Trials[JOURNAL]
Sun
200 papers
Effectiveness of digital inhaled therapy management and respiratory muscle training in moderate to severe COPD patients: study protocol for a randomized controlled, assessor-blinded, multicenter trial.
Xu Y, Zhou M, Hu X … +11 more , Pan L, Chen F, Chen B, Cao Q, Jiang T, Zhu J, Li N, Jiang A, Lian C, Chen Z, Ge H
Trials · 2026 Jun · PMID 42243883 · Full text
BACKGROUND: Digital inhaler therapy management can help patients promote adherence and correct inhaler techniques. Poor inhaler technique and suboptimal adherence contribute to COPD exacerbations, uncontrolled symptoms,...
BACKGROUND: Digital inhaler therapy management can help patients promote adherence and correct inhaler techniques. Poor inhaler technique and suboptimal adherence contribute to COPD exacerbations, uncontrolled symptoms, and a progressive decline in pulmonary function. Digital Inhaled Therapy Management (DITM) platforms can provide standardized technique training, objective adherence monitoring, and real-time feedback. Respiratory Muscle Training is a recommended component of pulmonary rehabilitation that can improve respiratory muscle strength and exercise tolerance. Whether DITM and IMT, alone or in combination, reduce exacerbations and improve patient-reported and physiologic outcomes compared with usual care remains uncertain. METHODS: This is a 1-year, multicenter, open-label, assessor-blinded, randomized, parallel-group superiority trial with participants randomly allocated to four arms (1:1:1:1): DITM, IMT, DITM + IMT, and usual care (verbal inhaler education). Adults ≥ 40 years with COPD per GOLD 2024, FEV1%pred < 60, symptomatic burden (e.g., CAT ≥ 10 and/or mMRC ≥ 2), and high risk of exacerbation (≥ 2 moderate or ≥ 1 severe in past 12 months) will be enrolled (N = 410). Follow-up contacts occur at 3, 6, and 12 months. The primary outcome timepoint is the cumulative 12-month rate of moderate-to-severe COPD exacerbations,with severe events defined as COPD-related hospitalizations, the 3-and 6-month contacts are used for event ascertainment and not as separate primary timepoint. Secondary outcomes include time to first moderate-to-severe exacerbation, CAT, mMRC, SGRQ-C, spirometry, inspiratory muscle strength (MIP/MEP), 6-min walk test, and device-derived metrics of inhaler adherence and technique. Analyses will follow intention-to-treat principles, using negative binomial or Poisson regression for exacerbation rates, Cox models for time-to-event outcomes, and mixed-effects models for repeated continuous outcomes. DISCUSSION: This trial will evaluate the effectiveness of DITM and IMT-alone and combined-on exacerbations, symptoms, and function in high-risk COPD. Findings may inform integration of digital self-management and inspiratory muscle training into routine COPD care. TRIAL REGISTRATION: ClinicalTrials.gov NCT06958666; registered in July 2025. Ethics approved was obtained from the Ethics Committee of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (Approval No. 20250119).
Gabapentin to achieve HIV viral load suppression in people with risky drinking in Mbarara, Uganda: study protocol for a randomized, double-blinded, placebo-controlled trial (GRAIL).
Truong V, Kekibiina A, Muyindike WR … +9 more , Gnatienko N, Tsui JI, Emenyonu NI, Cheng DM, Hahn JA, Allison O, Bullard MJ, Lunze K, Samet JH
Trials · 2026 Jun · PMID 42237416 · Full text
BACKGROUND: Ending the HIV epidemic requires achieving HIV viral load (HVL) suppression for key populations including those with risky drinking. Gabapentin can decrease alcohol use and thus holds potential for improving...
BACKGROUND: Ending the HIV epidemic requires achieving HIV viral load (HVL) suppression for key populations including those with risky drinking. Gabapentin can decrease alcohol use and thus holds potential for improving medication adherence and HIV viral load suppression for individuals with HIV and risky drinking. METHODS: The aim of this paper is to describe the protocol for a randomized, double-blinded, placebo-controlled trial (GRAIL [Gabapentin to Reduce Alcohol and Improve viral Load suppression]), to test the efficacy of gabapentin versus placebo on achieving undetectable HIV viral load among people with HIV with risky drinking. We will recruit and randomize 220 people with detectable HIV viral loads (≥ 200 copies/ml) and risky drinking. Participants will be randomized 1:1 to receive either gabapentin (1800 mg/day target dose) or placebo for 3 months in a double blind design. Both arms will receive a 5-min evidence-based counseling session aimed at reducing alcohol use. The primary outcome is undetectable viral load (< 200 copies/ml) at 3 months. Other secondary outcomes include undetectable viral load at 6 and 12 months, biomarker-confirmed recent alcohol consumption, antiretroviral therapy (ART) adherence, engagement in HIV care and pain severity. This study will take place in Mbarara, Uganda, as the country ranks among the top five for alcohol consumption globally and has 1.4 million people living with HIV. DISCUSSION: GRAIL tests the efficacy of gabapentin, a medication to decrease alcohol use to achieve HIV viral load suppression. This trial may identify a treatment strategy to prevent the transmission of HIV and improve health outcomes among a high-risk HIV population, specifically those with risky drinking. TRIAL REGISTRATION: This trial has been registered at ClinicalTrials.gov ( NCT05443555 ) on June 29, 2022.
Partially randomized preference trials in carceral health research: a methodology to advance equity and inclusion.
Berk J, Gordon M, Handley MA … +1 more , Jack HE
Trials · 2026 Jun · PMID 42237413 · Full text
BACKGROUND: Incarcerated people experience disproportionately poor health outcomes yet often remain excluded from clinical research due to ethical concerns of limited autonomy and coercion. As a result, traditional rando...
