Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease

NCT07484620 | Not Yet Recruiting

• 1 other identifier: R-0006/26
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric Inflammatory Bowel Disease; Health-Related Quality of Life; Fecal Calprotectin; Physical Fitness; Cardiorespiratory Fitness; Accelerometry; Cognitive Function; Disease Activity

Outcome Measures

Primary Outcomes (3)

• Cardiorespiratory fitness assessed by the 20-meter shuttle run test (20mSRT)

  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.

  Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)

• Handgrip strength

  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.

  Baseline (Week 0), post-intervention (Week 12) and follow-up (6-12 months)

• Standing Long Jump

  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.

  Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)

Secondary Outcomes (19)

• Speed and Agility (4 × 10 m Shuttle Run Test)

  Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)

• Moderate-to-Vigorous Physical Activity (MVPA)

  Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)

• Total Sedentary Time

  Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)

• Lean Body Mass

  Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)

• Body Fat Percentage

  Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)

Study Arms (1)

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.

Other: Physical Activity Intervention

Interventions

Physical Activity Intervention OTHER

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.

Physical Activity Intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: collaborator
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Carlos Martín-Martínez, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

• Paula Sánchez-Llorente

  Hospital Infantil Universitario Niño Jesús

  STUDY CHAIR

• Laura Palomino

  Hospital Infantil Universitario Niño Jesús

  STUDY CHAIR

• Rosa Ana Muñoz-Codoceo, PhD

  Hospital Infantil Universitario Niño Jesús

  STUDY CHAIR

• Marta Velasco Rodríguez-Belvís, PhD

  Hospital Infantil Universitario Niño Jesús

  STUDY CHAIR

Central Study Contacts

Carlos Martín-Martínez, PhD

CONTACT

+34635579829; carlos.martinm@urjc.es

Paula Sánchez-Llorente

CONTACT

+34636119002; psllorente@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Investigator

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)