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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02264275
Other study ID # DSBG-UniBasel-Ex-CED-2014-220
Secondary ID
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


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
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