BACKGROUND: Incarcerated people experience disproportionately poor health outcomes yet often remain excluded from clinical research due to ethical concerns of limited autonomy and coercion. As a result, traditional randomized controlled trials face significant challenges in carceral settings, driven by mistrust of the medical system, randomization limiting choice, and logistical barriers with blinding and masking. These challenges necessitate alternative methodologies that balance scientific rigor while empowering participant choice. MAIN TEXT: This commentary proposes partially randomized preference trials as a methodology to advance equity and inclusion in carceral health research. In these hybrid designs, participants with strong preferences choose their intervention, while those without strong preferences are randomized. This approach facilitates participant autonomy while maintaining causal inference capabilities. Further, the design allows researchers to quantify preference and selection effects, enhancing external validity (generalizability), and can increase patient recruitment and retention. We discuss practical considerations including sample size calculations and data analysis approaches that estimate treatment effects, selection bias, and preference bias. CONCLUSIONS: Partially randomized preference trials are a way to generate rigorous evidence in carceral settings while respecting participant autonomy. They may also be useful for engaging other communities with limited autonomy. This approach should be considered as a tool for advancing health equity and inclusion in research.
Behavioral telehealth in low-resource primary care settings for anxiety and depression in youth: protocol for a randomized effectiveness-implementation study.
Rodriguez F, Lynch FL, Gonzalez A … +10 more , Rozenman M, Dickerson J, O'Keeffe-Rosetti M, Donald J, Hatch B, Barker G, Henninger M, Shaw M, Vaughn KA, Weersing VR
Trials · 2026 Jun · PMID 42237407 · Full text
BACKGROUND: Anxiety and mood disorders in youth are prevalent and impairing, with high current and lifetime comorbidity. Untreated, these disorders lead to sustained functional impairment and increased risk for recurrent...
BACKGROUND: Anxiety and mood disorders in youth are prevalent and impairing, with high current and lifetime comorbidity. Untreated, these disorders lead to sustained functional impairment and increased risk for recurrent disorder and suicide. In addition, there are notable disparities in care, with both families experiencing increased social risk and youth of color significantly less likely to receive mental health services. In previous research, a primary-care-based transdiagnostic brief behavioral therapy (BBT) was developed and found to be effective for a broad population of youths with anxiety and depression. To increase dissemination potential to settings that serve low-resource families (e.g., community health centers [CHCs]), the intervention, now called "STEP-UP," has been expanded to support a digital health framework and delivery in Spanish. We describe the protocol for a hybrid type 1 randomized-effectiveness trial to test the effects of STEP-UP in a community sample of youths with anxiety and/or depression. METHOD: Youths (age = 8-16, N = 220) will be randomized to (a) STEP-UP or (b) assisted referral to treatment as usual (TAU+). Clinical effectiveness will be assessed by masked independent evaluators at posttreatment (week 16) and at follow-up (week 32). Implementation data will be pulled from the following: (a) Surveys of health system leaders, (b) surveys of and interviews with STEP-UP clinicians, and (c) electronic health record (EHR) and health system administrative data. Specific aims include testing the clinical effectiveness of STEP-UP and engagement of the intervention mechanism (Aim 1), probing cost-effectiveness (Aim 2), testing social determinants of health (SDOH) predictors and moderators to evaluate robustness of effects (Aim 3), and identifying target mechanisms for future implementation trials using the Consolidated Framework for Implementation Research (CFIR, Aim 4). DISCUSSION: Results of the randomized trial may help move effective treatments for youth anxiety and depression problems into widespread community practice. TRIAL REGISTRATION: NCT06273982. Registered on February 15, 2024.
Effectiveness and mechanisms of isometric resistance exercise to reduce blood pressure in a Chinese population: study protocol for a randomized-controlled trial.
Ng SN, Yip BH, Sit RW … +11 more , Woo KS, Wang S, Cohen DD, Lopez-Jaramillo P, Persu A, Tan GM, Cornelissen V, Pyun WB, Camafort BM, Wong SY, Lee EK
Trials · 2026 Jun · PMID 42237351 · Full text
BACKGROUND: Isometric resistance exercise training (IRT) involves sustained muscle contractions without changes in muscle length and joint angle, such as wall squats. Patients with hypertension may prefer IRT because the...
BACKGROUND: Isometric resistance exercise training (IRT) involves sustained muscle contractions without changes in muscle length and joint angle, such as wall squats. Patients with hypertension may prefer IRT because they are easy to learn, require no equipment, are convenient, time-efficient, and can be performed anywhere. However, IRT have not shown to reduce blood pressure (BP) as detected by ambulatory BP measurements (ABPM), the reference standard for BP measurement. This study aims to examine the effectiveness of an IRT program in reducing BP. METHODS: This randomized controlled trial (RCT) will involve 390 patients with a suboptimal daytime systolic BP of > 135-160 mmHg on a 24-h ABPM, who do not meet the current World Health Organization recommendations for physical activity. Participants will be randomly assigned to either the IRT (wall squat) group or stretching exercise (active control) group (1:1), using stratified and blocked randomization according to age (< 45, 45- < 60, and ≥ 60 years old), sex, and anti-hypertensive drug use (users versus non-users). Investigators will be blinded to randomization sequence and allocation. IRT group will receive a well-structured, widely accepted, and validated 24-week wall squat program (2 min per exercise, 2 min of rest between sets, and 3 sessions per week). Adherence will be monitored by regular patient communication via social media. The control group will receive the same treatment, with the exercise replaced by frequency-matched and time-matched stretching exercise. The primary outcome measure will be systolic daytime ABPM at 24 weeks. Secondary outcome measures will include other BP and ABPM parameters at 12 weeks, 24 weeks, and 12 months, carotid-femoral pulse wave velocity at 24 weeks and 12 months, and flow-mediated dilation at 24 weeks and 12 months. Safety data will be collected and reported. DISCUSSION: This trial will be the first adequately powered RCT to determine whether IRT can be recommended as a treatment for hypertension, involving a Chinese population. It will also contribute new knowledge regarding the mechanisms of IRT. This research has the potential to influence clinical practices. If positive results are obtained, this research could potentially alleviate the substantial burden on healthcare systems caused by poor BP control. TRIAL REGISTRATION: ClinicalTrials.gov NCT06510998. Registered on July19, 2024.
