Clinical trials

This study will investigate whether replacing grass-fed organic meat with legumes within a Mediterranean diet affects cardiometabolic health in healthy adults. Participants will be randomly assigned to follow a Mediterranean diet that includes either grass-fed organic meat or legumes as the main protein source for 8 weeks. The study will compare changes in blood cholesterol, blood glucose, inflammation, blood pressure, and other health measures between the two groups. The main outcome will be the change in LDL cholesterol, a type of cholesterol associated with cardiovascular health. The study will include healthy adults aged 25 to 65 years living in the Community of Madrid, Spain.

The goal of this RCT is to evaluate the effects of a virtual reality intervention on self-efficacy regarding alcohol and cannabis use among at-risk youth in various residential mental health treatment centers who have co-occurring disorders and are under the care of the association where they receive treatment. The main question it aims to answer is: • Does the VR intervention enhance the therapeutic effect of residential treatment on self-efficacy regarding alcohol and cannabis use? If there is a comparison group: Researchers will compare the intervention with the usual care (UC) that minors receive at the centers for the treatment of dual diagnosis to see if VR adds value to this treatment. Participants will be randomly assigned to each condition and will be evaluated before and after one month. In the experimental group, participants will receive a treatment session using VR software, during which they will undergo training in the following modules: The first phase is an assessment phase, during which objective measures are determined for 1) emotional recognition, 2) avoidance/approach toward related stimuli, 3) degree of compliance with social pressure, and 4) craving in the presence of the drug, exposure to cues, and/or conditioned contexts.

Breast cancer and its treatment with radiotherapy may be associated with systemic inflammatory, hematological, cardiac, body composition, functional and quality-of-life alterations. Exercise has emerged as a non-pharmacological strategy with potential benefits during oncological treatment; however, further evidence is needed regarding the effects of supervised moderate-intensity interval aerobic exercise during radiotherapy. This randomized controlled trial aims to evaluate the effects of a supervised moderate-intensity interval aerobic exercise programme on systemic inflammatory and immune-derived hematological indices, cardiac biomarkers, body composition, muscle strength, lower-limb power, sleep quality and breast cancer-specific quality of life in women with breast cancer undergoing radiotherapy. Participants will be allocated to either an experimental group performing supervised moderate-intensity interval aerobic exercise during radiotherapy or to a control group receiving usual care without structured exercise during the study period. Outcomes will be assessed at baseline and after completion of the intervention period.

This study aims to evaluate the effects of an 8-week inspiratory muscle training program on lung function and respiratory muscle strength in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, declines in functional performance, impaired respiratory performance, and a higher risk of disability. Inspiratory muscle training is a simple, low-cost intervention that may improve breathing function, inspiratory muscle strength, and overall health in very old adults, but evidence in this age group remains limited. Participants will be randomly assigned to one of two groups: a high-load inspiratory muscle training group or a low-load sham training group. Both groups will use a threshold device and perform 30 breaths once per day, five days per week, for eight weeks. The experimental group will train with progressively increasing resistance (50% to 80% of maximal inspiratory pressure), while the sham group will use a minimal and non-progressive load (15% of maximal inspiratory pressure). All sessions will be supervised and monitored for safety. The main goal of the study is to determine whether inspiratory muscle training improves maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP) and lung function. These outcomes will allow the evaluation of the clinical relevance of improvements in respiratory muscle strength in this population. Assessments will be performed before the intervention, immediately after the 8-week program, and again at one and three months after the end of the intervention to examine both immediate and short-term effects. This study may contribute valuable evidence regarding the safety, feasibility, and clinical benefits of inspiratory muscle training in frail very old adults, particularly its impact on respiratory muscle strength and lung function, supporting its potential implementation in rehabilitation and geriatric care.

