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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
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.
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)
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)
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
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: At final study visit, 12 weeks
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
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