Inflammatory Bowel Disease (IBD)FIT4IBDKidsNCT07355101

Personalized Exercise Coaching to Improve Quality of Life in Pediatric IBD

A study testing Intake session to define individualized physical activity goals, Personalized Motivational Coaching and 24 Week Exercise Programme in people with Inflammatory Bowel Disease (IBD), run by Universiteit Antwerpen at 1 site in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 6 to 18 years
Conditions the study is for: Inflammatory Bowel Disease (IBD)
What is being tested?: Intake session to define individualized physical activity goals, Personalized Motivational Coaching and 24 Week Exercise Programme
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteBelgium
Study dates: 1 Nov 2025to 1 Aug 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

Physical inability to perform a cardiopulmonary exercise test (CPET)
Participation in organized exercise training programs in a research setting
Medical contra-indications for exercise

Trial locations and contacts

1 site in 1 country.

Belgium1 site

University Hospital Antwerp
Edegem, Antwerpen, 2650

Other trials in Belgium

About this study

Official title: Personalized Exercise Coaching to Improve Quality of Life in Pediatric IBD - FIT4IBDKids: Study Protocol

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.

Read the detailed description

A 24 week exercise programme is designed by "Physical Activity on Prescription" (Bewegen Op Verwijzing). This multidisciplinary team develops personalized coaching programs designed to support physically inactive individuals in adopting a more active lifestyle. The intervention is characterized by professional guidance from a qualified and motivational coach, the development of a tailored physical activity plan, and continuous follow-up. The team will develop a holistic family-centered coaching trajectory for children aged six to 18 years. The intake session in which individualized physical activity goals are defined in collaboration with the child, encourages autonomy and active participation. Based on this initial assessment, a personalized coaching 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. All participants will participate in one supervised intake session with "Physical Activity on Prescription" (Bewegen Op Verwijzing) at baseline assessment. Furthermore, the online application UZA@Home provides digital support and guidance to patients throughout their trajectory at the University Hospital of Antwerp (UZA). 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. Through the patient portal, individuals receive feedback on their intervention program and are able to consult appointments or access their medical records. The primary outcomes of this trial include differences in cardiorespiratory fitness (CRF), as assessed by maximal oxygen uptake (VO₂max), in addition to patient-reported outcomes measured by the IMPACT-III, PedsQoL-MFS, and the disease activity indices PCDAI and PUCAI. Secondary outcomes encompass a range of physical health parameters, including heart rate variability (HRV), muscular strength, resting blood pressure, basal metabolic rate, aerobic capacity, and body mass index (BMI). Intramural inflammation will be quantified through fecal calprotectin levels. Furthermore, disease activity will be evaluated using intestinal ultrasonography, standard endoscopic procedures (no study specific procedures, only standard of care biopsies) and the analysis of gastrointestinal mucins. All measurements will be conducted during each physical follow-up visit at the hospital, which will occur at the beginning, mid-intervention (except for endoscopy) and after the 24 week intervention period.

Conditions: Inflammatory Bowel Disease (IBD)
Being tested: Intake session to define individualized physical activity goals, Personalized Motivational Coaching, 24 Week Exercise Programme
Keywords: Physical exercise, Fatigue, Children, Quality of Life, Adolescent
Medical subject headings: Inflammatory Bowel Diseases, Motor Activity, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intake session to define individualized physical activity goalsBehavioural
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.
Personalized Motivational CoachingBehavioural
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.
24 Week Exercise ProgrammeBehavioural
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.

Study groups in NCT07355101
Study group	Role	What they receive
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). Receives: 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). Receives: Behavioral: Intake session to define individualized physical activity goals; Behavioral: Personalized Motivational Coaching; Behavioral: 24 Week Exercise Programme

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in fatigue in children with IBD
This primary outcome will be characterized by a validated PedsQL™ Multidimensional Fatigue Scale (PedsQoL-MFS) questionnaire.
Measured: 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.
Measured: 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.
Measured: From start to end of the adjunctive 24 weeks exercise programme to current treatment.

