Clinical trial NCT00696852: Mindfulness, Yoga, and Cardiovascular Disease
Official title: Effects of Mindfulness and Yoga on Heart Rate Variability and Immune Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Stress
Anxiety
Depression
Keywords: Mindfulness
Meditation
Yoga
Inflammatory Markers
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-06-13
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Asthma, obstructive pulmonary disease, or any other respiratory disease
* Pregnant or breastfeeding
* An active/chronic infection, cancer, connective tissue, or other inflammatory disease

Primary outcomes:
measure: change in inflammatory markers
timeFrame: within 26 weeks of enrollment
Secondary outcomes:
measure: change in psychological and physiological markers of anxiety, depression, and cardiovascular disease
timeFrame: within 26 weeks from enrollment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Joan EB Fox, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: