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

Primary Purpose

Ulcerative Colitis, Crohn Disease, Depression

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Aerobic Exercise Training
Sponsored by
University of Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ulcerative Colitis focused on measuring Aerobic Exercise, Exercise, Exergame, Behavior, Video Game, Inflammatory Bowel Disease, Children, Adolescents, Pediatric, Physical Fitness

Eligibility Criteria

7 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitäre Psychiatrische Kliniken Basel (UPK)Recruiting
  • Universitäts-Kinderspital beider Basel (UKBB)Recruiting
  • Universität Basel (Departement für Sport, Bewegung und Gesundheit)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aerobic Exercise Training

Arm Description

An 8-week Nintendo Wii at-home dancing exergame Intervention

Outcomes

Primary Outcome Measures

Pediatric Disease Activity Index
Uses either Crohn's Disease or Ulcerative Colitis Disease Activity Index respective to the patient's disease

Secondary Outcome Measures

Sleep
Uses Insomnia Severity Index and Daily Sleep Log
Depressive Symptomology
Uses Child-S or Des-Teen with respect to participants age
Health Related Quality of Life
KIDSCREEN-27
Estimation of Vo2Max
Uses the Astrand-Rhyming cycle ergometer protocol

Full Information

First Posted
October 8, 2014
Last Updated
October 20, 2014
Sponsor
University of Basel
Collaborators
University Children's Hospital Basel, Psychiatric Hospital of the University of Basel
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1. Study Identification

Unique Protocol Identification Number
NCT02264275
Brief Title
Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Basel
Collaborators
University Children's Hospital Basel, Psychiatric Hospital of the University of Basel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise Training
Arm Type
Experimental
Arm Description
An 8-week Nintendo Wii at-home dancing exergame Intervention
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise Training
Other Intervention Name(s)
Nintendo Wii, Exergame, Dance Videogame
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pediatric Disease Activity Index
Description
Uses either Crohn's Disease or Ulcerative Colitis Disease Activity Index respective to the patient's disease
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Sleep
Description
Uses Insomnia Severity Index and Daily Sleep Log
Time Frame
8 Weeks
Title
Depressive Symptomology
Description
Uses Child-S or Des-Teen with respect to participants age
Time Frame
8 Weeks
Title
Health Related Quality of Life
Description
KIDSCREEN-27
Time Frame
8 Weeks
Title
Estimation of Vo2Max
Description
Uses the Astrand-Rhyming cycle ergometer protocol
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine A Elliot, Dr. phil.
Phone
0041 (0)61 377 87 80
Email
catherine.elliot@unibas.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine A Elliot, Dr. phil.
Organizational Affiliation
University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäre Psychiatrische Kliniken Basel (UPK)
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
4012
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge Brand, PD Dr. med.
Phone
061 325 51 14
Email
serge.brand@upkbs.ch
Facility Name
Universitäts-Kinderspital beider Basel (UKBB)
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raoul Furlano, Dr. med.
Phone
+ 41 (0)61 704 2905
Email
raoul.furlano@ukbb.ch
First Name & Middle Initial & Last Name & Degree
Raoul Furlano, Dr. med.
Facility Name
Universität Basel (Departement für Sport, Bewegung und Gesundheit)
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
4052
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Gerber, PD Dr. phil
Phone
061 377 87 83
Email
markus.gerber@unibas.ch
First Name & Middle Initial & Last Name & Degree
Catherine Elliot, Dr. phil.

12. IPD Sharing Statement

Citations:
PubMed Identifier
29233119
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.
Results Reference
derived
PubMed Identifier
29157584
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.
Results Reference
derived
Links:
URL
https://dsbg.unibas.ch/
Description
University of Basel, Department for Sport, Exercise and Health
URL
http://www.ukbb.ch/
Description
University of Basel Childrens Hospital

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

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