Secondary outcomes (9)

Heart rate variability (HRV)
A 24 h time-domain measures of SDNN (standard deviation of the IBI of normal sinus beats).
Measured: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Muscular strength
Objective grading by Handheld Dynamometers (HHDs) to provide a precise and numerical measure of muscle force, displaying the result in quantifiable units like Newtons or kilograms.
Measured: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Resting blood pressure
In resting conditions, systolic over diastolic blood pressure in mmHg.
Measured: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Body mass index (BMI)
Expressed in units of kg/m2, resulting from mass in kilograms (kg) and height in metres (m).
Measured: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Maximal oxygen uptake (VO₂max)
V̇O2max is expressed as a relative rate in (for example) millilitres of oxygen per kilogram of the body mass per minute (e.g., mL/(kg·min)).
Measured: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Intestinal ultrasonograph
The ultrasonographic evaluation of the small and large bowels should be performed with both low-frequency (2-5 MHz) and high-frequency (5-17 MHz) linear array probes to provide a correct assessment of the bowel wall thickness and discrimination of the five different bowel wall layers (lumen/mucosa interface, mucosa, submucosa, muscolaris propria, serosa).
Measured: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Standard endoscopic procedure
According Position Paper on Behalf of the IBD Group of the European Society for Pediatric Gastroenterology,
Hepatology and Nutrition:
1. Pediatric Endoscopy should be performed by a pediatric gastroenterologist, or in some cases, by a gastroenterologist with specific pediatric training and/or supported by a pediatric team in a pediatric-friendly setting, as described in the recent ESPGHAN/European Society for Gastrointestinal Endoscopy (ESGE) guidelines.
2. According to the revised Porto Criteria, endoscopy is usually recommended in the presence of alarming symptoms (ie, bloody diarrhea, weight loss, abdominal pain) and/or positive serum inflammatory markers (C-CRP) an/or ESR), and/or high levels of fecal calprotectin.
3. It is recommended to collect 2 biopsies samples from duodenum, stomach and esophagus during EGD, and from terminal ileum, cecum, transverse colon, sigmoid colon, and rectum during IC.
4. In severe acute colitis, a limited sigmoidoscopy may be safer.
Measured: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Fecal calprotectin level
Expressed in μg/g of faeces.
Measured: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Gastrointestinal mucins
GWAS for mucin genes including MUC3A, MUC3B, MUC12, and MUC17.
Measured: From start to end of the adjunctive 24 weeks exercise programme to current treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20251 Aug 2027

First posted21 Jan 2026
Study start1 Nov 2025
Primary completion1 Apr 2027 (estimated)
Study completion1 Aug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07355101
Sponsor's protocol ID: 7893
Acronym: FIT4IBDKids
Status last verified: Jan 2026
First submitted: 15 Dec 2025
Last updated: 21 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No individual participant data (IPD) will be shared. All anonymous data will be collected prospectively in REDCap (Research Electronic Data Capture) during scheduled hospital visits at baseline, throughout the intervention period (one follow-up point), and at study completion. Patient-reported outcomes will be obtained through validated questionnaires (IMPACT-III, PedsQoL-MFS, PCDAI, and PUCAI), administered electronically in the UZA@Home application. All data will be entered into a secure, password-protected electronic database compliant with GDPR and institutional data protection policies. Any discrepancies or missing values will be addressed according to a predefined data management plan. The four researchers adhere to the 'Guide on Good Data Protection Practice in Research' of the European University Institute (EUI). Technical appendix, statistical code, and dataset available from the Dryad repository.