Effects of two community-based multimodal exercise programs on physical activity, performance, fall prevention, and quality of life in older adults: a randomized clinical trial.
Hossain KMA, Hossain MZ, Jahan S … +7 more , Hossain KMA, Rahman E, Hossain MK, Galeb AH, Akter MS, Rikti JF, Kabir MF
Trials · 2026 Jun · PMID 42237301 · Full text
BACKGROUND: Aging involves a gradual physiological decline that affects physical activity, performance, fall risk, and quality of life in older adults. Exercise is a recommended intervention to counteract these effects;...
BACKGROUND: Aging involves a gradual physiological decline that affects physical activity, performance, fall risk, and quality of life in older adults. Exercise is a recommended intervention to counteract these effects; however, the comparative effectiveness of sensorimotor and strengthening exercise programs in community settings remains limited. Therefore, we aimed to evaluate the effectiveness of two community-based multimodal exercise programs (CMEPs) in improving physical activity, performance, fall prevention, and quality of life in older adults. METHODS: A multicenter, randomized clinical trial was conducted with 140 older adults randomly assigned to CMEP-I (sensorimotor exercise) or CMEP-II (strengthening exercise). Both interventions involved 24 supervised sessions over 8 weeks. Outcomes were measured at baseline and post-intervention using the Physical Activity Scale for Elderly (PASE), Short Functional Performance Battery (SPPB), Modified Falls Efficacy Scale (MFES), and 36-Item Short-Form Survey (SF-36). RESULTS: Both interventions led to improvements in outcome measures over time. CMEP-I showed significantly superior improvements to CMEP-II in physical activity (PASE, MD = 12.40; 95% CI: 5.92 to 18.88; ηp = 0.626), functional performance (SPPB, MD = 0.26; 95% CI: -0.17 to 0.68; ηp = 0.137), fall prevention (MFES, MD = 0.37; 95% CI: 0.28 to 0.46; ηp = 0.325), and quality of life (SF-36, MD = 3.07; 95% CI: 2.23 to 3.91; ηp = 0.642). No serious adverse events were reported. CONCLUSIONS: Sensorimotor exercise (CMEP-I) showed greater benefits across all outcomes compared with the strengthening exercise (CMEP-II). These findings support the inclusion of sensorimotor CMEPs in community health initiatives as accessible, low-cost strategies for promoting independence and healthy aging in resource-limited settings. TRIAL REGISTRATION: This trial is registered prospectively in the Clinical Trials Registry-India CTRI/2025/03/083260 (Registered on 24/03/2025).
Implementing a lifestyle toolkit in individuals with cardiometabolic multimorbidity: study protocol for a cluster randomised, type III effectiveness-implementation trial (SHRADDHA-CMM).
Sreedevi A, Janakiram C, Sasidharan N … +18 more , Menon VB, Cs D, Nair VG, Ms A, Gopal B, Numpeli M, Krishnan A, Rajeev J, Mini M, Balachandran P, Gutjahr G, Morisky P, Marten R, Loffredo G, Kunwar A, Rehman T, Pati S, Menon JC
Trials · 2026 Jun · PMID 42231468 · Full text
Lifestyle modification, including dietary interventions, physical activity, and stress management, has proven crucial in the non-pharmacological management of cardiometabolic diseases. However, the implementation of thes...
Lifestyle modification, including dietary interventions, physical activity, and stress management, has proven crucial in the non-pharmacological management of cardiometabolic diseases. However, the implementation of these interventions in the context of cardiometabolic multimorbidity (CMM) within the unique demographic and cultural milieu of India is inadequately explored, despite Indians exhibiting distinct susceptibility to cardiovascular diseases. This community-based study aims to address existing knowledge gaps by implementing a culturally tailored lifestyle toolkit based on the WHO-HEARTS framework among individuals with CMM and exploring the intergenerational preventive dimension. The study adopts a two-arm non-blinded cluster randomised controlled trial (c-RCT) design to include adults diagnosed with CMM, defined by the presence of two or more of diabetes mellitus, hypertension, stroke, or coronary heart disease, aged 18 years and above, providing informed consent, and agreeing to follow-up. The trial spans the 'Epidemiology of Non-communicable Diseases In Rural Areas' (ENDIRA) cohort in Ernakulam, Kerala. The intervention, 'SHRADDHA lifestyle toolkit', integrates guidance on diet, physical activity, stress management, tobacco and alcohol cessation, and drug adherence. It leverages frontline health workers and a digital health platform for implementation. Measurements involve use of point-of-care devices and digital tools. The study duration is 24 months, with a sample size of 2000 participants distributed across 18 clusters. Statistical analysis includes repeated-measures ANOVA and multilevel models, employing an intention-to-treat approach. The study's novelty lies in its holistic approach, addressing various facets of CMM comprehensively.Trial registration: The trial has been registered with the Clinical Trial Registry of India (CTRI) Reference Number-CTRI/2025/08/092529. Registered on August 6, 2025.
Three cluster randomised controlled trials in Portugal, Czechia and the United Kingdom to test the effectiveness and cost-effectiveness of an augmented social play intervention in schools to support real-world connection and sense of belonging (Lina trial protocol).
Malhotra T, Qureshi O, Barnard A … +16 more , Bird VJ, Brás P, Coelho VA, Fulop A, Feng Y, Hunčík T, Marchante M, McNamee P, Mittmann G, Mokaya N, Petřeková A, Primor AC, Šašinka Č, Šašinková A, Stuart B, Woodcock KA
Trials · 2026 Jun · PMID 42231355 · Full text
BACKGROUND: Mental ill-health and loneliness represent major challenges for today's youth, exacerbated by unprecedented societal demands, including concurrent socialisation in physical and digital worlds. A strong sense...
BACKGROUND: Mental ill-health and loneliness represent major challenges for today's youth, exacerbated by unprecedented societal demands, including concurrent socialisation in physical and digital worlds. A strong sense of belonging can buffer against these challenges, and in adolescents is largely constituted in schools. Augmented Social Play (ASP) involves smartphone-led cooperative face-to-face gameplay which integrates immersive storytelling, augmented reality, and evidence-based psychology to strengthen belonging. Building on this foundation, Lina is a multi-session intervention designed for classroom-based delivery during routine school lessons. METHODS: Three parallel hybrid type II cluster pragmatic randomised controlled trials will be conducted in secondary schools in Czechia, Portugal and the UK. The independently powered and analysed trials will examine the effectiveness of Lina-compared to standard lessons-in strengthening classroom belonging, reducing symptoms of mental ill-health and improving wellbeing, loneliness and stigma. Forty classes of students whose modal age is 12-13 years will participate in each country. Effectiveness will be examined on completion of Lina and after 6 months, using the student-report Delaware School Climate Survey, the Social Anxiety Scale for Adolescents, the Patient Health Questionnaire-8, the Social Awareness subscale of the Social-Emotional Learning Edition of the Strengths and Difficulties Inventory System, the WHO-5 Well-being Index, the UCLA Loneliness Scale and a tailored version of the Peer Mental Health Stigmatisation Scale-Revised. To examine cost-effectiveness, quality of life will be measured in a corresponding manner, using the Child Health Utility 9D and the EQ-5D-Y-3L, and analysed alongside bespoke resource-use inventories, completed via teachers and/or school records. An embedded developmental evaluation of implementation will draw on researcher observations of Lina, teacher-reported Feasibility, Acceptability and Appropriateness of Intervention questionnaires and teacher focus groups. A second developmental phase of implementation evaluation will follow the effectiveness trial, while control classes do Lina with their teachers. An integrated qualitative evaluation will examine students' experiences of Lina using individual interviews and focus groups, including a particular focus on students with characteristics that put their sense of belonging at risk. DISCUSSION: Findings will speak to the potential impact of Lina on youth mental health. They will also inform Lina implementation guidance for diverse national and international school contexts. TRIAL REGISTRY INFORMATION: This trial is prospectively registered with ISRCTN (Identifier: ISRCTN11613092), registered on 15 September 2025, https://doi.org/10.1186/ISRCTN11613092.
Full-thickness versus rectal suction biopsy for the diagnosis of Hirschsprung's disease: study protocol for a prospective, randomized open-label, within-patient crossover trail.
Bjørn N, Madsen G, Nielsen RG … +3 more , Pedersen AK, Qvist N, Ellebæk MB
Trials · 2026 May · PMID 42218492 · Full text
BACKGROUND: Hirschsprung disease (HD) is a congenital malformation characterized by the absence of ganglion cells in the bowel wall. The aganglionosis extends from the rectum and proximally into the gastrointestinal trac...
BACKGROUND: Hirschsprung disease (HD) is a congenital malformation characterized by the absence of ganglion cells in the bowel wall. The aganglionosis extends from the rectum and proximally into the gastrointestinal tract in various lengths. The diagnosis relies on histological examination of rectal biopsies. Two main biopsy techniques: rectal suction biopsy (RSB) or full-thickness biopsy (FTB) are available. They differ in the degree of invasiveness, postoperative complications and diagnostic accuracy. METHODS: This is a prospective trial including 300 patients aged 0-17 years scheduled for rectal biopsy on the suspicion of HD. Each patient will undergo both RSB and FTB and thus serve as its own control. The sequence of histological analysis of RSB and FTB will be randomized. The primary objective is to compare the diagnostic performance of FTB and RSB in children evaluated for Hirschsprung's disease. Specifically, the aim is to assess how effectively each technique obtains adequate tissue samples for nerve cell evaluation and to compare the rates of inconclusive biopsies associated with each method. The secondary objective is to evaluate the concordance to the National Institute for Health and Care Excellence (NICE) symptom-based criteria for rectal biopsy in children with severe constipation. DISCUSSION: The findings from the BIOPSY-STUDY are expected to provide high-quality evidence to guide biopsy selection in suspected Hirschsprung's disease. By directly comparing RSB and FTB within the same patients, the study aims to clarify diagnostic accuracy, reduce inconclusive results, and support more efficient, cost-effective clinical pathways. Despite being single-center, the rigorous design enhances internal validity and clinical relevance. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov NCT05307419. Registered on April 01, 2022.
A culturally adapted online Mediterranean diet intervention for metabolic dysfunction-associated steatotic liver disease (TIMA): study protocol for a randomized controlled trial.
Lin YC, Wang JR, Su TC … +19 more , Chen YJ, Lien HC, George ES, Yang LY, Hsiao TH, Lin HY, Wang YC, Tsai HJ, Chen CC, Lu IT, Lee SW, Chen YY, Liao YJ, Lin WT, Tung CF, Liao SC, Cheng HE, Peng YC, Lee TY
Trials · 2026 May · PMID 42216178 · Full text
BACKGROUND: The Mediterranean diet (MedDiet) is widely recognized for its beneficial effects on hepatic steatosis. However, optimal strategies to support dietary adherence among patients with metabolic dysfunction-associ...
BACKGROUND: The Mediterranean diet (MedDiet) is widely recognized for its beneficial effects on hepatic steatosis. However, optimal strategies to support dietary adherence among patients with metabolic dysfunction-associated steatotic liver disease (MASLD), particularly in non-Mediterranean regions where the MedDiet is not habitual, remain underexplored. OBJECTIVE: To evaluate the effectiveness of a culturally adapted MedDiet for MASLD through the implementation of real-time video counseling combined with behavior change techniques (BCTs). METHODS: This is a 12-week, single-center, two-arm, parallel-group randomized controlled trial registered at ClinicalTrials.gov (identifier: NCT06503120). Adults who fulfill the clinical diagnosis of MASLD and have ≥ 5% hepatic fat content on MRI-PDFF will be randomly assigned to receive either an isocaloric culturally adapted MedDiet intervention or standard care. The intervention comprises two components. First, participants will receive four structured real-time video counseling sessions (15-20 min each) at weeks 0, 3, 6, and 9. These sessions will be delivered by a registered dietitian via an online platform, guided by each participant's 3-day photographic food diary and a Taiwanese version Mediterranean Diet Adherence Screener scores to provide personalized dietary advice. Second, participants will receive weekly text messages underpinned by BCTs to address individual dietary gaps and reinforce adherence. The primary outcome is the relative change in intrahepatic fat content, assessed by MRI-PDFF at week 12. Secondary outcomes include the changes in liver enzymes, lipid profile, liver stiffness, serum metabolites, gut microbiota composition, dietary adherence, quality of life, and anthropometric measures. DISCUSSION: This is the first randomized controlled trial to evaluate a fully remote, dietitian-led culturally adapted MedDiet intervention using real-time video counseling and text-based BCTs in patients with MASLD. This approach may support scalable, patient-centered dietary strategies for improving liver and metabolic health in this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT06503120. Registered on July 9, 2024.
