NCT02043600已完成不适用
Randomized-controlled Trial of Yoga for Ulcerative Colitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Disease-specific quality of life
研究概览
简要总结
The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to self-care on quality of life, stress, psychological health, and physiological parameters in 77 patients with ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulcerative colitis (clinical, endoscopic and histological diagnosis)
- •Disease duration at least 12 months
- •Clinical remission for at least 4 weeks and less than 12 months
- •IBDQ < 170
- •Physical and mental ability to perform yoga
- •No regular practice of yoga or Pilates in the previous 12 months
排除标准
- •Clinically active disease (CAI > 4 Rachmilewitz)
- •Complete resection of the colon
- •Acute, infectious or chronic active ulcerative colitis
- •Severe disease precluding yoga practice
- •Malignancy with a disease-free survival < 5 years except curatively treated basalioma of the skin
- •Alcohol or drug abuse
- •Pregnancy
结局指标
主要结局
Disease-specific quality of life
时间窗: 3 months
Inflammatory Bowel Disease Questionnaire (IBDQ)
次要结局
- Safety(6 months)
- Body responsiveness(6 months)
- Faecal lactoferrin(6 months)
- Disease activity(6 months)
- Disease-specific quality of life(6 months)
- Generic quality of life(6 months)
- Body awareness(6 months)
- C-reactive protein(6 months)
- Faecal calprotectin(6 months)
- Salivary cortisol level(3 months)
- Steroid sensitivity(3 months)
- Self-efficacy(6 months)
- Blood sedimentation rate(6 months)
- Faecel PMN-elastase(6 months)
- Anxiety/depression(6 months)
- Hemogram(6 months)
- Positive/negative affect(6 months)
- Andrenergic sensitivity(3 months)
- Cholinergic sensitivity(3 months)
- Subjective stress(6 months)
研究者
Holger Cramer
Postdoctoral Researcher
Universität Duisburg-Essen
研究点 (2)
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