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

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ClinicalTrials.gov Identifier: NCT02264275
Recruitment Status : Unknown
Verified October 2014 by Catherine Elliot, University of Basel.
Recruitment status was:  Recruiting
First Posted : October 15, 2014
Last Update Posted : October 21, 2014
Sponsor:
Collaborators:
University Children's Hospital Basel
Psychiatric Hospital of the University of Basel
Information provided by (Responsible Party):
Catherine Elliot, 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Crohn Disease Depression Sleep Quality of Life Motor Activity Behavioral: Aerobic Exercise Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : October 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Sleep [ Time Frame: 8 Weeks ]
    Uses Insomnia Severity Index and Daily Sleep Log

  2. Depressive Symptomology [ Time Frame: 8 Weeks ]
    Uses Child-S or Des-Teen with respect to participants age

  3. Health Related Quality of Life [ Time Frame: 8 Weeks ]
    KIDSCREEN-27

  4. Estimation of Vo2Max [ Time Frame: 8 Weeks ]
    Uses the Astrand-Rhyming cycle ergometer protocol



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264275


Contacts
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Contact: Catherine A Elliot, Dr. phil. 0041 (0)61 377 87 80 catherine.elliot@unibas.ch

Locations
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Switzerland
Universitäre Psychiatrische Kliniken Basel (UPK) Recruiting
Basel, Basel Stadt, Switzerland, 4012
Contact: Serge Brand, PD Dr. med.    061 325 51 14    serge.brand@upkbs.ch   
Universitäts-Kinderspital beider Basel (UKBB) Recruiting
Basel, Basel Stadt, Switzerland, 4031
Contact: Raoul Furlano, Dr. med.    + 41 (0)61 704 2905    raoul.furlano@ukbb.ch   
Principal Investigator: Raoul Furlano, Dr. med.         
Universität Basel (Departement für Sport, Bewegung und Gesundheit) Recruiting
Basel, Basel Stadt, Switzerland, 4052
Contact: Markus Gerber, PD Dr. phil    061 377 87 83    markus.gerber@unibas.ch   
Principal Investigator: Catherine Elliot, Dr. phil.         
Sponsors and Collaborators
University of Basel
University Children's Hospital Basel
Psychiatric Hospital of the University of Basel
Investigators
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Principal Investigator: Catherine A Elliot, Dr. phil. University of Basel
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Catherine Elliot, Dr. Catherine Elliot, University of Basel
ClinicalTrials.gov Identifier: NCT02264275    
Other Study ID Numbers: DSBG-UniBasel-Ex-CED-2014-220
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014
Keywords provided by Catherine Elliot, University of Basel:
Aerobic Exercise
Exercise
Exergame
Behavior
Video Game
Inflammatory Bowel Disease
Children
Adolescents
Pediatric
Physical Fitness
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Depression
Behavioral Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases