Effect of Tai Chi as Treatment for IBS-C

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: Completed
• Conditions: Irritable Bowel Syndrome With Constipation
• Intervention / Treatment: Behavioral: Tai Chi

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
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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).	At final study visit, 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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).	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.	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.	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.	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.	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).	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).	At final study visit, 12 weeks
Stool Microbiome	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.	Change from baseline to final visit. Through study completion, up to 18 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.	At final study visit, 12 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): July 14, 2022

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Constipation
• Other Study ID 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