NCT05250310

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2025

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

February 10, 2022

Last Update Submit

February 9, 2026

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseasemetabolic abnormalitychair yogamicro RNA

Outcome Measures

Primary Outcomes (1)

  • micro RNA expression

    End of study, at 22 months

Secondary Outcomes (3)

  • Body weight

    End of study, at 22 months

  • Waist circumference

    End of study, at 22 months

  • Blood pressure

    End of study, at 22 months

Study Arms (2)

Yoga

ACTIVE COMPARATOR

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

Behavioral: Chair Yoga

Standard of Care

NO INTERVENTION

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

Interventions

Chair YogaBEHAVIORAL

Yoga poses performed in a chair

Yoga

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Annapoorna Kini, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two group randomization 1:1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cardiac Catheterization Laboratory

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 22, 2022

Study Start

January 24, 2022

Primary Completion

October 24, 2025

Study Completion

October 24, 2025

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)