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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05621694
Other study ID # STUDY00006571
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2017
Est. completion date January 31, 2022

Study information

Verified date September 2023
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date January 31, 2022
Est. primary completion date January 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Arizona State University Phoenix Arizona
United States Arizona State University Downtown Campus Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.2023.1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other The De Jong Gierveld Loneliness Scale 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
Other Flow State Scale 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
Other Meditative Movement Inventory 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
Primary Change in Blood Pressure 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 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. Change from pre-intervention mood to immediately post-50-minute intervention point
Secondary 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 Change from pre-intervention to immediately after the 50-minute intervention
Secondary Change in Salivary Oxytocin Saliva collection pre and post-intervention Change from pre-intervention to immediately after the 50-minute intervention
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