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Behavioral Intervention
Yoga for Cardiovascular Disease (SLYM II Trial)
N/A
Recruiting
Led By Annapoorna Kini, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects eligible for the study are 18-80 year old adults
Subjects diagnosed with metabolic syndrome, which is defined as three or more of the following conditions: (1) Central or abdominal obesity (waist circumference > 40 inches for men and > 35 inches for women); (2) High triglycerides (≥150 mg/dL or triglycerides treatment); (3) Low HDL cholesterol (<40 mg/dL for men and <50 mg/dL for women) or low HDL-C treatment; (4) High blood pressure (≥130/85 mmHg) or antihypertensive medications; (5) High fasting glucose (≥100 mg/dL) or type 2 diabetes mellitus
Must not have
Congestive heart failure, known arrthymias or prior Automated Implantable Cardioverter-Defibrillator /pacemaker or any metallic implants
Liver disease or alcohol use of more than 7 alcoholic drinks/week in women and more than 14 drinks/week in men
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, at 22 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a 16-week yoga program can improve micro RNA expression and reduce cardiovascular disease risk factors.
Who is the study for?
Adults aged 18-80 with metabolic syndrome and cardiovascular disease who have undergone certain heart procedures or have risk factors like high blood pressure can join. They must be able to do yoga and follow the study plan. People with severe heart failure, arrhythmias, implants, autoimmune diseases, recent transplants or pregnancy, severe lung disease, liver issues or heavy alcohol use cannot participate.
What is being tested?
The trial is testing if a 16-week chair yoga program can change micro RNA expression linked to heart disease and improve related health markers in patients with cardiovascular conditions.
What are the potential side effects?
Chair yoga is generally safe but may include muscle soreness or strain. Since it's gentle exercise designed for those with limited mobility, serious side effects are not common.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
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I have been diagnosed with metabolic syndrome, having at least three of the specified conditions.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have heart issues or metal implants in my body.
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I do not drink more than the recommended amount of alcohol weekly.
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I have severe breathing problems or a serious illness.
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I am unable or unwilling to practice yoga due to physical or psychological reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study, at 22 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study, at 22 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Blood pressure
Body weight
Waist circumference
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: YogaActive Control1 Intervention
Patients randomized to Yoga arm will practice chair yoga for 30 minutes at least three days a week for 16 weeks
Group II: Standard of CareActive Control1 Intervention
Control group patients will follow standard of care (SOC) treatment.
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
913 Previous Clinical Trials
572,681 Total Patients Enrolled
27 Trials studying Coronary Artery Disease
61,700 Patients Enrolled for Coronary Artery Disease
Annapoorna Kini, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
6 Previous Clinical Trials
5,235 Total Patients Enrolled
5 Trials studying Coronary Artery Disease
540 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart issues or metal implants in my body.I do not drink more than the recommended amount of alcohol weekly.I had a heart procedure at Mount Sinai or have heart disease risk factors.I have severe breathing problems or a serious illness.I am between 18 and 80 years old.I have a rheumatological or immunological disease.I have been diagnosed with metabolic syndrome, having at least three of the specified conditions.I am unable or unwilling to practice yoga due to physical or psychological reasons.You have had an organ or tissue transplant in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Yoga
- Group 2: Standard of Care
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.