Heart Focused Movement Effects on Cardiometabolic Risk

Arizona State University (ASU)

Status: Completed

Conditions: Cardiometabolic Risk Factors

Treatments: Behavioral: Heart rate variability biofeedback; Behavioral: Qigong/Tai Chi

Study type: Interventional

Funder types: Other

Identifiers

NCT05687240

00011769

Details and patient eligibility

About

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).

Full description

Heart rate variability biofeedback (HRVB) will be investigated as a target to optimize Qigong/Tai Chi (QTC) practices based on the expectation that learning to, and practicing changing heart rate variability (HRV) using HRVB, in addition to QTC, will result in higher levels of HRV and coherence than just the QTC alone. This study is designed as a two-group parallel randomized controlled trial to test effects of QTC compared to QTC plus HRVB on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary). Fifty participants will be recruited and randomized to one of these groups and receive daily text prompts for 8 weeks to practice (using video links) Tai Chi Easy for 10-30 minutes (length of practice, the participants' choice). Half of the participants randomized to the HRVB enhancement will also be coached to practice HRVB to achieve coherence in their heart beat rhythms prior to practice (QTC plus HRVB group). Data collection at baseline and post intervention will assess body mass index (BMI, waist circumference/percent body fat, sleep quality, stress, eating behaviors, emotion regulation, mood (depression and anxiety), cognitive performance and changes in HRV parameters (high frequency power and coherence).

Enrollment: 22 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Qigong/Tai Chi Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Qigong/Tai Chi

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

Experimental group

Description:

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.

Treatment:

Behavioral: Heart rate variability biofeedback

Behavioral: Qigong/Tai Chi