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

Not Applicable

• Conditions: Crohn Disease; Sleep; Quality of Life; Depression; Ulcerative Colitis; Motor Activity
• Interventions: Behavioral: Aerobic Exercise Training

• Registration Number: NCT02264275
• Lead Sponsor: University of Basel

Brief Summary

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

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.

Study Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-15
• Last Update Submitted: 2014-10-20
• Last Update Posted: 2014-10-21
• Primary Completion: 2015-02
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise Training	Aerobic Exercise Training	An 8-week Nintendo Wii at-home dancing exergame Intervention

Primary Outcome Measures

Name	Time	Method
Pediatric Disease Activity Index	8 Weeks	Uses either Crohn's Disease or Ulcerative Colitis Disease Activity Index respective to the patient's disease

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Universitäre Psychiatrische Kliniken Basel (UPK); 🇨🇭 Basel, Basel Stadt, Switzerland

Universitäts-Kinderspital beider Basel (UKBB); 🇨🇭 Basel, Basel Stadt, Switzerland

Universität Basel (Departement für Sport, Bewegung und Gesundheit); 🇨🇭 Basel, Basel Stadt, Switzerland