This randomized controlled clinical trial aims to evaluate the effectiveness of a standardized shoulder stabilization exercise program in amateur volleyball players diagnosed with atraumatic shoulder instability. Shoulder pain is one of the most prevalent musculoskeletal complaints, affecting up to two-thirds of the general population at some point in life and frequently leading to long-term symptoms, functional limitations, sleep disturbances, and high socio-economic costs. Atraumatic glenohumeral instability is particularly common among athletes performing overhead movements, such as volleyball players, who are repeatedly exposed to high-velocity external and internal rotation actions during serves and spikes. The Derby Shoulder Instability Rehabilitation Programme (DSIRP) is a structured, reproducible protocol integrating strengthening, proprioceptive, neuromuscular control, plyometric, and speed-oriented exercises. Although widely used in clinical practice, evidence supporting its superiority over the natural progression of the condition remains limited. More than 80% of physiotherapists in the United Kingdom do not use specific standardized protocols for atraumatic shoulder instability, highlighting the need for high-quality clinical trials that evaluate structured rehabilitation approaches. This study will recruit amateur volleyball players aged 20 to 30 years with a clinical diagnosis of atraumatic shoulder instability lasting more than 3 months. Participants will be randomized (1:1) into two parallel groups: an experimental group performing the DSIRP for 8 weeks (three 25-minute sessions per week), and a control group following a "wait-and-see" approach. Outcome measures will be assessed at baseline, 1 month, and 2 months (post-intervention). The primary outcomes include pain intensity measured with the Numeric Pain Rating Scale and shoulder disability measured with the Spanish version of the Shoulder Pain and Disability Index. Secondary outcomes include external rotation strength, grip strength, shoulder range of motion, and health-related quality of life assessed with the SF-12 questionnaire. All measurements use validated instruments with high reliability for clinical and research settings. Statistical analysis will follow an intention-to-treat approach using mixed-model repeated-measures ANOVA or non-parametric alternatives when appropriate. Effect sizes and Bonferroni correction for multiple comparisons will be applied. An independent biostatistician blinded to allocation will conduct the analysis. The study follows CONSORT and TIDieR guidelines for reporting and intervention description. This trial seeks to determine whether a structured, progressive stabilization protocol offers clinically meaningful improvements in pain, disability, strength, mobility, and quality of life compared with no intervention in young volleyball players with atraumatic shoulder instability. Results may support the implementation of standardized rehabilitation strategies in physiotherapy practice for this condition.

Physical inactivity, maladaptive exercise motives, and body image concerns are highly prevalent among young adult women and are associated with reduced psychological well-being and increased risk for disordered eating. This study protocol describes a randomized controlled trial designed to evaluate a multi-component psychoeducational intervention integrating Self-Determination Theory principles with functionality-oriented body image strategies to enhance autonomous motivation for exercise and promote psychological well-being among female university students. Female Health Sciences students aged 18-25 will be randomly allocated (1:1) to an experimental or control group following baseline assessment, and outcomes will be evaluated at baseline, post-intervention, and six-week follow-up. The six-session face-to-face intervention incorporates autonomy-supportive communication, competence-building activities, meaningful rationales, choice provision, and supportive relational climates, combined with functionality-based body image content. The primary outcome is autonomous motivation for exercise (BREQ-3; Relative Autonomy Index), and secondary outcomes include basic psychological need satisfaction and frustration, physical activity levels, positive body image, and eating disorder risk. Linear mixed-effects models will be used under an intention-to-treat approach, and mediation analyses will test whether changes in psychological need satisfaction underlie improvements in motivational quality. The intervention is expected to promote healthier motivational regulation, increase physical activity engagement, strengthen positive body image, and reduce maladaptive exercise drivers. Findings aim to inform scalable, theory-driven preventive strategies for improving health and well-being among young women in university settings.

The goal of this clinical trial is to see if a specific intervention program that uses virtual reality (VR) helps young people reduce aggressive behavior more than the same program without VR or their usual treatment. The study will also look at how the program affects anger, impulsivity, emotional control, and how participants understand and handle conflicts with others. The main questions the study wants to answer are: * Does the intervention program with VR help young people reduce aggressive behavior more than the same program without VR or just their usual treatment? * What changes in the mind and body are linked to improvements in aggressive behavior and emotional control? The researchers will compare three groups of young people: * Usual treatment plus the 4-session intervention program with VR. * Usual treatment plus the 4-session intervention program without VR. * Usual treatment only. Participants will: * Attend 4 individual sessions lasting 1 to 1.5 hours, once a week. * Take part in activities to learn how to recognize emotions, understand conflict situations, and manage anger and impulsivity. * Complete questionnaires about aggressive behavior, anger, impulsivity, emotional control, and how they interpret conflicts. * Have their aggressive behavior recorded through disciplinary reports at the center. * Provide saliva samples before and after sessions to measure hormones related to stress and aggression. * Wear a chest band that measures heart rate and a headset that records brain activity during the VR activities. All data will be kept confidential, and the identities of participants will be protected at all times.

This randomized controlled trial aims to compare the effectiveness of a cervical exercise program, transcutaneous neuromodulation of the spinal accessory nerve, and a placebo intervention on pain intensity, pressure pain threshold, cervical proprioception, functional disability, depression, anxiety, and stress in university students with chronic non-specific neck pain. The study will include a six-week intervention period with pre- and post-treatment assessments. The findings may contribute to the development of accessible physiotherapy interventions within university settings.

