Mindfulness, Yoga, and Cardiovascular Disease

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

Interventions

BEHAVIORAL

Mindfulness Meditation

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

BEHAVIORAL

Yoga

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

BEHAVIORAL

Exercise, Relaxation, and Health Education

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.

Sponsors & Collaborators

• The Cleveland Clinic

  lead OTHER

Principal Investigators

• Joan EB Fox, Ph.D. · The Cleveland Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2009-05-31

Completion

2009-05-31

Countries

• United States

Study Locations