Back to resultsMind-body Approach and Gut Microbiota in Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi versus wellness education
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 55 years
- Fulfills the American College of Rheumatology Criteria for symptomatic and radiographic osteoarthritis of the knee
- 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
Sites / Locations
- Tufts Medical Center, RheumatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Tai Chi
Wellnes Education
Arm Description
12 weeks of Tai Chi classes
12 weeks of Wellness Education classes
Outcomes
Primary Outcome Measures
Gut microbiota
Changes in gut composition, relative abundance and diversity, and Streptococcus abundance
Secondary Outcome Measures
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.
Change in Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (range 0-21, with higher scores indicating more severe symptoms).
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).
Change in Body mass index
Body mass index is measured as the weight (kg) divided by the height (m). squared
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05186714
Brief Title
Mind-body Approach and Gut Microbiota in Osteoarthritis
Official Title
Mind-body Approach and Gut Microbiota in Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi
Arm Type
Active Comparator
Arm Description
12 weeks of Tai Chi classes
Arm Title
Wellnes Education
Arm Type
Placebo Comparator
Arm Description
12 weeks of Wellness Education classes
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi versus wellness education
Intervention Description
12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)
Primary Outcome Measure Information:
Title
Gut microbiota
Description
Changes in gut composition, relative abundance and diversity, and Streptococcus abundance
Time Frame
From Week 0, to Week 12
Secondary Outcome Measure Information:
Title
Change in Western Ontario and McMaster University Index (WOMAC)
Description
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.
Time Frame
From Week 0, to Week 12, or to week 24
Title
Change in Hospital Anxiety and Depression Scale
Description
The Hospital Anxiety and Depression Scale (range 0-21, with higher scores indicating more severe symptoms).
Time Frame
From Week 0, to Week 12, or to Week 24
Title
Change in Medical Outcome 36-Item Short-Form Health Survey
Description
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).
Time Frame
From Week 0, to Week 12, or to Week 24
Title
Change in Body mass index
Description
Body mass index is measured as the weight (kg) divided by the height (m). squared
Time Frame
From Week 0, to Week 12, or to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chenchen Wang, MD. MSc
Phone
617-636-3251
Email
cwang2@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Coash, BS
Phone
6176369437
Email
elise.coash@tuftsmedicine.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenchen Wang, MD, MSc
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center, Rheumatology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Mind-body Approach and Gut Microbiota in Osteoarthritis
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