NCT04046003

Brief Summary

This study is to determine how 8-week Tai Chi intervention alters plasma endocannabinoid and its receptors in monocytes/marcrophages, plasma oxylipinds, plasma brain-derived neurotrophic factor, brain white matter connectivity/efficiency, and functional/clinical outcomes in women with knee OA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

4.8 years

First QC Date

July 26, 2019

Last Update Submit

March 27, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • endocannabinoid

    plasma endocannabinoid levels

    Changes from bseline endocannabinoid levels at 8 weeks

  • oxylipins

    plasma oxylipins levels

    Changes from baseline oxylipins levels at 8 weeks

Secondary Outcomes (7)

  • endocannabinoid receptors expression

    Changes from baseline the affinity of endocannabinoid receptor expression at 8 weeks

  • BDNF

    Changes from baseline BDNF levels at 8 weeks

  • white matter connectivity/efficiency of various fiber tracts in the brain

    Change from baselinewhite matter connectivity/efficiency of various fiber tracts in the brain at 8 weeks

  • pain sensitivity

    Change from baseline pain sensitivity scale at 8 weeks

  • Pain assessment

    Change from baseline pain scale at 8 weeks

  • +2 more secondary outcomes

Study Arms (1)

Tai Chi intervention

EXPERIMENTAL

24-form Yang style Tai Chi

Behavioral: Tai chi exercise

Interventions

24-form Yang style Tai Chi (60 min/session, 3 sessions/week) for 8 weeks

Tai Chi intervention

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal women.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women.
  • WOMAC pain score ≥ 50 on at least 1 of the 5 questions in pain subscale (range of 0 to 100, with higher scores indicating greater pain.
  • English literacy.
  • Able to undergo an MRI scan
  • Diagnosed Have the following symptoms associated with knee OA based on American College of Rheumatology clinical classification criteria for osteoarthritis (Peat 2006). Pain in the knee. Need to at least 3 of the following: over 50 years of age, less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement, or no palpable warmth of synovium.

You may not qualify if:

  • Prior experience with mind-body practice (e.g. TC, Qi Gong, yoga, or acupuncture) or physical therapy programs for knee OA within the past 3 months.
  • Severe medical limitations (i.e., dementia, symptomatic heart or vascular disease, or recent stroke) precluding full participation.
  • Medical/neurologic or other systemic diseases affecting the musculoskeletal systems (i.e. polio/Parkinson's/multiple sclerosis, etc. in addition to cerebral vascular accident or stroke) and diabetes with peripheral neuropathy affecting their sensory/balance.
  • Intra-articular steroid injection or reconstructive surgery on most severely affected knee in the past three months.
  • Intra-articular hyaluronic acid injections on most severely affected knee in the past six months.
  • Inability to walk without an assistive device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (1)

  • Shen CL, Newman JW, Elmassry MM, Borkowski K, Chyu MC, Kahathuduwa C, Neugebauer V, Watkins BA. Tai Chi exercise reduces circulating levels of inflammatory oxylipins in postmenopausal women with knee osteoarthritis: results from a pilot study. Front Med (Lausanne). 2023 Aug 16;10:1210170. doi: 10.3389/fmed.2023.1210170. eCollection 2023.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Chwan-Li Shen

    Texas Tech University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 24-form Yang style Tai Chi (60 min/session, 3 sessions/week) for 8 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2019

First Posted

August 6, 2019

Study Start

September 1, 2019

Primary Completion

June 30, 2024

Study Completion

August 31, 2024

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations