Clinical trial NCT04132804: Effect of Tai Chi as Treatment for IBS-C
Official title: Pilot Study Investigating the Effect of Tai Chi as Treatment for IBS-C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome With Constipation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-center pilot study. All patients enrolled in the study will participate in the Tai Chi treatment.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion

1. Age 18 - 70 years
2. BMI ≤ 35
3. Rome IV criteria for IBS-C
4. Continued IBS-C throughout run-in period
5. Compliant with reporting during run-in
6. Ability to follow verbal and written instructions
7. Ability to record daily patient reported outcomes via RedCap survey
8. Ability to use the GeoPain app on a smart phone
9. Ability to use Zoom as a platform for conducting study visits virtually
10. Ability to respond to 80% of the daily diaries
11. Ability to attend at least 7 out of 8 Tai Chi classes
12. Informed consent form signed by the subjects

Exclusion

1. 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
2. Non-English speaking
3. Participation in any other clinical trial with active intervention within the last 30 days
4. Non-compliance with reporting during run-in period
5. Inability to stand without assistance for 20 minutes
6. Patients reporting any usage of a prohibited medication during the run-in period
7. History of regular opiate or narcotic pain-reliever use
8. Current use of prescribed or illicit opioids
9. Change in current medication regimen related to GI motility, laxatives, or antidepressants
10. 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
11. Severe osteoarthritis
12. Severe rheumatoid arthritis
13. Severe constipation defined as \<1 bowel movement per week without use of laxatives
14. 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
15. History of small bowel resection (except if related to appendectomy)
16. Subjects anticipating surgical intervention during the study
17. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
18. Crohn's disease or ulcerative colitis
19. History of intestinal stricture (e.g., Crohn's disease)
20. BMI \>35
21. Pregnancy (or positive urine pregnancy test(s) in females of childbearing potential)
22. Known history of diabetes (type 1 or 2)
23. History of gastroparesis
24. History of abdominal radiation treatment
25. History of pancreatitis
26. History of malabsorption or celiac disease
27. History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
28. History of human immunodeficiency virus
29. History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
30. Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study
31. Any other clinically significant disease interfering with the assessments according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation)
32. Any relevant biochemical abnormality interfering with the assessments according to the Investigator
33. Inability to attend at least 7 out of the 8 Tai Chi classes
34. Inability to respond to 80% of the daily diaries

Primary outcomes:
measure: IBS Symptom Severity Score at 12 Weeks
timeFrame: At final study visit, 12 weeks.
Secondary outcomes:
measure: Likelihood of Continuing Treatment
timeFrame: Recorded at final study visit (following 8 weeks of treatment)
measure: Treatment Satisfaction
timeFrame: Recorded at final study visit (following 8 weeks of treatment)
measure: IBS Quality of Life (IBS-QOL) at 12 Weeks
timeFrame: At final study visit, 12 weeks
measure: Daily Bowel Movement Frequency at 12 Weeks
timeFrame: At final study visit, 12 weeks.
measure: Bloating Scale Score at 12 Weeks
timeFrame: At final study visit, 12 weeks
measure: Abdominal Discomfort Scale Score at 12 Weeks
timeFrame: At final study visit, 12 weeks.
measure: Constipation Severity Scale Score at 12 Weeks
timeFrame: At final study visit, 12 weeks.
measure: Hospital Anxiety and Depression Scale (HADS) Score at 12 Weeks
timeFrame: At final study visit, 12 weeks.
measure: Visceral Sensitivity Index (VSI) Score at 12 Weeks
timeFrame: At final study visit, 12 weeks
measure: Stool Microbiome
timeFrame: Change from baseline to final visit. Through study completion, up to 18 weeks
measure: Global Assessment of Relief at 12 Weeks
timeFrame: At final study visit, 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kyle Staller, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: