Mindfulness, Yoga, and Cardiovascular Disease - Full Text View

Sponsored by:	The Cleveland Clinic
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00696852

Purpose

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.

Condition	Intervention
Cardiovascular Disease Stress Anxiety Depression	Behavioral: Mindfulness Meditation Behavioral: Yoga Behavioral: Exercise, Relaxation, and Health Education

MedlinePlus related topics: Anxiety Depression Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:	Effects of Mindfulness and Yoga on Heart Rate Variability and Immune Markers

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

change in inflammatory markers [ Time Frame: within 26 weeks of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in psychological and physiological markers of anxiety, depression, and cardiovascular disease [ Time Frame: within 26 weeks from enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment:	105
Study Start Date:	June 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mindfulness Meditation: Active Comparator	Behavioral: Mindfulness Meditation The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.
Yoga: Active Comparator	Behavioral: Yoga The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.
Conventional Stress Reduction: Active Comparator	Behavioral: Exercise, Relaxation, and Health Education The Exercise, Relaxation and Health Education program will consist of a 90 min group session that will include relaxation and light stretching exercises, group support, and discussions of various health topics.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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?

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696852

Contacts

Contact: Didier Allexandre

216-445-3874

allexad@ccf.org

Locations

United States, Ohio
The Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Didier Allexandre 216-445-3874 allexad@ccf.org

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator:

Joan EB Fox, Ph.D.

The Cleveland Clinic

More Information

Responsible Party:	The Cleveland Clinic ( Joan Fox )
Study ID Numbers:	BHBI-1201
Study First Received:	June 11, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00696852
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

Mindfulness
Meditation
Yoga
Inflammatory Markers

Study placed in the following topic categories:

Depression
Stress
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009