Clinical trial NCT05687240: Heart Focused Movement Effects on Cardiometabolic Risk
Official title: Effects of QiGong and Tai Chi (QTC) and Heart Rate Variability Biofeedback (HRVB) on Older Adults' Cardiometabolic Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Risk Factors
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 22
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Vagal Tone
timeFrame: 8 Weeks
Secondary outcomes:
measure: Waist circumference
timeFrame: 8 Weeks
measure: Abdominal circumference
timeFrame: 8 Weeks
measure: Height
timeFrame: 8 Weeks
measure: Weight
timeFrame: 8 weeks
measure: Perceived stress (Perceived Stress Scale-10)
timeFrame: 8 Weeks
measure: Sleep (Insomnia Severity Index)
timeFrame: 8 Weeks
measure: Depression (Profile of Mood States subscale)
timeFrame: 8 Weeks
measure: Anxiety (Profile of Mood States subscale)
timeFrame: 8 Weeks
measure: Emotion regulation (Emotion Regulation Questionnaire)
timeFrame: 8 Weeks
measure: Eating Behaviors (Three Factor Eating Questionnaire)
timeFrame: 8 Weeks
measure: Awareness (one subscale of the Mindful Eating Questionnaire)
timeFrame: 8 Weeks
measure: Cognitive Performance (Weschler Adult Intelligence Scales -III, letter number sequencing and forward backward digit span tests)
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Linda Larkey, PhD
role: PRINCIPAL_INVESTIGATOR
References: