Personalized Exercise Coaching to Improve Quality of Life in Pediatric IBD - FIT4IBDKids: Study Protocol
Phase: NA
Conditions: Inflammatory Bowel Disease (IBD)
Sponsor: Universiteit Antwerpen

 
1 
Date of Document 
01 Jan 2026 
 
 
 
 
Personalized Exercise Coaching to 
Improve Quality of Life in Pediatric IBD 
- FIT4IBDKids 
 
 Study protocol. 
 
NCT Number: Not yet assigned 
 
Kips M.1,2*, Stiévenard T.1,2*, Van de Vijver E.1,2 
 
1 Laboratory of Experimental Medicine and Paediatrics, Faculty of Medicine and Health Sciences, University of Antwerp, 
Universiteitsplein 1, 2610 Antwerp, Wilrijk, Belgium; 
2 Department of Pediatrics, Antwerp University Hospital, Drie Eikenstraat 655, 2650 Edegem, Belgium. 
*Shared first authors 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
2 
Corresponding author: 
Van de Vijver, E. - E: els.vandevijver@uza.be 
Number of tables and figures: 
3 
Word count: 
1755 
Conflict of interest statement: 
None 
 
 
STUDY PROTOCOL 
 
Title 
Personalized Exercise Coaching to Improve Quality of Life in Pediatric IBD: FIT4IBDKids 
 
 
Abstract 
Introduction: Crohn’s disease and ulcerative colitis are the most common forms of pediatric inflammatory bowel 
disease (IBD), which is increasingly diagnosed in children and adolescents. Beyond gastrointestinal symptoms 
such as abdominal pain, diarrhea, and rectal bleeding, many pediatric patients experience persistent fatigue, 
reduced physical activity, and impaired quality of life. Current care still lacks structured exercise 
recommendations. Given the well-established physical and psychological benefits of physical activity, this study 
investigates whether tailored exercise can reduce fatigue, improve quality of life, and ease gastrointestinal 
symptoms in children with IBD. 
 

 
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Methods and analysis: This prospective controlled trial aims to include 70 children with IBD aged 6-18 years, 
divided into two groups based on baseline physical activity levels. Participants will complete a 24-week tailored 
exercise program, adjunctive to standard treatment, monitored using a Health Smartwatch. Primary outcomes 
are fatigue, quality of life, disease activity, and cardiorespiratory fitness, assessed via validated questionnaires 
and VO₂max testing. Secondary outcomes include muscle strength, aerobic capacity, heart rate variability, body-
mass index, and intestinal inflammation measured by fecal calprotectin, ultrasound, and mucin analysis.  
 
Ethics and dissemination: This study received ethical approval from the Ethics Committee at the University 
Hospital of Antwerp and the University of Antwerp and adheres to the Declaration of Helsinki. Written informed 
consent will be obtained from parents and participants. Exercise programs will be tailored to individual capacity, 
and adverse events will be monitored; participants may withdraw at any time. Results will consist of anonymized 
datasets, deposited in a secure repository to support transparency and reproducibility. 
 
 
Key messages 
What is already known on this topic: Pediatric IBD patients are troubled with reduced exercise capacity, reduced 
physical activity and greater fatigue compared to healthy peers. Previous studies suggest that physical activity 
may improve cardiorespiratory fitness and enhance psychological well-being in pediatric patients with IBD. 
 
What this study adds: This study provides novel insights into the benefits of structured physical activity, 
individual coaching and its potential role in multimodal management. Furthermore, the trial adds the effect of 
a durable exercise programme on fatigue and quality of life (QOL) in pediatric IBD patients. 
 
How this study might affect research, practice or policy: The findings could support the integration of structured 
exercise and coaching programs into routine care for pediatric IBD, providing a non-pharmacological approach 
to reduce fatigue and improve quality of life. Results may guide clinicians on safe and effective exercise 
prescriptions tailored to disease severity and baseline activity levels. 
 
