Mind-body Approach and Gut Microbiota in Osteoarthritis
1 other identifier
interventional
72
1 country
1
Brief Summary
This exploratory study is to compares mechanisms of mind-body exercise with wellness education program on gut microbiota for osteoarthritis as a basis for a future large-scale trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedSeptember 9, 2025
September 1, 2025
1.5 years
December 27, 2021
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Gut microbiota
Changes in gut composition, relative abundance and diversity, and Streptococcus abundance
From Week 0, to Week 12
Secondary Outcomes (7)
Change in Western Ontario and McMaster University Index (WOMAC)
From Week 0 to Week 12
Change in Hospital Anxiety and Depression Scale
From Week 0 to Week 12
Change in Body mass index
From Week 0 to Week 12
PROMIS-29
From Week 0 to Week 12
Patient Global, 0-100 cm VAS
From Week 0 to Week 12
- +2 more secondary outcomes
Study Arms (2)
Tai Chi
ACTIVE COMPARATOR12 weeks of Tai Chi classes
Wellnes Education
PLACEBO COMPARATOR12 weeks of Wellness Education classes
Interventions
12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)
Eligibility Criteria
You may qualify if:
- Age ≥ 55 years
- Fulfills the American College of Rheumatology Criteria for symptomatic OA
- Baseline (Month 0) WOMAC pain subscale score ≥ 40
You may not qualify if:
- Dementia, neurological disease, cancer, cardiovascular disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in the programs.
- Factors known or likely to impact the intestinal microbiota or known to be associated with microbial translocation: antibiotic or probiotic use within the previous 4 weeks, gastrointestinal morbidity (irritable bowel syndrome, inflammatory bowel disease, history of gastrointestinal cancer or surgical resection, or acute, severe gastrointestinal symptoms requiring medical attention), opportunistic infection, and evidence of hepatitis B or C virus infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tufts Medical Center, Rheumatology
Boston, Massachusetts, 02111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chenchen Wang, MD, MSc
Tufts Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2021
First Posted
January 11, 2022
Study Start
November 1, 2022
Primary Completion
May 1, 2024
Study Completion
June 1, 2025
Last Updated
September 9, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share