Publications

Cozijnsen MA, van Pieterson M, Samsom JN, Escher JC, de Ridder L. Top-down Infliximab Study in Kids with Crohn's disease (TISKids): an international multicentre randomised controlled trial. BMJ Open Gastroenterol. 2016 Dec 22;3(1):e000123. doi: 10.1136/bmjgast-2016-000123. eCollection 2016.
PubMed 28090335
Bishop J, Lemberg DA, Day A. Managing inflammatory bowel disease in adolescent patients. Adolesc Health Med Ther. 2014 Jan 6;5:1-13. doi: 10.2147/AHMT.S37956. eCollection 2014.
PubMed 24729736
Arruda JM, Bogetz AL, Vellanki S, Wren A, Yeh AM. Yoga as adjunct therapy for adolescents with inflammatory bowel disease: A pilot clinical trial. Complement Ther Med. 2018 Dec;41:99-104. doi: 10.1016/j.ctim.2018.09.007. Epub 2018 Sep 11.
PubMed 30477870
Legeret C, Mahlmann L, Gerber M, Kalak N, Kohler H, Holsboer-Trachsler E, Brand S, Furlano R. Favorable impact of long-term exercise on disease symptoms in pediatric patients with inflammatory bowel disease. BMC Pediatr. 2019 Aug 27;19(1):297. doi: 10.1186/s12887-019-1680-7.
PubMed 31455308
Scheffers LE, Vos IK, Utens EMWJ, Dieleman GC, Walet S, Escher JC, van den Berg LEM; Rotterdam Exercise Team. Physical Training and Healthy Diet Improved Bowel Symptoms, Quality of Life, and Fatigue in Children With Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2023 Aug 1;77(2):214-221. doi: 10.1097/MPG.0000000000003816. Epub 2023 May 3.
PubMed 37134004
Mackner LM, Greenley RN, Szigethy E, Herzer M, Deer K, Hommel KA. Psychosocial issues in pediatric inflammatory bowel disease: report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):449-58. doi: 10.1097/MPG.0b013e3182841263.
PubMed 23287808
Greenley RN, Hommel KA, Nebel J, Raboin T, Li SH, Simpson P, Mackner L. A meta-analytic review of the psychosocial adjustment of youth with inflammatory bowel disease. J Pediatr Psychol. 2010 Sep;35(8):857-69. doi: 10.1093/jpepsy/jsp120. Epub 2010 Feb 1.
PubMed 20123705
Shaw SY, Blanchard JF, Bernstein CN. Association between the use of antibiotics in the first year of life and pediatric inflammatory bowel disease. Am J Gastroenterol. 2010 Dec;105(12):2687-92. doi: 10.1038/ajg.2010.398. Epub 2010 Oct 12.
PubMed 20940708
Hou JK, Abraham B, El-Serag H. Dietary intake and risk of developing inflammatory bowel disease: a systematic review of the literature. Am J Gastroenterol. 2011 Apr;106(4):563-73. doi: 10.1038/ajg.2011.44.
PubMed 21468064
Bager P, Simonsen J, Nielsen NM, Frisch M. Cesarean section and offspring's risk of inflammatory bowel disease: a national cohort study. Inflamm Bowel Dis. 2012 May;18(5):857-62. doi: 10.1002/ibd.21805. Epub 2011 Jul 7.
PubMed 21739532
Kugathasan S, Judd RH, Hoffmann RG, Heikenen J, Telega G, Khan F, Weisdorf-Schindele S, San Pablo W Jr, Perrault J, Park R, Yaffe M, Brown C, Rivera-Bennett MT, Halabi I, Martinez A, Blank E, Werlin SL, Rudolph CD, Binion DG; Wisconsin Pediatric Inflammatory Bowel Disease Alliance. Epidemiologic and clinical characteristics of children with newly diagnosed inflammatory bowel disease in Wisconsin: a statewide population-based study. J Pediatr. 2003 Oct;143(4):525-31. doi: 10.1067/s0022-3476(03)00444-x.
PubMed 14571234
Muise AM, Snapper SB, Kugathasan S. The age of gene discovery in very early onset inflammatory bowel disease. Gastroenterology. 2012 Aug;143(2):285-8. doi: 10.1053/j.gastro.2012.06.025. Epub 2012 Jun 21. No abstract available.
PubMed 22727850
Knights D, Lassen KG, Xavier RJ. Advances in inflammatory bowel disease pathogenesis: linking host genetics and the microbiome. Gut. 2013 Oct;62(10):1505-10. doi: 10.1136/gutjnl-2012-303954.
PubMed 24037875
Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):307-17. doi: 10.1038/nature10209.
PubMed 21677747
van Rheenen PF, Aloi M, Assa A, Bronsky J, Escher JC, Fagerberg UL, Gasparetto M, Gerasimidis K, Griffiths A, Henderson P, Koletzko S, Kolho KL, Levine A, van Limbergen J, Martin de Carpi FJ, Navas-Lopez VM, Oliva S, de Ridder L, Russell RK, Shouval D, Spinelli A, Turner D, Wilson D, Wine E, Ruemmele FM. The Medical Management of Paediatric Crohn's Disease: an ECCO-ESPGHAN Guideline Update. J Crohns Colitis. 2021 Feb 1;15(2):jjaa161. doi: 10.1093/ecco-jcc/jjaa161. Epub 2020 Oct 7.
PubMed 33026087

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalized Exercise Coaching to Improve Quality of Life in Pediatric IBD - FIT4IBDKids: Study Protocol
ClinicalTrials.gov ID: NCT07355101
Acronym / sponsor ID: FIT4IBDKids / 7893
Conditions: Inflammatory Bowel Disease (IBD)
Keywords: Physical exercise, Fatigue, Children, Quality of Life, Adolescent
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 70 participants (estimated)
Lead sponsor: Universiteit AntwerpenUniversity, hospital or other
Study start: 1 Nov 2025 (actual)
Primary completion: 1 Apr 2027 (estimated)
Study completion: 1 Aug 2027 (estimated)
First posted: 21 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Higher exercise habits	Experimental	Behavioral: Intake session to define individualized physical activity goals, Behavioral: Personalized Motivational Coaching, Behavioral: 24 Week Exercise ProgrammeThe 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).
Lower exercise habits	Active comparator	Behavioral: Intake session to define individualized physical activity goals, Behavioral: Personalized Motivational Coaching, Behavioral: 24 Week Exercise ProgrammePeers 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).

Who may qualify

Ages: 6 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intake session to define individualized physical activity goalsThe 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.	Behavioural	Higher exercise habits, Lower exercise habits
Personalized Motivational CoachingA 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.	Behavioural	Higher exercise habits, Lower exercise habits
24 Week Exercise ProgrammeA 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.	Behavioural	Higher exercise habits, Lower exercise habits

Primary outcome

Change in fatigue in children with IBD
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
This primary outcome will be characterized by a validated PedsQL™ Multidimensional Fatigue Scale (PedsQoL-MFS) questionnaire.
Change in Quality of Life in children with IBD
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
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.
Change in disease severity in children with IBD
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
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.

