Mind-body ExercisePhase 1TC-eCBNCT03823157
Tai Chi and eCB in Women
A Phase 1 study testing Tai Chi in people with Mind-body Exercise, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mind-body Exercise
- What is being tested?
- Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: 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.
Read the 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.
- Conditions
- Mind-body Exercise
- Being tested
- Tai Chi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
mind-body exercise
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | Tai Chi exercise Receives: Behavioral: Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma eCB level
AEA and 2-AG
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Aug 2019
- Primary completion31 Jul 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mind-body ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Tai Chi exercise
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chwan-li Shen, PhD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823157
- Sponsor's protocol ID
- Tai Chi and eCB in women
- Acronym
- TC-eCB
- Status last verified
- Mar 2025
- First submitted
- 28 Jan 2019
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi and eCB in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03823157
- Acronym / sponsor ID
- TC-eCB / Tai Chi and eCB in women
- Conditions
- Mind-body Exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Tai Chi exercise
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai ChiTai Chi exercise |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chimind-body exercise | Behavioural | Tai Chi |
Primary outcome
plasma eCB level
Time frame: 1 week
AEA and 2-AG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chwan-li Shen, PhD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tai Chi in people with Mind-body Exercise, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma eCB level (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.