Trial Outcomes & Findings for Effect of Tai Chi as Treatment for IBS-C (NCT NCT04132804)

Last Updated: 2022-07-27

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

At final study visit, 12 weeks.

Results posted on

2022-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	31
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Tai Chi as Treatment for IBS-C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tai Chi Treatment n=31 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	42.2 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants
Body Mass Index, kg/m^2	23.4 kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants
Waist circumference, cm	85.4 cm STANDARD_DEVIATION 10.9 • n=5 Participants
IBS Symptom Severity Score	232.8 score on a scale STANDARD_DEVIATION 110.3 • n=5 Participants
Hospital Anxiety and Depression Score	15.1 score on a scale STANDARD_DEVIATION 6.1 • n=5 Participants
IBS Quality of Life Score	91.0 score on a scale STANDARD_DEVIATION 31.5 • n=5 Participants
Visceral Sensitivity Index Score	48.4 score on a scale STANDARD_DEVIATION 17.8 • n=5 Participants
Visual Analogue Abdominal Pain Scale Score	1.8 score on a scale STANDARD_DEVIATION 0.8 • n=5 Participants
Bowel movement frequency	1.4 movements per day STANDARD_DEVIATION 1.1 • n=5 Participants
Constipation severity	3.4 score on a scale STANDARD_DEVIATION 2.6 • n=5 Participants
Abdominal discomfort severity	4.3 score on a scale STANDARD_DEVIATION 2.3 • n=5 Participants
Bloating severity	5.0 score on a scale STANDARD_DEVIATION 2.3 • n=5 Participants
Global Assessment of Relief	3.4 score on a scale STANDARD_DEVIATION 0.9 • n=5 Participants

PRIMARY outcome

Timeframe: At final study visit, 12 weeks.

Population: Patients who completed the study in its entirety.

Outcome measures

Outcome measures
Measure	Tai Chi Treatment n=20 Participants 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.
IBS Symptom Severity Score at 12 Weeks	184.7 score on a scale Standard Deviation 99.2

SECONDARY outcome

Timeframe: Recorded at final study visit (following 8 weeks of treatment)

Population: Patients who completed the study in its entirety.

A 5-point scale indicating likelihood of continuing Tai Chi as a treatment where 1 represents least likelihood and 5 represents greatest likelihood.

Outcome measures

Outcome measures
Measure	Tai Chi Treatment n=20 Participants 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.
Likelihood of Continuing Treatment	4.2 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Recorded at final study visit (following 8 weeks of treatment)

Population: Patients who completed the study in its entirety.

A 5-point scale indicating satisfaction with Tai Chi treatment where 1 represents the least satisfaction and 5 represents the most satisfaction

Outcome measures

Outcome measures
Measure	Tai Chi Treatment n=20 Participants 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.
Treatment Satisfaction	4 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: At final study visit, 12 weeks

Population: Patients who completed the study in its entirety.

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).

Outcome measures

Outcome measures
Measure	Tai Chi Treatment n=20 Participants 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.
IBS Quality of Life (IBS-QOL) at 12 Weeks	79.8 score on a scale Standard Deviation 33.5

SECONDARY outcome

Timeframe: At final study visit, 12 weeks.

Population: Patients who completed the study in its entirety.

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.

Outcome measures

Outcome measures
Measure	Tai Chi Treatment n=20 Participants 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.
Daily Bowel Movement Frequency at 12 Weeks	1.4 movements per day Standard Deviation 0.8

SECONDARY outcome

Timeframe: At final study visit, 12 weeks

Population: Patients who completed the study in its entirety.

A 10-point scale indicating bloating severity where 0 represents the least severity and 10 represents the most severity.

Outcome measures

Outcome measures
Measure	Tai Chi Treatment n=20 Participants 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.
Bloating Scale Score at 12 Weeks	4.1 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: At final study visit, 12 weeks.

Population: Patients who completed the study in its entirety.

A 10-point scale indicating abdominal discomfort severity where 0 represents the least severity and 10 represents the most severity.

Outcome measures

Outcome measures
Measure	Tai Chi Treatment n=20 Participants 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.
Abdominal Discomfort Scale Score at 12 Weeks	3.3 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: At final study visit, 12 weeks.

Population: Patients who completed the study in its entirety.

A 10-point scale indicating constipation severity where 0 represents the least severity and 10 represents the most severity.

Outcome measures

Outcome measures
Measure	Tai Chi Treatment n=20 Participants 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.
Constipation Severity Scale Score at 12 Weeks	3.4 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: At final study visit, 12 weeks.

Population: Patients who completed the study in its entirety.

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).

Outcome measures

Outcome measures
Measure	Tai Chi Treatment n=20 Participants 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.
Hospital Anxiety and Depression Scale (HADS) Score at 12 Weeks	13.3 score on a scale Standard Deviation 8.0

SECONDARY outcome

Timeframe: At final study visit, 12 weeks

Population: Patients who completed the study in its entirety.

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).

Outcome measures

Outcome measures
Measure	Tai Chi Treatment n=20 Participants 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.
Visceral Sensitivity Index (VSI) Score at 12 Weeks	53.6 score on a scale Standard Deviation 19.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At final study visit, 12 weeks

Population: Patients who completed the study in its entirety.

A 7-point scale indicating overall IBS symptom relief where 1 represents completely relieved and 7 represents completely worse.

Outcome measures

Outcome measures
Measure	Tai Chi Treatment n=20 Participants 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.
Global Assessment of Relief at 12 Weeks	3.4 score on a scale Standard Deviation 0.9

Adverse Events

Tai Chi Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tai Chi Treatment n=31 participants at risk 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.
Gastrointestinal disorders Serious	3.2% 1/31 • Number of events 1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kyle Staller

Massachusetts General Hospital

Phone: 617-726-5565

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place