Aerobic exercise as a therapeutic intervention for post-traumatic stress disorder in women who have experienced intimate partner violence: study protocol for an open-label randomised controlled trial.
Copas C, Knight JM, Griffith S … +7 more , Astridge A, Martins BD, McDonald SJ, Chen Z, O'Brien TJ, Shultz SR, Symons GF
Trials · 2026 May · PMID 42216059 · Full text
BACKGROUND: Women with a history of intimate partner violence (IPV) are at risk for post-traumatic stress disorder (PTSD). The effectiveness of aerobic exercise in reducing PTSD symptom burden has been established in oth...
BACKGROUND: Women with a history of intimate partner violence (IPV) are at risk for post-traumatic stress disorder (PTSD). The effectiveness of aerobic exercise in reducing PTSD symptom burden has been established in other patient populations; however, its utility in the context of IPV victim-survivors has received little investigation. Therefore, the primary aim of this study is to determine if 4 weeks of daily structured aerobic exercise compared to daily stretching can reduce PTSD symptom burden in women IPV victim-survivors, offering a potential accessible and self-directed treatment avenue. METHODS: The target sample size of 120 women (aged 18-70) with a history of IPV (last instance > 3 months ago) and probable PTSD (via the PTSD Checklist for DSM-5; PCL-5) will be recruited via community advertisement in Melbourne, Australia. The trial will be completed at the Alfred Centre, Monash University. Participants will complete an exercise tolerance test via the Buffalo Concussion Bike Test and then will be randomised into either aerobic exercise or passive stretching. Participants will be instructed to complete 20 min of allocated aerobic exercise or stretching for 4 weeks and given a written diary and a Fitbit smartwatch to track program adherence. The primary outcome, PTSD symptoms via the PCL-5, will be collected at baseline, 1, 2, 3, and 4 weeks (primary endpoint). Secondary outcomes, including additional determinants of health (i.e. sleep, pain, substance use), cognitive testing, concussion-like symptoms in participants with a history of IPV-related brain injury, blood-based biomarkers, and feasibility and adherence to the prescribed program, will also be collected weekly at baseline, 1-, 2-, 3-, and 4-week follow-ups. DISCUSSION: This trial is an open-label randomised controlled trial to compare the effectiveness of a structured aerobic exercise program to passive stretching in women victim-survivors of IPV with probable PTSD. Results from this trial will help guide the development of individualised, financially accessible, and self-directed care plans for women living with PTSD and other persisting mental and physical health impacts of IPV. TRIAL REGISTRATION: ACTRN12624000893505. Trial registered retrospectively. Registered on 22/07/2024. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12624000893505.
Effects of device-based and manual sensory acuity training on nonspecific chronic low back pain: a three-arm randomized controlled trial protocol.
Gurluk A, Saribas PK, Ozkocak G … +2 more , Tarakci D, Hocaoglu E
Trials · 2026 May · PMID 42210430 · Full text
BACKGROUND: Nonspecific chronic low back pain (NCLBP) is a prevalent and disabling condition often associated with impaired sensory discrimination and altered cortical representation. Sensory acuity training (SAT) has em...
BACKGROUND: Nonspecific chronic low back pain (NCLBP) is a prevalent and disabling condition often associated with impaired sensory discrimination and altered cortical representation. Sensory acuity training (SAT) has emerged as a promising strategy to target these neurophysiological mechanisms; however, the comparative effectiveness of technology-based versus manual sensory acuity interventions remains unclear. This protocol comprises a three-arm, randomized controlled trial designed to evaluate the effects of technology-based and manual SAT, in addition to conventional physiotherapy, compared with conventional physiotherapy alone, on pain and sensory discrimination performance in individuals with NCLBP. METHODS: This single-blind, three-arm parallel randomized controlled trial will recruit 66 adults with NCLBP (> 3 months). Participants will be randomly allocated (1:1:1) to the technology-based SAT, the manual SAT, or a control group. All participants will also receive 30 min of conventional physiotherapy, three times per week for 4 weeks. A blinded assessor will conduct evaluations at baseline, post-intervention, and follow-up. Primary outcomes include pain intensity measured by the visual analog scale, disability evaluated using the Roland-Morris Disability Questionnaire, manual two-point discrimination testing, and sensory acuity performance assessed through TactiPain parameters. Secondary outcomes include pressure pain threshold, joint position sense, laterality performance, central sensitization levels, fear of movement, pain catastrophizing, lumbar body awareness, and quality of life. DISCUSSION: This trial aims to provide high-quality evidence on whether technology-based SAT offers additional benefits compared with manual SAT or a control intervention. By addressing cortical- and sensory-based mechanisms underlying NCLBP, this study may inform the development of more targeted rehabilitation strategies, contribute to clinical decision-making, and guide future research on technology-assisted approaches in musculoskeletal pain rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov NCT07277803. Registered on December 2025.
Community-engaged participatory methods for embedding equity in trial design.
Svobodova M, Jacob N, Robinson CL … +11 more , Thomas B, Bryan H, Segrott J, Bridges S, Din M, Herbert A, Hamad I, Ilias AH, Zhang R, Bandyopadhyay S, Hayan K
Trials · 2026 May · PMID 42210404 · Full text
BACKGROUND: Certain populations are consistently under-represented in randomised controlled trials (RCTs), including people from minority ethnic backgrounds and those experiencing socioeconomic disadvantage, language bar...
