Status:
COMPLETED
Mindfulness, Yoga, and Cardiovascular Disease
Lead Sponsor:
The Cleveland Clinic
Conditions:
Cardiovascular Disease
Stress
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
In this study, we will conduct a preliminary, yet comprehensive evaluation of Mindfulness and Yoga, as compared to an exercise and education-based stress-reduction program. and simultaneous evaluation...
Eligibility Criteria
Inclusion
- between the age of 40 and 75
- A Framingham score \>10
- A DASS-21 anxiety score \>5
- A DASS-21 stress score \>10
- A DASS-21 depression score \> than 6
- A systolic blood pressure \> 140
- A diastolic blood pressure \> 90
- Diagnosed with diabetes
- Willing to accept randomization into and participation in one of the three intervention programs: Mindfulness, Yoga, or Conventional Stress Reduction
Exclusion
- Already practicing Mindfulness, Yoga, or similar meditative mind-body practices on a weekly basis
- Already enrolled in a lifestyle modification program including exercise or diet program
- Yoga or meditation be incompatible with religious or philosophical beliefs
- Experienced a major stressful life event in the last three months prior to the beginning of the intervention that is likely to affect the outcomes of the study
- Currently being treated or on medications for psychiatric conditions, including depression, anxiety, anger, or hostility
- A depression score \>20 on the DASS-21 questionnaire
- A history of myocardial disease, peripheral vascular disease, cerebrovascular disease, atrial fibrillation, pacemaker placement, heart failure, valvular heart disease, congenital heart disease, Wolf-Parkinson White Syndrome, cardiomyopathy, or severe left ventricular systolic dysfunction
- Take melatonin supplements or any herbal supplement that contains melatonin or 5-LO inhibitors (turmeric, curcumin, ginger and frankincense herbal extracts)
- Currently using any drugs that contain beta-adrenergic blocking agents, beta-agonists, glucocorticoids, psychotropic medications, drugs that block 5-LO pathway (zileuton, monetlukast), TNF-a blocking agents (infliximab, etanercept, adalimumab)
- A planned change in blood pressure, anticoagulant medication and lipids lower agents (such as aspirin, statin and plavix) 1 month prior and during the intervention
- Asthma, obstructive pulmonary disease, or any other respiratory disease
- Pregnant or breastfeeding
- An active/chronic infection, cancer, connective tissue, or other inflammatory disease
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00696852
Start Date
June 1 2008
End Date
May 1 2009
Last Update
September 24 2012
Active Locations (1)
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1
The Cleveland Clinic
Cleveland, Ohio, United States, 44195