Clinical trial NCT02264275: Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Crohn Disease
Depression
Sleep
Quality of Life
Motor Activity
Keywords: Aerobic Exercise
Exercise
Exergame
Behavior
Video Game
Inflammatory Bowel Disease
Children
Adolescents
Pediatric
Physical Fitness
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: University Children's Hospital Basel
name: Psychiatric Hospital of the University of Basel
First posted: 2014-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pediatric Disease Activity Index
timeFrame: 8 Weeks
Secondary outcomes:
measure: Sleep
timeFrame: 8 Weeks
measure: Depressive Symptomology
timeFrame: 8 Weeks
measure: Health Related Quality of Life
timeFrame: 8 Weeks
measure: Estimation of Vo2Max
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäre Psychiatrische Kliniken Basel (UPK)
state: Basel Stadt
city: Basel
country: Switzerland
facility: Universitäts-Kinderspital beider Basel (UKBB)
state: Basel Stadt
city: Basel
country: Switzerland
facility: Universität Basel (Departement für Sport, Bewegung und Gesundheit)
state: Basel Stadt
Study officials:
affiliation: University of Basel
name: Catherine A Elliot, Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahlmann L, Gerber M, Furlano RI, Legeret C, Kalak N, Holsboer-Trachsler E, Brand S. Psychological wellbeing and physical activity in children and adolescents with inflammatory bowel disease compared to healthy controls. BMC Gastroenterol. 2017 Dec 12;17(1):160. doi: 10.1186/s12876-017-0721-7.
citation: Mahlmann L, Gerber M, Furlano RI, Legeret C, Kalak N, Holsboer-Trachsler E, Brand S. Impaired objective and subjective sleep in children and adolescents with inflammatory bowel disease compared to healthy controls. Sleep Med. 2017 Nov;39:25-31. doi: 10.1016/j.sleep.2017.08.015. Epub 2017 Sep 21.