Mind-body Approach and Gut Microbiota in Osteoarthritis

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis
• Interventions: Behavioral: Tai Chi versus wellness education

• Registration Number: NCT05186714
• Lead Sponsor: Tufts Medical Center

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-11
• Study Start: 2022-11-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tai Chi	Tai Chi versus wellness education	12 weeks of Tai Chi classes
Wellnes Education	Tai Chi versus wellness education	12 weeks of Wellness Education classes

Primary Outcome Measures

Name	Time	Method
Gut microbiota	From Week 0, to Week 12	Changes in gut composition, relative abundance and diversity, and Streptococcus abundance

Secondary Outcome Measures

Name	Time	Method
Arthritis Self-efficacy	From Week 0 to Week 12	Arthritis Self-efficacy Scale score (SD) (Range, 1-10)
Patient Global, 0-100 cm VAS	From Week 0 to Week 12	Global knee pain assessment (range, 0 \[no pain\]-100 \[extreme pain\]),
Change in Hospital Anxiety and Depression Scale	From Week 0 to Week 12	The Hospital Anxiety and Depression Scale (range 0-21, with higher scores indicating more severe symptoms).
Change in Body mass index	From Week 0 to Week 12	Body mass index is measured as the weight (kg) divided by the height (m). squared
Change in Western Ontario and McMaster University Index (WOMAC)	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 \[extreme difficulty\].
PROMIS-29	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).
PROMIS Pain Interference	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).

Trial Locations

Locations (1)

Tufts Medical Center, Rheumatology; 🇺🇸 Boston, Massachusetts, United States