Mind-body Approach and Gut Microbiota in Osteoarthritis

NCT ID: NCT05186714

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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This exploratory study is to determine the effect of mind-body exercise on gut microbiota in patients with osteoarthritis. We will randomize 80 eligible individuals who meet the American College of Rheumatology criteria for osteoarthritis into Tai Chi or wellness education interventions for 12 weeks. Using 16S rRNA amplicon sequencing of fecal DNA samples we will compare the changes in gut microbiota profiles using 16S rRNA gene amplicon sequencing, and quantity of Streptococcus species using quantitative PCR, as well as their association with clinical outcomes. This exploratory study will guide the development of theoretically informed, effective treatment for a high-risk population further enlighten us about the pathogenesis of metabolic osteoarthritis pain.This proposal will provide crucial preliminary knowledge of the mechanism underlying Tai Chi mind-body therapy for metabolic osteoarthritis.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tai Chi

12 weeks of Tai Chi classes

Group Type ACTIVE_COMPARATOR

Tai Chi versus wellness education

Intervention Type BEHAVIORAL

12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)

Wellnes Education

12 weeks of Wellness Education classes

Group Type PLACEBO_COMPARATOR

Tai Chi versus wellness education

Intervention Type BEHAVIORAL

12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)

Interventions

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Tai Chi versus wellness education

12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 55 years
* Fulfills the American College of Rheumatology Criteria for symptomatic OA
* Baseline (Month 0) WOMAC pain subscale score ≥ 40

Exclusion Criteria

* 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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tufts Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chenchen Wang, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

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Tufts Medical Center, Rheumatology

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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122321

Identifier Type: -

Identifier Source: org_study_id

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