NCT05621694

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

May 25, 2022

Last Update Submit

September 8, 2023

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Profile of Mood States; Short Form

    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)

    Change from pre-intervention to immediately after the 50-minute intervention

  • Change in Salivary Oxytocin

    Change from pre-intervention to immediately after the 50-minute intervention

Other Outcomes (3)

  • The De Jong Gierveld Loneliness Scale

    pre-intervention only

  • Flow State Scale

    immediately after the intervention

  • Meditative Movement Inventory

    immediately after the intervention

Study Arms (1)

Qigong/Tai Chi Intervention

EXPERIMENTAL

Tai chi and Qigong combined into a simplified, standard practice, "Tai Chi Easy"

Behavioral: Tai Chi Easy

Interventions

Tai Chi EasyBEHAVIORAL

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

Also known as: Qigong/Tai Chi; taiji
Qigong/Tai Chi Intervention

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55-80 --BP above 120/80 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arizona State University Downtown Campus

Phoenix, Arizona, 85004, United States

Location

Arizona State University

Phoenix, Arizona, 85005, United States

Location

Related 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.2023.102918. Epub 2023 Jan 7.

    PMID: 36626941RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Linda K Larkey, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Meditative movement practice: Tai Chi Easy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

November 18, 2022

Study Start

September 30, 2017

Primary Completion

January 31, 2020

Study Completion

January 31, 2022

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available after study results are published and for 5 years after.
Access Criteria
Requests from active researchers with current positions in research institutions will be reviewed by PI

Locations

US(2)