BACKGROUND: Certain populations are consistently under-represented in randomised controlled trials (RCTs), including people from minority ethnic backgrounds and those experiencing socioeconomic disadvantage, language barriers, or marginalisation within health systems. This under-representation contributes to widening health inequities. While UK guidance such as the National Institute for Health and Care Research INCLUDE resources supports more inclusive research, practical methodologies for embedding equity in trial design remain limited. This paper draws on two linked public involvement projects: Talking Trials (2021-2023), working with ethnically diverse urban communities in Cardiff, and Let's Talk Research (2025), working with residents in a socioeconomically disadvantaged rural Welsh community. METHODS: Both projects used participatory methods including arts-based activities, deliberative dialogue, and co-production. Talking Trials incorporated thematic analysis of workshop reflections; both projects generated learning through reflective discussions with community partners. RESULTS: Community-based public contributors identified features that made research feel relevant and equitable: trusted relationships, time for dialogue, and support to understand complex concepts. Creative and dialogue-based approaches made research concepts accessible, reduced power imbalances, and supported contributors to move from unfamiliarity to active involvement. Sustained structures, such as advisory groups and community connectors, were important for maintaining trust and enabling continued engagement. Context strongly shaped involvement, with different forms of disadvantage requiring different types of support. CONCLUSIONS: Community-engaged, arts-based, and context-sensitive methods can meaningfully enhance equity in trial design. Embedding involvement early, investing in trusted partnerships, and sustaining long-term structures support more relevant, acceptable, and inclusive trials. These findings offer practical methodologies for trial teams seeking to embed equity from the outset.
Study protocol of a randomized controlled trial on the effectiveness of animated storytelling videos in reducing body image dissatisfaction among adolescents.
Liu L, Yang J, Tan F … +2 more , Chen Y, Zhao X
Trials · 2026 May · PMID 42210319 · Full text
INTRODUCTION: Body image dissatisfaction is a concern that affects individuals of all ages, particularly adolescents. Research has demonstrated that such dissatisfaction can lead to a range of psychological and behaviour...
INTRODUCTION: Body image dissatisfaction is a concern that affects individuals of all ages, particularly adolescents. Research has demonstrated that such dissatisfaction can lead to a range of psychological and behavioural issues. In China, societal beauty standards often emphasize ideals such as "thinness as beauty" and "fair skin covering a hundred flaws," which contribute to widespread body image dissatisfaction. There is a notable lack of effective, adolescent-friendly interventions that can be widely implemented in China. This project presents a protocol for a program designed to promote a positive body image among adolescents. METHODS: A two-armed randomised controlled trial is designed to evaluate the effectiveness of the Body-Bright Program. Adolescents aged 15-19 years, recruited through posters, were screened for body image dissatisfaction and then allocated to either the intervention group or the control group. Participants in the intervention group will receive the Body-Bright Program, which includes an animated storytelling video lasting 3-4 min, followed by guided discussions and a homework assignment of diary writing. Participants in the control group watch animations unrelated to body image. The intervention is conducted weekly at school by two licensed psychologists over 3 weeks. The primary outcome is body image satisfaction, and the secondary outcomes include appearance comparison, self-esteem, appearance anxiety, and media influence. These outcomes are evaluated at four time points: pre-test, post-test, and follow-ups at 1 month and 3 months. DISCUSSION: This research aims to develop evidence-based animated storytelling videos for addressing body image dissatisfaction, providing support for interventions that are accessible, scalable, and cost-effective. The Body-Bright Program will be shared with psychologists, teachers, and parents, as well as communicated to the public and health organizations responsible for recommending treatments and establishing mental health guidelines for adolescents. TRIAL REGISTRATION: This trial was registered at the Chinese Clinical Trials Registry (ChiCTR2500102732; www.chictr.org.cn ; Registration Date 19th May 2025).
Correction: Working to Increase Stability through Exercise (WISE): screening, recruitment, and baseline characteristics.
Sciamanna CN, Ballentine NH, Bopp M … +19 more , Chinchilli VM, Ciccolo JT, Delauter G, Fisher A, Fox EJ, De Beur SMJ, Kearcher K, Kraschnewski JL, Lehman E, McTigue KM, McAuley E, Paranjape A, Rodriguez-Colon S, Rovniak LS, Rutt K, Smyth JM, Stewart KJ, Stuckey HL, Tsay A
Trials · 2026 May · PMID 42210237 · Full text
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The VIA Family 2.0 study: a randomized clinical trial evaluating a family-based intervention for children born to parents with mental illnesses-study protocol.
Heuckendorff S, Ranning A, Ingversen S … +12 more , Vinding R, Bärs EM, Forman J, Müller AD, Hjorthøj C, Moszkowicz M, Kristensen JS, Lauritsen MB, Sandberg J, Eplov LF, Nordentoft M, Thorup AAE
Trials · 2026 May · PMID 42192567 · Full text
BACKGROUND: Children of parents with mental illness face significant increased risks of developing mental health problems and experiencing developmental delays or other negative life outcomes due to genetic and environme...
BACKGROUND: Children of parents with mental illness face significant increased risks of developing mental health problems and experiencing developmental delays or other negative life outcomes due to genetic and environmental factors. Parental symptoms often disrupt caregiving, leading to family stress, inadequate routines, and insufficient stimulation and support in the home. Research, including findings from the Danish High Risk and Resilience Study, the VIA cohort, has shown substantial developmental, social, and cognitive challenges in these children. This study aims to evaluate the efficacy of a team-based, multidisciplinary preventive intervention compared with standard treatment for families with recent parental mental illness via a series of predefined outcome measures. METHODS/DESIGN: This randomized controlled trial, VIA Family 2.0, includes 304 children aged 3-17 years and 128 children aged 0-2 years with a parent with a psychiatric diagnosis and having received treatment within the past three years. The families will be assessed at baseline and thereafter randomized to either treatment as usual or VIA Family 2.0 intervention. The intervention group will be assigned to a multidisciplinary team with expertise from municipal services, child and adolescent psychiatry, and adult psychiatry. A case manager coordinates all the elements and supports the family with their challenges, on the basis of their own motivation. The study period is 24 months, and all participants will be assessed at baseline and after 24 months. The primary outcomes are cognitive, language and motor development for infants and toddlers aged 0-2 years (Bayley-4, Bayley Scales of Infant and Toddler Development), well-being and behavioral and social development for children aged 3-17 years (the Strengths and Difficulties Questionnaire (SDQ)), perceived parental stress for parents (Parental Stress Scale, PSS), and family functioning for the family (Family Assessment Device, FAD). DISCUSSION: This study examines the impact of a cross-sectoral intervention that integrates expertise across sectors. This study contributes critical knowledge about whether improving family resilience, supporting children's development, and reducing risk loads through holistic family support is possible. This research highlights the potential of preventive public health initiatives to promote well-being and reduce long-term adverse outcomes in a high-risk group of children and adolescents. TRIAL REGISTRATION: The study is registered at ClinicalTrials.Gov (NCT06312410) on March 15, 2024.
A randomized, double-blind, controlled, parallel group study with amustaline/glutathione pathogen reduced red blood cells in regions at potential risk for Zika virus transfusion-transmitted infections (RedeS Study)-protocol for a phase 3 clinical trial.
Ayala EFC, Colon LV, Aydinok Y … +21 more , Arboleda-Osorio B, Bracey A, Fasano R, Yee M, Sarode R, Zubair AC, Nizzi F, Shah S, Snyder EL, Treml A, Zheng Y, Takemoto C, Green J, Jackson B, Pitman JP, Gniadek TJ, Liu K, Bentow S, Corash L, Mufti N, Benjamin RJ
Trials · 2026 May · PMID 42186075 · Full text
BACKGROUND: Red blood cell (RBC) transfusion may be lifesaving, however transfusion-transmitted infections (TTI) and transfusion-associated graft-versus-host disease (TA-GVHD) still pose a threat despite current donor se...
BACKGROUND: Red blood cell (RBC) transfusion may be lifesaving, however transfusion-transmitted infections (TTI) and transfusion-associated graft-versus-host disease (TA-GVHD) still pose a threat despite current donor selection and testing requirements. Amustaline (S-303)/glutathione (GSH) pathogen reduction (PR) is designed to inactivate infectious microbes and leukocytes in RBCs. The RedeS study evaluates the safety and efficacy of amustaline/GSH PR-RBCs compared to conventional RBCs in a broad spectrum of patients requiring acute and/or repeated RBC transfusion support. METHODS: RedeS is a Phase 3, prospective, multi-center, randomized, double-blind, active-controlled, parallel-design study, with a 6-month extension option to evaluate patients requiring repeated transfusions including red cell exchange (RCE). Eligible subjects will be stratified according to site, baseline bleeding status and participation in the extension period. The study arms include a transfusion period of 28-days for anemia with any bleeding or non-bleeding patients or a 28-day + 6-month extension for non-bleeding patients with chronic anemia requiring repeated simple transfusions, or for patients with sickle cell disease (SCD) expected to receive three RCE procedures. The study will seek to enroll 600-800 subjects in the overall safety analysis, including ~ 140 repeatedly-transfused subjects in the 6-month extension including up to 30 subjects receiving three RCE procedures. The primary safety endpoints are the proportion of patients with any treatment-emergent adverse events (TEAEs) related to study RBC transfusion through 28 days after the last study transfusion, and the proportion of patients with treatment-emergent antibodies with confirmed specificity to PR-RBCs. The primary efficacy endpoint is the hemoglobin (Hb) increment in subjects who are non-bleeding at baseline, adjusted for the grams of Hb transfused and averaged over multiple transfusions. With 352 evaluable transfused non-bleeding subjects (176 per treatment group) from either arm, the study will have 80% power to demonstrate non-inferiority, defined as a Hb increment treatment difference of no more than 15% of the Control group mean, assuming a Control arm coefficient of variation of 50%. DISCUSSION: RedeS will characterize the safety of amustaline/GSH PR-RBCs and is designed to demonstrate the non-inferiority of PR-RBCs to conventional RBCs with respect to Hb increment, a common pragmatic clinical assessment of RBC transfusion effectiveness. TRIAL REGISTRATION: A Randomized, Double-Blind, Controlled, Parallel Group Study with the INTERCEPT Blood System for red blood cells in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections (RedeS Study). CLINICALTRIALS: gov ID NCT03037164. Registered on 27 January 2017 at https://clinicaltrials.gov/ct2/show/NCT03037164.
Effectiveness of transcutaneous spinal direct current stimulation combined with exercise training in patients with anterior cruciate ligament reconstruction: study protocol for a randomized controlled trial.
Ma J, Chen L, Tong S … +11 more , Li G, Wu S, Luo Q, Yang X, Li H, Xiong J, Hong C, Duan C, Fu D, Tang P, Hou J
Trials · 2026 May · PMID 42186052 · Full text
BACKGROUND: Current standardized rehabilitation protocols for anterior cruciate ligament reconstruction (ACLR) often fail to fully resolve functional deficits arising from initial injury and subsequent surgery. These lin...
