[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587922":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":61,"locations":69,"responsibleParty":108,"collaborators":111,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":26,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":138,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Instituto de Investigacion Sanitaria La Fe","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Guided physical exercise with telerehabilitation","EXPERIMENTAL","Participants will engage in structured physical exercises, including both aerobic and strength training, guided and monitored by physiotherapists. These exercises will be performed both in person and remotely with the support of telerehabilitation.",[13],"Behavioral: Controlled exercise with telerehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"Common physical exercise recommendations given in routine clinical practice","ACTIVE_COMPARATOR","Participants will receive the usual dietary and physical activity recommendations during medical assessments and group sessions.",[19],"Behavioral: Usual Care Group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Usual Care Group","Participants will receive the standard intervention provided by the healthcare service, which includes recommendations for physical exercise, physical activity, and healthy eating. This intervention is delivered by the Endocrinology and Nutrition Department at Hospital Universitario y Politécnico La Fe and consists of periodic individual follow-ups (at least three in-person visits per year, both pre- and post-bariatric surgery) by specialized medical staff in Endocrinology and licensed Nutrition and Dietetics professionals. Additionally, it includes five preoperative group sessions focusing on various aspects of healthy nutrition, physical exercise, and physical activity.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Controlled exercise with telerehabilitation","Participants will receive the same standard care as the control group, including the same number of visits with the physician and nutritionist and participation in group sessions. Additionally, they will follow a structured physical exercise program, tailored to individual capabilities, combining aerobic and strength exercises, which will primarily be carried out at home with the assistance of telerehabilitation. Physical exercise will be structured in different phases: prior to surgery (prehabilitation), after surgery (rehabilitation), with maintenance periods in between.",[9],[32,36,40,43,46,49,52,54,56,59],{"name":33,"affiliation":34,"role":35},"Paolo Rossetti, Medicine","IIS La Fe","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":39},"Rodrigo Martín","Grupo de investigación Clinimetría y desarrollo tecnológico en ejercicio terapéutico (CLIDET)","STUDY_DIRECTOR",{"name":41,"affiliation":34,"role":42},"Pilar Masdeu, Medicine","STUDY_CHAIR",{"name":44,"affiliation":45,"role":42},"Noemí Moreno","CLIDET",{"name":47,"affiliation":48,"role":42},"Ana Belén Crujeiras","Unidad de Epigenómica en el Instituto de Investigación Sanitaria de Santiago (IDIS)",{"name":50,"affiliation":51,"role":42},"Maria Dolores Herranz Lopez","Universidad Miguel Hernández",{"name":53,"affiliation":45,"role":42},"Adrián Escriche",{"name":55,"affiliation":45,"role":42},"Cristina Flor",{"name":57,"affiliation":58,"role":42},"Albert Lecube","Sociedad Española para el Estudio de la Obesidad (SEEDO)",{"name":60,"affiliation":51,"role":42},"Enrique Roche Collado",[62,66],{"name":33,"role":63,"phone":64,"phoneExt":26,"email":65},"CONTACT","+34608109913","rossetti_paolo@gva.es",{"name":41,"role":63,"phone":67,"phoneExt":26,"email":68},"+34645741579","pilarmasdeu97@gmail.com",[70,83],{"facility":71,"status":72,"city":73,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":26},"Facultad de Fisioterapia, universidad de Valencia","ACTIVE_NOT_RECRUITING","Valencia","46010","Spain","ES",{"type":78,"coordinates":79},"Point",[80,81],-0.37966,39.47391,{"lat":81,"lon":80},{"facility":84,"status":85,"city":73,"state":73,"zip":86,"country":75,"countryCode":76,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Hospital La Fe","RECRUITING","46026",{"type":78,"coordinates":88},[80,81],{"lat":81,"lon":80},[91,92,95,96,98,100,102,104,106],{"name":41,"role":63,"phone":67,"phoneExt":26,"email":68},{"name":33,"role":63,"phone":93,"phoneExt":26,"email":94},"+34608109918","prossetti73@gmail.com",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":41,"role":97,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":99,"role":97,"phone":26,"phoneExt":26,"email":26},"Eva