Effect of Tai Chi as Treatment for IBS-C

Not Applicable

Completed

Conditions: Irritable Bowel Syndrome With Constipation

Interventions: Behavioral: Tai Chi

Registration Number: NCT04132804

Lead Sponsor: 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tai Chi Treatment	Tai Chi	All patients in the trial will receive 1-hour Tai Chi lessons once per week for a total of 8 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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
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.
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.
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).
Stool Microbiome	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	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.