Mindfulness, Yoga, and Cardiovascular Disease

NCT00696852 | Completed

• 1 other identifier: BHBI-1201
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Stress; Anxiety; Depression

Keywords

Mindfulness; Meditation; Yoga; Inflammatory Markers

Outcome Measures

Primary Outcomes (1)

• change in inflammatory markers

  within 26 weeks of enrollment

Secondary Outcomes (1)

• change in psychological and physiological markers of anxiety, depression, and cardiovascular disease

  within 26 weeks from enrollment

Study Arms (3)

Mindfulness Meditation

ACTIVE COMPARATOR

Behavioral: Mindfulness Meditation

Yoga

ACTIVE COMPARATOR

Behavioral: Yoga

Conventional Stress Reduction

ACTIVE COMPARATOR

Behavioral: Exercise, Relaxation, and Health Education

Interventions

Mindfulness Meditation BEHAVIORAL

The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.

Also known as: MBSR

Mindfulness Meditation

Yoga BEHAVIORAL

The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.

Yoga

Exercise, Relaxation, and Health Education BEHAVIORAL

The Exercise, Relaxation and Health Education program will consist of a 90 min group session that will include simple relaxation (such as progressive muscle relaxation) and light stretching exercises, group support, and discussions of various health topics and on stress reduction.

Also known as: Progressive muscle relaxation

Conventional Stress Reduction

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Anxiety Disorders; Depression

Interventions

Mindfulness; Yoga; Exercise; Autogenic Training

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Hypnosis

Study Officials

• Joan EB Fox, Ph.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 13, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

US (1)