Effect of Tai Chi as Treatment for IBS-C

May 22, 2026 updated by: Kyle Staller, MD, MPH, Massachusetts General Hospital

Pilot Study Investigating the Effect of Tai Chi as Treatment for IBS-C

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tai Chi Treatment
All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IBS Symptom Severity Score at 12 Weeks
Time Frame: 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).
At final study visit, 12 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Likelihood of Continuing Treatment
Time Frame: Recorded at final study visit (following 8 weeks of treatment)
A 5-point scale indicating likelihood of continuing Tai Chi as a treatment where 1 represents least likelihood and 5 represents greatest likelihood.
Recorded at final study visit (following 8 weeks of treatment)
Treatment Satisfaction
Time Frame: Recorded at final study visit (following 8 weeks of treatment)
A 5-point scale indicating satisfaction with Tai Chi treatment where 1 represents the least satisfaction and 5 represents the most satisfaction
Recorded at final study visit (following 8 weeks of treatment)
IBS Quality of Life (IBS-QOL) at 12 Weeks
Time Frame: At final study visit, 12 weeks
Questionnaire about the quality of life of those with IBS. All questions rated from 1 to 5. Higher ratings represent worse quality of life. Subscales exist for dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship. Subscales are summed for the total composite score. Primary interest in this study will be the total composite score. Higher total composite score represents greater symptom severity (min score= 34, max score= 170).
At final study visit, 12 weeks
Daily Bowel Movement Frequency at 12 Weeks
Time Frame: At final study visit, 12 weeks.
Number of complete spontaneous bowel movements (csbm) per week. Bowel movements reported daily. Reported outcome is mean number of bowel movements reported at the final study visit.
At final study visit, 12 weeks.
Bloating Scale Score at 12 Weeks
Time Frame: At final study visit, 12 weeks
A 10-point scale indicating bloating severity where 0 represents the least severity and 10 represents the most severity.
At final study visit, 12 weeks
Abdominal Discomfort Scale Score at 12 Weeks
Time Frame: At final study visit, 12 weeks.
A 10-point scale indicating abdominal discomfort severity where 0 represents the least severity and 10 represents the most severity.
At final study visit, 12 weeks.
Constipation Severity Scale Score at 12 Weeks
Time Frame: At final study visit, 12 weeks.
A 10-point scale indicating constipation severity where 0 represents the least severity and 10 represents the most severity.
At final study visit, 12 weeks.
Hospital Anxiety and Depression Scale (HADS) Score at 12 Weeks
Time Frame: At final study visit, 12 weeks.
Questionnaire about depression and anxiety severity. All questions rated from 0 to 3. Higher ratings represent greater severity. Subscales exist for depression and anxiety. Subscales are summed for the total composite score. Higher scores represents greater severity (min score= 0, max score= 21 for both subscales; min score= 0, max score= 42 for total score).
At final study visit, 12 weeks.
Visceral Sensitivity Index (VSI) Score at 12 Weeks
Time Frame: At final study visit, 12 weeks
Questionnaire about visceral sensitivity severity. All questions rated from 1 to 6. Higher ratings represent greater severity. No subscales. Scores for questions are summed for a total score. Higher total score represents greater symptom severity (min score= 15, max score= 90).
At final study visit, 12 weeks
Global Assessment of Relief at 12 Weeks
Time Frame: At final study visit, 12 weeks
A 7-point scale indicating overall IBS symptom relief where 1 represents completely relieved and 7 represents completely worse.
At final study visit, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kyle Staller, MD, MPH, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019P000361

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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