Back to resultsEffect of Tai Chi as Treatment for IBS-C
Primary Purpose
Irritable Bowel Syndrome With Constipation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tai Chi Treatment
Arm Description
All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Treatment Satisfaction
A 5-point scale indicating satisfaction with Tai Chi treatment where 1 represents the least satisfaction and 5 represents the most satisfaction
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).
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.
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.
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.
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.
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).
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).
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.
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.
Full Information
NCT ID
NCT04132804
First Posted
August 21, 2019
Last Updated
July 21, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04132804
Brief Title
Effect of Tai Chi as Treatment for IBS-C
Official Title
Pilot Study Investigating the Effect of Tai Chi as Treatment for IBS-C
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
July 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi Treatment
Arm Type
Experimental
Arm Description
All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
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.
Primary Outcome Measure Information:
Title
IBS Symptom Severity Score at 12 Weeks
Description
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).
Time Frame
At final study visit, 12 weeks.
Secondary Outcome Measure Information:
Title
Likelihood of Continuing Treatment
Description
A 5-point scale indicating likelihood of continuing Tai Chi as a treatment where 1 represents least likelihood and 5 represents greatest likelihood.
Time Frame
Recorded at final study visit (following 8 weeks of treatment)
Title
Treatment Satisfaction
Description
A 5-point scale indicating satisfaction with Tai Chi treatment where 1 represents the least satisfaction and 5 represents the most satisfaction
Time Frame
Recorded at final study visit (following 8 weeks of treatment)
Title
IBS Quality of Life (IBS-QOL) at 12 Weeks
Description
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).
Time Frame
At final study visit, 12 weeks
Title
Daily Bowel Movement Frequency at 12 Weeks
Description
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.
Time Frame
At final study visit, 12 weeks.
Title
Bloating Scale Score at 12 Weeks
Description
A 10-point scale indicating bloating severity where 0 represents the least severity and 10 represents the most severity.
Time Frame
At final study visit, 12 weeks
Title
Abdominal Discomfort Scale Score at 12 Weeks
Description
A 10-point scale indicating abdominal discomfort severity where 0 represents the least severity and 10 represents the most severity.
Time Frame
At final study visit, 12 weeks.
Title
Constipation Severity Scale Score at 12 Weeks
Description
A 10-point scale indicating constipation severity where 0 represents the least severity and 10 represents the most severity.
Time Frame
At final study visit, 12 weeks.
Title
Hospital Anxiety and Depression Scale (HADS) Score at 12 Weeks
Description
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).
Time Frame
At final study visit, 12 weeks.
Title
Visceral Sensitivity Index (VSI) Score at 12 Weeks
Description
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).
Time Frame
At final study visit, 12 weeks
Title
Stool Microbiome
Description
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.
Time Frame
Change from baseline to final visit. Through study completion, up to 18 weeks
Title
Global Assessment of Relief at 12 Weeks
Description
A 7-point scale indicating overall IBS symptom relief where 1 represents completely relieved and 7 represents completely worse.
Time Frame
At final study visit, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Staller, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Tai Chi as Treatment for IBS-C
We'll reach out to this number within 24 hrs