Heart Focused Movement Effects on Cardiometabolic Risk
- Conditions
- Cardiometabolic Risk Factors
- Interventions
- Behavioral: Qigong/Tai ChiBehavioral: Heart rate variability biofeedback
- Registration Number
- NCT05687240
- Lead Sponsor
- Arizona State University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 31.5 inch or above waist circumference women
- 35.5 inch or above waist circumference men
- Has a smartphone or tablet
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Qigong/Tai Chi Intervention Qigong/Tai Chi Meditative movement practice based on qigong and tai chi, delivered via video link Qigong/Tai Chi (QTC) + Heart Rate Variability (HRVB) Intervention Heart rate variability biofeedback 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. Qigong/Tai Chi (QTC) + Heart Rate Variability (HRVB) Intervention Qigong/Tai Chi 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.
- Primary Outcome Measures
Name Time Method Vagal Tone 8 Weeks 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.
- Secondary Outcome Measures
Name Time Method Waist circumference 8 Weeks Waist circumference is measured using tape measure around the waist (after exhale). This is part of the protocol for overall body composition computations using the Marine/Navy protocol.
Abdominal circumference 8 Weeks Abdominal circumference is measured using tape measure around the abdomen/ This is part of the protocol for overall body composition computations using the Marine/Navy Protocol
Weight 8 weeks Digital scales measurement is used to record weight in pounds.
Anxiety (Profile of Mood States subscale) 8 Weeks Questionnaire includes a 6-item subscale rating level of anxiety. Participants respond to a single word item by marking a response scale of 0 to 4, with totals ranging from 0-24. Higher scores indicate higher experience of Anxiety.
Eating Behaviors (Three Factor Eating Questionnaire) 8 Weeks Questionnaire about the typical eating habits of the participants related to various states of mind or emotions; includes 21 items scored 1-4; total scores range from 21 to 84 with higher scores indicating more controlled/managed and less emotional eating behaviors.
Cognitive Performance (Weschler Adult Intelligence Scales -III, letter number sequencing and forward backward digit span tests) 8 Weeks The Letter-number sequencing, and forward backward digit span tests of the Weschler Adult Intelligence Scale (WAIS) III will be administered to study participants to examine cognitive performance. Sets of letters and sets of numbers are read to the participant iteratively; after each set is read, the participant is to repeat back according to instructions to repeat or to repeat in backward order. The first sets are smaller numbers of presented items, increasing with each set of presentations, and are continued until the participant fails a full set. higher scores indicate better cognitive performance. Scores are based on a score of 1 per presented item completed correctly until failure, range 0-51(30 for digits forward/backward and 21 for letter number sequencing).
Height 8 Weeks Measured using tape measure to record inches while participant is standing against a wall.
Perceived stress (Perceived Stress Scale-10) 8 Weeks Questionnaire about the amount of stress participants are experiencing daily use includes 10 items with a 0-4 response format. Total scores range from 0-40 with higher scores indicating more perceived stress.
Sleep (Insomnia Severity Index) 8 Weeks Questionnaire about the sleeping habits of participants includes 7 items with response format of 0-4. Total scores range from 0 to 28 with higher scores indicating more severe insomnia: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Depression (Profile of Mood States subscale) 8 Weeks Questionnaire includes a 6-item subscale rating level of depression. Participants respond to a single word item by marking a response scale of 0 to 4, with totals ranging from 0-24. Higher scores indicate higher experience of depression.
Emotion regulation (Emotion Regulation Questionnaire) 8 Weeks Questionnaire about the emotional regulation of the participants includes 10 items describing ways of regulating emotion with response options from 1-7. Total scores range from 10-70 with higher scores indicating more emotion regulation patterns.
Awareness (one subscale of the Mindful Eating Questionnaire) 8 Weeks The Awareness subscale of the Mindful Eating Questionnaire including 7 items about degree of attention while eating; response format 1-4 (with total score range 7-28) shows higher scores representing more awareness/mindfulness in eating behavior.
Trial Locations
- Locations (1)
Arizona State University
🇺🇸Phoenix, Arizona, United States