Trials最新文献

Background: Effective strategies for managing ischemia-reperfusion injury in acute myocardial infarction remain limited, despite advances in reperfusion therapy. Transcutaneous electrical nerve stimulation (TENS), a safe and non-invasive intervention with good patient compliance, modulates pain perception and autonomic activity via specific neural pathways. These properties make it a promising candidate for integration into secondary prevention following percutaneous coronary intervention (PCI). Therefore, this randomized controlled trial investigates the potential of TENS as an innovative therapeutic approach in patients with ST-segment elevation myocardial infarction (STEMI).

Methods: This study was a multicenter randomized controlled trial designed to assess the effect of TENS in STEMI patients undergoing reperfusion. Using a randomization of district groups, 200 eligible patients will be randomized to either the treatment group or the control group (1:1 ratio), with all patients receiving standard PCI. The intervention will be administered for 3 days. The primary endpoint is myocardial infarct size (assessed by serial cardiac biomarker measurements), and secondary endpoints include inflammatory markers, myocardial injury markers, left ventricular function, heart rate variability, and major cardiovascular events. All patients will be followed for 12 weeks.

Discussion: This trial aims to explore TENS as a novel, non-invasive strategy for mitigating reperfusion injury and enhancing secondary prevention in STEMI patients, addressing a critical gap in current post-PCI management.

Trial registration: www.chictr.org.cn, Registration No. ChiCTR2400082515. Registered on 30 March 2024.

Background: A high prevalence of child overweight and obesity worldwide calls for innovative multi-setting intervention approaches, and thorough evaluation. This paper describes the protocol for the process evaluation of the Generation Healthy Kids (GHK) program-a school- and community-based intervention to promote healthy weight and wellbeing among 6-11-year-old children in Denmark. The process evaluation will explore (1) implementation, impact mechanisms and contextual factors influencing intervention outcomes and (2) potential ethical issues and unintended outcomes.

Methods: GHK aims to promote healthy weight and wellbeing through regular physical activity, healthy eating, improved sleep and balanced screen media behaviour among children in 1st-3rd grade. Intervention development was informed by United Kingdom Medical Research Council guidelines, previous evidence, theory, context knowledge, stakeholder input and a feasibility study. Intervention activities are designed to develop food, digital and physical literacy; awareness of sleep and screen media practices; social cohesion in the school class; and a supportive healthy environment. Pre-defined components in schools include a free lunch program 4 days a week; compulsory 40-min high-intensity physical activity sessions 3 days a week; equipment for active recess; classroom exercises on food literacy, screen media use, and sleep; and workshops and guidelines for parents on children's sleep and screen media behaviour. Local community interventions promoting child health and well-being will be co-created with community stakeholders. The 'Supersetting Approach' will be used to develop coordinated interventions across relevant settings. The 2-school year intervention will be tested in a cluster-randomized controlled trial with 12 intervention schools and 12 control schools, assessed at baseline (autumn 2023), and approximately 6 and 18 months later. The process evaluation will be guided by the project's program theory, process evaluation- and implementation science concepts and system approaches. It will include quantitative and qualitative methods and perspectives of children, parents, school staff and community stakeholders.

Discussion: The process evaluation will facilitate (1) interpretation of intervention effects; (2) understanding of context, impact mechanisms, synergies, implementation issues and evaluation approaches related to combining pre-defined components with system approaches and co-created activities; and (3) refinement of intervention and implementation strategies prior to potential scale-up.

Trial registration: ClinicalTrials.gov: NCT05940675. Registered on 4 July 2023.

Background: Methotrexate (MTX) is recommended as first-line therapy in patients with rheumatoid arthritis (RA), proven to be effective, safe and inexpensive. However, a significant proportion of patients does not achieve disease remission with MTX monotherapy. Main reasons include insufficient dose up-titration to the maximal recommended oral dose or the delayed switch to a subcutaneous administration route. We hypothesise, that by dose and route optimisation, a higher proportion of patients can achieve remission. Further, exploratory biomarkers will give new insights on individual MTX metabolism and drug adherence.

