Effect of Tai Chi as Treatment for IBS-C

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Irritable Bowel Syndrome With Constipation

Intervention / Treatment
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* Behavioral: Tai Chi


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi Treatment<br>All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks. | Behavioral: Tai Chi<br>* 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.<br>|

What is the study measuring?
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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 |