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临床试验/ISRCTN13021107
ISRCTN13021107已完成未知

A randomised controlled trial investigating the feasibility and acceptability of high-­intensity interval training and moderate-­intensity continuous training in adults with inactive or mildly active Crohn’s disease

niversity of Hertfordshire0 个研究点目标入组 36 人开始时间: 2015年12月2日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
36

研究概览

简要总结

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28373911 protocol 2019 Results article in https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-019-0936-x results (added 20/08/2020) 2019 Results article in https://doi.org/10.1371/journal.pone.0222060 Affective and enjoyment responses (added 04/01/2023)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Aged between 16 and 65 years
  • 2. Clinical diagnosis of CD for at least 4 weeks before the screening visit
  • 3. Mildly active (150 to 219 on Crohn’s Disease Activity Index [CDAI]) or inactive (<150 on CDAI) CD assessed no greater than 4 weeks before the screening visit
  • 4. Faecal calprotectin <250 mcg/g recorded no greater than 4 weeks before the screening visit
  • 5. Stable medications for at least 4 weeks before the screening visit
  • 6. Able to provide written informed consent and complete the study questionnaires
  • 7. Able to travel to the research centre for assessment visits and exercise sessions

排除标准

  • 1.Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine
  • 2. Coexistent serious autoimmune disease such as rheumatoid arthritis or systemic sclerosis
  • 3. Planned major surgery within the first 3 months after randomisation
  • 4. Pregnant
  • 5. Female planning pregnancy within the first 3 months after randomisation
  • 6. Poor tolerability of venepuncture
  • 7. Lack of adequate venous access for required blood sampling
  • 8. Current participation in more than 90 min/week of purposeful exercise, such as jogging or swimming
  • 9. Participation in another clinical trial for with concurrent participation is deemed inappropriate

研究者

发起方
niversity of Hertfordshire

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