Trials最新文献

Background: Benign paroxysmal positional vertigo (BPPV), particularly involving the posterior semicircular canal (PC-BPPV), is the most common peripheral vestibular disorder, characterized by brief episodes of vertigo triggered by positional changes. It affects quality of life, increases fall risk, and restricts daily and occupational activities. Vestibular rehabilitation therapy (VRT) is an exercise-based approach that is commonly used in clinical management. Mobile health-based formats represent a delivery option for vestibular rehabilitation in the management of PC-BPPV, through structured, user-accessible applications such as the Vertigo Coach. The application integrates habituation, gaze stabilization, and balance exercises with progress tracking and educational content and functions as a structured adjunct to canalith repositioning techniques for presenting exercises and documenting usage. Although preliminary studies indicate feasibility, high-quality evidence from randomized controlled trials evaluating smartphone-based vestibular rehabilitation remains limited.

Objective: To evaluate the effects of smartphone-based habituation exercises compared with conventional booklet-based exercises, when combined with CRTs, on dizziness, vertigo severity, and quality of life in individuals with PC-BPPV.

Methods: A single-blind, two-arm parallel-group randomized controlled trial will be conducted with 84 participants aged 18-65 years diagnosed with PC-BPPV. Participants will be randomized into two groups: Group A (n = 43) will receive a printed instructional booklet, and Group B (n = 43) will use the Vertigo Coach smartphone application. Both groups will receive standardized CRTs. A 6-week VRT program will be delivered in the assigned format, with assessments at baseline, 3 weeks, and 6 weeks. Primary outcomes include dizziness severity, vertigo-related disability, and quality of life, measured using validated tools.

Discussion: Mobile health-based formats may provide an alternative method for delivering vestibular rehabilitation in the management of PC-BPPV. This trial will examine whether app-based VRT produces comparable or differential effects relative to booklet-based home programs when administered with CRTs. The findings may inform the use of digital formats for vestibular rehabilitation by providing data on feasibility, symptom change, and user-reported outcomes. Such approaches may offer structured home-based exercise information and facilitate access to rehabilitation resources.

Ethics and dissemination: The trial has been reviewed and approved by the Institutional Ethics Committee (reference no. DMIHER (DU)/IEC/2025/628).

Trial registration number: CTRI/2025/03/083581. Registered on April 2nd 2025.

Background: Heart failure (HF) is a chronic condition characterized by significant functional limitations, with exercise intolerance as a major determinant of reduced quality of life. Supervised aerobic exercise is a core intervention in cardiac rehabilitation, yet adherence and tolerance may be hindered by physical and motivational factors. Immersive technologies such as virtual reality (VR) have shown potential to increase engagement and positive perceptions during exercise. This study aims to evaluate the influence of VR on tolerance to cycle-ergometer aerobic exercise in hospitalized patients with HF.

Methods: We will conduct a randomized, controlled, parallel-group trial with 1:1 allocation. Adult inpatients with a diagnosis of HF will be screened for eligibility and randomly assigned to two groups: control (cycle-ergometer aerobic exercise) and intervention (the same exercise combined with an Meta Quest 2 VR device). Each participant will complete a single session of up to 20 min, consisting of five blocks of 3 min of continuous pedaling interspersed with one-minute passive rests, with early termination in case of intolerance. The primary outcome is effective exercise time (minutes) until interruption due to physical limitation or symptoms. Secondary outcomes include rating of perceived exertion, hemodynamic parameters, exercise enjoyment (PACES) and usability of the technology (SUS, intervention group only).

Discussion: This study will investigate whether VR can improve tolerance to aerobic exercise during hospitalization for HF, potentially providing preliminary evidence to guide the use of immersive technologies in cardiac rehabilitation. If benefits are observed, VR could be incorporated as a complementary tool to optimize adherence, motivation and safety in supervised exercise programs in this clinical context.

Trial registration: The trial was registered in the Brazilian Clinical Trials Registry (ReBEC), under the identifier RBR-4hrmkzz, on March 11, 2022.

Background: This protocol was developed to describe the design of a randomised controlled trial that will examine the clinical efficacy of a 4-week comparison of high-intensity vs. low-intensity physical training for people suffering from anxiety. The hypothesis is that the high-intensity group will have greater benefit in terms of reduced anxiety symptoms, improved physical health (blood pressure) and better adherence.

Methods: Thirty adults aged 18 to 70 years diagnosed with an anxiety disorder will be recruited for this study. Participants will be randomised into an intervention group (high-intensity training) and a control group (low-intensity training). Randomisation will be performed using counterbalanced block randomisation in a 1:1 ratio, stratified by sex. Both groups will perform 4 weeks of twice-weekly training supervised by an exercise physiologist. The primary outcome will be the total score on the Hospital Anxiety and Depression Scale (HADS) and the total score on the Beck Anxiety Inventory (BAI). The secondary outcomes include blood-pressure changes and adherence. Evaluations will be performed at baseline and following 4 weeks of the interventions, and 6 months after the termination of the intervention period (secondary endpoint).

Discussion: By investigating the clinical efficacy of a 4-week training intervention, we hope to provide applicable and generalisable knowledge about the efficacy of physical training for people suffering from anxiety disorders.

Trial registration: Clinical Trials NCT06881758 . Registered on 17 March 2025.

