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Effect of Tai Chi as Treatment for IBS-C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132804
Recruitment Status : Completed
First Posted : October 21, 2019
Results First Posted : October 29, 2021
Last Update Posted : July 27, 2022
Sponsor:
Information provided by (Responsible Party):
Kyle Staller, MD, MPH, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Irritable Bowel Syndrome With Constipation
Intervention Behavioral: Tai Chi
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description

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

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.
Period Title: Overall Study
Started 31
Completed 20
Not Completed 11
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description

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

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.
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  87.1%
>=65 years
4
  12.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
42.2  (15.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
29
  93.5%
Male
2
   6.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Hispanic or Latino
2
   6.5%
Not Hispanic or Latino
29
  93.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
American Indian or Alaska Native
0
   0.0%
Asian
7
  22.6%
Native Hawaiian or Other Pacific Islander
3
   9.7%
Black or African American
1
   3.2%
White
20
  64.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
Body Mass Index, kg/m^2  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 31 participants
23.4  (4.6)
Waist circumference, cm  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 31 participants
85.4  (10.9)
IBS Symptom Severity Score  
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 31 participants
232.8  (110.3)
Hospital Anxiety and Depression Score  
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 31 participants
15.1  (6.1)
IBS Quality of Life Score  
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 31 participants
91.0  (31.5)
Visceral Sensitivity Index Score  
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 31 participants
48.4  (17.8)
Visual Analogue Abdominal Pain Scale Score  
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 31 participants
1.8  (0.8)
Bowel movement frequency  
Mean (Standard Deviation)
Unit of measure:  Movements per day
Number Analyzed 31 participants
1.4  (1.1)
Constipation severity  
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 31 participants
3.4  (2.6)
Abdominal discomfort severity  
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 31 participants
4.3  (2.3)
Bloating severity  
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 31 participants
5.0  (2.3)
Global Assessment of Relief  
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 31 participants
3.4  (0.9)
1.Primary Outcome
Title IBS Symptom Severity Score at 12 Weeks
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study in its entirety.
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
184.7  (99.2)
2.Secondary Outcome
Title Likelihood of Continuing Treatment
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study in its entirety.
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.2  (1.1)
3.Secondary Outcome
Title Treatment Satisfaction
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study in its entirety.
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
4  (0.9)
4.Secondary Outcome
Title IBS Quality of Life (IBS-QOL) at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study in its entirety.
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
79.8  (33.5)
5.Secondary Outcome
Title Daily Bowel Movement Frequency at 12 Weeks
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study in its entirety.
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: movements per day
1.4  (0.8)
6.Secondary Outcome
Title Bloating Scale Score at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study in its entirety.
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.1  (2.9)
7.Secondary Outcome
Title Abdominal Discomfort Scale Score at 12 Weeks
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study in its entirety.
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.3  (2.7)
8.Secondary Outcome
Title Constipation Severity Scale Score at 12 Weeks
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study in its entirety.
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.4  (3.1)
9.Secondary Outcome
Title Hospital Anxiety and Depression Scale (HADS) Score at 12 Weeks
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study in its entirety.
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
13.3  (8.0)
10.Secondary Outcome
Title Visceral Sensitivity Index (VSI) Score at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study in its entirety.
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
53.6  (19.4)
11.Secondary Outcome
Title Stool Microbiome
Hide 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
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Global Assessment of Relief at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study in its entirety.
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.4  (0.9)
Time Frame The time over which each participant was assessed was 14 weeks. This time frame includes 2 weeks of run-in screening, 8 weeks of Tai Chi treatment, and 4 weeks of follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tai Chi Treatment
Hide Arm/Group Description

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

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.
All-Cause Mortality
Tai Chi Treatment
Affected / at Risk (%)
Total   0/31 (0.00%)    
Hide Serious Adverse Events
Tai Chi Treatment
Affected / at Risk (%) # Events
Total   1/31 (3.23%)    
Gastrointestinal disorders   
Serious † [1]  1/31 (3.23%)  1
†
Indicates events were collected by systematic assessment
[1]
Emergency Room visit as recommended by provider for evaluation of SBO due to no BM in 8 days, and subsequent discharge same day. Subject ceased participation in the study during the 2 week run-in period. SAE occurred prior to intervention.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tai Chi Treatment
Affected / at Risk (%) # Events
Total   0/31 (0.00%)    
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kyle Staller
Organization: Massachusetts General Hospital
Phone: 617-726-5565
EMail: kstaller@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Kyle Staller, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04132804    
Other Study ID Numbers: 2019P000361
First Submitted: August 21, 2019
First Posted: October 21, 2019
Results First Submitted: August 31, 2021
Results First Posted: October 29, 2021
Last Update Posted: July 27, 2022