Cardiometabolic Risk FactorsNCT05687240
Heart Focused Movement Effects on Cardiometabolic Risk
A study testing Qigong/Tai Chi and Heart rate variability biofeedback in people with Cardiometabolic Risk Factors, run by Arizona State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk Factors
- What is being tested?
- Qigong/Tai Chi and Heart rate variability biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 31.5 inch or above waist circumference women
- 35.5 inch or above waist circumference men
- Has a smartphone or tablet
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of QiGong and Tai Chi (QTC) and Heart Rate Variability Biofeedback (HRVB) on Older Adults' Cardiometabolic Risk
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).
Read the 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).
- Conditions
- Cardiometabolic Risk Factors
- Being tested
- Qigong/Tai Chi, Heart rate variability biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong/Tai ChiBehavioural
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 biofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Qigong/Tai Chi Intervention | Active comparator | Meditative movement practice based on qigong and tai chi, delivered via video link Receives: 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. Receives: Behavioral: Qigong/Tai Chi; Behavioral: Heart rate variability biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Weeks
Secondary outcomes (12)
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.
Measured: 8 Weeks
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
Measured: 8 Weeks
Height
Measured using tape measure to record inches while participant is standing against a wall.
Measured: 8 Weeks
Weight
Digital scales measurement is used to record weight in pounds.
Measured: 8 weeks
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.
Measured: 8 Weeks
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)
Measured: 8 Weeks
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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).
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Dec 2020
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Larkey, Arizona State University
- Investigators
- Linda Larkey, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687240
- Sponsor's protocol ID
- 00011769
- Status last verified
- Feb 2024
- First submitted
- 4 Jun 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of QiGong and Tai Chi (QTC) and Heart Rate Variability Biofeedback (HRVB) on Older Adults' Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT05687240
- Acronym / sponsor ID
- 00011769
- Conditions
- Cardiometabolic Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong/Tai Chi Intervention | Active comparator | Behavioral: Qigong/Tai ChiMeditative movement practice based on qigong and tai chi, delivered via video link |
| Qigong/Tai Chi (QTC) + Heart Rate Variability (HRVB) Intervention | Experimental | Behavioral: Qigong/Tai Chi, Behavioral: Heart rate variability biofeedbackMeditative 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 31.5 inch or above waist circumference women
- 35.5 inch or above waist circumference men
- Has a smartphone or tablet
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qigong/Tai ChiParticipants 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. | Behavioural | Qigong/Tai Chi (QTC) + Heart Rate Variability (HRVB) Intervention, Qigong/Tai Chi Intervention |
| Heart rate variability biofeedbackRandomized 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. | Behavioural | Qigong/Tai Chi (QTC) + Heart Rate Variability (HRVB) Intervention |
Primary outcome
Vagal Tone
Time frame: 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.
12 secondary outcomes
Waist circumference
Time frame: 8 Weeks
Abdominal circumference
Time frame: 8 Weeks
Height
Time frame: 8 Weeks
Weight
Time frame: 8 weeks
Perceived stress (Perceived Stress Scale-10)
Time frame: 8 Weeks
Sleep (Insomnia Severity Index)
Time frame: 8 Weeks
Depression (Profile of Mood States subscale)
Time frame: 8 Weeks
Anxiety (Profile of Mood States subscale)
Time frame: 8 Weeks
Emotion regulation (Emotion Regulation Questionnaire)
Time frame: 8 Weeks
Eating Behaviors (Three Factor Eating Questionnaire)
Time frame: 8 Weeks
Awareness (one subscale of the Mindful Eating Questionnaire)
Time frame: 8 Weeks
Cognitive Performance (Weschler Adult Intelligence Scales -III, letter number sequencing and forward backward digit span tests)
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Larkey, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong/Tai Chi and Heart rate variability biofeedback in people with Cardiometabolic Risk Factors, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vagal Tone (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.