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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability (HRV) | A 24 h time-domain measures of SDNN (standard deviation of the IBI of normal sinus beats). | From start to end of the adjunctive 24 weeks exercise programme to current treatment. |
| Muscular strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Els Van de Vijver, MD, PhD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Edegem | Antwerpen | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28090335 | Background | 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. | |
| 24729736 | Background |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2026 | Jan 2, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D009043 | Motor Activity |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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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.
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|
| 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. |
|
| 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. |
|
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.
| 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. | 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). | 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)). | 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). | 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:
| From start to end of the adjunctive 24 weeks exercise programme to current treatment. |
| Fecal calprotectin level | Expressed in μg/g of faeces. | 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. | From start to end of the adjunctive 24 weeks exercise programme to current treatment. |
| 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. |
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| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |