Depression Clinical Trial
— Ex-CEDOfficial 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
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.
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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 |
Lead Sponsor | Collaborator |
---|---|
University of Basel | University Children's Hospital Basel, University Psychiatric Clinic Basel |
Switzerland,
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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