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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132804
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Kyle Staller, MD, MPH, Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Constipation Behavioral: Tai Chi Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Pilot Study Investigating the Effect of Tai Chi as Treatment for IBS-C
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Tai Chi Treatment
All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.
Behavioral: 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.




Primary Outcome Measures :
  1. IBS Severity Scoring System [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
    Questionnaire about severity of IBS symptoms. 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 sore= 0, max score= 500).


Secondary Outcome Measures :
  1. Likelihood of continuing treatment [ Time Frame: Recorded at final study visit (following 8 weeks of treatment) ]
    A 5-point scale indicating likelihood of continuing to practice Tai Chi treatment where 1 represents least likelihood and 5 represents greatest likelihood

  2. Treatment satisfaction [ Time Frame: 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

  3. IBS Quality of Life (IBS-QOL) [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 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).

  4. Bowel movement frequency [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
    Number of complete spontaneous bowel movements (csbm) per week. Bowel movements reported daily.

  5. Bloating Scale [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
    A 10-point scale indicating bloating severity where 0 represents the least severity and 10 represents the most severity

  6. Abdominal Discomfort Scale [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
    A 10-point scale indicating abdominal discomfort severity where 0 represents the least severity and 10 represents the most severity

  7. Constipation Severity Scale [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
    A 10-point scale indicating constipation severity where 0 represents the least severity and 10 represents the most severity

  8. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 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).

  9. Visceral Sensitivity Index (VSI) [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 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).

  10. Stool microbiome [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]

    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 microbal presence therefore we do not have a specific list of microbes that will be assessed.

    Microbe diversity will be measured in relative abundance.


  11. Global Assessment of Relief [ Time Frame: Change from baseline to final visit. Through study completion, up to 18 weeks ]
    A 7-point scale indicating overall IBS symptom relief where 1 represents completely relieved and 7 represents completely worse.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 - 65 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. Informed consent form signed by the subjects

Exclusion Criteria:

  1. Unwilling to abstain from participation in Tai Chi (other than that provided for the study) or other mind-body practices (i.e. yoga) 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. Current use of prescribed or illicit opioids
  8. Change in current medication regimen related to GI motility, laxatives, or antidepressants
  9. 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
  10. Severe osteoarthritis
  11. Severe rheumatoid arthritis
  12. Severe constipation defined as <1 bowel movement per week without use of laxatives
  13. 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
  14. History of small bowel resection (except if related to appendectomy)
  15. Subjects anticipating surgical intervention during the study
  16. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
  17. Crohn's disease or ulcerative colitis
  18. History of intestinal stricture (e.g., Crohn's disease)
  19. BMI >35
  20. Pregnancy (or positive urine pregnancy test(s) in females of childbearing potential)
  21. Known history of diabetes (type 1 or 2)
  22. History of gastroparesis
  23. History of abdominal radiation treatment
  24. History of pancreatitis
  25. History of malabsorption or celiac disease
  26. History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
  27. History of human immunodeficiency virus
  28. History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
  29. Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study
  30. Any other clinically significant disease interfering with the assessments according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation)
  31. Any relevant biochemical abnormality interfering with the assessments according to the Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132804


Contacts
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Contact: Kyle Staller, MD, MPH 617-724-6038 kstaller@mgh.harvard.edu
Contact: Braden Kuo, MD 617-726-5525 bkuo@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mimi Paz    617-643-5742    mpaz3@mgh.harvard.edu   
Principal Investigator: Kyle Staller, MD, MPH         
Sub-Investigator: Braden Kuo, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Kyle Staller, MD, MPH Massachusetts General Hospital
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Responsible Party: Kyle Staller, MD, MPH, Assistant Professor in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04132804    
Other Study ID Numbers: 2019P000361
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Constipation
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases