Clinical trials

The increasing number of adults aged 75 years and older highlights the need for effective, low-cost interventions to preserve cardiovascular health, functional independence, and cognitive performance and to support healthy aging. Beetroot extract (BE), derived from "Beta vulgaris", contains high levels of inorganic nitrate and other bioactive compounds that may positively influence vascular and neuromuscular function. In parallel, multicomponent physical exercise is recognized as an effective strategy to improve physical and cognitive outcomes in older adults. However, evidence on the independent and combined effects of BE supplementation and structured exercise in very old adults remains limited. This randomized controlled trial is designed to evaluate the effects of BE supplementation, alone and in combination with a multicomponent physical exercise program, on blood pressure, functional performance, and cognitive function in adults aged 75 years and older. Participants will be randomly assigned to one of four groups: BE supplementation, multicomponent exercise, combined BE supplementation and exercise, or a control condition, over a predefined intervention period. The exercise program will include strength, balance, mobility, and aerobic components specifically adapted to the abilities and safety requirements of old adults. The primary outcomes of the study will assess changes in cardiovascular health, physical and functional performance, and cognitive function using standardized and validated assessment tools. Secondary outcomes will include additional indicators of physical capacity and health-related quality of life. This trial aims to provide clinically relevant evidence on whether BE supplementation, alone or in combination with multicomponent exercise, represents a practical and scalable intervention to improve cardiovascular, functional, and cognitive health in adults aged 75 years and older.

Older adults with breast cancer frequently present with frailty, decreased functional reserve, and increased risk of postoperative complications. Prehabilitation programs have emerged as a promising strategy to improve physical function and clinical outcomes; however, evidence in geriatric oncology remains limited, particularly regarding the role of biological markers in predicting response to such interventions. This study aims to evaluate the effectiveness of a multicomponent prehabilitation program in older adults with breast cancer, focusing on functional status, clinical outcomes, and quality of life. In addition, the study seeks to characterize biological markers associated with frailty and treatment response, with the goal of identifying potential predictors of benefit from prehabilitation. Participants will undergo a structured prehabilitation intervention including physical exercise, nutritional optimization, and comprehensive geriatric assessment. Clinical, functional, and biomarker data will be collected longitudinally. The results of this study may contribute to improving personalized care strategies in geriatric oncology and to identifying patients who are most likely to benefit from prehabilitation programs.

The goal of this observational study is to deepen our understanding of long COVID by determining the prevalence of the main complications and medium- to long-term sequelae of COVID-19 in Navarre. Sociodemographic variables such as age, sex, ethnicity, smoking history, and comorbidities will be collected, as well as clinical and disease management variables such as persistent COVID-19 symptoms at 3 months, all with the aim of characterizing patients with long COVID. All patient data will be collected in a single visit.

The Diactive-1 project aims to establish the Diactive-1 mobile application as a clinical tool for managing type 1 diabetes in children and adolescents in several hospitals from Spain. The successful implementation of the app in new healthcare centers nationwide represents a key step toward the development of a comprehensive and scalable program. This approach seeks not only to optimize current patient care but also to democratize access to an innovative, evidence-based intervention that supports daily diabetes management. In this new phase, the project will integrate the application into routine clinical care for patients with type 1 diabetes through the use of a simple handgrip strength measurement. A dedicated web platform (www.diactive.es) is being developed to allow clinicians to enter basic patient data, including handgrip strength, sex, and email address. Based on this information, the system will automatically generate a personalized download link for the Diactive-1 app, accompanied by tailored guidance and an initial fitness level classification (low, medium, or high) according to European reference values. This process will define each user's baseline fitness level and facilitate the use of Diactive-1 as an integrated and individualized disease management tool. The ultimate goal is to strengthen clinical decision-making, improve patient engagement, and extend the benefits of digital health to a broader pediatric population living with type 1 diabetes.

The aim of this research is to analyze whether nutritional intervention combined with a multicomponent physical training program based on strength, balance, and aerobic exercises can prevent disability caused during hospitalization in individuals aged 75 years or older admitted for medical conditions, thereby improving functional and cognitive capacity. To achieve this objective, we will conduct a randomized clinical trial in which patients are randomly assigned to either the control group, which does not perform the physical training, or the intervention group, which participates in the multicomponent physical training program.

