectiveness of ESM-supported blended care as an early fatigue intervention and identify its potential working mechanisms. It lays the groundwork for implementing ESM tools in clinical practice.</p><p><strong>Trial registration: </strong>ClinicalTrials, NCT06562335. Registered on 24 July 2024, https://clinicaltrials.gov/study/NCT06562335 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"255"},"PeriodicalIF":2.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12291284/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144709013","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}

{"title":"PRALINE: study protocol for a phase IIb inpatient stroke rehabilitation randomized controlled trial investigating longitudinal outcomes after progressive abduction loading therapy.","authors":"Heidi R Roth, Carolina Carmona, Gina Clark, Jane E Gyarmaty, Julius P A Dewald, Elise Giblin, Richard L Harvey, Jacquelyn Jaskiewicz, Kwang-Youn A Kim, Nicola Lancki, Alexis Luhrsen, Ahalya Mandana, Deepali Manikonda, Andrew Morris, Sonia Sheth, Mary Ellen Stoykov, Amanda C Young, Donna Zielke, Michael D Ellis","doi":"10.1186/s13063-025-08969-6","DOIUrl":"10.1186/s13063-025-08969-6","url":null,"abstract":"<p><strong>Background: </strong>Stroke is the leading cause of long-term disability with paucity of evidence-based interventions for individuals with severe upper extremity impairment in the affected arm. Loss of independent joint control limits reaching distance and velocity contributing to activity and participation limitations. Emerging evidence demonstrates improved independent upper extremity joint movement with training combining shoulder abduction loading during high repetition, task-specific reaching practice. The purpose of this study is to compare outcomes for one-year post-stroke for participants who receive reaching training with vs without progressive shoulder abduction loading during upper extremity reaching training using a standardized mechantronic device.</p><p><strong>Methods: </strong>This is a phase II, double-blinded randomized clinical trial conducted at two inpatient rehabilitation hospitals. Eighty-six individuals will be recruited upon admission to acute inpatient rehabilitation and randomly allocated to either the experimental or active comparator intervention groups. Both groups will receive reaching training with the affected upper extremity in a standardized mechatronic device 4 days per week while in inpatient or day rehabilitation. Outcomes will be assessed at baseline, weekly while in inpatient and day rehabilitation, and every other month after discharge until one year post-stroke. Primary outcomes include change in reaching function of the affected upper extremity, measured by kinematic evaluation. This captures the loss of independent joint control due to flexion synergy expression. Secondary outcomes include measures of severity of flexion synergy motor impairment, Action Research Arm Test, Fugl-Meyer Assessment, and the Stroke Impact Scale.</p><p><strong>Discussion: </strong>This study will test the efficacy of progressive shoulder abduction loading during reaching training using a mechatronic device. The results of this study have the potential to inform clinical practice for upper extremity reaching training for individuals with severe upper extremity impairment post-stroke to reduce flexion synergy expression.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov, NCT04118998. Registered on 8 October 2019.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"250"},"PeriodicalIF":2.0,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12278522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144675870","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}