Effect of Tai Chi as Treatment for IBS-C
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|ClinicalTrials.gov Identifier: NCT04132804|
Recruitment Status : Completed
First Posted : October 21, 2019
Results First Posted : October 29, 2021
Last Update Posted : July 27, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome With Constipation||Behavioral: Tai Chi||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|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)|
|Official Title:||Pilot Study Investigating the Effect of Tai Chi as Treatment for IBS-C|
|Actual Study Start Date :||July 21, 2020|
|Actual Primary Completion Date :||April 30, 2021|
|Actual Study Completion Date :||July 14, 2022|
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.
- IBS Symptom Severity Score at 12 Weeks [ Time Frame: 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).
- Likelihood of Continuing Treatment [ Time Frame: 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 [ 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
- IBS Quality of Life (IBS-QOL) at 12 Weeks [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
- 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 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 [ Time Frame: 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.
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.
|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Kyle Staller, MD, MPH||Massachusetts General Hospital|
Documents provided by Kyle Staller, MD, MPH, Massachusetts General Hospital:
|Responsible Party:||Kyle Staller, MD, MPH, Assistant Professor in Medicine, Massachusetts General Hospital|
|Other Study ID Numbers:||
|First Posted:||October 21, 2019 Key Record Dates|
|Results First Posted:||October 29, 2021|
|Last Update Posted:||July 27, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Digestive System Diseases