9 secondary outcomes

Heart rate variability (HRV)
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Muscular strength
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Resting blood pressure
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Body mass index (BMI)
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Maximal oxygen uptake (VO₂max)
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Intestinal ultrasonograph
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Standard endoscopic procedure
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Fecal calprotectin level
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.
Gastrointestinal mucins
Time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
Background: PubMed 28090335Cozijnsen MA, van Pieterson M, Samsom JN, Escher JC, de Ridder L. Top-down Infliximab Study in Kids with Crohn's disease (TISKids): an international multicentre randomised controlled trial. BMJ Open Gastroenterol. 2016 Dec 22;3(1):e000123. doi: 10.1136/bmjgast-2016-000123. eCollection 2016.
Background: PubMed 24729736Bishop J, Lemberg DA, Day A. Managing inflammatory bowel disease in adolescent patients. Adolesc Health Med Ther. 2014 Jan 6;5:1-13. doi: 10.2147/AHMT.S37956. eCollection 2014.
Background: PubMed 30477870Arruda JM, Bogetz AL, Vellanki S, Wren A, Yeh AM. Yoga as adjunct therapy for adolescents with inflammatory bowel disease: A pilot clinical trial. Complement Ther Med. 2018 Dec;41:99-104. doi: 10.1016/j.ctim.2018.09.007. Epub 2018 Sep 11.
Background: PubMed 31455308Legeret C, Mahlmann L, Gerber M, Kalak N, Kohler H, Holsboer-Trachsler E, Brand S, Furlano R. Favorable impact of long-term exercise on disease symptoms in pediatric patients with inflammatory bowel disease. BMC Pediatr. 2019 Aug 27;19(1):297. doi: 10.1186/s12887-019-1680-7.
Background: PubMed 37134004Scheffers LE, Vos IK, Utens EMWJ, Dieleman GC, Walet S, Escher JC, van den Berg LEM; Rotterdam Exercise Team. Physical Training and Healthy Diet Improved Bowel Symptoms, Quality of Life, and Fatigue in Children With Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2023 Aug 1;77(2):214-221. doi: 10.1097/MPG.0000000000003816. Epub 2023 May 3.
Background: PubMed 23287808Mackner LM, Greenley RN, Szigethy E, Herzer M, Deer K, Hommel KA. Psychosocial issues in pediatric inflammatory bowel disease: report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):449-58. doi: 10.1097/MPG.0b013e3182841263.
Background: PubMed 20123705Greenley RN, Hommel KA, Nebel J, Raboin T, Li SH, Simpson P, Mackner L. A meta-analytic review of the psychosocial adjustment of youth with inflammatory bowel disease. J Pediatr Psychol. 2010 Sep;35(8):857-69. doi: 10.1093/jpepsy/jsp120. Epub 2010 Feb 1.
Background: PubMed 20940708Shaw SY, Blanchard JF, Bernstein CN. Association between the use of antibiotics in the first year of life and pediatric inflammatory bowel disease. Am J Gastroenterol. 2010 Dec;105(12):2687-92. doi: 10.1038/ajg.2010.398. Epub 2010 Oct 12.
Background: PubMed 21468064Hou JK, Abraham B, El-Serag H. Dietary intake and risk of developing inflammatory bowel disease: a systematic review of the literature. Am J Gastroenterol. 2011 Apr;106(4):563-73. doi: 10.1038/ajg.2011.44.
Background: PubMed 21739532Bager P, Simonsen J, Nielsen NM, Frisch M. Cesarean section and offspring's risk of inflammatory bowel disease: a national cohort study. Inflamm Bowel Dis. 2012 May;18(5):857-62. doi: 10.1002/ibd.21805. Epub 2011 Jul 7.
Background: PubMed 14571234Kugathasan S, Judd RH, Hoffmann RG, Heikenen J, Telega G, Khan F, Weisdorf-Schindele S, San Pablo W Jr, Perrault J, Park R, Yaffe M, Brown C, Rivera-Bennett MT, Halabi I, Martinez A, Blank E, Werlin SL, Rudolph CD, Binion DG; Wisconsin Pediatric Inflammatory Bowel Disease Alliance. Epidemiologic and clinical characteristics of children with newly diagnosed inflammatory bowel disease in Wisconsin: a statewide population-based study. J Pediatr. 2003 Oct;143(4):525-31. doi: 10.1067/s0022-3476(03)00444-x.
Background: PubMed 22727850Muise AM, Snapper SB, Kugathasan S. The age of gene discovery in very early onset inflammatory bowel disease. Gastroenterology. 2012 Aug;143(2):285-8. doi: 10.1053/j.gastro.2012.06.025. Epub 2012 Jun 21. No abstract available.
Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared. All anonymous data will be collected prospectively in REDCap (Research Electronic Data Capture) during scheduled hospital visits at baseline, throughout the intervention period (one follow-up point), and at study completion. Patient-reported outcomes will be obtained through validated questionnaires (IMPACT-III, PedsQoL-MFS, PCDAI, and PUCAI), administered electronically in the UZA@Home application. All data will be entered into a secure, password-protected electronic database compliant with GDPR and institutional data protection policies. Any discrepancies or missing values will be addressed according to a predefined data management plan. The four researchers adhere to the 'Guide on Good Data Protection Practice in Research' of the European University Institute (EUI). Technical appendix, statistical code, and dataset available from the Dryad repository.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Els Van de Vijver, MD, PhD principal investigator

University Hospital, Antwerp

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fatigue in children with IBD (time frame: From start to end of the adjunctive 24 weeks exercise programme to current treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07355101, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.