Key words: Inflammatory bowel disease (IBD), Children, Physical exercise, Fatigue, Quality of Life, Adolescent 
 
 

 
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Introduction 
Inflammatory bowel diseases (IBD) are chronic inflammatory gastrointestinal disorders, most commonly 
represented by Crohn’s disease (CD) and Ulcerative colitis (UC).(1-2) Approximately, the disorders affect 100 to 
200 per 100 000 children in the United States, with an ever-more rising incidence of 10 pediatric patients per 
100 000 peers.(1, 3-4) Most frequently, the onset of IBD appears before the age of 35, often in adolescence and 
young adulthood.(3) IBD results from the interaction between patients’ microbiome, a genetic predisposition 
and environmental factors. These influences converge and lead to a dysregulated mucosal immune response 
against the commensal intestinal microbiota of the host.(5-6) Several studies have investigated genetic risk 
factors in pediatric patients, further supporting the association between a higher burden of common risk 
variants and rarer variants with high penetrance, and early-onset IBD.(7-8) Yet, the contribution of 
environmental influences at young age cannot be disregarded, as lifestyle factors are associated with a 
predisposition to IBD. Inadequate representation of gut taxa, dysbiosis and an overall restriction in the diversity 
of intestinal bacterial species may interfere with gut homeostasis, generate tissue dysfunction, and promote 
inflammation.(7,9) Implicated risk factors include a lack of exposure to breast milk, fatty diet, early exposure to 
antibiotics and Cesarean section.(10-12) Although symptoms of IBD vary, patients usually complain of abdominal 
pain, diarrhea, rectal bleeding, extreme fatigue and weight loss.(2) The development of gastrointestinal 
symptoms at any point in time, with recurrent and remitting course, implies reduced quality of life, substantial 
morbidity, high medical costs and significantly lower physical activity levels.(1) Therefore, in pediatric IBD 
patients, a reduced exercise capacity is being observed compared to healthy peers.  
 
Lately, significant advances have been seen in the multimodal care of children with IBD. Given the expansion of 
therapeutic options, physicians’ goals have shifted from solely symptom control to improving QoL, reducing 
fatigue and mucosal healing with consequent reduction of bowel damage.(5) This could be a promising 
approach: considering pediatric IBD patients show higher rates of fatigue, impaired QoL, difficulties in social 
functioning and GI manifestations.(13-14) Nonetheless, physical activity is known to be associated with many 
physiological and psychological health benefits across the lifespan. Assessing this adjunctive lifestyle 
intervention, scientific trials reported less fatigue (PedsQoL-MFS), an improved QoL (IMPACT-III), an increased 
exercise capacity and a decrease in IBD disease activity.(15-17) 
 
However, the lack of standardized physical exercise programmes adjunctive to medical treatment guidelines 
implies a critical gap in literature. Currently, the state of the art standard of care only includes 
immunosuppressives, dietary advice and psychological counseling.(2, 18-19) With a growing population of 
pediatric patients facing IBD, we need to gain a better understanding of new approaches in effective, multimodal 
therapies. The aim of this study is to assess the effectiveness of physical exercise on reducing fatigue, improving 
QoL and intestinal manifestations in children with IBD. The information provided in the present study may be 

 
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useful for the multimodal management of children with IBD in whom fatigue, lower QoL and GI manifestations 
are an important burden. 
 
 
Research Objective 
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. Table 1 shows the research objective 
according to the PECO framework. 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.  
 
Table 1. Research objective within the PECO framework  
Population: 
Children diagnosed with IBD (ESPGHAN Guidelines), aged between 6 and 18 years old 
Intervention: 
An adjunctive 24 weeks exercise programme to current treatment, quantified by Health 
Smartwatch 
Comparison: 
Outcomes after adjunctive exercise programme to current treatment 
Outcome 
Fatigue, QoL and GI manifestations 
 
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.  
 
 
Methods 
Study Design 
This study is designed as a prospective single-center controlled trial. In consonance with a comprehensive 
baseline assessment, children with IBD will be allocated into two groups. The protocol adheres to the SPIRIT 

 
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(Standard Protocol Items: Recommendations for Interventional Trials) Statement: a minimum set of 
recommendations for reporting the protocol of a randomized trial. This study was registered with project ID 
7893 and EDGE number 004446. Figure 1 shows the flowchart of study design. 
 
 
Study Population 
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.  
 
The following exclusion criteria are proposed: 
1. Diabetes Mellitus (all types, according to the American Diabetes Association (ADA)) 
2. Malnutrition or Failure to Thrive, suspected or confirmed  
3. Children with malignancy 
4. Children with an acute phase of IBD disease activity 
5. Children who are too fatigued to apply 
6. Children < 120 cm, as VO2 max cannot be measured 
7. Physical inability to perform a cardiopulmonary exercise test (CPET) 
8. Participation in organized exercise training programs in a research setting 
9. Medical contra-indications for exercise 
 

 
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Sample Size Calculation 
To ensure sufficient statistical 80% power for detecting significant differences in the outcomes, a sample size of 
70 children with IBD has been determined. Each group will consist of 35 participants. Given the established 
graded and positive association between PAI and VO₂peak, this sample size is expected to allow detection of a 
moderate effect size with 80% power at a significance level of 0.05. The calculation accounts for variability in 
VO₂peak among pediatric IBD populations, and a margin has been included to accommodate potential attrition. 
Relevant covariates such as age, sex, and disease severity will be controlled for in the analysis to strengthen the 
internal validity of the study. 
 
Intervention 
The 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 

 
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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. 
 
Planned Measurement Methods 
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. 
 
Data Collection and Processing 
All 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. 
Physiological measurements, including VO₂max, heart rate variability (HRV), muscle strength, resting blood 
pressure, basal metabolic rate, aerobic capacity, and BMI, will be assessed using standardized protocols by 
trained healthcare professionals. Patient-reported outcomes will be obtained through validated questionnaires 
(IMPACT-III, PedsQoL-MFS, PCDAI, and PUCAI), administered electronically in the UZA@Home application. Stool 
samples for fecal calprotectin analysis will be collected according to standard clinical procedures, while intestinal 
inflammation and disease activity will be further evaluated via intestinal ultrasound, endoscopy, and mucin 
quantification. 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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Ethics 
This study received ethical approval from the Ethics Committee at the University Hospital of Antwerp and the 
University of Antwerp (BUN B3002025000122) on October 20, 2025. Written informed consent will be obtained 
from parents and participants. 
 
 
Results 
All statistical analyses will be conducted using R (R Foundation for Statistical Computing, Vienna, Austria), with 
a two-sided significance threshold set at p < 0.05. Study findings will be reported in accordance with the 
CONSORT framework where applicable. Descriptive statistics will be used to summarize baseline characteristics 
and outcome measures, presented as means with standard deviations for normally distributed variables or 
medians with interquartile ranges for non-normally distributed variables. Data visualization, such as box plots 
and line graphs, will be included to illustrate key outcomes and temporal changes. All analyses will be 
transparently documented, and both statistically significant and non-significant findings will be presented to 
ensure balanced interpretation. The protocol fulfills all SPIRIT guidelines. Results will consist of anonymized 
datasets, deposited in a secure repository to support transparency and reproducibility. 
 
 
 
Discussion 
SWOT Analysis 
Tailored exercise interventions in pediatric populations with chronic diseases are currently underrepresented in 
clinical research. This study will implement a 24-week individualized intervention program, developed by a 
multidisciplinary team based on each participant’s baseline assessment. Table 2 covers the most significant 
characteristics of our research within the SWOT framework. 
 
Table 2. Research characteristics within the SWOT framework  
Strengths: 
Weaknesses: 
● 
Hybrid intervention model enhancing 
patient engagement and long-term 
behavioral change 
● 
No randomized cross over trial, yet other 
stratification models will be applied 

 
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● 
Assessment of both validated patient-
reported outcome measures and objective, 
disease-specific clinical parameters 
Opportunities: 
Threats: 
● 
Motivational coaching and digital support 
could be reimbursed 
● 
Often physical inability to perform a 
cardiopulmonary exercise test (CPET) 
● 
Compliance in chronic pediatric patients 
 
Tailored exercise interventions in pediatric populations with chronic diseases are currently underrepresented in 
clinical research. This study will implement a 24-week individualized intervention program, developed by a 
multidisciplinary team based on each participant’s baseline assessment. The intervention integrates the 
established “Physical Activity on Prescription” (Bewegen op Verwijzing) model, which is designed by professional 
guidance from a qualified and motivational coach, the development of a tailored physical activity plan, and 
continuous follow-up. All participants will receive digital support via the UZA@Home platform, which is 
integrated into the care trajectory at the University Hospital of Antwerp (UZA). This tool offers tailored feedback 
on the intervention and promotes treatment adherence. Together, these tools ensure a hybrid intervention 
model combining in-person and digital support, aiming to enhance patient engagement and long-term 
behavioral change. The impact of the intervention will be evaluated using both validated patient-reported 
outcome measures and objective, disease-specific clinical parameters. 
 
 
Author contributions 
MK and TS designed the protocol together and drafted this manuscript. EV critically revised the manuscript and 
approved the final version.  
 
 
Conflicts of interest 
No funding or conflicts of interest. 
 
 
References 
 

 
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