Irritable Bowel Syndrome With Constipation
Conditions
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.
Interventions
BEHAVIORALTai 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-center pilot study. All patients enrolled in the study will participate in the Tai Chi treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IBS Symptom Severity Score at 12 Weeks | At final study visit, 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
| Measure | Time frame | Description |
|---|---|---|
| Likelihood of Continuing Treatment | Recorded at final study visit (following 8 weeks of 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 | Recorded at final study visit (following 8 weeks of treatment) | 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 | At final study visit, 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 | At final study visit, 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 | At final study visit, 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 | At final study visit, 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 | At final study visit, 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 | At final study visit, 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 | At final study visit, 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). |
| Global Assessment of Relief at 12 Weeks | At final study visit, 12 weeks | A 7-point scale indicating overall IBS symptom relief where 1 represents completely relieved and 7 represents completely worse. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKyle Staller, MD, MPH
Massachusetts General Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tai Chi Treatment 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. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Tai Chi Treatment |
|---|---|
| Abdominal discomfort severity | 4.3 score on a scale STANDARD_DEVIATION 2.3 |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 42.2 years STANDARD_DEVIATION 15.7 |
| Bloating severity | 5.0 score on a scale STANDARD_DEVIATION 2.3 |
| Body Mass Index, kg/m^2 | 23.4 kg/m^2 STANDARD_DEVIATION 4.6 |
| Bowel movement frequency | 1.4 movements per day STANDARD_DEVIATION 1.1 |
| Constipation severity | 3.4 score on a scale STANDARD_DEVIATION 2.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Global Assessment of Relief | 3.4 score on a scale STANDARD_DEVIATION 0.9 |
| Hospital Anxiety and Depression Score | 15.1 score on a scale STANDARD_DEVIATION 6.1 |
| IBS Quality of Life Score | 91.0 score on a scale STANDARD_DEVIATION 31.5 |
| IBS Symptom Severity Score | 232.8 score on a scale STANDARD_DEVIATION 110.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 2 Participants |
| Visceral Sensitivity Index Score | 48.4 score on a scale STANDARD_DEVIATION 17.8 |
| Visual Analogue Abdominal Pain Scale Score | 1.8 score on a scale STANDARD_DEVIATION 0.8 |
| Waist circumference, cm | 85.4 cm STANDARD_DEVIATION 10.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 1 / 31 |
Outcome results
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).
Time frame: At final study visit, 12 weeks.
Population: Patients who completed the study in its entirety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Treatment | IBS Symptom Severity Score at 12 Weeks | 184.7 score on a scale | Standard Deviation 99.2 |
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.
Time frame: At final study visit, 12 weeks.
Population: Patients who completed the study in its entirety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Treatment | Abdominal Discomfort Scale Score at 12 Weeks | 3.3 score on a scale | Standard Deviation 2.7 |
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.
Time frame: At final study visit, 12 weeks
Population: Patients who completed the study in its entirety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Treatment | Bloating Scale Score at 12 Weeks | 4.1 score on a scale | Standard Deviation 2.9 |
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.
Time frame: At final study visit, 12 weeks.
Population: Patients who completed the study in its entirety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Treatment | Constipation Severity Scale Score at 12 Weeks | 3.4 score on a scale | Standard Deviation 3.1 |
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.
Time frame: At final study visit, 12 weeks.
Population: Patients who completed the study in its entirety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Treatment | Daily Bowel Movement Frequency at 12 Weeks | 1.4 movements per day | Standard Deviation 0.8 |
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.
Time frame: At final study visit, 12 weeks
Population: Patients who completed the study in its entirety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Treatment | Global Assessment of Relief at 12 Weeks | 3.4 score on a scale | Standard Deviation 0.9 |
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).
Time frame: At final study visit, 12 weeks.
Population: Patients who completed the study in its entirety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Treatment | Hospital Anxiety and Depression Scale (HADS) Score at 12 Weeks | 13.3 score on a scale | Standard Deviation 8 |
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).
Time frame: At final study visit, 12 weeks
Population: Patients who completed the study in its entirety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Treatment | IBS Quality of Life (IBS-QOL) at 12 Weeks | 79.8 score on a scale | Standard Deviation 33.5 |
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.
Time frame: Recorded at final study visit (following 8 weeks of treatment)
Population: Patients who completed the study in its entirety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Treatment | Likelihood of Continuing Treatment | 4.2 score on a scale | Standard Deviation 1.1 |
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.
Time frame: Change from baseline to final visit. Through study completion, up to 18 weeks
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
Time frame: Recorded at final study visit (following 8 weeks of treatment)
Population: Patients who completed the study in its entirety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Treatment | Treatment Satisfaction | 4 score on a scale | Standard Deviation 0.9 |
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).
Time frame: At final study visit, 12 weeks
Population: Patients who completed the study in its entirety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi Treatment | Visceral Sensitivity Index (VSI) Score at 12 Weeks | 53.6 score on a scale | Standard Deviation 19.4 |