This study aims to evaluate the effects of an 8-week inspiratory muscle training program on maximal inspiratory pressure and functional capacity in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, declines in functional performance, impaired respiratory performance, and a higher risk of disability. Inspiratory muscle training is a simple, low-cost intervention that may improve breathing function, inspiratory muscle strength, and overall health in very old adults, but evidence in this age group remains limited. Participants will be randomly assigned to one of two groups: a high-load inspiratory muscle training group or a low-load sham training group. Both groups will use a threshold device and perform 30 breaths once per day, five days per week, for eight weeks. The experimental group will train with progressively increasing resistance (50% to 80% of maximal inspiratory pressure), while the sham group will use a minimal and non-progressive load (15% of maximal inspiratory pressure). All sessions will be supervised and monitored for safety. The main goal of the study is to determine whether inspiratory muscle training improves maximal inspiratory pressure (MIP), an established measure of global inspiratory muscle strength. Secondary outcomes include measures of functional capacity, reflecting the ability to perform physical tasks relevant to daily living in very old adults. These outcomes will allow the evaluation of the clinical relevance of improvements in inspiratory muscle strength in this population. Assessments will be performed before the intervention, immediately after the 8-week program, and again at one and three months after the end of the intervention to examine both immediate and short-term effects. This study may contribute valuable evidence regarding the safety, feasibility, and clinical benefits of inspiratory muscle training in frail very old adults, particularly its impact on inspiratory muscle strength and functional capacity, supporting its potential implementation in rehabilitation and geriatric care.

The goal of this clinical trial is to evaluate the effectiveness of using virtual reality glasses to reduce the need for rescue analgesia in patients with acute postoperative pain after knee arthroplasty. The main questions it aims to answer are: * What is the impact of virtual reality use on postoperative pain perception as measured by the Visual Analogue Scale (VAS)? * What potential adverse effects are associated with the use of virtual reality in the postoperative context? * What is the level of satisfaction and acceptance of virtual reality as a complementary strategy for pain management? * How does virtual reality influence quality of life and psychosocial variables in patients with acute postoperative pain after knee arthroplasty?

Primary Objective: To clarify whether arthroscopic reconstruction with allograft provides tangible benefits over the modified open Broström-Gould technique, or if both are equivalent in efficacy and safety. The clinical AOFAS scale will be used for assessment. Secondary Objectives: To determine if there are differences in health outcomes and patient-perceived pain using the specific SP-36 scale and verbal numeric rating scale (VNRS). Additionally, to assess differences in postoperative complication rates and time to return to daily life activities between the two surgical techniques. Study Design: Prospective, randomized, controlled clinical trial with two parallel groups stratified by age and functional demand. Condition or Disorder Being Studied: Chronic lateral ankle instability. Study Population and Sample Size: The target population includes subjects diagnosed with chronic lateral ankle instability. The study population consists of patients diagnosed in the Orthopedics consultations at Hospital Infanta Elena who meet the inclusion and exclusion criteria. Based on sample size calculations, a total of 36 patients will be recruited. However, due to the prospective nature and stratification by epidemiological and functional variables, the sample size may be increased to ensure comparable groups in each stratum. Study Timeline and Estimated Completion Date: The study is expected to begin in the third quarter of 2025. Recruitment is estimated to last 24 months, with a follow-up period of 12 months, for a total duration of 3 years, ending in the third quarter of 2028.

This study aims to evaluate the effect of a vegan Mediterranean diet compared to a traditional Mediterranean diet on inflammatory biomarkers, functional capacity, and quality of life in patients with fibromyalgia.

This study aims to evaluate the effects of moderate-to-high intensity aerobic exercise on primary dysmenorrhea, a common condition characterized by painful menstrual cramps. The study will involve women diagnosed with primary dysmenorrhea, who will be randomly assigned to one of two groups: Experimental Group: Participants will perform a supervised aerobic exercise program tailored to their fitness level. Control Group: Participants will continue their usual care without any additional interventions. The study will run from February 2025 to April 2025 in Madrid, Spain. Before starting, all participants will complete a questionnaire to gather information about their demographics, menstrual cycle characteristics, medical history, and physical activity levels. This will help ensure an accurate diagnosis of primary dysmenorrhea and provide baseline data for comparison. Participants will be randomly assigned to their groups using a computer-generated sequence, with allocation managed confidentially to avoid bias. The study's single-blind design ensures that the evaluators will not know the group assignments. The goal of this research is to determine whether regular aerobic exercise can serve as an effective, non-pharmacological intervention to reduce the severity of menstrual pain and improve the quality of life for women with primary dysmenorrhea. The findings will inform patients, families, and healthcare providers about potential lifestyle strategies to manage this condition.