Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease

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Conditions studied: Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), Inflamatory Bowel Disease

In brief

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. The 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. Physical 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. The 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. This 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.

Key facts

Study ID: NCT07484620
Run by: Universidad Complutense de Madrid
People needed: 100
Starts: 2026-04-01
Expected to finish: 2026-12-01
Last updated by the study team: 2026-03-24

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Children and adolescents aged 6 to 17 years
Confirmed diagnosis of Crohn's disease or ulcerative colitis
Clinical remission or mild-to-moderate disease activity
Medical clearance to participate in physical activity
Ability to complete study assessments and follow-up procedures
Written informed consent from a parent or legal guardian and assent from the participant

You may not qualify if…

Severe disease activity or acute flare requiring hospitalization
Medical contraindications to exercise (e.g., severe cardiopulmonary disease, uncontrolled anemia, significant musculoskeletal conditions)
Major surgery within the previous 3 months
Participation in another interventional clinical trial
Cognitive or behavioral conditions preventing participation
Any condition considered unsafe by the investigators or treating physician

Where it is running

Hospital Infantil Universitario Niño Jesús — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

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