Personalized Exercise Coaching to Improve Quality of Life in Pediatric IBD (FIT4IBDKids)

Universiteit Antwerpen

Status: Active, not recruiting

Conditions: Inflammatory Bowel Disease (IBD)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07355101

7893

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Higher exercise habits

Experimental group

Description:

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).

Treatment:

Behavioral: Intake session to define individualized physical activity goals

Behavioral: 24 Week Exercise Programme

Behavioral: Personalized Motivational Coaching

Lower exercise habits

Active Comparator group

Description:

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).

Treatment:

Behavioral: Intake session to define individualized physical activity goals

Behavioral: 24 Week Exercise Programme

Behavioral: Personalized Motivational Coaching