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Mindfulness, Yoga, and Cardiovascular Disease
This study has been completed.
Study NCT00696852   Information provided by The Cleveland Clinic
First Received: June 11, 2008   Last Updated: October 27, 2009   History of Changes

June 11, 2008
October 27, 2009
June 2008
May 2009   (final data collection date for primary outcome measure)
change in inflammatory markers [ Time Frame: within 26 weeks of enrollment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00696852 on ClinicalTrials.gov Archive Site
change in psychological and physiological markers of anxiety, depression, and cardiovascular disease [ Time Frame: within 26 weeks from enrollment ] [ Designated as safety issue: No ]
Same as current
 
Mindfulness, Yoga, and Cardiovascular Disease
Effects of Mindfulness and Yoga on Heart Rate Variability and Immune Markers

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.

 
 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
  • Cardiovascular Disease
  • Stress
  • Anxiety
  • Depression
  • Behavioral: Mindfulness Meditation
  • Behavioral: Yoga
  • Behavioral: Exercise, Relaxation, and Health Education
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
64
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00696852
Joan Fox, The Cleveland Clinic
BHBI-1201
The Cleveland Clinic
 
Principal Investigator: Joan EB Fox, Ph.D. The Cleveland Clinic
The Cleveland Clinic
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP