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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~end of study, at 22 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, at 22 months for reporting.

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
904 Previous Clinical Trials
541,701 Total Patients Enrolled
26 Trials studying Coronary Artery Disease
31,700 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

Chair Yoga (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05250310 — N/A
Coronary Artery Disease Research Study Groups: Yoga, Standard of Care
Coronary Artery Disease Clinical Trial 2023: Chair Yoga Highlights & Side Effects. Trial Name: NCT05250310 — N/A
Chair Yoga (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05250310 — N/A
~0 spots leftby Dec 2024
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