Methods: The MethMax trial is a prospective, randomised, assessor-blinded, parallel-group, superiority, low-intervention trial, including 182 patients across 7 European countries. Patients with active RA, naïve to biologic (except tumour necrosis factor alpha inhibitors; TNFi) or targeted synthetic antirheumatic drugs, who have been on a stable oral MTX therapy for the past 3 months are randomised in a 1:1 ratio to 25 mg MTX weekly, either administered orally or subcutaneously. Additionally, both arms receive a short-term glucocorticoid regimen with a four-week tapering and withdrawal protocol. The primary endpoint is the difference in proportion of patients achieving remission defined as the Clinical Disease Activity Index (CDAI) ≤ 2.8 at week 24, comparing the dose/route optimisation and oral dose optimisation. The active study duration for each patient is 24 weeks. Study visits take place at baseline, weeks 4, 12, 16 and 24. Clinical efficacy and safety parameters are obtained at each visit. Patient-reported outcomes, exploratory biomarkers as well as medication adherence are assessed. Written consent is obtained for all participants. The study has received regulatory approval via the Clinical Trials Information System and Medicines and Healthcare products Regulatory Agency and has included the first patient in August 2024.

Discussion: The anticipated results will provide insights whether the subcutaneous administration of 25 mg MTX is advantageous in achieving CDAI remission when compared to the oral intake after 24 weeks and inform the community regarding the utility of established and newly developed biomarkers, as well as the potential impact of inadequate drug adherence. The MethMax study is aimed to optimise individual therapy in RA and provide more precise pharmacological MTX management recommendations.

Background: Physical exercise has emerged as a promising non-pharmacological approach for improving cognitive and physical function in older adults with mild cognitive impairment (MCI). However, most existing interventions in nursing homes lack a strong theoretical foundation, standardized delivery, and evidence-based practice. This study aims to develop and evaluate a multicomponent exercise program grounded in the Health Action Process Approach-Theory of Planned Behavior theory (HAPA-TPB) to improve adherence and cognitive outcomes in older adults with MCI living in nursing homes.

Methods: This is a randomized, single-blind, parallel-group controlled trial conducted in nursing homes in Huzhou, China. A total of 156 older adults with MCI were randomly assigned to either a 12-week, group-based multicomponent exercise intervention or a control group receiving usual care. The intervention, theoretically grounded in an integrated HAPA-TPB framework, integrates aerobic, resistance, and mind-body training with structured behavioral change strategies designed to enhance motivation, adherence, and sustained engagement, including peer interaction. The primary outcome is cognitive function assessed by the Montreal Cognitive Assessment-Basic (MoCA-B). Secondary outcomes include physical performance, sleep quality, intrinsic capacity, frailty, social support, and intervention feasibility.

Results: A total of 1351 participants completed preliminary eligibility screening, of whom 156 were eligible and randomized (78 per group). The mean (SD) age was 69.19 years (SD = 8.97), and 69.23% of participants were female. Baseline characteristics were comparable across groups in terms of demographic, socioeconomic, and health status indicators. Baseline cognitive function, assessed using the MoCA-B, showed no significant between-group difference (intervention: mean = 17.29, SD = 2.32; control: mean = 16.74, SD = 2.19; F = 2.320, p = 0.130), indicating comparability prior to the intervention.

Discussion: This MIND-STEP study will provide high-quality evidence on the effectiveness and implementation of a theory-based, multicomponent exercise intervention for older adults with MCI in nursing homes. Findings will inform future intervention design and policy development to promote cognitive and functional health in institutionalized older populations.

Trial registration: Chinese Clinical Trial Registry ChiCTR2400088301. Registered on 15 August 2024.

Background: Recruitment and retention remain persistent challenges in Alzheimer's disease (AD) clinical trials, particularly as studies increasingly focus on earlier disease stages and require longer participation and more invasive procedures. Understanding how trial enrollment and participation are experienced is critical to improving acceptability and sustaining engagement. Qualitative interviews conducted alongside clinical trials offer an opportunity to capture participant and study partner perspectives on the trial experience. In INTERCEPT-AD, a phase 1 trial evaluating safety and tolerability of the Aβ oligomer-selective monoclonal antibody sabirnetug (ACU193) among participants with mild cognitive impairment or mild dementia due to Alzheimer's disease (AD), semi-structured qualitative interviews concerning trial experience were conducted with a subset of participants and their study partners.

Methods: Participant/study partner dyads completed qualitative interviews following the final study visit. A semi-structured interview guide elicited descriptions regarding motivations for participating, enrollment decision-making, and positive and negative aspects of participation. Principles of applied qualitative thematic analysis guided the qualitative analyses. Exploratory analyses examined how factors differ by participant gender.

