Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorUniversidad Complutense de Madrid
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Physical Activity Intervention
Other interventionParticipants 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Physical Activity InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)2
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.
Time frame
Baseline (Week 0), post-intervention (Week 12) and follow-up (6-12 months)3
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.
Time frame
Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)Secondary outcomes
1
Speed and Agility (4 × 10 m Shuttle Run Test)
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.
Time frame
Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)2
Moderate-to-Vigorous Physical Activity (MVPA)
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.
Time frame
Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)3
Total Sedentary Time
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.
Time frame
Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)4
Lean Body Mass
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.
Time frame
Baseline (Week 0), post-intervention (Week 12), and follow-up (6-12 months)Sponsors and contacts
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Universidad Complutense de Madrid
Lead sponsor
Universidad Rey Juan Carlos
Sponsor institution
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Collaborator
Universidad Rey Juan Carlos
Collaborator
Source ClinicalTrials.gov
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