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Completed

NCT Number: NCT04132804

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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).

  10. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 21, 2019
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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