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Qigong/Tai Chi + HRV Biofeedback for Cardiometabolic Risk
N/A
Waitlist Available
Led By Linda Larkey, PhD
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests effects of 8-weeks of Qigong/Tai Chi on physical and mental health (e.g. BMI, sleep, stress, etc.).
Who is the study for?
This trial is for adults with a waist circumference of at least 35.5 inches for men or 31.5 inches for women, who own a smartphone or tablet. It's not suitable for individuals unable to stand or walk, those with severe heart arrhythmias, heart transplants, pacemakers, or who regularly practice meditative movements and HRVB training.
What is being tested?
The study compares two groups: one practicing Qigong/Tai Chi (QTC) and the other combining QTC with Heart Rate Variability Biofeedback (HRVB). Over eight weeks, it will measure changes in heart rate variability and cardiometabolic risk factors like body fat and stress levels.
What are the potential side effects?
Since this trial involves movement exercises and biofeedback rather than medication, side effects are minimal but may include muscle soreness or strain from physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Vagal Tone
Secondary study objectives
Abdominal circumference
Anxiety (Profile of Mood States subscale)
Awareness (one subscale of the Mindful Eating Questionnaire)
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Qigong/Tai Chi (QTC) + Heart Rate Variability (HRVB) InterventionExperimental Treatment2 Interventions
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.
Group II: Qigong/Tai Chi InterventionActive Control1 Intervention
Meditative movement practice based on qigong and tai chi, delivered via video link
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Qigong/Tai Chi
2020
N/A
~30
Heart rate variability biofeedback
2024
N/A
~160
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Who is running the clinical trial?
Arizona State UniversityLead Sponsor
303 Previous Clinical Trials
108,066 Total Patients Enrolled
Linda Larkey, PhDPrincipal InvestigatorArizona State University
2 Previous Clinical Trials
268 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe heart condition such as arrhythmia, heart transplant, or a pacemaker that can affect the accuracy of heart rate variability measurements.You own a smartphone or tablet.You have been practicing meditation or other relaxation techniques two or more times a month for at least six months.
Research Study Groups:
This trial has the following groups:- Group 1: Qigong/Tai Chi Intervention
- Group 2: Qigong/Tai Chi (QTC) + Heart Rate Variability (HRVB) Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.