Results: Twenty-eight participants (64.2% female) and their study partners were interviewed, representing 43% of the trial population (n = 65; 53.8% female). Participants and study partner dyads described varied pathways to trial awareness and enrollment decision-making, including both independent and family-involved decisions. Motivations for participation reflected anticipated personal benefit as well as altruistic goals. While interactions with study staff were viewed positively, dyads reported meaningful burdens related to travel, time commitment, and study procedures, with cognitive testing more frequently described as challenging than invasive procedures. A recurring theme was the desire for clearer communication and greater access to study-related information, including test results and treatment assignment. Exploratory analyses suggested that perceived burden and enrollment decision-making may differ by participant gender.

Conclusions: Study findings suggest opportunities to enhance the AD trial experience by addressing trial-related burdens and logistical aspects of participation. Exploratory gender analyses yielded additional insight into the patient trial experience but should be further examined along with race/ethnicity and study partner characteristics to enhance clinical study design and execution.

Background: Prior studies show significant increases in cardiorespiratory fitness (V̇O₂max) and other health-related outcomes in response to reduced exertion high-intensity interval training (REHIT), yet these studies are characterized by small sample sizes which casts doubt on the true efficacy of this form of physical activity for enhancing fitness and health. We propose a definitive randomized controlled exercise training study in a large sample of inactive adults to examine the effects of REHIT on outcomes related to cardiometabolic health in comparison to a non-exercise control group.

Methods: After baseline testing, 120 inactive men and women ages 18-64 years will be randomized to a non-exercising control group or undergo 12 weeks of REHIT. Participants will be healthy, weight stable, and have BMI < 35 kg/m² and be required to maintain their habitual physical activity and dietary patterns during the study. Training will be supervised and performed 2 days per week. Changes in V̇O₂max, body composition, and substrate metabolism will be monitored to assess adaptations in cardiometabolic health in response to REHIT. To assess the feasibility of REHIT, various perceptual measures including RPE, affective valence, and enjoyment will be recorded, and quality of life will be measured.

Discussion: Data from the current study will advance physical activity research by bolstering the implementation of REHIT, which will contribute to reduced risk factors of cardiovascular disease and, in turn, improved public health.

Trial registration: OSF (osf.io/wvcz4). Registered on November 3, 2025.

Clinicaltrials: gov NCT07328568. Registered on January 8, 2026.

Background: It is estimated that almost all women undergoing cesarean section experience some pain in the immediate postpartum period. In the face of pain that limits self-care and care for the newborn, antalgic postures can be adopted that can increase the painful sensation. Evidence indicates that physiotherapeutic interventions using non-pharmacological resources can help manage pain complaints and promote greater quality of life during this period. The objective of this study is to evaluate the effectiveness of physiotherapeutic interventions for preventing and relieving pain in women in the immediate postpartum period following a cesarean section.

Methods: Randomized, parallel, and open clinical trial, with postpartum women over 15 years of age, underwent cesarean section more than 8 h ago, hemodynamically stable, conscious, oriented, in good clinical condition as per progress in the medical record, after having had the bladder catheter removed and having fed after surgery, admitted to rooming-in wards at the time of allocation. Postpartum women will be allocated up to 24 h after the cesarean section to ensure the feasibility of follow-up. Through simple randomization, the postpartum women will be allocated into two groups: intervention and control. The randomization lists will be organized by a center, which will manage the allocation groups and will be prepared using the Social Package for the Social Sciences program, version 23.0. Women allocated to the intervention group will receive a protocol of physiotherapeutic interventions to prevent and relieve pain in women in the immediate postpartum period following a cesarean section, and those in the control group will receive standard care at the study center. The primary outcome will consist of post-cesarean pain scores 24 h after allocation, measured using the Visual Analog Pain Scale.

Discussion: Suppose the effectiveness of the physiotherapeutic interventions is proven based on the protocol developed for the study. In that case, it can be applied in the immediate postpartum period following a cesarean section, with the potential for preventing and relieving pain.

Trial registration: REBEC RBR-84pqzdw (UTN: U1111-1308-5716). Registered on June 08, 2024.

Background: Digital interventions for older adults may significantly extend preventive action to postpone disability and preserve health-related quality of life. However, more evidence is needed from multi-domain interventions using broad-scale objective and self-report assessments and intra-individual change data-analytical techniques.

