Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being in an Uncontrolled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
研究概览
简要总结
The study aims to test the effect of Ashtanga yoga on well-being in patients with irritable bowel syndrome (IBS). The intervention comprises group sessions on the Ashtanga school of yoga. Participants are recruited from primary care and measurements on well-being and IBS symptoms are conducted at pre-treatment, post-treatment and 6-month follow-up.
详细描述
The intervention comprises participants with IBS to undergo Ashtanga yoga sessions in a group led by an authorized yoga teacher for a total period of 10 weeks. The first 4 weeks consisted of 1 session/week and the following 6 weeks consisted of 1 session/2 weeks. All movements and exercises are performed based on the individual's personal capacity in order to avoid distinct discomfort or pain. Patients testing positive for IBS will be recruited for the study from primary care. Measurements of IBS symptoms, visceral sensitivity, extraintestinal symptoms and quality of life will be assessed at pre-treatment, post-treatment and 6-month follow-up. Specific statistical methods will be performed to assess changes from pre- to post-treatments and changes from post-treatment to 6-month-follow-up. Effects sizes for within group changes will also be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS diagnosis
排除标准
- •Prior yoga practise, unable to speak Swedish, other serious illness
结局指标
主要结局
Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
时间窗: Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS; \[17\] is a scale that measure the global severity of IBS-symptoms. It includes five items; pain severity, pain frequency, bowel bloating, bowel habit dissatisfaction and life interference that are scored on a visual analogue scale (VAS) 0-100 mm. The total score ranges from 0-500 with higher scores indicating more severe symptoms.
Change in Gastrointestinal Symptom Rating Scale - IBS version (GSRS-IBS)
时间窗: Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
Gastrointestinal Symptom Rating Scale - IBS version (GSRS-IBS; \[18\] measures the severity of IBS-symptoms experienced over the past week. The scale consists of 13 items measuring five symptom domains of IBS: satiety, pain, diarrhea, constipation and bloating. The symptoms are rated on a scale ranging from 1 (= no discomfort) to 7 (= very severe discomfort) with a total score from 13-91. Higher scores indicating more severe symptoms.
次要结局
- Visceral Sensitivity Index (VSI)(Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks))
- Hospital Anxiety and Depression Scale (HADS)(Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks))
- IBS Quality of Life (IBSQOL)(Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks))
- The Patient Health Questionnaire 12 (PHQ-12)(Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks))
研究者
Perjohan Lindfors
MD, PhD
Karolinska Institutet