HypertensionNCT05621694
Exploring Oxytocin Response to Meditative Movement
A study testing Tai Chi Easy in people with Hypertension, run by Arizona State University at 2 sites in United States.
Trial summary
This pilot study is designed to test effects of a single session of meditative movement (Tai Chi Easy) on older adults' blood pressure, perceptions of connection, mood, and oxytocin levels. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Tai Chi Easy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2017to 31 Jan 2022
- Phase
- Interventional
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55-80 --BP above 120/80 -
Who cannot join
- having a neurologic disorder such as Parkinson's, seizure disorder, multiple sclerosis, Alzheimer's disease
- answered "yes" to one or more questions on the Physical Activity Readiness Questionnaire (PAR-Q). The PAR-Q is a seven-question assessment that determines one's readiness, safety and ability to engage in physical activity and is safely validated for older adults
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arizona State University Downtown Campus
Phoenix, Arizona, 85004
Arizona State University
Phoenix, Arizona, 85005
About this study
This pilot study is designed to test effects of a single session of meditative movement (Tai Chi Easy) on older adults' blood pressure, perceptions of connection, mood, and oxytocin levels.
Read the detailed description
Endogenous oxytocin (the "cuddle hormone") is associated with lowering blood pressure (BP), suggesting that finding ways to increase oxytocin even in the absence of social connection, may be beneficial. Meditative movement emphasizing breath, meditative state and flow-inducing movements holds potential for reducing BP, improving mood and releasing oxytocin. In a single-group pilot study we exposed 21 OAs with mild-moderate hypertension to a 50-minute "Tai Chi Easy (TCE)" (simplified Tai Chi/Qigong) session, collecting BP, saliva samples for oxytocin, and psychosocial measures (connection, mood) pre/post intervention.
- Conditions
- Hypertension
- Being tested
- Tai Chi Easy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi EasyBehavioural
Also called Qigong/Tai Chi; taiji
A meditative movement practice that includes simple qigong movement/breath practices and single, repeated tai chi movements taught to generate a meditative state and flow
| Study group | Role | What they receive |
|---|---|---|
| Qigong/Tai Chi Intervention | Experimental | Tai chi and Qigong combined into a simplified, standard practice, "Tai Chi Easy" Receives: Behavioral: Tai Chi Easy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Pressure
Using blood pressure cuff, conducting two consecutive readings of systolic and diastolic
Measured: Change from baseline (pre-intervention) blood pressure to immediately after the 50-minute intervention
Secondary outcomes (3)
Change in Profile of Mood States; Short Form
Using only subscales for depression and tension, 14 items with response format 0-4, reporting mean of responses, range 0-4 with higher scores indicating higher levels of depression and tension.
Measured: Change from pre-intervention mood to immediately post-50-minute intervention point
Change in perception of Connection (this is not a published scale, no formal name, created for this study)
Two items assessing perception of connection with others and connection with self, score range
Measured: Change from pre-intervention to immediately after the 50-minute intervention
Change in Salivary Oxytocin
Saliva collection pre and post-intervention
Measured: Change from pre-intervention to immediately after the 50-minute intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start30 Sep 2017
- Primary completion31 Jan 2020
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Meditative movement practice: Tai Chi Easy
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda K Larkey, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621694
- Sponsor's protocol ID
- STUDY00006571
- Status last verified
- Sep 2023
- First submitted
- 25 May 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will publish with indication that IPD data that is de-identified is available upon request.
Publications
Larkey LK, James T, Han S, James DL. Pilot study of Qigong/Tai Chi Easy acute effects of meditative movement, breath focus and "flow" on blood pressure, mood and oxytocin in older adults. Complement Ther Med. 2023 Mar;72:102918. doi: 10.1016/j.ctim.2023.102918. Epub 2023 Jan 7.
PubMed 36626941
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Oxytocin Response to Meditative Movement
- ClinicalTrials.gov ID
- NCT05621694
- Acronym / sponsor ID
- STUDY00006571
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 18 Nov 2022 (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.
This pilot study is designed to test effects of a single session of meditative movement (Tai Chi Easy) on older adults' blood pressure, perceptions of connection, mood, and oxytocin levels.
Detailed description
Endogenous oxytocin (the "cuddle hormone") is associated with lowering blood pressure (BP), suggesting that finding ways to increase oxytocin even in the absence of social connection, may be beneficial. Meditative movement emphasizing breath, meditative state and flow-inducing movements holds potential for reducing BP, improving mood and releasing oxytocin. In a single-group pilot study we exposed 21 OAs with mild-moderate hypertension to a 50-minute "Tai Chi Easy (TCE)" (simplified Tai Chi/Qigong) session, collecting BP, saliva samples for oxytocin, and psychosocial measures (connection, mood) pre/post intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Meditative movement practice: Tai Chi Easy
| Arm | Type | Receives |
|---|---|---|
| Qigong/Tai Chi Intervention | Experimental | Behavioral: Tai Chi EasyTai chi and Qigong combined into a simplified, standard practice, "Tai Chi Easy" |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 55-80 --BP above 120/80 -
Key exclusion criteria (2 listed)
- having a neurologic disorder such as Parkinson's, seizure disorder, multiple sclerosis, Alzheimer's disease
- answered "yes" to one or more questions on the Physical Activity Readiness Questionnaire (PAR-Q). The PAR-Q is a seven-question assessment that determines one's readiness, safety and ability to engage in physical activity and is safely validated for older adults
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 Chi EasyAlso: Qigong/Tai Chi; taijiA meditative movement practice that includes simple qigong movement/breath practices and single, repeated tai chi movements taught to generate a meditative state and flow | Behavioural | Qigong/Tai Chi Intervention |
Primary outcome
Change in Blood Pressure
Time frame: Change from baseline (pre-intervention) blood pressure to immediately after the 50-minute intervention
Using blood pressure cuff, conducting two consecutive readings of systolic and diastolic
3 secondary outcomes
Change in Profile of Mood States; Short Form
Time frame: Change from pre-intervention mood to immediately post-50-minute intervention point
Change in perception of Connection (this is not a published scale, no formal name, created for this study)
Time frame: Change from pre-intervention to immediately after the 50-minute intervention
Change in Salivary Oxytocin
Time frame: Change from pre-intervention to immediately after the 50-minute intervention
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 11 Sep 2023.
- Results publication: PubMed 36626941Larkey LK, James T, Han S, James DL. Pilot study of Qigong/Tai Chi Easy acute effects of meditative movement, breath focus and "flow" on blood pressure, mood and oxytocin in older adults. Complement Ther Med. 2023 Mar;72:102918. doi: 10.1016/j.ctim.2023.102918. Epub 2023 Jan 7.
- Individual participant dataSharing planned: Yes. Will publish with indication that IPD data that is de-identified is available upon request.
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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.
Linda K Larkey, PhD principal investigator
Arizona State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Easy in people with Hypertension, run by Arizona State University at 2 sites 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 1 inclusion and 2 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 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Change in Blood Pressure (time frame: Change from baseline (pre-intervention) blood pressure to immediately after the 50-minute intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05621694, which also lists 1 linked publication.
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 11 Sep 2023.