The goal of this clinical trial is to evaluate whether a combined intervention of therapeutic exercise and anti-inflammatory nutritional supplementation improves physical performance and reduces systemic inflammation in frail, malnourished older adults. The main questions it aims to answer are: Does the addition of an anti-inflammatory nutritional supplement (Alisenoc™) to a multicomponent exercise program (Vivifrail) lead to greater improvements in physical performance compared to standard exercise and conventional nutritional support? Does the combined intervention reduce levels of inflammatory biomarkers (e.g., IL-6, TNF-α, IL-8, GDF-15) in this population? Are there measurable changes in body composition (e.g., muscle mass, fat mass, bone health) following the intervention? Does the intervention impact clinical outcomes such as hospital readmissions, functional independence, or mortality over the following 12 months? Researchers will compare two groups: One group receiving the Vivifrail exercise program plus a daily dose of the anti-inflammatory nutritional supplement Alisenoc™. Another group receiving the same Vivifrail program plus an isocaloric, protein-equivalent conventional supplement. Participants will: Be aged 75 years or older and identified as frail and malnourished according to Fried and GLIM criteria. Undergo baseline evaluation including functional performance (SPPB), body composition via bioimpedance analysis, and blood sample collection for inflammatory biomarkers. Be randomly assigned to one of the two intervention groups. Follow a 12-week home-based multicomponent exercise program guided by educational materials and supervised remotely. Consume the assigned oral nutritional supplement daily for the same 12-week period. Return for outcome assessments at 12 weeks, and again at 6 and 12 months for long-term follow-up. All study procedures will take place at the Hospital Universitario de Navarra (HUN), Spain. Participants will be recruited from outpatient geriatrics and nutrition clinics and assessed at a dedicated research unit with nursing support. The intervention is designed to be feasible, scalable, and representative of real-world multidisciplinary care in older populations with high vulnerability. The study aims to provide evidence for an integrative, personalized approach to reversing frailty through combined physical and nutritional strategies targeting the biological basis of inflammaging.

The study focuses on patients who require outpatient infusion of therapy ("Infusions, Intravenous"\[Mesh\]) "Administration, Intravenous"\[Mesh\] ("Home Infusion Therapy"\[Mesh\]) "Parenteral Nutrition, Home"\[Mesh\] via a peripherally inserted central catheter (PICC) ("Central Venous Catheters"\[MeSH\] "Catheterization, Central Venous"\[MeSH\] "Catheterization, Peripheral" \[MeSH\] "Vascular Access Devices"\[Mesh\] )

The aim of this study is to evaluate the effectivity of the combined motor imagery and action observation therapies to improve functional parameters such as strenght, range of motion, pain or fear of movements among others in relation to upper limb in breast cancer survivors. The main question it aims to answer is: Will a combined therapy of motor imagery and action observation improve the strenght, rang of motion, pain, limb diameter and fear of movement of the upper limb in breast cancer survivor females? The participants will be part of the IM-OA23 proyect that consist on seeing some diferent videos about upper limb mobility and then they'll have to imagine the movements and to performed themselves. Researches will compare two groups (control group and intervention group) to evaluate the diferences between them.

The goal of this clinical trial is to determine whether a multicomponent exercise program improves functional capacity and cognitive status in hospitalized elderly patients aged 75 and older. Additionally, the study aims to assess the impact of this program on medication use, quality of life, and overall health outcomes. Key questions include whether the program enhances functional and cognitive capacities and which subgroups benefit most, such as frail patients or those with cognitive impairment. Participants will engage in a structured exercise program that includes strength training, balance exercises, and walking, all designed to improve mobility and reduce fall risk. They will attend supervised sessions several times a week, allowing for individualized attention and adjustments based on their abilities and health status. Throughout the study, changes in functional capacity will be monitored using standardized assessments that measure mobility, strength, and overall physical functioning. Cognitive assessments will evaluate any changes in cognitive status during the intervention and follow-up periods post-discharge. Participants will provide information on medication usage to analyze whether the exercise program can reduce the need for medications or help manage common polypharmacy issues. Surveys and interviews will assess participants' quality of life, including physical, emotional, and social well-being, before and after the intervention. Follow-up assessments will track progress and outcomes, ensuring long-term benefits of the exercise program are documented. The study will include a diverse sample from multiple centers, focusing on individuals aged over 75 who are hospitalized in Geriatrics and Internal Medicine services across participating centers (HUN, CHU-T, ULSBM, and HNSM). Exclusion criteria will ensure safety, excluding those with terminal illnesses or significant contraindications for exercise. This clinical trial aims to recruit 296 patients, providing valuable insights into the benefits of physical activity for elderly patients during hospitalization and informing future care practices.

