[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Cadiz\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":164},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,89,112,137],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100650152","self-selected-versus-physiotherapist-prescribed-resistance-training-program-in-people-with-chronic-low-back-pain-100650152",false,"NCT07745465","Self-Selected Versus Physiotherapist-Prescribed Resistance Training Program In People With Chronic Low Back Pain","Efficacy of a Self-Selected Resistance Training Program Compared With a Physiotherapist-Prescribed Resistance Training Program in People With Chronic Low Back Pain (MyBack Exercise): A Randomized Control Pilot Study","MyBackExercise","Inclusion Criteria\n\na) Male and female participants aged 18-65 years b) Low back pain, with or without referred pain to the lower limb, persisting for ≥12 weeks c) Not currently engaged in a regular structured exercise programme d) Sufficient cognitive and communication abilities to complete the assessment scales and participate in the study intervention Exclusion Criteria\n\n1. Lumbar radiculopathy or radicular pain syndrome, defined by clinical signs of nerve root involvement (e.g., dermatomal pain, neurological deficits, or positive neurodynamic tests)\n2. Serious spinal or non-spinal pathology explaining low back pain, identified through clinical assessment (e.g., malignancy, vertebral fracture, spinal infection, cauda equina syndrome, inflammatory spinal disease, vascular, visceral or other serious causes).\n3. Medical contraindications to exercise, as determined by the treating physician The presence of lumbar degenerative imaging findings (e.g., degenerative disc disease, lumbar spondylosis, facet joint osteoarthritis, or Modic changes) will not constitute an exclusion criterion, provided that the clinical presentation is consistent with chronic low back pain.","ALL","18 Years","65 Years",{"count":21,"type":22},34,"ESTIMATED","INTERVENTIONAL",[25],"NA","Chronic low back pain is a public health issue affecting over 20% of the Spanish population, causing disability, reduced quality of life, and work absenteeism. Over the past decades, the benefits of physical exercise for improving symptoms in patients with chronic low back pain have been studied. Exercise has also been shown to improve quality of life, general health, self-efficacy, and fear of pain, regardless of pathology. Research on the effect of physical exercise in chronic low back pain patients has shown promising results. Therefore, the therapeutic exercise program proposed in this study may help participants adopt healthy habits that positively impact their quality of life.\n\nThis will be a clinical trial in patients with chronic low back pain. The main purpose of the study is to evaluate the efficacy of a self-selected resistance training program versus physiotherapist-prescribed exercises in improving pain intensity and disability in adults with chronic low back pain. Secondary objectives include evaluating differences between the two groups after 12 weeks in treatment satisfaction, degree of compliance, kinesiophobia, self-efficacy, muscle endurance, and lumbar electromyographic activity.\n\nIf you agree to participate, a member of the research team experienced in exercise programs for chronic low back pain will instruct you on how to perform the program. The follow-up study will include 34 participants randomly assigned to two groups: one group performing self-selected resistance exercises, and one group performing physiotherapist-prescribed exercises. The study will last 12 weeks, assessing your condition at the start and end of the study. You will complete questionnaires on pain intensity (Numerical Pain Rating Scale, NPRS), disability (Oswestry Disability Index, ODI), treatment satisfaction (CRES-4), adherence to treatment, kinesiophobia (TSK-11), self-efficacy (Pain Self-Efficacy Questionnaire, PSEQ), muscle endurance (Biering-Sørensen test), and surface electromyographic activity of the erector spinae (longissimus) muscle (sEMG-ESL) using the mDurance® device.\n\nPOTENTIAL BENEFITS AND RISKS OF PARTICIPATION Expected direct benefits of participation may include improvements in pain intensity, disability, treatment satisfaction, adherence to therapeutic exercise, kinesiophobia, self-efficacy, muscle endurance, and electromyographic activity.\n\nHowever, it is possible that you may not experience any personal benefit. The information obtained will contribute to scientific knowledge about CLBP and may help others in the future.\n\nALTERNATIVE TREATMENTS Chronic low back pain is a pathological entity with extensive study, which can present different conservative therapeutic options, such as psychological therapy, regular physical exercise and the adoption of healthy habits.\n\nCOMPENSATION Participation in this study will not incur any costs for you. OTHER RELEVANT INFORMATION Any new information discovered during your participation that may affect your willingness to participate in the study will be communicated to you by your doctor as soon as possible.\n\nIf you decide to withdraw your consent to participate in this study, no new data will be added to the database, and if samples have already been collected, you may request the destruction of all previously obtained, identifiable samples to avoid further analysis.