[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630203":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":34,"locations":42,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":18,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":95,"whyStopped":18,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Universidad Complutense de Madrid","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Physical Activity Intervention","EXPERIMENTAL","Participants will take part in a structured physical activity program lasting 12 weeks. The intervention consists of supervised, age-appropriate exercise sessions combining aerobic and strength-based activities, adapted to each participant's clinical status and functional capacity. All participants receive the same intervention and serve as their own control through pre- and post-intervention assessments.",[13],"Other: Physical Activity Intervention",[15],{"type":6,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"Participants will complete a 12-week structured physical activity program consisting of 2-3 supervised sessions per week combining moderate-intensity aerobic exercise and muscle-strengthening activities. The program is age-appropriate, individualized to clinical status and fitness level, and delivered under professional supervision.",[9],null,[20,24,28,30,32],{"name":21,"affiliation":22,"role":23},"Carlos Martín-Martínez, PhD","Universidad Rey Juan Carlos","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":26,"role":27},"Paula Sánchez-Llorente","Hospital Infantil Universitario Niño Jesús","STUDY_CHAIR",{"name":29,"affiliation":26,"role":27},"Laura Palomino",{"name":31,"affiliation":26,"role":27},"Rosa Ana Muñoz-Codoceo, PhD",{"name":33,"affiliation":26,"role":27},"Marta Velasco Rodríguez-Belvís, PhD",[35,39],{"name":21,"role":36,"phone":37,"phoneExt":18,"email":38},"CONTACT","+34635579829","carlos.martinm@urjc.es",{"name":25,"role":36,"phone":40,"phoneExt":18,"email":41},"+34636119002","psllorente@salud.madrid.org",[43],{"facility":26,"status":18,"city":44,"state":44,"zip":18,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Madrid","Spain","ES",{"type":48,"coordinates":49},"Point",[50,51],-3.70256,40.4165,{"lat":51,"lon":50},[54],{"name":31,"role":36,"phone":55,"phoneExt":56,"email":57},"+34915035900","624","rosana.munoz@salud.madrid.org",{"type":23,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":22,"oldNameTitle":18,"oldOrganization":18},"Carlos Martín Martínez","Professor\u002FInvestigator",[62,64],{"name":63,"class":6},"Hospital Infantil Universitario Niño Jesús, Madrid, Spain",{"name":22,"class":6},"100630203","physical-activity-and-fitness-in-pediatric-inflammatory-bowel-disease-100630203",false,"NCT07484620","Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease","Effects of Physical Activity and Physical Fitness on Inflammation, Clinical Outcomes, and Quality of Life in Pediatric Inflammatory Bowel Disease","PAFIT-IBD","Inclusion Criteria:\n\n* Children and adolescents aged 6 to 17 years\n* Confirmed diagnosis of Crohn's disease or ulcerative colitis\n* Clinical remission or mild-to-moderate disease activity\n* Medical clearance to participate in physical activity\n* Ability to complete study assessments and follow-up procedures\n* Written informed consent from a parent or legal guardian and assent from the participant\n\nExclusion Criteria:\n\n* Severe disease activity or acute flare requiring hospitalization\n* Medical contraindications to exercise (e.g., severe cardiopulmonary disease, uncontrolled anemia, significant musculoskeletal conditions)\n* Major surgery within the previous 3 months\n* Participation in another interventional clinical trial\n* Cognitive or behavioral conditions preventing participation\n* Any condition considered unsafe by the investigators or treating physician","ALL","6 Years","17 Years",{"count":77,"type":78},100,"ESTIMATED","INTERVENTIONAL",[81],"NA","Pediatric inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is a chronic condition associated not only with intestinal inflammation but also with reduced physical fitness, fatigue, impaired quality of life, and psychosocial difficulties. Although physical activity and physical fitness are recognized as important determinants of health in the general pediatric population, their role as modifiable prognostic factors in children and adolescents with IBD remains insufficiently studied, particularly using objective measures and longitudinal designs in hospital settings.\n\nThe present hospital-based study aims to investigate the effects of physical activity and physical fitness on inflammation, clinical outcomes, and quality of life in children and adolescents with IBD. The project comprises three phases: (1) an observational cross-sectional and longitudinal assessment, (2) a randomized controlled trial (RCT) evaluating a structured physical activity intervention, and (3) a medium-term follow-up at 6-12 months.\n\nPhysical activity will be assessed objectively using accelerometry and subjectively using validated questionnaires. Physical fitness will be evaluated with the ALPHA fitness battery adapted to the hospital setting, with cardiorespiratory fitness assessed by the 20-meter shuttle run test as the primary outcome of the RCT. Clinical outcomes will include objective inflammatory markers (fecal calprotectin and C-reactive protein), disease activity indices (PCDAI or PUCAI), musculoskeletal health, fatigue, cognitive functioning, and health-related quality of life. Nutritional status and dietary quality will also be assessed, and selected biological markers will be analyzed in a subsample.\n\nThe RCT will examine whether a 12-week supervised physical activity program improves cardiorespiratory fitness compared with usual care, and whether changes in fitness are accompanied by improvements in inflammatory burden and patient-reported outcomes. Longitudinal analyses will explore the sustainability of these effects over time.\n\nThis study will provide comprehensive, objective evidence on the role of physical activity and physical fitness as modifiable factors in pediatric IBD. The results are expected to inform clinical practice, support the integration of structured physical activity into multidisciplinary care, and contribute high-quality data for publication in international peer-reviewed journals.",[84,85],"Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)","Inflamatory Bowel Disease",[87,88,89,90,91,92,93,94],"Pediatric Inflammatory Bowel Disease","Health-Related Quality of Life","Fecal Calprotectin","Physical Fitness","Cardiorespiratory Fitness","Accelerometry","Cognitive Function","Disease Activity","NOT_YET_RECRUITING","2026-03-19",{"date":98,"type":99},"2026-03-24","ACTUAL",{"date":101,"type":78},"2026-04-01",{"date":103,"type":78},"2026-12-01",{"name":5,"class":6},1]