Effect of Tai Chi as Treatment for IBS-C

Irritable Bowel Syndrome With Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132804
• Other study ID #: 2019P000361
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: July 14, 2022

Study information

• Verified date: July 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 14, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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