Heart Focused Movement Effects on Cardiometabolic Risk

Cardiometabolic Risk Factors Clinical Trial

Official title:

Effects of QiGong and Tai Chi (QTC) and Heart Rate Variability Biofeedback (HRVB) on Older Adults' Cardiometabolic Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05687240
• Other study ID #: 00011769
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2024
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiometabolic Risk Factors

Intervention

Behavioral:
• Qigong/Tai Chi
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.
• Heart rate variability biofeedback
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.

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Waist circumference	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.	8 Weeks
Secondary	Abdominal circumference	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	8 Weeks
Secondary	Height	Measured using tape measure to record inches while participant is standing against a wall.	8 Weeks
Secondary	Weight	Digital scales measurement is used to record weight in pounds.	8 weeks
Secondary	Perceived stress (Perceived Stress Scale-10)	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.	8 Weeks
Secondary	Sleep (Insomnia Severity Index)	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)	8 Weeks
Secondary	Depression (Profile of Mood States subscale)	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.	8 Weeks
Secondary	Anxiety (Profile of Mood States subscale)	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.	8 Weeks
Secondary	Emotion regulation (Emotion Regulation Questionnaire)	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.	8 Weeks
Secondary	Eating Behaviors (Three Factor Eating Questionnaire)	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.	8 Weeks
Secondary	Awareness (one subscale of the Mindful Eating Questionnaire)	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.	8 Weeks
Secondary	Cognitive Performance (Weschler Adult Intelligence Scales -III, letter number sequencing and forward backward digit span tests)	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).	8 Weeks