Mindfulness, Yoga, and Cardiovascular Disease
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About
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 of the effect of an 8 week program of Mindfulness, 12 weeks of Yoga practice, and 12 weeks of an exercise and education-based program.
105 otherwise healthy individuals, who have cardiovascular risk factors and mild to moderate stress or anxiety will be randomly assigned to one of the three intervention groups: an 8 week program of Mindfulness, 12 week program of Yoga practice, and 12 week exercise and education-based group program. All subjects will perform daily practice that will continue after the weekly sessions end, allowing a follow up assessment at 24 weeks. Self-reported mood and psychological distress and physiological indicators of function of the ANS and stress hormones will be assessed at baseline, 8 weeks, 12 weeks and 24 weeks. Blood and urine samples will be collected at baseline and 8 weeks to determine levels inflammatory and atherosclerosis markers.
We anticipate that the study will provide information on the efficacy of the Mindfulness and Yoga interventions as stress-reduction practices, variability in potential markers for activation of the brain/cardiovascular system connections, and preliminary estimates of effect size for each of these markers. Thus, the study will provide the data needed for designing a future study that will rigorously address these questions in a larger, randomized trial of Mindfulness and Yoga in patients with cardiovascular risk.
Enrollment
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Inclusion criteria
- 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 criteria
- 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
Trial design
Primary purpose
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Interventional model
Masking
64 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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