Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease

NCT07484620 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-09-03

No results posted yet for this study

Summary

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.

Conditions

  • Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
  • Inflamatory Bowel Disease

Interventions

OTHER

Physical Activity Intervention

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.

Sponsors & Collaborators

  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain

    collaborator OTHER
  • Universidad Rey Juan Carlos

    collaborator OTHER
  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • Carlos Martín-Martínez, PhD · Universidad Rey Juan Carlos

  • Paula Sánchez-Llorente · Hospital Infantil Universitario Niño Jesús

  • Laura Palomino · Hospital Infantil Universitario Niño Jesús

  • Rosa Ana Muñoz-Codoceo, PhD · Hospital Infantil Universitario Niño Jesús

  • Marta Velasco Rodríguez-Belvís, PhD · Hospital Infantil Universitario Niño Jesús

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-11-01
Completion
2026-12-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07484620 on ClinicalTrials.gov