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

Depression Clinical Trial

— Ex-CED  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02264275
• Other study ID #: DSBG-UniBasel-Ex-CED-2014-220
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2014
• Last updated: October 20, 2014
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: October 2014
• Source: University of Basel
• Contact: Catherine A Elliot, Dr. phil.
• Phone: 0041 (0)61 377 87 80
• Email: catherine.elliot[@]unibas.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 20 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Depression
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Motor Activity
• Quality of Life
• Sleep
• Ulcerative Colitis

Intervention

Behavioral:
• Aerobic Exercise Training
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).

Locations

Country	Name	City	State
Switzerland	Universitäre Psychiatrische Kliniken Basel (UPK)	Basel	Basel Stadt
Switzerland	Universität Basel (Departement für Sport, Bewegung und Gesundheit)	Basel	Basel Stadt
Switzerland	Universitäts-Kinderspital beider Basel (UKBB)	Basel	Basel Stadt

Sponsors (3)

Lead Sponsor	Collaborator
University of Basel	University Children's Hospital Basel, University Psychiatric Clinic Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Disease Activity Index	Uses either Crohn's Disease or Ulcerative Colitis Disease Activity Index respective to the patient's disease	8 Weeks	No
Secondary	Sleep	Uses Insomnia Severity Index and Daily Sleep Log	8 Weeks	No
Secondary	Depressive Symptomology	Uses Child-S or Des-Teen with respect to participants age	8 Weeks	No
Secondary	Health Related Quality of Life	KIDSCREEN-27	8 Weeks	No
Secondary	Estimation of Vo2Max	Uses the Astrand-Rhyming cycle ergometer protocol	8 Weeks	No

External Links

•   University of Basel Childrens Hospital
•   University of Basel, Department for Sport, Exercise and Health