Effect of Tai Chi as Treatment for IBS-C

NCT04132804 | Completed Results DMC

• 1 other identifier: 2019P000361
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Irritable Bowel Syndrome With Constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Likelihood of Continuing Treatment

  Recorded at final study visit (following 8 weeks of treatment)

• Treatment Satisfaction

  Recorded at final study visit (following 8 weeks of treatment)

• IBS Quality of Life (IBS-QOL) at 12 Weeks

  At final study visit, 12 weeks

• Daily Bowel Movement Frequency at 12 Weeks

  At final study visit, 12 weeks.

• Bloating Scale Score at 12 Weeks

  At final study visit, 12 weeks

Study Arms (1)

Tai Chi Treatment

EXPERIMENTAL

All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.

Behavioral: Tai Chi

Interventions

Tai Chi BEHAVIORAL

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.

Tai Chi Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Tai Ji

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Results Point of Contact

• Title: Dr. Kyle Staller
• Organization: Massachusetts General Hospital

kstaller@mgh.harvard.edu

617-726-5565

Study Officials

• Kyle Staller, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Medicine

Model Details: This is a single-center pilot study. All patients enrolled in the study will participate in the Tai Chi treatment.

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: October 21, 2019
• Study Start: July 21, 2020
• Primary Completion: April 30, 2021
• Study Completion: July 14, 2022
• Last Updated: July 27, 2022
• Results First Posted: October 29, 2021

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)