\n\nYou should also be aware that you may be excluded from the study if the sponsor or researchers deem it necessary, either for safety reasons or because they believe you are not complying with the established procedures.\n\nIn either case, you will receive a clear explanation of the reason for your withdrawal from the study. The sponsor may suspend the study for any of the reasons stipulated in current legislation.\n\nBy signing the attached consent form, you agree to comply with the study procedures explained to you. When your participation is over, you will receive the best available treatment that your doctor considers most appropriate for your condition.",[28],"People With Chronic Low Back Pain",[30,31,32,33,34],"Chronic Low Back Pain","Exercise Therapy","Resistance Training","Self-selected exercise","Physiotherapy","NOT_YET_RECRUITING","2026-07-29",{"date":38,"type":39},"2026-08-04","ACTUAL",{"date":41,"type":22},"2026-09-01",{"date":43,"type":22},"2027-12",{"name":45,"class":46},"University of Cadiz","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100649726","in-person-online-and-hybrid-healthy-aging-education-for-pre-frailty-and-frailty-in-older-adults-100649726","NCT07738393","In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults","Effectiveness and Cost-Effectiveness of In-Person, Online, and Hybrid Healthy-Aging Education for Community-Dwelling Older Adults With Pre-Frailty or Frailty: A Four-Arm Randomized Controlled Trial (FRAGSALUD-ON)","FRAGSALUD-ON","Inclusion Criteria:\n\n* Community-dwelling adults aged 65 years or older.\n* Presence of pre-frailty or frailty according to the prespecified operationalization of the Fried frailty phenotype, defined as meeting at least one of the five Fried criteria (pre-frailty: 1-2 criteria; frailty: 3-5 criteria).\n* Ability to understand spoken and written Spanish sufficiently to follow the intervention and study procedures.\n* Access at home to Wi-Fi or mobile data and to a smartphone, tablet, or computer capable of connecting to the internet.\n* Ability to attend the study assessments and, if randomized to the in-person or hybrid intervention, the scheduled face-to-face sessions.\n* Ability to understand the study information and provide written informed consent.\n\nExclusion Criteria:\n\n* Permanent residence in a nursing home or other long-term residential care institution.\n* Robust status according to the Fried frailty phenotype, defined as meeting none of the five Fried criteria.\n* Severe dementia or any cognitive, neurological, or psychiatric condition that precludes valid informed consent or the ability to understand and follow the study procedures.\n* Use of systemic antibiotics during the 3 months preceding baseline stool-sample collection.\n* Known terminal illness or receipt of end-of-life care, with an anticipated life expectancy of less than 12 months, based on available clinical documentation or assessment by a qualified clinician.\n* Current participation in another interventional study involving an investigational medicinal product or a structured physical activity, nutritional, cognitive, or social intervention that overlaps with the FRAGSALUD-ON intervention or follow-up period.",{"count":56,"type":22},276,[25],"The goal of this clinical trial is to determine whether a 6-month healthy-aging education program delivered in person, online, or in a hybrid format reduces frailty and is cost-effective compared with usual care in community-dwelling adults aged 65 years or older with pre-frailty or frailty.\n\nThe main questions are:\n\n* Do the three educational programs, considered together, reduce the prespecified 40-item Frailty Index (40-FI) at 6 months more than usual care?\n* Are effects maintained 6 months after the programs end?\n* How do the in-person, online, and hybrid educational programs differ in multidomain frailty outcomes, implementation, costs, and quality-adjusted life-years?\n* Are changes in prespecified blood biomarkers and gut microbiota associated with changes in frailty and related outcomes?\n\nThe study will enroll 276 participants. Randomization will occur at household level so that enrolled cohabitants receive the same assignment. Households will be allocated to in-person education, online education, hybrid education, or usual care. All three educational programs address physical activity, nutrition, cognitive and emotional well-being, and social connection. Assessments will occur at baseline, 6 months, and 12 months; blood and stool samples will be collected at baseline and 6 months. The trial will compare the average effect of the three active programs with usual care and will estimate modality-specific clinical and economic outcomes.",[60,61],"Frailty","Pre-Frailty",[63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79],"Cost-effectiveness","Digital health","Community-Dwelling Older Adults","Healthy Aging","Health Education","Online Education","Gut Microbiota","Physical activity","Frail Older Adults","Artificial Intelligence-Assisted Education","Frailty Index","Fried Frailty Phenotype","Cognitive Function","Cost-Utility Analysis","Malnutrition risk","Multidomain Health Education","Physical Function","2026-07-27",{"date":82,"type":39},"2026-07-31",{"date":84,"type":22},"2026-09-15",{"date":86,"type":22},"2028-06-15",{"name":45,"class":46},1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":4},"100633667","efficacy-of-immersive-virtual-reality-combined-with-stationary-cycling-on-gait-in-individuals-with-stroke-100633667","NCT07529665","Efficacy of Immersive Virtual Reality Combined With Stationary Cycling on Gait in Individuals With Stroke","Inclusion Criteria:\n\n* Men and women aged 18 years or older with a medically documented diagnosis of hemorrhagic or ischemic stroke.