Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:44 AM
Study NCT ID:
NCT07484620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-03-10', 'size': 206912, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-03-19T11:16', 'hasProtocol': True}, {'date': '2026-03-10', 'size': 327933, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2026-03-19T11:16', 'hasProtocol': False}, {'date': '2026-03-10', 'size': 187607, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-03-19T11:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiorespiratory fitness assessed by the 20-meter shuttle run test (20mSRT)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Cardiorespiratory fitness will be assessed using the ALPHA 20-meter shuttle run test (20mSRT). Participants run back and forth between two lines 20 meters apart at increasing speeds guided by audio signals. The outcome is the number of laps completed before exhaustion. Higher values indicate better cardiorespiratory fitness.'}, {'measure': 'Handgrip strength', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12) and follow-up (6-12 months)', 'description': 'Upper-limb muscular strength will be assessed using handgrip dynamometry. Participants perform maximal voluntary contractions using a calibrated handgrip dynamometer. The outcome will be expressed in kilograms (kg), with higher values indicating greater muscular strength.'}, {'measure': 'Standing Long Jump', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Lower-body muscular power will be assessed using the standing long jump test. Participants jump forward as far as possible from a standing position. The outcome will be recorded as the distance jumped in centimeters (cm), with greater distances indicating greater muscular power.'}], 'secondaryOutcomes': [{'measure': 'Speed and Agility (4 × 10 m Shuttle Run Test)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Speed and agility will be evaluated using the ALPHA 4 × 10 meter shuttle run test. Participants run back and forth between two lines four times as quickly as possible. The outcome is recorded as the time required to complete the test in seconds. Lower times indicate better performance.'}, {'measure': 'Moderate-to-Vigorous Physical Activity (MVPA)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Moderate-to-vigorous physical activity will be measured objectively using accelerometry worn for 7 consecutive days. The outcome represents the average daily minutes spent in moderate-to-vigorous physical activity according to validated pediatric accelerometer cut-points. Higher values indicate higher levels of moderate-to-vigorous physical activity.'}, {'measure': 'Total Sedentary Time', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Total sedentary time will be measured using accelerometry over 7 consecutive days. The outcome represents the average number of minutes per day spent in sedentary behavior according to established accelerometer thresholds. Higher values indicate lower levels of physical activity.'}, {'measure': 'Lean Body Mass', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Body composition will be assessed using bioelectrical impedance analysis. The outcome will be lean body mass expressed in kilograms (kg), representing the estimated mass of non-fat tissues. Higher values indicate greater lean mass.'}, {'measure': 'Body Fat Percentage', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Body composition will be assessed using bioelectrical impedance analysis. The outcome will be body fat percentage (%), which estimates the proportion of total body mass composed of fat tissue. Scores range from 0 to 100. Higher values indicate greater adiposity.'}, {'measure': 'Body Mass Index (BMI) z-Score', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). Age- and sex-specific BMI z-scores will be calculated using established pediatric growth reference standards. BMI z-scores provide a standardized measure of relative body mass in children and adolescents. Higher z-score values indicate greater relative body mass for age and sex. In pediatric populations, BMI z-scores below approximately -2 indicate underweight, values between -2 and +1 generally indicate normal weight, values above +1 indicate overweight, and values above +2 indicate obesity.'}, {'measure': 'Self-Reported Physical Activity (Physical Activity Questionnaire for Children PAQ-C)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Self-reported physical activity will be assessed using the Physical Activity Questionnaire for Children (PAQ-C) aged 6-14 years. Scores range from 1 to 5, with higher scores indicating higher levels of physical activity.'}, {'measure': 'Self-Reported Physical Activity (Physical Activity Questionnaire for Adolescents PAQ-A)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Self-reported physical activity will be assessed using the Physical Activity Questionnaire for Adolescents (PAQ-A) aged 14-17 years. Scores range from 1 to 5, with higher scores indicating higher levels of physical activity.'}, {'measure': 'Fecal Calprotectin', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Fecal calprotectin concentration will be measured from stool samples as a biomarker of intestinal inflammation. Results will be expressed in micrograms per gram of stool (µg/g). Higher values indicate greater intestinal inflammation. In clinical practice, fecal calprotectin levels below approximately 50 µg/g are generally considered within the normal range, while levels above 200 µg/g are commonly associated with active intestinal inflammation in inflammatory bowel disease.'