Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents

Study Overview
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Brief Summary
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The purpose of this study is to determine if aerobic exercise training can serve as comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating depressive symptoms and augmenting sleep while bolstering health related quality of life in youth with Crohn's Disease and Ulcerative Colitis.

Detailed Description
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An AET intervention is designed to increase the aerobic fitness levels of IBD sufferers through daily activity, which is notably lower in this population and could be beneficial for sufferers managing this lifelong disease. With an increase in physical activity, the exergame aims to introduce, instill and integrate daily physical activity in the lives of IBD sufferers. The Just Dance Kids exergame for Nintendo Wii employs moderate intensity physical activity and is well suited for this study. The exergame intervention protocol will comprise a ramped duration aerobic exercise training starting with 10 minutes in week 1 and rises to 30 minutes per session in weeks 5 through 8. Just Dance Kids will be used by participants under the age of 11 and Just Dance for participants over the age of 10 due to the age appropriate dancing skill required in each game. The aim is to determine if this moderate intensity, 5 times per week exercise could decrease IBD flare-ups, improve cardiovascular fitness, reduce depressive symptoms, improve quality and quantity of sleep and improve the health-related quality of life in children and adolescents with IBD.

Official Title
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The Influence of Aerobic Exercise Training on Disease Symptoms, Cardiovascular Fitness, Depression, Sleep and Quality of Life in Children and Adolescents Suffering From Inflammatory Bowel Disease in Switzerland

Conditions
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Ulcerative Colitis, Crohn Disease, Depression, Sleep, Quality of Life, Motor Activity

Intervention / Treatment
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* Behavioral: Aerobic Exercise Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 7 through 20 at start of study willing and able to volunteer in the study able to communicate and to complete questionnaires in German have a functioning television with Nintendo Wii compatibility at home provide participant written informed consent (when ≥11 years old at start of study) provide parental/legal caregiver written informed consent (when participant is ≤17 years old at start of study) provide oral informed consent (when ≤10 years old at start of study) Exclusion Criteria: refusal to give necessary oral or written informed consent by patient and/or parent (legal caregiver) not aged 7 through 20 at start of study not willing and able to volunteer in the study has sibling enrolled in this study has severe physical diseases of the locomotor apparatus, psychotic disorders, severe affective disorders, eating disorders, mental retardation, autism spectrum disorder inability to communicate and complete questionnaires in German does not own a functional and Nintendo Wii-compatible television at home among female adolescents, pregnancy, breastfeeding or intention to get pregnant during the study has clinically significant cardiovascular disease enrolment of the investigator, his/her family members, employees and other dependent persons

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic Exercise Training<br>An 8-week Nintendo Wii at-home dancing exergame Intervention | Behavioral: Aerobic Exercise Training<br>* The aerobic exercise training uses a television attached to a Nintendo Wii videogame console with a dance game to be played by participants on 5 days per week using a ramped-duration schedule (from 10-30 minutes of moderate physical activity daily).<br>* Other names: Dance Videogame;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Disease Activity Index | Uses either Crohn's Disease or Ulcerative Colitis Disease Activity Index respective to the patient's disease | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep | Uses Insomnia Severity Index and Daily Sleep Log | 8 Weeks | 
| Depressive Symptomology | Uses Child-S or Des-Teen with respect to participants age | 8 Weeks | 
| Health Related Quality of Life | KIDSCREEN-27 | 8 Weeks | 
| Estimation of Vo2Max | Uses the Astrand-Rhyming cycle ergometer protocol | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerobic Exercise, Exercise, Exergame, Behavior, Video Game, Inflammatory Bowel Disease, Children, Adolescents, Pediatric, Physical Fitness