Irritable Bowel Syndrome With ConstipationNCT04132804
Effect of Tai Chi as Treatment for IBS-C
A study testing Tai Chi in people with Irritable Bowel Syndrome With Constipation, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation
- What is being tested?
- Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2020to 14 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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).
Read the 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.
- Being tested
- Tai Chi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Treatment | Experimental | All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks. Receives: Behavioral: Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS Symptom Severity Score at 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).
Measured: At final study visit, 12 weeks.
Secondary outcomes (10)
Likelihood of Continuing Treatment
A 5-point scale indicating likelihood of continuing Tai Chi as a treatment where 1 represents least likelihood and 5 represents greatest likelihood.
Measured: Recorded at final study visit (following 8 weeks of treatment)
Treatment Satisfaction
A 5-point scale indicating satisfaction with Tai Chi treatment where 1 represents the least satisfaction and 5 represents the most satisfaction
Measured: Recorded at final study visit (following 8 weeks of treatment)
IBS Quality of Life (IBS-QOL) at 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).
Measured: At final study visit, 12 weeks
Daily Bowel Movement Frequency at 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.
Measured: At final study visit, 12 weeks.
Bloating Scale Score at 12 Weeks
A 10-point scale indicating bloating severity where 0 represents the least severity and 10 represents the most severity.
Measured: At final study visit, 12 weeks
Abdominal Discomfort Scale Score at 12 Weeks
A 10-point scale indicating abdominal discomfort severity where 0 represents the least severity and 10 represents the most severity.
Measured: At final study visit, 12 weeks.
Constipation Severity Scale Score at 12 Weeks
A 10-point scale indicating constipation severity where 0 represents the least severity and 10 represents the most severity.
Measured: At final study visit, 12 weeks.
Hospital Anxiety and Depression Scale (HADS) Score at 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).
Measured: At final study visit, 12 weeks.
Visceral Sensitivity Index (VSI) Score at 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).
Measured: At final study visit, 12 weeks
Global Assessment of Relief at 12 Weeks
A 7-point scale indicating overall IBS symptom relief where 1 represents completely relieved and 7 represents completely worse.
Measured: At final study visit, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start21 Jul 2020
- Primary completion30 Apr 2021
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel Syndrome With ConstipationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center pilot study. All patients enrolled in the study will participate in the Tai Chi treatment.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Staller, MD, MPH, Massachusetts General Hospital
- Investigators
- Kyle Staller, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132804
- Sponsor's protocol ID
- 2019P000361
- Status last verified
- Jul 2022
- First submitted
- 21 Aug 2019
- Last updated
- 18 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Investigating the Effect of Tai Chi as Treatment for IBS-C
- ClinicalTrials.gov ID
- NCT04132804
- Acronym / sponsor ID
- 2019P000361
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Posted 29 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center pilot study. All patients enrolled in the study will participate in the Tai Chi treatment.
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Treatment | Experimental | Behavioral: Tai ChiAll patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiTai 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. | Behavioural | Tai Chi Treatment |
Primary outcome
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).
10 secondary outcomes
Likelihood of Continuing Treatment
Time frame: Recorded at final study visit (following 8 weeks of treatment)
Treatment Satisfaction
Time frame: 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
Daily Bowel Movement Frequency at 12 Weeks
Time frame: At final study visit, 12 weeks.
Bloating Scale Score at 12 Weeks
Time frame: At final study visit, 12 weeks
Abdominal Discomfort Scale Score at 12 Weeks
Time frame: At final study visit, 12 weeks.
Constipation Severity Scale Score at 12 Weeks
Time frame: At final study visit, 12 weeks.
Hospital Anxiety and Depression Scale (HADS) Score at 12 Weeks
Time frame: At final study visit, 12 weeks.
Visceral Sensitivity Index (VSI) Score at 12 Weeks
Time frame: At final study visit, 12 weeks
Global Assessment of Relief at 12 Weeks
Time frame: At final study visit, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Staller, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi in people with Irritable Bowel Syndrome With Constipation, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS Symptom Severity Score at 12 Weeks (time frame: At final study visit, 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.