Improving Wellbeing in Ischemic Heart Disease
1 other identifier
interventional
48
1 country
1
Brief Summary
The purpose of this research is to see if Heart Health Yoga (HHY) Program when added on to standard cardiac rehabilitation (CR) will improve overall wellbeing and quality of life for patients experiencing ischemic heart disease, heart problems caused by narrowed heart arteries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
June 24, 2021
CompletedFirst Posted
Study publicly available on registry
July 23, 2021
CompletedStudy Start
First participant enrolled
August 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedMarch 17, 2025
March 1, 2025
2.3 years
June 24, 2021
March 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in health-related quality of life
Measured in arbitrary units using the MacNew heart disease questionnaire. The MacNew heart disease measures health-related quality of life questionnaire using a global score.
Baseline, 6 weeks
Secondary Outcomes (8)
6 minute walk test distance measured in meters
Baseline, 6 weeks, 8 weeks, 12 weeks
High sensitivity C-Reactive Protein (CRP)
Baseline, 12 weeks
AM cortisol
Baseline, 12 weeks
Height
Baseline, 6 weeks, 8 weeks, 12 weeks
Weight
Baseline, 6 weeks, 8 weeks, 12 weeks
- +3 more secondary outcomes
Study Arms (2)
Cardiac rehabilitation with standard psychosocial care plus Heart Health Yoga
EXPERIMENTALSubjects will participate in 12-weeks of cardiac rehabilitation with standard psychosocial care plus Heart Health Yoga
Cardiac rehabilitation with standard psychosocial care
ACTIVE COMPARATORSubjects will participate in 12-weeks of cardiac rehabilitation with standard psychosocial education component
Interventions
Yoga-based digital intervention
Standard psychosocial education component
Eligibility Criteria
You may qualify if:
- Adults 18-65 years of age.
- Willing and able to provide informed consent.
- Have a computer and smartphone for access to study videos and online questionnaires, and willing and able to download Fitbit app.
You may not qualify if:
- Unable to provide informed consent.
- Orthopedic injury/limitation or any other contraindications to exercise.
- Known active psychiatric conditions including bipolar disorder, schizophrenia, mania, obsessive compulsive disorder.
- Active treatment with antipsychotic medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bryan J Taylor, PhD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 24, 2021
First Posted
July 23, 2021
Study Start
August 30, 2021
Primary Completion
December 31, 2023
Study Completion
January 1, 2025
Last Updated
March 17, 2025
Record last verified: 2025-03