SLYM II: The Effect of Structured Lifestyle Modification and Yoga Practice on Metabolic Processes Associated With Cardiovascular Disease

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Recruiting

CT.gov ID

NCT05250310

Collaborator

(none)

120

Enrollment

Location

Arms

22.2

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the prospective randomized single center study is to evaluate the effect of a short-term (16 weeks) yoga program on micro RNA (miRNA) expression and cardiovascular disease (CVD) risk factors in patients with CVD.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Behavioral: Chair Yoga	N/A

Detailed Description

Cardiovascular disease (CVD) and metabolic syndrome (MetS) are major public health problems in the USA and worldwide. Yoga has been proven effective in numerous studies to improve cardiovascular risk factors, with a reduction in the risk of heart attacks and strokes. MicroRNAs (miRNAs) have recently emerged as key regulators of metabolism by playing a crucial role in cholesterol and lipid metabolism, fatty acid metabolism, insulin and glucose homeostasis. Yoga has been shown to induce a dynamic shift in miRNAs and reset their target genes expression associated with metabolites and pathways connected to CVD and MetS to a normal physiological state. 120 subjects will be included in the study. After recruitment, subjects will be randomized to one of two groups: Yoga (n=60) or Control (n=60) group. Patients randomized to Yoga, will practice yoga poses in a chair for 30 min at least 3 days a week by watching video instruction for 16 weeks. Control group patients will follow standard of care (SOC) treatment. At the enrollment day and at the 16-weeks follow-up visit, 15ml of blood will be collected from all participants for miRNAs expression profile.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two group randomization 1:1Two group randomization 1:1

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Effect of Structured Lifestyle Modification and Yoga Practice on Metabolic Processes Associated With Cardiovascular Disease

Actual Study Start Date :

Jan 24, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Yoga Patients randomized to Yoga arm will practice chair yoga for 30 minutes at least three days a week for 16 weeks	Behavioral: Chair Yoga Yoga poses performed in a chair
No Intervention: Standard of Care Control group patients will follow standard of care (SOC) treatment.

Arm

Intervention/Treatment

Active Comparator: Yoga

Patients randomized to Yoga arm will practice chair yoga for 30 minutes at least three days a week for 16 weeks

Behavioral: Chair Yoga

Yoga poses performed in a chair

No Intervention: Standard of Care

Control group patients will follow standard of care (SOC) treatment.

Outcome Measures

Primary Outcome Measures

micro RNA expression [End of study, at 22 months]

Secondary Outcome Measures

Body weight [End of study, at 22 months]
Body weight, kg
Waist circumference [End of study, at 22 months]
Waist circumference, inches
Blood pressure [End of study, at 22 months]
blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Subjects eligible for the study are 18-80 year old adults.
Underwent percutaneous coronary intervention (PCI) at the catheterization lab of Mount Sinai Hospital (New York, New York) or have non-obstructive coronary artery disease and at least one CVD risk factor (hypertension, hypercholesterolemia, diabetes mellitus, or obesity) or metabolic abnormality (fasting plasma glucose ≥ 100 mg/dl, documented previous diagnosis of hypertension, serum triglycerides ≥ 150 mg/dl, or HDL cholesterol < 40 mg/dl).
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.
Participants must be able to willingly consent to study participation and must be able to comply with the study requirements.

Exclusion Criteria:

Physical/psychological limitation or unwillingness to practice yoga,
Congestive heart failure, known arrthymias or prior Automated Implantable Cardioverter-Defibrillator /pacemaker or any metallic implants,
Rheumatological/immunological diseases,
History of transplant,
Moderate to severe chronic obstructive pulmonary disease, debilitating or severe systemic Illness,
Subjects who are pregnant or postpartum less than 6 months,
Liver disease or alcohol use of more than 7 alcoholic drinks/week in women and more than 14 drinks/week in men