Clinical trial NCT05250310: The Effect of Structured Lifestyle Modification and Yoga Practice on Metabolic Processes Associated With Cardiovascular Disease
Official title: The Effect of Structured Lifestyle Modification and Yoga Practice on Metabolic Processes Associated With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
metabolic abnormality
chair yoga
micro RNA
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomization 1:1
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: micro RNA expression
timeFrame: End of study, at 22 months
Secondary outcomes:
measure: Body weight
timeFrame: End of study, at 22 months
measure: Waist circumference
timeFrame: End of study, at 22 months
measure: Blood pressure
timeFrame: End of study, at 22 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Annapoorna Kini, MD
role: PRINCIPAL_INVESTIGATOR
References: