Clinical trials

The goal of this clinical trial is to investigate how a short-term interruption of metformin treatment affects insulin sensitivity, glucose control, and metabolic flexibility in adults with metabolic syndrome who are taking metformin as part of their usual medical treatment. Temporary interruptions in metformin treatment may occur in real-life situations, such as missed doses, medication access problems, travel, or planned short-term discontinuation for clinical reasons. This study aims to understand whether stopping metformin for 14 days leads to rapid changes in glucose metabolism or whether the effects of previous metformin treatment may persist during a short period without the medication. The main questions it aims to answer are: Does stopping metformin for 14 days worsen glucose control or insulin sensitivity measured by oral glucose tolerance tests, HbA1c, and continuous glucose monitoring? Does stopping metformin for 14 days affect metabolic flexibility, measured by indirect calorimetry during the oral glucose tolerance test? Does stopping metformin for 14 days affect blood lipids, liver and inflammatory markers, red blood cell parameters, kidney function markers, fasting lactate levels, blood pressure, or heart rate? Researchers will compare participants who stop metformin for 14 days with participants who continue their usual metformin treatment to see whether temporary metformin discontinuation affects insulin sensitivity, glucose control, metabolic flexibility, and other cardiometabolic markers. Participants in the metformin discontinuation group will stop taking metformin for 14 days. They will attend study visits on day 0, day 4, day 7, and day 14. At each visit, they will complete an oral glucose tolerance test, have blood samples taken, and undergo indirect calorimetry measurements before and after the glucose drink. Blood pressure and heart rate will also be measured during the test. Participants will wear a continuous glucose monitor throughout the 14-day period to track glucose levels and help detect any potentially unsafe increase in blood glucose. Participants in the usual-treatment group will continue taking metformin as prescribed. They will attend study visits on day 0 and day 14. At each visit, they will complete an oral glucose tolerance test, have blood samples taken, and undergo indirect calorimetry, blood pressure, and heart rate measurements during the test. At the study visits, researchers will assess glucose and insulin responses, HbA1c, continuous glucose monitoring data, metabolic flexibility, blood lipid profile, liver and inflammatory markers, red blood cell parameters, kidney function markers, fasting lactate levels, blood pressure, and heart rate.

The REFLEX study is a randomized, controlled clinical trial designed to evaluate the impact of a 16-week supervised, combined exercise program on metabolic flexibility and cardiorespiratory fitness in breast cancer survivors. While cancer treatments have significantly improved survival rates, the disease and its therapies often cause systemic mitochondrial dysfunction and muscle loss. This leads to persistent "metabolic inflexibility"-a reduced ability to efficiently switch between burning carbohydrates and fats for energy. This inflexibility, exacerbated by sedentary behavior and cancer-related fatigue, can severely diminish a patient's functional autonomy and overall quality of life. The trial focuses on assessing whether exercise can restore this metabolic adaptability in women aged 18 to 70 with stage I-III breast cancer who are currently on hormonal treatment and completed neo/adjuvant chemotherapy within the past 6 months. The study operates on the primary hypothesis that an individualized exercise intervention will significantly improve the participants' metabolic flexibility-measured via the metabolic crossover point-and overall aerobic capacity (VO2max) when compared to a control group. Additionally, the trial will analyze secondary outcomes, including changes in cardiovascular and metabolic risk factors, muscle strength, body composition (such as bone mineral density), and patient-reported outcomes assessing quality of life, fatigue, joint pain, anxiety, and depression. A total of 44 participants will be randomly assigned to either the intervention or control group. Participants in the intervention group will complete a 16-week program consisting of two weekly supervised sessions. Each session lasts between 55 and 85 minutes and includes a tailored combination of aerobic and strength training based on the individual's baseline fitness and metabolic thresholds. Participants in the control group. will receive standard educational materials via email, featuring healthy lifestyle and exercise guidelines from the World Health Organization (WHO) and the American College of Sports Medicine (ACSM). To evaluate the program's effectiveness, comprehensive medical and functional assessments will be conducted at baseline, immediately after the 16-week intervention, and at a 3-month follow-up. These evaluations include submaximal and maximal exercise tests on a cycle ergometer to analyze respiratory gases, detailed blood tests, body composition imaging (DXA scans), and maximum dynamic strength testing. Ultimately, the research aims to generate high-quality evidence to optimize standard exercise recommendations for breast cancer survivors and improve their long-term health and resilience.

This study adapts and evaluates the Spanish version of eTIPS, an early home-based therapy program for infants at risk of unilateral cerebral palsy after perinatal stroke. The project has three parts: translation and cultural adaptation of the original materials, a pilot randomized feasibility study comparing eTIPS with usual care, and a qualitative study exploring family experiences, barriers, and facilitators to using the program at home. In the first part, the study team will translate and culturally adapt the eTIPS materials for Spanish-speaking families, review them with experts, and test whether the content is clear, relevant, and usable. In the second part, families with infants diagnosed with perinatal stroke or at high risk of unilateral cerebral palsy will be assigned to either the eTIPS program or usual clinical care to assess recruitment, retention, adherence, safety, acceptability, and preliminary effects on infant motor development and family outcomes. In the third part, caregivers in the intervention group will take part in interviews to better understand how the program fits into daily life and what could improve future implementation.

This study will evaluate whether an intensive day camp that combines somatosensory and motor training for the affected upper limb improves hand function and participation in children with unilateral cerebral palsy more than an intensive motor-only camp of equal duration and intensity. Children aged 5 to 15 years with unilateral spastic cerebral palsy and Manual Ability Classification System (MACS) levels I-III will be randomly assigned to one of two intervention groups. The experimental group will receive an 8-day, 40-hour camp including structured tactile, proprioceptive and vestibular stimulation integrated into meaningful functional tasks for the upper limb. The control group will receive an 8-day, 40-hour camp focused exclusively on intensive motor training without specific somatosensory stimulation. The primary outcome is the change in spontaneous bimanual performance of the affected hand, measured with the Assisting Hand Assessment (AHA). Secondary outcomes include measures of unilateral upper limb function, somatosensory function, hand grip strength, gross motor function, balance, trunk control, participation in daily activities and objective upper limb activity measured with wrist-worn accelerometers. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up visits approximately 2 and 3 months after the camp.

This study aims to evaluate the effectiveness and usability of HEMImprove 1.0, a gamified mobile application designed to improve upper limb motor function in adolescents with unilateral cerebral palsy. Participants will be randomly assigned to an intervention group using the app or a control group performing conventional home exercises. The intervention will last four weeks, with assessments before and after the intervention to measure motor function, motivation, and quality of life improvements.

The primary goal of this research project is to develop different prediction models in fibromyalgia disease through the application of machine learning techniques and to assess the explainability of the results. As specific objective the research project intends to evaluate the influence of psychosocial variables, fatigue, and sleep quality on the prediction of disease severity in patients with fibromyalgia using an artificial intelligence-based model.

The present study aims to evaluate the effectiveness of an 8-week combined lumbar motor control and gluteal muscle strengthening program in individuals with chronic non-specific low back pain

This randomized, sham-controlled clinical trial aims to evaluate the efficacy and safety of bipolar radiofrequency in the treatment of genitourinary syndrome of menopause (GSM) in postmenopausal women. Participants will be randomly assigned to receive either active bipolar radiofrequency treatment or a sham procedure. The primary objective is to determine whether bipolar radiofrequency improves vaginal and sexual function. Secondary objectives include assessment of pain with vaginal penetration, vaginal lubrication and tissue distensibility, patient-reported vulvovaginal symptom severity, and treatment safety and tolerability.

This pilot study aims to assess the feasibility, adherence, and preliminary efficacy of a home-based telerehabilitation protocol using the HOME Kit Tablet system in children aged 6 to 18 years with cerebral palsy. The study follows a randomized controlled design with parallel groups and single-blind evaluation. The intervention group will use a digitally supervised rehabilitation system, while the control group will follow a traditional home therapy protocol without technological tools.

Nuts have a high nutrient density, and numerous studies have reported their cardiometabolic benefits. Although observational studies in adults have indicated a potential link between nut consumption and improved mental health, there is still insufficient evidence from experimental studies to draw firm conclusions about this association.

Title: Out-of-hospital cardiorespiratory arrest and learning cardiopulmonary resuscitation in the school setting: evidence synthesis. CPR-KNOW PROYECT. Background: The high incidence, associated morbidity and mortality, and the great individual, social and economic impact of out-of-hospital cardiorespiratory arrest (OHCA) make it a priority for all health systems worldwide. To increase the rates of potential first responders who act appropriately, applying basic life support (BLS) measures in the OHCA, the European Resuscitation Council includes among its latest recommendations the training of all school children through the "Kids Save Lives" initiative. Objectives: to determine, through a randomized clinical trial, the effectiveness of two training strategies for increasing theoretical and practical knowledge of BLS in schoolchildren and adolescents. Methodology: To evaluate the effectiveness of two (Cardiopulmonary Resuscitation) CPR teaching interventions in improving the following outcome variables: theoretical knowledge and practical skills, CPR quality; as well as its relationship with the anthropometric, sociodemographic and physical condition variables of the schoolers. * Intervention group 1 (IG1): a 2-hour theoretical-practical session on the BLS sequence taught by a Nursing professional performing the practice with a mannequin. Instructor/school ratio: 1/25 for the theoretical session and a school/mannequin ratio: 2-3/1. * Intervention group 2 (IG2): a session with short video (approximately 5-10 min) and other teaching resources (puzzle), without practice on a mannequin. Video/school ratio: 1/25 and a school/teaching resource (puzzle) ratio: 1/1.

The "Little Movers" study promotes healthy motor development in early childhood by providing education to caregivers and professionals in the child's environment and by implementing early detection strategies for motor delays. The primary prevention component includes structured educational workshops designed for three age groups: 0-12 months, 13-24 months, and 25-36 months. These workshops focus on typical motor milestones, the importance of active play, early stimulation strategies, and how to recognize early warning signs of motor development delays. Participation impact will be measured using pre- and post-workshop surveys and semi-structured interviews with parents, caregivers, and educators. The secondary and tertiary prevention component consists of a longitudinal observational study that follows infants aged 0 to 12 months. Motor development will be assessed using validated tools, including the Standardized Infant Hand Assessment (s-HAI), the Hammersmith Infant Neurological Examination (HINE), the Infant Motor Profile (IMP), and the Ages and Stages Questionnaire (ASQ-3). Infants with typical development will be reassessed annually, while those at risk or showing signs of motor delay will be monitored monthly. The goal is to detect motor delays as early as possible to allow timely referral and intervention.

The PIRIC-FEp study will be a randomized clinical trial in sedentary patients with heart failure and stable preserved ejection fraction. Objectives: 1) To evaluate the efficacy of remote ischemic preconditioning performed by nurses, a noninvasive cardioprotective intervention that uses cycles of ischemia and reperfusion in the extremities, in improving exercise capacity, cardiac function, endothelial function and arterial stiffness, and 2) To analyze its impact on quality of life and its cost-effectiveness compared to conventional treatment. Methodology: Patients will be recruited in Health Centers in the city. Those assigned to the intervention group will wear a self-administered blood pressure cuff, inflated to 220 mmHg for 5 minutes, followed by 5 minutes of deflation, in repeated cycles four times, five days a week for three months. The control group will receive standard counseling. All participants will be examined, at baseline and at three months. Adherence will be defined as completing at least 70% of the sessions. Different parameters will be evaluated, including sociodemographic variables, patient's medical history, echocardiography, cardiopulmonary exercise test, endothelial function, arterial stiffness, quality of life, spirometry, blood tests, among others. The study will be approved by an Ethics Committee, participants will be informed and will have to sign a written consent. The statistical analysis will include three phases: verification of randomization, use of covariance models for dependent variables, and sensitivity analysis with propensity score matching. All analyses will be performed on an intention-to-treat basis.

This clinical trial aims to evaluate the therapeutic effectiveness of transcranial direct current stimulation (tDCS), a non-invasive technique that modulates cortical excitability, in combination with gait training in patients with multiple sclerosis (MS). The study focuses on improving balance and walking ability, which are commonly impaired in this population. A randomized, triple-blind, controlled design will be used, comparing an active tDCS group with a sham stimulation group, both receiving the same gait training protocol. Outcomes will include functional and clinical measures related to mobility, balance, and fatigue. The project builds on previous meta-analytical evidence suggesting positive effects of tDCS in MS and aims to confirm these findings using an optimized stimulation protocol.

