Exploring Oxytocin Response to Meditative Movement

September 8, 2023 updated by: Arizona State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Arizona State University Downtown Campus
      • Phoenix, Arizona, United States, 85005
        • Arizona State University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

51 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 55-80 --BP above 120/80 -

Exclusion Criteria:

  • 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

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Qigong/Tai Chi Intervention
Tai chi and Qigong combined into a simplified, standard practice, "Tai Chi Easy"
Behavioral: Tai Chi Easy
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
Other Names:
  • Qigong/Tai Chi; taiji

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline (pre-intervention) blood pressure to immediately after the 50-minute intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Profile of Mood States; Short Form
Time Frame: Change from pre-intervention mood to immediately post-50-minute intervention point
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.
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
Two items assessing perception of connection with others and connection with self, score range
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
Saliva collection pre and post-intervention
Change from pre-intervention to immediately after the 50-minute intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The De Jong Gierveld Loneliness Scale
Time Frame: pre-intervention only
6 items each scored either 0 (not at all) 1 (somewhat lonely) or 2 (more lonely), score is computed as a mean across items, range 0-6 with higher scores indicating more loneliness
pre-intervention only
Flow State Scale
Time Frame: immediately after the intervention
Used to assess perceptions of the experience of flow while performing the Tai Chi Easy intervention. 36 items, Score range 36-80, high scores indicate greater sense of flow.
immediately after the intervention
Meditative Movement Inventory
Time Frame: immediately after the intervention
Scales that assess the experience of meditative state and breath focus during intervention, 11 items, score range 11-66 (or reported as a mean of the scores on the scale, then 1-6 range), with higher numbers indicating less breath focus and meditative state.
immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arizona State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linda K Larkey, PhD, Arizona State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00006571

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will publish with indication that IPD data that is de-identified is available upon request.

IPD Sharing Time Frame

Data will be available after study results are published and for 5 years after.

IPD Sharing Access Criteria

Requests from active researchers with current positions in research institutions will be reviewed by PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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