NCT07484620Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 10 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Universidad Complutense de Madrid
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07484620
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Apr 2026 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery within the previous 3 months
Other illness
- Severe disease activity or acute flare requiring hospitalization
- Medical contraindications to exercise (e.g., severe cardiopulmonary disease, uncontrolled anemia, significant musculoskeletal conditions)
- Cognitive or behavioral conditions preventing participation
- Any condition considered unsafe by the investigators or treating physician
Other
- Participation in another interventional clinical trial
Who the study is looking for
- 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
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.