NCT07484620: PAFIT-IBD

Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease

Not yet recruiting NA Last updated 24 March 2026

What this trial tests

NA trial testing Physical Activity Intervention in Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis) in 100 participants. Not yet recruiting.

Timeline

1 April 2026

Primary endpoint
1 November 2026

1 December 2026

Quick facts

Lead sponsor	Universidad Complutense de Madrid
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 April 2026
Primary completion	1 November 2026
Estimated completion	1 December 2026
Sites	1 location across Spain

Drugs / interventions tested

• Physical Activity Intervention

Conditions studied

• Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis) — all drugs for Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis) →
• Inflamatory Bowel Disease — all drugs for Inflamatory Bowel Disease →

Sponsor

Universidad Complutense de Madrid — full company profile →

Who can join

Adults 6 to 17, any sex, with Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis) or Inflamatory Bowel Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.