Mind-body Approach and Gut Microbiota in Osteoarthritis

Tufts University

Status: Completed

Conditions: Osteoarthritis

Treatments: Behavioral: Tai Chi versus wellness education

Study type: Interventional

Funder types: Other

Identifiers

NCT05186714

122321

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 72 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups, including a placebo group

Tai Chi

Active Comparator group

Description:

12 weeks of Tai Chi classes

Treatment:

Behavioral: Tai Chi versus wellness education

Wellnes Education

Placebo Comparator group

Description:

12 weeks of Wellness Education classes

Treatment:

Behavioral: Tai Chi versus wellness education