Effect of Tai Chi as Treatment for IBS-C

NCT ID: NCT04132804

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-21
• Study Completion Date: 2022-07-14

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.

Conditions

Irritable Bowel Syndrome With Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tai Chi Treatment

All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.

Group Type: EXPERIMENTAL

Tai Chi

Intervention Type: BEHAVIORAL

Tai Chi Chuan (taijiquan) or Tai Chi is a mind-body practice borne of Chinese philosophy and martial arts which has been practiced for centuries to promote deep relaxation, strengthened health, and to prevent injuries and illness.

Interventions

Tai Chi

Tai Chi Chuan (taijiquan) or Tai Chi is a mind-body practice borne of Chinese philosophy and martial arts which has been practiced for centuries to promote deep relaxation, strengthened health, and to prevent injuries and illness.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyle Staller, MD, MPH

Assistant Professor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyle Staller, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019P000361

Identifier Type: -

Identifier Source: org_study_id