Status:
COMPLETED
Effect of Tai Chi as Treatment for IBS-C
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Irritable Bowel Syndrome With Constipation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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).
Detailed Description
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 IB...
Eligibility Criteria
Inclusion
- Inclusion
- Age 18 - 70 years
- BMI ≤ 35
- 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
- Exclusion
- 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)
- BMI \>35
- 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
Exclusion
Key Trial Info
Start Date :
July 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04132804
Start Date
July 21 2020
End Date
July 14 2022
Last Update
July 27 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114