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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Recorded at final study visit (following 8 weeks of treatment) |
| Treatment Satisfaction |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Staller, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Patients who completed the study in its entirety. | Posted | Mean | Standard Deviation | score on a scale | At final study visit, 12 weeks. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious | Gastrointestinal disorders | Systematic Assessment | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyle Staller | Massachusetts General Hospital | 617-726-5565 | kstaller@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2020 | Aug 31, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D026302 | Tai Ji |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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This is a single-center pilot study. All patients enrolled in the study will participate in the Tai Chi treatment.
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A 5-point scale indicating satisfaction with Tai Chi treatment where 1 represents the least satisfaction and 5 represents the most satisfaction |
| Recorded at final study visit (following 8 weeks of treatment) |
| 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). | At final study visit, 12 weeks |
| 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. | At final study visit, 12 weeks. |
| 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. | At final study visit, 12 weeks |
| 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. | At final study visit, 12 weeks. |
| 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. | At final study visit, 12 weeks. |
| 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). | At final study visit, 12 weeks. |
| 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). | At final study visit, 12 weeks |
| 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. | At final study visit, 12 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index, kg/m^2 | Mean | Standard Deviation | kg/m^2 |
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| Waist circumference, cm | Mean | Standard Deviation | cm |
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| IBS Symptom Severity Score | Mean | Standard Deviation | score on a scale |
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| Hospital Anxiety and Depression Score | Mean | Standard Deviation | score on a scale |
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| IBS Quality of Life Score | Mean | Standard Deviation | score on a scale |
|
| Visceral Sensitivity Index Score | Mean | Standard Deviation | score on a scale |
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| Visual Analogue Abdominal Pain Scale Score | Mean | Standard Deviation | score on a scale |
|
| Bowel movement frequency | Mean | Standard Deviation | movements per day |
|
| Constipation severity | Mean | Standard Deviation | score on a scale |
|
| Abdominal discomfort severity | Mean | Standard Deviation | score on a scale |
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| Bloating severity | Mean | Standard Deviation | score on a scale |
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| Global Assessment of Relief | Mean | Standard Deviation | score on a scale |
|
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| 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. | Patients who completed the study in its entirety. | Posted | Mean | Standard Deviation | score on a scale | Recorded at final study visit (following 8 weeks of treatment) |
|
|
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| 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 | Patients who completed the study in its entirety. | Posted | Mean | Standard Deviation | score on a scale | Recorded at final study visit (following 8 weeks of treatment) |
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| 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). | Patients who completed the study in its entirety. | Posted | Mean | Standard Deviation | score on a scale | At final study visit, 12 weeks |
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| 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. | Patients who completed the study in its entirety. | Posted | Mean | Standard Deviation | movements per day | At final study visit, 12 weeks. |
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| 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. | Patients who completed the study in its entirety. | Posted | Mean | Standard Deviation | score on a scale | At final study visit, 12 weeks |
|
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| 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. | Patients who completed the study in its entirety. | Posted | Mean | Standard Deviation | score on a scale | At final study visit, 12 weeks. |
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| 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. | Patients who completed the study in its entirety. | Posted | Mean | Standard Deviation | score on a scale | At final study visit, 12 weeks. |
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| 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). | Patients who completed the study in its entirety. | Posted | Mean | Standard Deviation | score on a scale | At final study visit, 12 weeks. |
|
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| 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). | Patients who completed the study in its entirety. | Posted | Mean | Standard Deviation | score on a scale | At final study visit, 12 weeks |
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| 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. | Patients who completed the study in its entirety. | Posted | Mean | Standard Deviation | score on a scale | At final study visit, 12 weeks |
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| D026741 |
| Physical Therapy Modalities |