Pilot Study Investigating the Effect of Tai Chi as Treatment for IBS-C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- IBS Symptom Severity Score at 12 Weeks
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of Tai Chi practice in reducing symptoms of Irritable Bowel Syndrome with Constipation (IBS-C).
详细描述
This is a single-center pilot study investigating the efficacy of Tai Chi practice in reducing symptoms of IBS. The investigators hope that subjects practicing Tai Chi will have reduced symptoms of IBS-C as measured through overall global symptom relief as well as the IBS-SSS, IBS-QOL, VSI, HADS, Visual Analogue Pain Scale, and changes in bloating, abdominal pain, abdominal distention, and constipation severity. The study will also use daily entries made through the GeoPain app to record trends in pain intensity.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 70 years
- •Rome IV criteria for IBS-C
- •Continued IBS-C throughout run-in period
- •Compliant with reporting during run-in
- •Ability to follow verbal and written instructions
- •Ability to record daily patient reported outcomes via RedCap survey
- •Ability to use the GeoPain app on a smart phone
- •Ability to use Zoom as a platform for conducting study visits virtually
- •Ability to respond to 80% of the daily diaries
- •Ability to attend at least 7 out of 8 Tai Chi classes
- •Informed consent form signed by the subjects
- •Unwilling to abstain from participation in Tai Chi (other than that provided for the study) or other mind-body practices (i.e. yoga that is new to regimen) until completion of the study
- •Non-English speaking
- •Participation in any other clinical trial with active intervention within the last 30 days
- •Non-compliance with reporting during run-in period
- •Inability to stand without assistance for 20 minutes
- •Patients reporting any usage of a prohibited medication during the run-in period
- •History of regular opiate or narcotic pain-reliever use
- •Current use of prescribed or illicit opioids
- •Change in current medication regimen related to GI motility, laxatives, or antidepressants
- •Abdominal pain severity of 4 on a 0-4 visual analogue scale, where 4 is the worst possible pain, during pre-screen or run-in
- •Severe osteoarthritis
- •Severe rheumatoid arthritis
- •Severe constipation defined as <1 bowel movement per week without use of laxatives
- •History of GI lumen surgery (including gastric bypass) at any time or other GI or abdominal operations within 60 days prior to entry into the study
- •History of small bowel resection (except if related to appendectomy)
- •Subjects anticipating surgical intervention during the study
- •Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
- •Crohn's disease or ulcerative colitis
- •History of intestinal stricture (e.g., Crohn's disease)
- •Pregnancy (or positive urine pregnancy test(s) in females of childbearing potential)
- •Known history of diabetes (type 1 or 2)
- •History of gastroparesis
- •History of abdominal radiation treatment
- •History of pancreatitis
- •History of malabsorption or celiac disease
- •History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
- •History of human immunodeficiency virus
- •History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
- •Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study
- •Any other clinically significant disease interfering with the assessments according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation)
- •Any relevant biochemical abnormality interfering with the assessments according to the Investigator
- •Inability to attend at least 7 out of the 8 Tai Chi classes
- •Inability to respond to 80% of the daily diaries
排除标准
- 未提供
研究组 & 干预措施
Tai Chi Treatment
All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.
干预措施: Tai Chi (Behavioral)
结局指标
主要结局
IBS Symptom Severity Score at 12 Weeks
时间窗: At final study visit, 12 weeks.
Questionnaire involves yes/no questions, entering numbers, rating scales from 0 to 100, and marking locations of pain. No subscales. Total score is derived by multiplying the number of days of pain (0 to 10) by 10 and summing it with the value from each of 4 scales (0 to 100). Higher total score represents greater symptom severity (min score= 0, max score= 500).
次要结局
- Likelihood of Continuing Treatment(Recorded at final study visit (following 8 weeks of treatment))
- Treatment Satisfaction(Recorded at final study visit (following 8 weeks of treatment))
- IBS Quality of Life (IBS-QOL) at 12 Weeks(At final study visit, 12 weeks)
- Daily Bowel Movement Frequency at 12 Weeks(At final study visit, 12 weeks.)
- Bloating Scale Score at 12 Weeks(At final study visit, 12 weeks)
- Abdominal Discomfort Scale Score at 12 Weeks(At final study visit, 12 weeks.)
- Constipation Severity Scale Score at 12 Weeks(At final study visit, 12 weeks.)
- Hospital Anxiety and Depression Scale (HADS) Score at 12 Weeks(At final study visit, 12 weeks.)
- Visceral Sensitivity Index (VSI) Score at 12 Weeks(At final study visit, 12 weeks)
- Stool Microbiome(Change from baseline to final visit. Through study completion, up to 18 weeks)
- Global Assessment of Relief at 12 Weeks(At final study visit, 12 weeks)
研究者
Kyle Staller, MD, MPH
Assistant Professor in Medicine
Massachusetts General Hospital