NCT05687240

Brief Summary

This study is designed as a two-group parallel randomized controlled trial (N=50) to test effects of 8-weeks of Qigong/Tai Chi (QTC) intervention compared to QTC plus HRVB on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary) (e.g., BMI, waist circumference/percent body fat, sleep quality, stress, anxiety/depression, emotional regulation, eating behaviors, and cognitive performance).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

June 4, 2021

Last Update Submit

February 8, 2024

Conditions

Cardiometabolic Risk Factors

Outcome Measures

Primary Outcomes (1)

  • Vagal Tone

    Measured using resting Heart rate variability and computing parameters of high frequency power and coherence. Will be assessed with participants following a videoguide "to measure their heart rate" that helps them set up equipment and account, seated for 5 minutes of interbeat interval capture using the Inner Balance Bluetooth (HeartMath product) software and earlobe heart beat sensor.

    8 Weeks

Secondary Outcomes (12)

  • Waist circumference

    8 Weeks

  • Abdominal circumference

    8 Weeks

  • Height

    8 Weeks

  • Weight

    8 weeks

  • Perceived stress (Perceived Stress Scale-10)

    8 Weeks

  • +7 more secondary outcomes

Study Arms (2)

Qigong/Tai Chi Intervention

ACTIVE COMPARATOR

Meditative movement practice based on qigong and tai chi, delivered via video link

Behavioral: Qigong/Tai Chi

Qigong/Tai Chi (QTC) + Heart Rate Variability (HRVB) Intervention

EXPERIMENTAL

Meditative movement practice based on qigong and tai chi, delivered via video link with the addition of a brief practice with a the feedback on heart rate variability from an Inner Balance app.

Behavioral: Qigong/Tai ChiBehavioral: Heart rate variability biofeedback

Interventions

Qigong/Tai ChiBEHAVIORAL

Participants will engage in 8 weeks of gentle movement/mindfulness videos provided in a daily text prompt, asking that this be practices most days of the week. A choice of practice video links will be provided, ranging from 10-30 minutes in length, and later confirmation texts will be employed to document if practiced, and what length was chosen.

Qigong/Tai Chi (QTC) + Heart Rate Variability (HRVB) InterventionQigong/Tai Chi Intervention
Heart rate variability biofeedbackBEHAVIORAL

Randomized participants will be coached to practice a breathing technique that focuses attention on the sensations in the heart area, slowing and deepening the breath, and activating through memory or imagery a positive emotion. This practice is used along with a feedback device that provides information on achievement of the heart rate variability target, "coherence" that represents a neurocardiac state associated with vagal tone, or balance.

Qigong/Tai Chi (QTC) + Heart Rate Variability (HRVB) Intervention

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • inch or above waist circumference women
  • inch or above waist circumference men
  • Has a smartphone or tablet

You may not qualify if:

  • Those who are unable to stand for 10-minute segments (e.g., wheelchair or walker bound and too weak), and/or unable to walk
  • People who have been regularly practicing any form of meditative movement and or HRVB training regularly (i.e., 2 or more times per month for the past 6 months)
  • Individuals with diagnosed severe heart arrhythmias, heart transplant, or those with pacemakers would be excluded because either of those interferes with accurately assessing HRV parameters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85005, United States

Location

Study Officials

  • Linda Larkey, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 4, 2021

First Posted

January 18, 2023

Study Start

December 1, 2020

Primary Completion

June 30, 2023

Study Completion

July 31, 2023

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations

US(1)