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Effect of Tai Chi as Treatment for IBS-C

December 20, 2019

Overview

This study investigates how effective the practice of Tai Chi is in reducing symptoms associated with irritable bowel syndrome with constipation (IBS-C). Tai Chi is a mind-body practice that is a combination of Chinese philosophy and martial arts and is known to promote relaxation, health, and injury prevention.

 

Study Information

All participants will receive a 1-hour Tai Chi lesson every week for 8 weeks. Participants will then be measured for pain relief and symptom severity and be asked to input pain records into the GeoPain app. Investigators are looking for 24 participants. The study started on October 31, 2019 and is estimated to be completed by August 1, 2020.

 

Inclusion Criteria

 

  • Age 18 – 65 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 smartphone
  • Informed consent form signed by the subjects

 

Exclusion Criteria

 

  • Unwilling to abstain from participation in Tai Chi (other than that provided for the study) or other mind-body practices (i.e. yoga) 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
  • 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

 

Location

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Contact: Abbey Bailey, BA    617-643-5742 abailey0@mgh.harvard.edu  

Contact: Kyle Staller, MD, MPH    617-724-6038 kstaller@mgh.harvard.edu

 

Sponsors/Collaborators

Massachusetts General Hospital

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