Personalized Exercise Coaching to Improve Quality of Life in Pediatric IBD

NCT07355101 | Active Not Recruiting DMC

• 1 other identifier: 7893
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this research is to gain novel insights into the potential of physical activity in reducing fatigue, improving QoL and GI manifestations in children with IBD. The study design will be composed of two parallel groups to investigate the role of physical activity: on the one hand patients with higher exercise habits, on the other hand children with lower exercise habits. To this end, the two groups of pediatric IBD patients will undergo a 24 weeks exercise programme, adjunctive to their current treatment, quantified by a Health Smartwatch (Garmin Inc.). The primary outcomes will then be characterized by the PedsQoL-MFS, IMPACT-III, PCDAI and PUCAI questionnaires, as well as VO2-max quantification. The proposed research will confirm or refute current hypotheses about physical training suggesting an improvement in quality of life (QoL), fatigue and bowel symptoms in children with IBD. Furthermore, investigating the effectiveness on secondary outcomes including muscle strength and aerobic capacity will be a new contribution to current knowledge.

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

Physical exercise; Fatigue; Children; Quality of Life; Adolescent

Outcome Measures

Primary Outcomes (3)

• Change in fatigue in children with IBD

  This primary outcome will be characterized by a validated PedsQL™ Multidimensional Fatigue Scale (PedsQoL-MFS) questionnaire.

  From start to end of the adjunctive 24 weeks exercise programme to current treatment.

• Change in Quality of Life in children with IBD

  This primary outcomes will be characterized by the IMPACT-III questionnaire. IMPACT-III is a valid health-related quality of life questionnaire for pediatric patients who have an Inflammatory Bowel Disease (IBD). It was developed among children and adolescents who have IBD. The questionnaire can be administered as a self-report to individuals who have IBD. It provides a measure of patient views on aspects of their health like: physical well-being, emotional and social functioning, body Image.

  From start to end of the adjunctive 24 weeks exercise programme to current treatment.

• Change in disease severity in children with IBD

  This primary outcome will be characterized by the Pediatric Crohn's Disease Activity Index (PCDAI) which stratifies severity of Crohn's disease in pediatric patients or the Pediatric Ulcerative Colitis Activity Index (PUCAI) which determines severity of ulcerative colitis (UC) in pediatric patients.

  From start to end of the adjunctive 24 weeks exercise programme to current treatment.

Secondary Outcomes (9)

• Heart rate variability (HRV)

  From start to end of the adjunctive 24 weeks exercise programme to current treatment.

• Muscular strength

  From start to end of the adjunctive 24 weeks exercise programme to current treatment.

• Resting blood pressure

  From start to end of the adjunctive 24 weeks exercise programme to current treatment.

• Body mass index (BMI)

  From start to end of the adjunctive 24 weeks exercise programme to current treatment.

• Maximal oxygen uptake (VO₂max)

  From start to end of the adjunctive 24 weeks exercise programme to current treatment.

Study Arms (2)

Higher exercise habits

EXPERIMENTAL

The first group of this study will consist of children with higher exercise habits, in particular obtaining a weekly Personal Activity Intelligence (PAI) score ≥100 at baseline. (The personalized metric for physical activity tracking named PAI quantifies how much physical activity per week is needed to reduce the risk of premature mortality from non-communicable diseases).

Behavioral: Intake session to define individualized physical activity goals; Behavioral: Personalized Motivational Coaching; Behavioral: 24 Week Exercise Programme

Lower exercise habits

ACTIVE COMPARATOR

Peers in the second group will reach PAI scores \<100 at baseline. (The personalized metric for physical activity tracking named PAI quantifies how much physical activity per week is needed to reduce the risk of premature mortality from non-communicable diseases).

Behavioral: Intake session to define individualized physical activity goals; Behavioral: Personalized Motivational Coaching; Behavioral: 24 Week Exercise Programme

Interventions

Intake session to define individualized physical activity goals BEHAVIORAL

The intake session of a 24 week exercise programme, designed by "Physical Activity on Prescription" (Bewegen Op Verwijzing), will define individualized physical activity goals in collaboration with the child, which encourages autonomy and active participation.

Higher exercise habits; Lower exercise habits

Personalized Motivational Coaching BEHAVIORAL

A personalized coaching program designed by a multidisciplinary team to support physically inactive individuals in adopting a more active lifestyle. The intervention is characterized by professional guidance from a qualified and motivational coach with continuous follow-up. It is a holistic family-centered coaching trajectory for children aged six to 18 years. Its primary aim is to empower patients by equipping them with the necessary tools to actively engage in their treatment, while ensuring high-quality care as close to home as possible.

Higher exercise habits; Lower exercise habits

24 Week Exercise Programme BEHAVIORAL

A development of a 24 week tailored physical activity plan based on an initial assessment of PAI. The personalized exercise plan will be co-created with each child and their family, aiming to increase physical activity levels in a structured and supportive manner. The intervention will span a minimum duration of six months, in order to reduce the risk of drop-out and to promote long-term sustainability of behavioral change.

Higher exercise habits; Lower exercise habits

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnose with IBD (Crohn's Disease or Ulcerative Colitis) according to the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Guidelines.

You may not qualify if:

• Diabetes Mellitus (all types, according to the American Diabetes Association (ADA))
• Malnutrition or Failure to Thrive, suspected or confirmed
• Children with malignancy
• Children with an acute phase of IBD disease activity
• Children who are too fatigued to apply
• Children \< 120 cm, as VO2 max cannot be measured
• Physical inability to perform a cardiopulmonary exercise test (CPET)
• Participation in organized exercise training programs in a research setting
• Medical contra-indications for exercise

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerpen, 2650, Belgium

Location

Related Publications (19)

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MeSH Terms

Conditions

Inflammatory Bowel Diseases; Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Els Van de Vijver, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical student

Model Details: Children with IBD will be allocated into two groups. The first group of this study will consist of children with higher exercise habits, in particular obtaining a weekly Personal Activity Intelligence (PAI) score ≥100 at baseline. Peers in the second group will reach PAI scores \<100 at baseline. The personalized metric for physical activity tracking named PAI quantifies how much physical activity per week is needed to reduce the risk of premature mortality from non-communicable diseases. PAI and objectively measured cardiorespiratory fitness (as indicated by VO2peak) are positively associated in a graded fashion. Seventy pediatric patients will be included in this trial. Children were considered eligible for inclusion aged between six and 18 years old and diagnosed with IBD (Crohn's Disease or Ulcerative Colitis) according to the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Guidelines.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 21, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)