Method: SMART-AGE examines the effect of an app-based multilevel treatment designed to enhance social participation, physical fitness, and health awareness. The target population comprises healthy and community-dwelling adults 67 years and older with basic digital skills in two socially diverse communities. Treatment relies on an Android-based tablet computer, on which three apps offering interventions in the core areas of social participation, physical fitness, and health awareness are pre-installed. A feedback app designed to provide participants with a feedback option at any time is also offered. Participants are randomly assigned to three intervention arms and assessed at baseline and after 3 and 6 months. Arm 1 receives the full intervention, consisting of the social participation app, the physical fitness app, the health awareness app, and the feedback app. The health awareness app is available in months 4 to 6, meaning that participants receive the full three-app intervention only in the second half of the intervention period. Arm 2 receives the social participation app and the feedback app throughout the intervention. Arm 3 serves as an active control condition in that a stand-alone tablet with a low-dose introduction to publicly available standard apps is provided. The data protocol includes assessment of three primary outcome domains: social support and loneliness, motor capacity and physical performance, and health awareness and health locus of control. Potential moderators (e.g., cognitive function, depression) as well as various technology-oriented constructs (e.g., skills, acceptance) are also assessed. App use data are automatically collected across the full intervention interval in arms 1 and 2. Data management is conducted within a cloud-based REDCap architecture. Feedback recordings via the feedback app are collected in arms 1 and 2 and undergo qualitative analysis.

Discussion: The SMART-AGE intervention aims to enhance core domains of health-related quality of life in community-dwelling older adults through an app-based multi-domain intervention and a user-centered approach.

Trial registration: German-Clinical-Trials-Register, DRKS00034316. Registered 29-May-2024, https://drks.de/search/en/trial/DRKS00034316. The study's design and hypotheses were also pre-registered in the Open Science Framework (OSF) prior to study enrollment (https://doi.org/10.17605/OSF.IO/YQEBW, 2023-04-28).

Aims: Based on the observed correlation between core symptoms and fine motor function in children with ASD, this study aimed to evaluate the therapeutic effect of a novel, fine motor task-oriented sports game intervention, compared to traditional SI.

Methods: Forty-five children with ASD were randomly allocated to two groups. The experimental group received the fine motor-oriented sports game intervention, while the control group received traditional SI. Core symptoms and fine motor function were assessed using the ABC, CABS, CARS, and PDMS-FM scales at both baseline and post-intervention, with the ABC scale serving as the primary outcome measure.

Results: In the randomized comparison, the experimental group showed superior outcomes to the control group post-intervention, with significantly greater reductions in ABC, CARS, and CABS scores and a greater increase in PDMS-FM score (all P < 0.05).

Conclusions: The fine motor-oriented sports game intervention proved more effective than SI in ameliorating the core symptoms and improving fine motor function in children with ASD.

Trial registration: The study has been registered at ChiCTR.org (ChiCTR2400086052) on 2024-06-24.

Background: Previous studies have evaluated traditional Chinese medicine (TCM) clinical randomized controlled trial (RCT) literature broadly, but they have provided limited depth in evaluating the specific aspects of trial quality.

Objective: This study aims to develop a specialized literature quality assessment system for TCM RCTs.

Methods: We integrated international standards with TCM characteristics to create a checklist for evaluating basic method information and intervention operations. A rating system was established to classify content into four categories based on completeness and accuracy.

Results: We assessed 2776 TCM RCTs across six disease categories. For basic method information, "outcome indicators" and "participants' medical sources" were commonly mentioned but often vague, with accurate rates of 60.73% and 74.52%, respectively. Critical elements, including "TCM diagnosis and diagnostic basis," "TCM syndromes (clinically defined patterns of symptoms that guide TCM therapy)," "randomization methods," and "blinding" were frequently omitted, with omission rates ranging from 68.58% to 97.48%. For interventions, "treatment group intervention" had higher completeness (97.83%) than "control group intervention" (82.68%). Inaccurate reporting commonly stemmed from incomplete descriptions of interventions or unspecified drug compositions.

Conclusion: Our results suggested a serious concern that TCM-related concepts were often missing in trial designs for TCM RCTs, which might impede the development of TCM theories. Also, this study's inaccurate trial designs and intervention descriptions can provide cautionary examples for future RCT protocols or reports in TCM to avoid.