The goal of this clinical trial is to study and evaluate whether a protocol of creatine supplementation, with or without multicomponent training, improves functional and cognitive capacity in individuals over 75 years old. The results of this study will further our understanding of creatine supplementation effects in the context of older patients and in combination with multicomponent training, thereby enhancing patient care strategies. Additionally, the goal is to improve the quality of life for the elderly and the efficiency of the healthcare system. The main questions it aims to answer are: 1. Does creatine supplementation alone provide physical, functional and cognitive benefits to people over 75 years of age? 2. Is creatine supplementation safe for people over 75 years old? Researchers will compare creatine monohydrate supplementation with or without multicomponent training intervention to placebo supplementation with or without multicomponent training intervention to see if the creatine supplementation protocol leads to significant improvements in functional and cognitive outcomes. This comparison will help determine the effectiveness of the supplementation intervention in enhancing the overall well-being of elderly patients. Participants will: * Engage in a structured multicomponent exercise program designed specifically for elderly patients. This program will include activities focused on strength training, balance exercises, and walking to improve mobility and reduce the risk of falls. * Attend supervised exercise sessions several times a week, allowing for individualized attention and adjustments based on each participants abilities and health status. * Be monitored for changes in functional capacity using standardized assessments, which will measure improvements in mobility, strength, and overall physical functioning. * Undergo cognitive assessments to evaluate any changes in cognitive status throughout the intervention and during follow-up periods after discharge. * Participate in surveys and interviews to assess their quality of life, including physical, emotional, and social well-being, before and after the intervention. * Attend follow-up assessments at designated intervals to track their progress and outcomes, ensuring that any long-term benefits of the exercise program are recognized and documented. Inclusion criteria will focus on individuals aged over 75 years. Participants must be capable of communication and ambulation, either independently or with assistance. * Life expectancy ≥ 6 months. * Barthel Index \> 60. Exclusion criteria will ensure the safety and appropriateness of the intervention. Individuals who explicitly refuse to participate or cannot provide informed consent will be excluded. Additionally, those with a life expectancy of less than three months, terminal illnesses, or significant medical contraindications for exercise will not be eligible. Participants with moderate to severe neurocognitive disorders or disabilities that severely limit mobility will also be excluded to maintain the integrity of the intervention. This clinical trial aims to recruit a total of 120 participants from the Geriatric Department or Primary Care, providing a comprehensive dataset to analyze the effectiveness and safety of the multicomponent exercise program. By examining the outcomes related to functional capacity, cognitive status, and quality of life, the study seeks to provide valuable insights into the benefits of physical activity for elderly patients during hospitalization.

The present study aims to analyze different care routes of the peripheral access central venous catheter to assess which alternative allows a moderate reduction in the level of complications associated with prolonged care frequency, due to the reduction of device manipulation. A high level of patient satisfaction is detected due to the controlled follow-up of the device care, as well as a decrease in the need for transfer to a center for follow-up. Objective: Identify the type of care frequency for PIVCs most beneficial for the reduction of complications associated with extraluminal device care (thrombosis, phlebitis, accidental removal, obstruction).

Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. Objectives: To validate a newly created device for the reduction of complications related to the use of intravenous therapy Methods: A multidisciplinary team composed of eight professionals specializing in the field of critical care and an engineering professional in industrial design was responsible for collecting, evaluating, and materializing the ideas and needs arising from clinical practice in a device that met the standards of the same.

This study will be conducted in a hospital in Spain to investigate how a special intervention using immersive virtual reality technology can benefit hospitalized older adults with difficulties in their daily functionality. The main objective of this study is to evaluate whether a cognitive stimulation intervention through immersive virtual reality, along with specific physical exercises, can improve the cognitive and physical function of hospitalized older patients. It is expected that this innovative intervention will have a positive impact on the quality of life of these patients. Participants eligible for the study must be over 75 years old, have severe functional dependency upon hospital admission, and be willing to participate. Those with severe dementia or other terminal illnesses will be excluded. Participants will be randomly assigned to one of four study groups: a control group without intervention and three intervention groups, including viewing Spanish landscapes through virtual reality, performing specific physical exercises, or a combination of both interventions. At the end of the study, various aspects such as cognitive and physical function, mood, quality of life, muscle strength, and acceptance of virtual reality technology by patients will be evaluated. This study aims to provide new insights into the care of hospitalized older adults and explore innovative ways to improve their well-being during their hospital stay

The aim of this trial is to test the efficacy of regular resistance exercise in early pregnancy to prevent gestational diabetes mellitus in overweight/ obese pregnant women.

In this project the investigators propose to carry out a clinical trial that compares non-endoscopic treatment of cholecystitis with antibiotics versus endoscopic drainage in non-operable acute cholecystitism (AC), especially focused on the rate of subsequent EBP and recurrence of AC, as well as the impact on the quality of life, also exploring the costs. The ultimate goal of this project is to generate knowledge and scientific evidence that makes it easier for health professionals to choose the most appropriate strategy for non-operable patients with lithiasic AC. Ourworking hypothesis is that endoscopic treatment (EUS-GBD) will significantly reduce the number of EBP compared to non-endoscopic treatment in patients with non-operable lithiasic AC.

The main aims of this study are: 1. \- to evaluate post-surgical morbidity and mortality outcomes, following the criteria and the definitions from Claven-Dindo and ISGPS international classifications, of the patients operated by the HPB Surgical Unit. 2. \- to evaluate survival and disease-free survival rates of the patients operated by the HPB Surgical Unit due to tumoral cause.