}, {'measure': 'C-Reactive Protein (CRP)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Serum C-reactive protein (CRP) concentration will be measured from blood samples as a marker of systemic inflammation. Results will be expressed in milligrams per liter (mg/L), with higher values indicating greater systemic inflammation. In clinical practice, CRP concentrations below approximately 3 mg/L are generally considered within the normal range, whereas higher levels may indicate the presence of systemic inflammation. In patients with inflammatory bowel disease, elevated CRP levels are commonly associated with active inflammatory disease.'}, {'measure': "Disease Activity (Pediatric Crohn's Disease Activity Index PCDAI)", 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': "Clinical disease activity will be assessed using validated pediatric indices. Crohn's disease activity will be measured using the Pediatric Crohn's Disease Activity Index (PCDAI; range 0-100, higher scores indicate more severe disease activity)."}, {'measure': 'Disease Activity (Pediatric Ulcerative Colitis Activity Index PUCAI)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Clinical disease activity will be assessed using validated pediatric indices. Ulcerative colitis activity will be measured using the Pediatric Ulcerative Colitis Activity Index (PUCAI; range 0-85, higher scores indicate more severe disease activity).'}, {'measure': 'Health-Related Quality of Life (IMPACT-III)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Health-related quality of life will be assessed using the Inflammatory Bowel Disease Questionnaire for Children (IMPACT-III). The questionnaire includes multiple domains related to emotional functioning, social functioning, and disease-related concerns. Total scores range from 35 to 175, with higher scores indicating better health-related quality of life.'}, {'measure': 'Fatigue (Pediatric Quality of Life Inventory Multidimensional Fatigue Scale)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Fatigue will be assessed using the Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale, a validated questionnaire designed to measure fatigue symptoms in children and adolescents. Scores range from 0 to 100, with higher scores indicating lower levels of fatigue and better functioning.'}, {'measure': 'Executive Function (BENCI Neuropsychological Battery)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Executive functions will be assessed using the computerized BENCI neuropsychological battery administered on an iPad. The battery evaluates cognitive domains including attention, inhibition, working memory, and cognitive flexibility. Standardized scores will be used to quantify cognitive performance, with higher scores indicating better cognitive functioning.'}, {'measure': 'Attention-Deficit/Hyperactivity Symptoms (ADHD Rating Scale)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Symptoms of attention-deficit/hyperactivity disorder will be assessed using the ADHD Rating Scale, a standardized questionnaire evaluating inattentive and hyperactive-impulsive symptoms in children and adolescents. Total scores range from 0 to 54, with higher scores indicating greater severity of ADHD symptoms.'}, {'measure': "Anxiety Symptoms (Revised Children's Anxiety and Depression Scale)", 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': "Anxiety symptoms will be assessed using the Revised Children's Anxiety and Depression Scale (RCADS). The questionnaire evaluates several domains of anxiety symptoms in children and adolescents. Total scores vary depending on the subscale used, with higher scores indicating greater anxiety symptom severity."}, {'measure': 'Academic Performance (School Grades)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': "Academic performance will be evaluated using school grades obtained from school reports. Grades will be analyzed according to the national grading scale used in the participant's educational system, with scores ranging from 0 to 10 and higher values indicating better academic performance."}, {'measure': 'Mediterranean Diet Adherence (KIDMED Index)', 'timeFrame': 'Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)', 'description': 'Diet quality will be assessed using the Mediterranean Diet Quality Index for Children and Adolescents (KIDMED). Scores range from -4 to 12, with higher scores indicating better adherence to the Mediterranean diet.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Inflammatory Bowel Disease', 'Health-Related Quality of Life', 'Fecal Calprotectin', 'Physical Fitness', 'Cardiorespiratory Fitness', 'Accelerometry', 'Cognitive Function', 'Disease Activity'], 'conditions': ['Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)', 'Inflamatory Bowel Disease']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Pediatric inflammatory bowel disease (IBD), encompassing Crohn's disease and ulcerative colitis, is a chronic condition frequently diagnosed during childhood and adolescence. In addition to persistent intestinal inflammation, pediatric IBD is associated with reduced physical activity levels, impaired physical fitness, fatigue, musculoskeletal complaints, cognitive and psychosocial difficulties, and diminished health-related quality of life. Despite advances in pharmacological treatment, many children and adolescents continue to experience functional limitations that are not fully addressed by standard medical care.\n\nPhysical activity and physical fitness are modifiable lifestyle factors with well-established benefits in healthy pediatric populations, including anti-inflammatory effects, improved cardiorespiratory and muscular fitness, and better mental health and quality of life. However, in pediatric IBD, evidence remains limited, particularly from studies using objective measurements of physical activity and fitness, randomized controlled designs, and longitudinal follow-up in hospital-based settings. Furthermore, the relationships between physical activity, physical fitness, inflammation, clinical outcomes, and quality of life have not been comprehensively examined within a single integrated study framework.\n\nThis hospital-based study aims to evaluate the role of physical activity and physical fitness as modifiable factors influencing inflammation, clinical outcomes, and quality of life in children and adolescents with IBD. The study is conducted in three sequential phases: (1) an observational cross-sectional and longitudinal assessment, (2) a randomized controlled trial (RCT) of a structured physical activity intervention, and (3) a medium-term follow-up at 6 to 12 months.\n\nIn the observational phase, participants aged 8 to 17 years with a confirmed diagnosis of Crohn's disease or ulcerative colitis will undergo comprehensive baseline assessments. Physical activity will be measured objectively using accelerometry over seven consecutive days and supplemented by validated questionnaires. Physical fitness will be assessed using the ALPHA fitness battery adapted to the hospital environment, including cardiorespiratory fitness measured by the 20-meter shuttle run test, muscular strength, agility, and body composition. 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 evaluated, and selected biological markers will be analyzed in a subsample.\n\nIn the interventional phase, eligible participants will be randomized to either a 12-week structured physical activity program or usual care. The intervention consists of supervised, age-appropriate exercise sessions combining aerobic and strength-based activities, tailored to participants' clinical status and functional capacity. The primary outcome of the RCT is the change in cardiorespiratory fitness, assessed by the number of laps completed in the 20-meter shuttle run test. Secondary outcomes include changes in inflammatory markers, disease activity indices, physical fitness components, fatigue, cognitive performance, nutritional status, and quality of life.\n\nThe follow-up phase will assess the sustainability of changes in physical activity, physical fitness, inflammation, and clinical outcomes at 6 to 12 months after baseline assessment or completion of the intervention. Longitudinal analyses will examine whether baseline and intervention-induced changes in physical activity and physical fitness predict medium-term clinical and patient-reported outcomes.\n\nAll questionnaires, cognitive assessments, and consent procedures will be administered electronically using secure institutional platforms. Data will be collected and stored in a pseudonymized manner in accordance with applicable data protection regulations.\n\nThis study is designed to provide high-quality, objective evidence on the clinical relevance of physical activity and physical fitness in pediatric IBD. By integrating functional, inflammatory, and patient-centered outcomes, the findings are expected to inform multidisciplinary care strategies and support the incorporation of structured physical activity into routine clinical management for children and adolescents with IBD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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"}, 'identificationModule': {'nctId': 'NCT07484620', 'acronym': 'PAFIT-IBD', 'briefTitle': 'Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Effects of Physical Activity and Physical Fitness on Inflammation, Clinical Outcomes, and Quality of Life in Pediatric Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'R-0006/26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Activity Intervention', 'description': "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.", 'interventionNames': ['Other: Physical Activity Intervention']}], 'interventions': [{'name': 'Physical Activity Intervention', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Physical Activity Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Rosa Ana Muñoz-Codoceo, PhD', 'role': 'CONTACT', 'email': 'rosana.munoz@salud.madrid.org', 'phone': '+34915035900', 'phoneExt': '624'}], 'facility': 'Hospital Infantil Universitario Niño Jesús', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Carlos Martín-Martínez, PhD', 'role': 'CONTACT', 'email': 'carlos.martinm@urjc.es', 'phone': '+34635579829'}, {'name': 'Paula Sánchez-Llorente', 'role': 'CONTACT', 'email': 'psllorente@salud.madrid.org', 'phone': '+34636119002'}], 'overallOfficials': [{'name': 'Carlos Martín-Martínez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Rey Juan Carlos'}, {'name': 'Paula Sánchez-Llorente', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Infantil Universitario Niño Jesús'}, {'name': 'Laura Palomino', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Infantil Universitario Niño Jesús'}, {'name': 'Rosa Ana Muñoz-Codoceo, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Infantil Universitario Niño Jesús'}, {'name': 'Marta Velasco Rodríguez-Belvís, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Infantil Universitario Niño Jesús'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Infantil Universitario Niño Jesús, Madrid, Spain', 'class': 'OTHER'}, {'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor/Investigator', 'investigatorFullName': 'Carlos Martín Martínez', 'investigatorAffiliation': 'Universidad Rey Juan Carlos'}}}}