M Gacó Santana, Nutrition",{"name":101,"role":97,"phone":26,"phoneExt":26,"email":26},"Juan Francisco Merino Torres, Medicine",{"name":103,"role":97,"phone":26,"phoneExt":26,"email":26},"Andrea Micó, Nutrition",{"name":105,"role":97,"phone":26,"phoneExt":26,"email":26},"Matilde Rubio, Medicine",{"name":107,"role":97,"phone":26,"phoneExt":26,"email":26},"Angela Durá de Miguel, Nutrition",{"type":35,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Paolo Rossetti","Clinical Researcher",[112,114],{"name":113,"class":6},"University of Valencia",{"name":115,"class":6},"Universidad Miguel Hernandez de Elche","100587922","exercise-to-fight-obesity-100587922",false,"NCT06934681","Exercise to Fight Obesity","Impact of a Structured Physical Exercise Program on Body Composition in Morbid Obesity: A Randomized Controlled Trial","ExFO","Inclusion Criteria:\n\n* Age: 18-65 years\n* BMI ≥35 with comorbidities, or ≥40, regardless of comorbidity presence\n\nExclusion Criteria:\n\n* Participation in a structured physical exercise program within the past 6 months\n* Presence of musculoskeletal or systemic diseases that prevent participation in a physical exercise program\n* Uncontrolled hypertension\n* Uncontrolled diabetes, particularly in the presence of severe complications (neuropathy and\u002For diabetic foot, proliferative retinopathy)\n* Uncontrolled or unstable cardiovascular disease (acute myocardial infarction within the past year, angina, heart failure, peripheral artery disease)","ALL","18 Years","65 Years",{"count":128,"type":129},72,"ESTIMATED","INTERVENTIONAL",[132],"NA","This clinical trial aims to determinate whether a structured exercise program, supported by telerehabilitation, can help individuals with severe obesity who are going to undergo bariatric surgery.\n\nThe main objective of this study is whether a structured exercise program, including both supervised and home-based workouts, leads to greater body fat loss and improved strength compared to usual care. Furthermore, it also aims to evaluate other potentially affected aspects, such as body composition and functionality, quality of life, cardiovascular fitness, and various genetic and metabolic factors.\n\nThis study is a randomized clinical trial with two groups:\n\n* The intervention group will follow a structured exercise program both pre- and post- surgery.\n* The control group will receive standard care, including nutritional counseling and general health advice.\n\nThe study will include 72 adults with severe obesity (36 men and 36 women), all of whom will be randomly assigned to either the intervention or control group.\n\nParticipants in the exercise group will follow these steps:\n\n1. Before Surgery (Prehabilitation): A 26-week program with aerobic and strength exercises, done in-person or remotely 2-4 times per week.\n2. Pre-Surgery Maintenance: A flexible period before surgery where participants continue exercising on their own.\n3. After Surgery (Rehabilitation): A 20-week program focused on recovery and strength.\n4. Post-Surgery Maintenance: A long-term, self-guided phase to maintain progress.\n\nParticipants in the exercise group will also receive the same care as the control group, including nutrition counseling and medical checkups.\n\nTo evaluate participant progress, a series of measurements will be carried out, including:\n\n* BMI and body composition\n* Physical function assessed through isometric strength tests and other measures such as the Sit-to-Stand test and the 6-Minute Walk Test\n* Quality of life and lifestyle assessed using validated questionnaires\n* Daily physical activity measured with pedometers\n* Metabolic and genetic analysis from blood samples\n\nIf proven effective, this program could help establish structured exercise with telerehabilitation as a standard component of obesity care. The results may support the integration of exercise programs into clinical practice, leading to improved long-term outcomes for individuals with severe obesity undergoing bariatric surgery. Additionally, insights into genetic and metabolic factors may contribute to the development of personalized treatment strategies.",[135,136,137],"Morbid Obesity","Bariatric Surgery","Telerehabilitation",[139,140,137,141,142,143,144,145],"Bariatric surgery","Physical Exercise","Prehabilitation","Rehabilitation","Body composition","Morbid obesity","Functional capacity","2025-05-31",{"date":148,"type":149},"2025-06-04","ACTUAL",{"date":151,"type":149},"2025-05-19",{"date":153,"type":129},"2029-04",{"name":5,"class":6},2]