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临床试验/NCT02264275
NCT02264275Unknown不适用

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

University of Basel6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
6
主要终点
Pediatric Disease Activity Index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
7 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Aerobic Exercise Training

Experimental

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

干预措施: Aerobic Exercise Training (Behavioral)

结局指标

主要结局

Pediatric Disease Activity Index

时间窗: 8 Weeks

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

次要结局

  • Depressive Symptomology(8 Weeks)
  • Estimation of Vo2Max(8 Weeks)
  • Health Related Quality of Life(8 Weeks)
  • Sleep(8 Weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Elliot

Dr. Catherine Elliot

University of Basel

研究点 (6)

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