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Completed

NCT Number: NCT05186714

Mind-body Approach and Gut Microbiota in Osteoarthritis

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center, Rheumatology

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi versus wellness education

Behavioral

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

Primary outcomes

  1. Gut microbiota

    Time frame: From Week 0, to Week 12

    Changes in gut composition, relative abundance and diversity, and Streptococcus abundance

Secondary outcomes

  1. Change in Western Ontario and McMaster University Index (WOMAC)

    Time frame: From Week 0 to Week 12

    WOMAC version 3.1 questionnaire (pain subscale range, 0 [no pain]-20 [extreme pain]; the stiffness subscale range, 0 [no stiffness]-8 [extreme stiffness]; function subscale range, 0 [no difficulty with daily activities]-68 [extreme difficulty].

  2. Change in Hospital Anxiety and Depression Scale

    Time frame: From Week 0 to Week 12

    The Hospital Anxiety and Depression Scale (range 0-21, with higher scores indicating more severe symptoms).

  3. Change in Body mass index

    Time frame: From Week 0 to Week 12

    Body mass index is measured as the weight (kg) divided by the height (m). squared

  4. PROMIS-29

    Time frame: From Week 0 to Week 12

    PROMIS-29 measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance).

  5. Patient Global, 0-100 cm VAS

    Time frame: From Week 0 to Week 12

    Global knee pain assessment (range, 0 [no pain]-100 [extreme pain]),

  6. PROMIS Pain Interference

    Time frame: From Week 0 to Week 12

    PROMIS Pain Interference score (short form 6b item short form evaluating the extent to which pain interferes with physical, emotional and social activities).

  7. Arthritis Self-efficacy

    Time frame: From Week 0 to Week 12

    Arthritis Self-efficacy Scale score (SD) (Range, 1-10)

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 11, 2022
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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