Effects of Mindfulness and Yoga on Heart Rate Variability and Immune Markers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- The Cleveland Clinic
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- change in inflammatory markers
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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 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.
Investigators
Joan Fox
Staff
The Cleveland Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
change in inflammatory markers
Time Frame: within 26 weeks of enrollment
Secondary Outcomes
- change in psychological and physiological markers of anxiety, depression, and cardiovascular disease(within 26 weeks from enrollment)