- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03823157
Tai Chi and eCB in Women (TC-eCB)
March 27, 2025 updated by: Texas Tech University Health Sciences Center
Tai Chi and eCB in Postmenopausal Women
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.
Study Overview
Detailed Description
The endocannabinoid system (ECS) is widely found in central and peripheral systems, and the immune system.
Emerging studies have shown endocannabinoid plays a role in appetite, pain sensation, control of chronic pain, macronutrient metabolism, mood/mood disorder, and regulation of immune cell functions.
Moderate-intensity aerobic exercise has shown to increase circulatory endocannabinoids.
Moderate-intensity exercise improves cognition, memory, and wellbeing in adults.
Exercisers experience decreased tension, depression, and anger.
Therefore, these findings in humans suggest a likely relationship for exercise effecting well-being via ECS.
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 15 qualified subjects.
All subjects will be assigned to Tai Chi group for one week including 3 sessions, 60 minutes per session, on 3 non-consecutive days.
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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Lubbock, Texas, United States, 79430
- Texas Tech University Health Sciences Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tai Chi
Tai Chi exercise
|
mind-body exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
plasma eCB level
Time Frame: 1 week
|
AEA and 2-AG
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chwan-li Shen, PhD, Texas Tech University Health Sciences Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Actual)
July 31, 2024
Study Completion (Actual)
October 31, 2024
Study Registration Dates
First Submitted
January 28, 2019
First Submitted That Met QC Criteria
January 28, 2019
First Posted (Actual)
January 30, 2019
Study Record Updates
Last Update Posted (Actual)
April 2, 2025
Last Update Submitted That Met QC Criteria
March 27, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Tai Chi and eCB in women
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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