Effect of Tai Chi as Treatment for IBS-C

• ClinicalTrials.gov Identifier: NCT04132804
• Recruitment Status: Completed
• First Posted: October 21, 2019
• Results First Posted: October 29, 2021
• Last Update Posted: July 27, 2022
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Kyle Staller, MD, MPH, Massachusetts General Hospital

Tracking Information

• First Submitted Date: August 21, 2019
• First Posted Date: October 21, 2019
• Results First Submitted Date: August 31, 2021
• Results First Posted Date: October 29, 2021
• Last Update Posted Date: July 27, 2022
• Actual Study Start Date: July 21, 2020
• Actual Primary Completion Date: April 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 1, 2021)

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).

Original Primary Outcome Measures (submitted: October 16, 2019)

IBS Severity Scoring System [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]

Questionnaire about severity of IBS symptoms. 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 sore= 0, max score= 500).

Current Secondary Outcome Measures (submitted: October 1, 2021)

• 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.
• 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
• 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).
• 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.
• 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.
• 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.
• 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.
• 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).
• 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).
• Stool Microbiome [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
  Difference in microbiome (presence, absence, abundance, diversity) before treatment (baseline) versus after treatment. Pan-microbial (bacterial, archaeal, viral, and eukaryotic) taxonomic profiles will be determined using MetaPhlAn2 which identifies taxa to the strain level and quantifies their relative abundances. Functional genomic profiles, detailed species-specific reconstruction of microbial metabolic pathways, their complement of gene orthologs, taxonomic distributions, and abundances will be generated with HUMAnN2, providing taxon-specific profiles of gene families and pathways to survey microbial community metabolic potential in each metagenome. Intestinal contents appear different from person to person in terms of microbial presence therefore we do not have a specific list of microbes that will be assessed. Microbe diversity will be measured in relative abundance. Data have not yet been reported as funding has not been acquired for this level of analysis at this time.
• 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.

Original Secondary Outcome Measures (submitted: October 16, 2019)

• Likelihood of continuing treatment [ Time Frame: Recorded at final study visit after 8 weeks of treatment ]
  A 5-point scale indicating likelihood of continuing to practice Tai Chi treatment where 1 represents least likelihood and 5 represents greatest likelihood
• Treatment satisfaction [ Time Frame: Recorded at final study visit after 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
• IBS Quality of Life (IBS-QOL) [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 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).
• Bowel movement frequency [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
  Number of complete spontaneous bowel movements (csbm) per week. Bowel movements reported daily.
• Bloating Scale [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
  A 10-point scale indicating bloating severity where 0 represents the least severity and 10 represents the most severity
• Abdominal Discomfort Scale [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
  A 10-point scale indicating abdominal discomfort severity where 0 represents the least severity and 10 represents the most severity
• Constipation Severity Scale [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
  A 10-point scale indicating constipation severity where 0 represents the least severity and 10 represents the most severity
• Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 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).
• Visceral Sensitivity Index (VSI) [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 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).
• Stool microbiome [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
  Difference in microbiome (presence, absence, abundance, diversity) before treatment (baseline) versus after treatment. Pan-microbial (bacterial, archaeal, viral, and eukaryotic) taxonomic profiles will be determined using MetaPhlAn2 which identifies taxa to the strain level and quantifies their relative abundances. Functional genomic profiles, detailed species-specific reconstruction of microbial metabolic pathways, their complement of gene orthologs, taxonomic distributions, and abundances will be generated with HUMAnN2, providing taxon-specific profiles of gene families and pathways to survey microbial community metabolic potential in each metagenome. Intestinal contents appear different from person to person in terms of microbal presence therefore we do not have a specific list of microbes that will be assessed. Microbe diversity will be measured in relative abundance.
• Global Assessment of Relief [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
  A 7-point scale indicating overall IBS symptom relief where 1 represents completely relieved and 7 represents completely worse.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Tai Chi as Treatment for IBS-C
• Official Title: Pilot Study Investigating the Effect of Tai Chi as Treatment for IBS-C
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment

• Condition: Irritable Bowel Syndrome With Constipation

Intervention

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.

Study Arms

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.

Intervention: Behavioral: Tai Chi

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 1, 2021): 31
• Original Estimated Enrollment (submitted: October 16, 2019): 24
• Actual Study Completion Date: July 14, 2022
• Actual Primary Completion Date: April 30, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04132804
• Other Study ID Numbers: 2019P000361
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kyle Staller, MD, MPH, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kyle Staller, MD, MPH; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: July 2022