Background: Cardiovascular and cerebrovascular diseases are the leading causes of death in the Chinese population, and hypertension is one of the key risk factors. However, the blood pressure control rate of hypertensive patients is low at present. The main factors include the limited capacity of primary care workers and poor self-management among hypertensives. The purpose of this program is to use a clinical decision support system (CDSS) and an Internet of Things-based comprehensive hypertension management system (CATCH) to provide decision support for the diagnosis and treatment of hypertension for primary care clinicians and to improve the standardisation of the diagnosis, monitoring, treatment, and continuous management of hypertension among them.

Methods: This study is a stepped wedge cluster randomised controlled trial conducted in 12 community health centres in the Third People's Hospital of Longgang District, Shenzhen City, China. All participants who are registered in the community and with systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg at the screening clinic will be asked to participate in the study. The intervention is a CATCH composite of a hypertension auxiliary decision-making module, clinical diagnosis and treatment knowledge education system, and quality control system. All 12 clusters will be divided into 4 clusters and 5 stages according to a randomised method, with each stage lasting 3 months, ensuring that the entire trial will be completed within 12 months.

Discussion: The CATCH trial uses CDSS and IoT to improve hypertension management in primary care. This stepped wedge trial enhances guideline adherence and patient outcomes through remote monitoring and quality control. All centres receive the intervention, ensuring equitable access to it. Results will guide future hypertension strategies.

Trial registration: The trial was registered at the National Medical Research Registration and Record Filing Information System of China in December 2024, was retrospectively registered at the Chinese Clinical Trial Registry (ChiCTR) (Registration number: ChiCTR2500098845) https://www.chictr.org.cn/.

Background: Major depressive disorder is a leading cause of disability worldwide, with treatment-resistant depression (TRD) affecting approximately one-third of patients and leading to increased morbidity and healthcare costs. Electroconvulsive therapy (ECT) remains a key treatment for TRD, but its efficacy is limited, and it is associated with cognitive side effects and delayed symptom relief. Repetitive transcranial magnetic stimulation (rTMS) shares action mechanisms with ECT and has shown potential in enhancing ECT efficacy in a previous trial. The STIMAGNECT 2 trial aims to evaluate whether an rTMS add-on protocol can improve ECT outcomes in TRD patients after 10 ECT sessions.

Methods: Eighty patients with TRD will be enrolled in a prospective multicentric double-blind randomized controlled trial. All patients will receive a total of 10 ECT sessions. Patients will be randomly assigned to an active or sham rTMS arm. The rTMS protocol (either active or sham) consists of 5 rTMS sessions over 4 days before the beginning of the ECT protocol, with an additional rTMS session the day before each ECT session from the 6th ECT session onward. The main outcome is the response rate following 10 ECT sessions, defined as the proportion of patients achieving a ≥ 50% reduction in their Hamilton Depression Rating Scale (HAMD, 21 items). Secondary outcomes include changes in depression severity (HAMD and QIDS-SR-16) at baseline, during the protocol (Day 4, Day 19, Day 26) and at the end of the protocol, as well as assessment of side effects (adapted UKU), cognitive function (memory, attention, visuospatial abilities, subjective cognitive complaint), autobiographical memory (TEMPau), and ECT session parameters such as seizure characteristics and anesthetic doses. Additionally, potential changes in regional gray matter density, cortical thickness, brain connectivity, and GABA levels will be compared between groups using several magnetic resonance imaging (MRI) sequences (3D, resting-state functional MRI, magnetic resonance spectroscopy).

Discussion: The aim of this trial is to optimize neurostimulation protocols using the synergistic effects of rTMS and ECT in order to improve the treatment of TRD.

Trial registration: ClinicalTrials.gov NCT06391723 Id RCB: 2023-A01813-42. The trial was registered on January 30, 2024.

Background: The high incidence of consciousness disturbance in patients with traumatic brain injury has become a public health and economic concern. Therefore, implementing effective rehabilitation to facilitate awakening in patients with disorders of consciousness is essential. Sensory stimulation, recognized as safe, effective, and affordable, is gaining attention for awakening patients. Additionally, involving family in sensory stimulation is believed to enhance consciousness levels in TBI patients with disorders of consciousness. Thus, we propose a multi-center randomized study to assess the effectiveness of sensory stimulation with family involvement in improving consciousness in TBI patients.

Methods: A multi-center randomized controlled trial with a 3-month follow-up is set in Shanghai and Taicang, Jiangsu, China. Control group participants will receive standard neurosurgical care, whereas the intervention group will get standard care plus a family-involved sensory stimulation program covering vision, hearing, touch, taste, smell, body position, and emotional inputs. The primary outcome is the patient's consciousness level, evaluated using the Glasgow Coma Scale (GCS). The secondary outcomes include the patient's consciousness level (assessed by the Coma Recovery Scale-Revised and the Full Outline of Unresponsiveness score) and the occurrence of complications in patients. Data were collected at baseline (T0) and at 1 week (T1), 1 month (T2), 2 months (T3), and 3 months (T4) from baseline.

Ethics and dissemination: The research protocol was approved by the Ethics Committee of Tongji Hospital of Tongji University, prior to commencement. Informed consent will be obtained from the immediate family members of all participants, as they lack decision-making capacity.

Trials registration: This study was approved by the Ethics Committee of Tongji Hospital of Tongji University (approval number: MR-31-23-050769). And we completed the registration in the Chinese Clinical Trial Registry (approval number: ChiCTR2400080063).