\n* At least 6 months post-stroke.\n* Presence of hemiparesis.\n* Mild to moderate balance impairment, defined as a Berg Balance Scale score \\\u003C 50.\n* Gait impairment, defined as a Wisconsin Gait Scale score \\> 20.\n* Preserved active movement in the lower limbs and ability to mount and remain seated on the stationary bicycle.\n\nExclusion Criteria:\n\n* Severe cardiac conditions.\n* Visual or auditory impairments limiting the use of virtual reality head-mounted displays.\n* Medical history of epilepsy.\n* Severe attentional impairment or inability to cooperate with the study intervention.\n* Severe cognitive impairment and marked difficulties in comprehension.\n* Severe vestibular disorders and predisposition to dizziness or vomiting.",{"count":96,"type":22},25,[25],"The purpose of this study is to evaluate whether an intervention based on immersive virtual reality combined with stationary cycling, in addition to neurological physiotherapy, improves gait in individuals with stroke. The study will also assess the effects of this intervention on balance, coordination, motor function, muscle tone, and participants' and therapists' satisfaction.\n\nThe main questions this study aims to answer are:\n\n* Does immersive virtual reality combined with stationary cycling improve gait compared with neurological physiotherapy alone?\n* Does this combined intervention improve balance, coordination, motor function, and muscle tone in individuals with stroke?\n* How do participants and therapists perceive the use of immersive virtual reality combined with stationary cycling during rehabilitation?\n\nResearchers will compare a program that combines immersive virtual reality and stationary cycling with neurological physiotherapy to a neurological physiotherapy program alone.\n\nParticipants will:\n\n* Take part in two intervention periods, with a total of 16 sessions over 8 weeks (two sessions per week).\n* Receive intervention sessions that include immersive virtual reality combined with stationary cycling and neurological physiotherapy, or neurological physiotherapy alone, depending on the intervention period.\n* Complete assessments of gait, balance, and motor function at baseline, after the first intervention period, and after the second intervention period.",[100],"Stroke",[102,103],"virtual reality","stationary cycling","2026-04-10",{"date":106,"type":39},"2026-04-14",{"date":108,"type":22},"2026-05",{"date":110,"type":22},"2027-06",{"name":45,"class":46},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":134,"leadSponsor":136,"locationsCount":88},"100613505","effectiveness-of-an-mhealth-intervention-based-on-rehabilitation-and-a-personalised-nutrition-plan-in-the-recovery-and-improvement-of-dysphagia-in-patients-diagnosed-with-stroke-100613505","NCT07267468","Effectiveness of an mHealth Intervention, Based on Rehabilitation and a Personalised Nutrition Plan, in the Recovery and Improvement of Dysphagia in Patients Diagnosed With Stroke","Inclusion Criteria:\n\n* Subjects aged 18 years or older.\n* Patients with any degree of impairment in swallowing\u002Foropharyngeal dysphagia to liquids following a stroke (ACV).\n\nExclusion Criteria:\n\n* Hospitalized patients presenting any type of visual barrier.\n* Patients in terminal palliative care.\n* Patients in the final days of life phase.\n* Patients with severe cognitive impairment.\n* Patients with a language barrier regarding the use of the App.\n\nSubject Withdrawal Criteria:\n\n* Revocation of consent. In this case, the subject will exit the study and will not be replaced by another subject, being considered a \"loss\".\n* Lack of adherence to the prescribed training plan exceeding 20% of the scheduled sessions.",{"count":119,"type":22},74,[25],"The goal of this clinical trial is to evaluate the efficacy of an mHealth intervention as a complement to usual clinical practice for the improvement and recovery of dysphagia in patients who have suffered a stroke. The main question it aims to answer is:\n\n\\- Does the mHealth intervention improve the recovery of dysphagia in post-stroke patients compared to usual care alone?\n\nResearchers will compare patients receiving the mHealth intervention plus usual care to see if the combined approach leads to better dysphagia outcomes, reduced negative consequences (e.g., malnutrition, pneumonia), and improved quality of life compared to usual care alone.\n\nParticipants will be recruited and:\n\n* Receive a diagnosis and usual care for post-stroke dysphagia.\n* Be assigned to either the mHealth intervention group (using a smartphone\u002Ftablet app for information and follow-up) or the control group (usual care only).\n* Be followed up to assess dysphagia recovery, reduction in negative outcomes (like aspiration pneumonia, dehydration), and changes in quality of life.",[100,123],"Deglutition Disorders",[100,123,125,126,127,128],"Pneumonia, Aspiration","Nutrition","Rehabilitation","mHealth","RECRUITING","2026-01-30",{"date":132,"type":39},"2026-02-03",{"date":130,"type":39},{"date":135,"type":22},"2026-11-30",{"name":45,"class":46},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":88},"100568477","effectiveness-of-inspiratory-muscle-training-for-people-with-ischemic-heart-disease-revascularized-by-percutaneous-transluminal-coronary-angioplasty-100568477","NCT06681740","Effectiveness of Inspiratory Muscle Training for People With Ischemic Heart Disease Revascularized by Percutaneous Transluminal Coronary Angioplasty.","CARDIOINSPIRE - Effectiveness of Adding Inspiratory Muscle Training to a Cardiac Rehabilitation Program for People With Ischemic Heart Disease Revascularized by Percutaneous Transluminal Coronary Angioplasty.","CARDIOINSPIRE","Inclusion Criteria:\n\n* people with Myocardial Ischemia and percutaneous transluminal coronary angioplasty\n* both sexes\n* over 18 years old\n* under 80 years of age\n* absence of cognitive deficits and\u002For physical limitations that would prevent them from performing physical exercise or completing the questionnaires required for participation in the study.\n\nExclusion Criteria:\n\n* disease or condition that contraindicates exercise such as severe hypertrophic obstructive cardiomyopathy\n* severe aortic stenosis and\u002For dissecting aortic aneurysm\n* patients who refuse treatment or do not sign the informed consent.","80 Years",{"count":147,"type":22},72,[25],"Myocardial Ischemia (MI) consists of the narrowing of the internal lumen of the arteries that perfuse the heart. As the section of the artery decreases, so does the blood flow and therefore the supply of oxygen to the myocardium, which can cause angina pectoris or even an acute myocardial infarction. It is the leading cause of death from cardiovascular disease, responsible for 9.44 million deaths in 2021 and 185 million disability-adjusted life years. For this reason, it is one of the most important public health problems in all countries in the world that entails high health and social spending.\n\nThe non-pharmacological strategy with the most evidence currently to improve the quality of life of patients and also prevent subsequent cardiovascular events are cardiac rehabilitation programs (CRP). These include smoking cessation, control of other cardiovascular risk factors, health education, psychological therapy and a multimodal exercise program. Two types of exercise are performed, cardiovascular or aerobic resistance and strength. There is limited evidence on the addition of inspiratory muscle training (IMT) in people with MI. For this reason, it is not routinely recommended in clinical practice guidelines. Therefore, this thesis project, based on a clinical trial, tries to increase knowledge on this topic.\n\nIn view of the above, the main objective of this project is to analyze the effectiveness of adding inspiratory muscle training to a CRP of people with ischemic heart disease revascularized by percutaneous transluminal coronary angioplasty (PTCA) after 16 intervention sessions, based on to functional capacity, in addition to muscle strength, social support, anxiety, depression, coping with the disease, sexual dysfunction, quality of life, quality of sleep, eating habits and body composition. On the other hand, the secondary objectives are to know the biopsychosocial profile of this population and analyze gender differences through a subgroup analysis.\n\nTo achieve these objectives, a low-risk randomized and controlled clinical trial will be carried out in parallel at the Virgen de la Victoria University Hospital in Málaga (HUVV). People from this health area diagnosed with MI who have undergone PTCA will be recruited. The control group will complete the usual 8-week cardiac rehabilitation program with 2 weekly sessions of multicomponent exercise (cardiovascular and strength), one weekly session of health education and another of group psychological therapy. The intervention group will do the same program to which an IMT will be added. It will be performed with loads of 70% of the Maximum Inspiratory Pressure (MIP) value, completing 3 sets of 10 repetitions, 4 days a week, with 3 minutes of rest between sets, during the 8 weeks that the PRC lasts. Different measurements will be made and various tests and questionnaires will be passed before and after the PRC and the effect of adding or not adding the IMT on the variables to be analyzed will be analyzed using statistical methods.\n\nIt is expected that some of the variables will improve since there is some evidence (low and moderate) of this, as concluded by a recent review. Furthermore, in similar clinical populations such as patients with heart failure (HF), there is a high level of evidence that several of these parameters improve. Therefore, it can be expected that the results are similar in MI. In those variables without prior evidence, we hypothesize that there will be an improvement, since increasing MIP in isolation has been shown, in different clinical populations, to improve the functional capacity and quality of life of the study subjects.\n\nIf the expected benefits are finally observed, the current evidence on the use of IMT in CRPs for people with MI and PTCA will increase. In anticipation of the accumulated evidence of the effectiveness of the proposed treatment, the results derived from the present study may recommend including the IMT as another fundamental component of the CRP for this subgroup of patients.",[151,152],"Myocardial Ischemia","Coronary Arterial Disease (CAD)",[151,152,154,155],"Inspiratory Muscle Training","Cardiac Rehabilitation","2025-09-23",{"date":158,"type":39},"2025-09-29",{"date":160,"type":39},"2024-11-11",{"date":162,"type":22},"2026-03-31",{"name":45,"class":46},""]