NCT03823157

Brief Summary

The endocannabinoid system (ECS) is widely found in central and peripheral systems, and the immune system. Moderate-intensity aerobic exercise has shown to increase circulatory endocannabinoids. In this study, we will study Tai Chi, a mind-body moderate-intensity exercise, intervention for its effects on ECS in women. A pre-post design trial will be conducted on 18 qualified subjects. We will measure plasma eCB levels at baseline, before and after 4th session of Tai Chi. All data will be analyzed statistically at p\<0.05.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2019

Longer than P75 for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

January 28, 2019

Last Update Submit

March 27, 2025

Conditions

Mind-body Exercise

Outcome Measures

Primary Outcomes (1)

  • plasma eCB level

    AEA and 2-AG

    1 week

Study Arms (1)

Tai Chi

EXPERIMENTAL

Tai Chi exercise

Behavioral: Tai Chi

Interventions

Tai ChiBEHAVIORAL

mind-body exercise

Tai Chi

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women (menopause is defined as the absence of menstrual period for 12 months, not related to pregnancy/lactation, hormonal contraception). Age 40-70 years old with BMI between 25-35 kg/m2.
  • English literacy.

You may not qualify if:

  • prior experience with mind-body practice (e.g., TC, Qi Gong, yoga, meditation).
  • 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.
  • taking pain/anti-inflammatory and sleep medications within the 3 months before study starts.
  • taking hormone-replacement therapy within the 3 months before study starts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Interventions

Tai Ji

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Chwan-li Shen, PhD

    Texas Tech University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Tai Chi exercise
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 30, 2019

Study Start

August 1, 2019

Primary Completion

July 31, 2024

Study Completion

October 31, 2024

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations

US(1)