Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents
Ex-CED
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
1 other identifier
interventional
60
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedOctober 21, 2014
October 1, 2014
4 months
October 8, 2014
October 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pediatric Disease Activity Index
Uses either Crohn's Disease or Ulcerative Colitis Disease Activity Index respective to the patient's disease
8 Weeks
Secondary Outcomes (4)
Sleep
8 Weeks
Depressive Symptomology
8 Weeks
Health Related Quality of Life
8 Weeks
Estimation of Vo2Max
8 Weeks
Study Arms (1)
Aerobic Exercise Training
EXPERIMENTALAn 8-week Nintendo Wii at-home dancing exergame Intervention
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Basellead
- University Children's Hospital Baselcollaborator
- Psychiatric Hospital of the University of Baselcollaborator
Study Sites (3)
Universitäre Psychiatrische Kliniken Basel (UPK)
Basel, Canton of Basel-City, 4012, Switzerland
Universitäts-Kinderspital beider Basel (UKBB)
Basel, Canton of Basel-City, 4031, Switzerland
Universität Basel (Departement für Sport, Bewegung und Gesundheit)
Basel, Canton of Basel-City, 4052, Switzerland
Related Publications (2)
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.
PMID: 29233119DERIVEDMahlmann 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.
PMID: 29157584DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine A Elliot, Dr. phil.
University of Basel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Catherine Elliot
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 15, 2014
Study Start
October 1, 2014
Primary Completion
February 1, 2015
Study Completion
March 1, 2015
Last Updated
October 21, 2014
Record last verified: 2014-10