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

October 20, 2014 updated by: Catherine Elliot, University of Basel

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4012
        • Recruiting
        • Universitäre Psychiatrische Kliniken Basel (UPK)
        • Contact:
      • Basel, Basel Stadt, Switzerland, 4031
        • Recruiting
        • Universitäts-Kinderspital beider Basel (UKBB)
        • Contact:
        • Principal Investigator:
          • Raoul Furlano, Dr. med.
      • Basel, Basel Stadt, Switzerland, 4052
        • Recruiting
        • Universität Basel (Departement für Sport, Bewegung und Gesundheit)
        • Contact:
        • Principal Investigator:
          • Catherine Elliot, Dr. phil.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aerobic Exercise Training
An 8-week Nintendo Wii at-home dancing exergame 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).
Other Names:
  • Nintendo Wii
  • Exergame
  • Dance Videogame

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Basel

Collaborators

Psychiatric Hospital of the University of Basel
University Children's Hospital Basel

Investigators

  • Principal Investigator: Catherine A Elliot, Dr. phil., University of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ANTICIPATED)

February 1, 2015

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (ESTIMATE)

October 15, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 20, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSBG-UniBasel-Ex-CED-2014-220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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