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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: Behavioral: Tai Chi versus wellness education

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 Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chenchen Wang, MD. MSc; Phone Number: 617-636-3251; Email: cwang2@tuftsmedicalcenter.org
• Study Contact Backup: Name: Elise Coash, BS; Phone Number: 6176369437; Email: elise.coash@tuftsmedicine.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts Medical Center, Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tai Chi; 12 weeks of Tai Chi classes	Behavioral: Tai Chi versus wellness education; 12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)
Placebo Comparator: Wellnes Education; 12 weeks of Wellness Education classes	Behavioral: Tai Chi versus wellness education; 12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota	Changes in gut composition, relative abundance and diversity, and Streptococcus abundance	From Week 0, to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Western Ontario and McMaster University Index (WOMAC)	The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.	From Week 0, to Week 12, or to week 24
Change in Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale (range 0-21, with higher scores indicating more severe symptoms).	From Week 0, to Week 12, or to Week 24
Change in Medical Outcome 36-Item Short-Form Health Survey	The Medical Outcomes Study 36-Item Short-Form Physical and Mental summary Scores for the quality-of-life components (range, 0 to 100, with higher scores indicating better health status).	From Week 0, to Week 12, or to Week 24
Change in Body mass index	Body mass index is measured as the weight (kg) divided by the height (m). squared	From Week 0, to Week 12, or to Week 24

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Investigators: Principal Investigator: Chenchen Wang, MD, MSc, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 122321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No