BACKGROUND: Current standardized rehabilitation protocols for anterior cruciate ligament reconstruction (ACLR) often fail to fully resolve functional deficits arising from initial injury and subsequent surgery. These lingering issues are tied to neural impairments such as reduced corticospinal excitability and weakened motor cortex activation, which disrupt sensorimotor signal transmission, impair motor control, and hinder recovery even after post-operative rehabilitation. Growing evidence suggests that advancing post-ACLR care should synchronize the normalization of neural pathways with peripheral musculoskeletal recovery. Transcutaneous spinal direct current stimulation (tsDCS), an emerging non-invasive neuromodulatory technique, can modulate neural function and enhance motor performance. This study aims to investigate the safety and efficacy of interventions that combine simultaneous exercise with tsDCS in the rehabilitation of patients following ACLR. METHODS: This study will be a double-blind, randomized controlled trial with a two-arm parallel-group design and a 1:1 allocation ratio. All participants get routine rehabilitation. Patients will remain supine during stimulation, with a total duration of 20 min and a constant current of 2.0 mA. The experimental group receives tsDCS plus exercise training, with cathode at T10 spinous process and anode at uninjured deltoid. During tsDCS, they perform straight leg raises with the reconstructed limb. The control group gets sham stimulation plus exercise training. The primary outcome is the Knee Injury and Osteoarthritis Outcome Score at 18 months post-surgery. This study explores the effect of tsDCS intervention on early corticospinal excitability in post-ACLR patients, with indicators measured via transcranial magnetic stimulation. The secondary outcomes include self-reported measures such as pain, sports psychology, motor function and quality of life, as well as objective assessments such as range of motion, muscle strength, muscle endurance, gait, balance, proprioception, stability and cerebral function changes. DISCUSSION: This study addresses a critical gap in ACLR rehabilitation, as standardized protocols often overlook neural impairments linked to persistent functional deficits. The combined intervention of tsDCS and exercise training is expected to promote accelerated rehabilitation after ACLR. This study offers guidance for optimizing neuromodulatory strategies in orthopedic rehabilitation. TRIAL REGISTRATION: ChiCTR ChiCTR2400079530. Registered on 05 January 2024. https://www.chictr.org.cn/showproj.html?proj=216406 .
Circulating tumor DNA-based assessment of disease progression after liver resection or transplantation for metastatic colorectal cancer or hepatocellular carcinoma-study protocol for a randomized, controlled trial.
Górzyńska I, Kornasiewicz O, Koniczka A … +7 more , Moskowicz A, Skubisz K, Pepłowski J, Lesiak A, Stokłosa T, Wójcicka A, Grąt M
Trials · 2026 May · PMID 42185926 · Full text
BACKGROUND/AIM: Hepatocellular carcinoma (HCC) and colorectal cancer liver metastases (CRLM) carry high recurrence rates after surgery or transplantation. Conventional imaging and biomarkers have limited sensitivity for...
BACKGROUND/AIM: Hepatocellular carcinoma (HCC) and colorectal cancer liver metastases (CRLM) carry high recurrence rates after surgery or transplantation. Conventional imaging and biomarkers have limited sensitivity for detecting minimal residual disease (MRD). Circulating tumor DNA (ctDNA) is a promising biomarker that may enable earlier recurrence detection compared with standard methods. The aim of this randomized controlled trial is to evaluate the clinical utility of ctDNA monitoring in the early detection of disease recurrence and its impact on monitoring progression in patients undergoing liver resection or transplantation for HCC and CRLM. METHODS: This randomized, controlled trial will enroll 300 patients undergoing liver resection or transplantation for CRLM or HCC. Participants will be randomized 2:1 to ctDNA monitoring or standard follow-up. ctDNA will be analyzed at three predefined time points (baseline, 1 month, and 6 months postoperatively) and compared with tumor tissue mutation profiles generated by next-generation sequencing (NGS). All patients will be followed for 24 months with imaging, tumor markers, and quality-of-life assessments. The primary endpoint is ctDNA-defined recurrence. Secondary endpoints include recurrence-free survival, overall survival, time to recurrence detection, patient-reported outcomes, and cost-effectiveness. DISCUSSION: This study will assess whether ctDNA-guided monitoring enables earlier recurrence detection and improves clinical decision-making after liver resection or transplantation. Incorporating ctDNA into surveillance may support earlier therapeutic intervention, optimize follow-up strategies, and enhance long-term outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT07001085. Registered on 2025.
Identifying underrepresented groups in oncology clinical trials using routinely collected data in an English academic trial setting.
Synesi G, Lewis R, Kilburn L … +2 more , Bliss J, Hall E
Trials · 2026 May · PMID 42177546 · Full text
BACKGROUND: To facilitate equitable access to novel treatments, cancer trial participants should represent as far as possible those that will receive the treatment in practice. We can identify groups who rarely participa...
BACKGROUND: To facilitate equitable access to novel treatments, cancer trial participants should represent as far as possible those that will receive the treatment in practice. We can identify groups who rarely participate in cancer trials by collecting demographic data from participants. In the UK, there is no standardised practice around demographic data capture, leading to inconsistent collection across trials. A lack of systematically collected and published quantitative data from participants in UK cancer trials may limit our ability to identify underrepresented groups. METHODS: We reviewed availability and completeness of demographic data recorded from 2235 participants in six bladder and six head and neck cancer trials conducted by the Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU) between 2001 and 2023. To assess the representativeness of trial populations, demographic data from trial participants were compared with published data (NHS Digital) from 260,350 people who were treated for these cancers between 2013 and 2022 in England, using chi-squared goodness-of-fit tests and one-sample tests of proportion. A survey was distributed to 12 clinical trials units conducting similar trials to establish which demographic data are routinely collected across the UK. RESULTS: Data on ethnicity, postcode, smoking status, and co-morbidity burden were inconsistently captured across ICR-CTSU trials, with missing data. Amongst the overall trial population, people older than 80 (n = 486/2235, 22%), females (n = 466/2235, 21%), people living in the most deprived areas (n = 390/1447, 27%), and ethnic minority groups (n = 5/275, 2%) were underrepresented, with some differences by treatment modality. Responses from UK trial teams showed that aside from age and sex (routinely captured), smoking status was the most consistently captured (13/17 trials). CONCLUSIONS: This study provides quantitative data on cancer trial participants examining several demographic factors and indicates potentially underrepresented groups in trials of the disease subtypes investigated. Missing data were likely observed as a result of data cleaning being focused on items directly addressing the research question. Collecting and analysing a broad range of demographic data with a focus on inclusivity can inform researchers of groups who may benefit from tailored interventions to increase accessibility to cancer trials in the future.
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