This request pertains to a series of related projects on a common theme. Specifically, this set of projects aims to analyze the impact of new alternatives in materials and structures of artificial turf on athlete performance and perception, within the context of the elimination of microplastics as per Commission Regulation (EU) 2023/2055 of September 25, 2023. Third-generation sports artificial turf is notable for including performance infill (granules) that provide the necessary functionality and safety for sports practice. The vast majority of fields worldwide use materials that do not comply with the new European regulation, which has granted an eight-year moratorium. Therefore, there is little time to find new alternatives. The challenge lies not only in developing new structural solutions but also in understanding their impact on athletes. This issue is of high severity, as these sports facilities are the largest in terms of space and host the highest number of Physical Activity and Sports practitioners in Europe (mainly Football, Rugby, Hockey, and Padel). For this reason, over the past year, the IGOID Group has requested various projects to cover all the necessary phases and nuances to address this issue. The activities included in these projects are divided into two phases: Phase 1: Evaluation of Sports Surfaces in the Laboratory (durability and surface-player and surface-ball interaction). Tests will be conducted on artificial turf samples constructed with SBR rubber (the main material to be replaced under the EU regulation), natural-origin infills, polymeric infills larger than 5 mm, and other infills. Initially, a market analysis and classification will be carried out, followed by laboratory tests. Across all projects, a minimum of 30 alternatives are expected to be analyzed. Phase 2: Field Study. Tests will be conducted on a sample of athletes on constructed surfaces representing the different alternatives evaluated in Phase 1. Performance tests and a battery of assessments will be carried out to understand athlete perception. A sample of 30 athletes will be randomly divided into groups to perform different repetitions of the test batteries, covering a minimum of six different sports facilities.

The goal of this clinical trial is to evaluate if recovery interventions using cold and hot water immersion can reduce the risk of injuries in amateur soccer players. The main questions it aims to answer are: Do cold water immersions reduce muscle fatigue and improve performance more effectively than hot water immersions? What is the optimal timing and duration for these recovery interventions to maximize their effectiveness? Researchers will compare: Cold Water Immersion (CWI) Hot Water Immersion (HWI) No Immersion (NI) Thermographic Immersion (TI) based on individual thermal profiles Participants will: Undergo thermographic assessments to determine their thermal profiles. Perform physical tests such as isometric strength tests, countermovement jumps (CMJ), and squats with 50% body weight. Complete wellness questionnaires to assess their subjective recovery and fatigue levels. Provide blood and urine samples for biomarker analysis. Participate in recovery interventions (CWI, HWI, or TI) based on their assigned group.

The study aims to evaluate the effectiveness of Redcord treatment for neurogenic bowel dysfunction in patients with multiple sclerosis. The main objectives are: * Assess the impact of Redcord on bowel function and quality of life in multiple sclerosis patients. * Compare the outcomes of Redcord treatment with standard care practices. Participants will undergo Redcord therapy sessions and their bowel function will be monitored and compared to a control group receiving standard care. The study will measure improvements in bowel control, frequency, and overall patient satisfaction.

Diastasis recti abdominis is a pathology that appears in a high percentage of women during the postpartum period. However, there is little evidence about its treatment. The present protocol aims to evaluate the efficacy of radiofrequency as an alternative for the treatment of abdominal diastasis along with abdominal exercises compared to the only intervention through abdominal exercise. An aleatory clinical testing will be conducted where 44 women diagnosed with diastasis recti abdominis in the postpartum period will be recruited. A common exercise protocol will be applied for two groups of participants, and both of them will have to be able to carry out the activities autonomously at home. In addition, control sessions will be held weekly for both groups where one of the groups, the control group (n=22), will receive radiofrequency therapy with the machine in athermic mode, while the other group, the experimental group (n=22), will receive a weekly session under the established diathermy protocol. The sessions will last 30 minutes and will take place for 10 consecutive weeks. Three variables will be evaluated: the width of the diastasis measured in centimeters, life quality measured using the Short form (36) questionnaire, and the perception of the pain measured with the visual analogue scale. Three evaluations will be done: at the beginning of the study, after ten weeks and three months later.

There are few studies that already have validated specific raw accelerometer cut-points for people over 65 years old. The purpose of the present study is to validate raw accelerometer cut points for general people over 65 years old and specific raw accelerometer cut points based on the functional status of older adults over 65 years old. The study will be carried out with an observational approach. Participants will be divided into 4 groups. First of them will be made grouping all subjects and the rest divided according to their functional status. They will perform different-intensity physical activities while wearing accelerometers attached to their body and wearing a portable gas analyser too. Their intensity will be assessed based on their own Rest Metabolic Rate (RMR). Energy expenditure and accelerations will be matched and, based on that, sedentary behaviour, light physical activity and moderate-to-vigorous physical activity cut-points will be derived.