Cardiovascular DiseaseNCT00696852
Mindfulness, Yoga, and Cardiovascular Disease
A study testing Mindfulness Meditation, Yoga and Exercise, Relaxation, and Health Education in people with Cardiovascular Disease and Stress, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Stress, Anxiety
- What is being tested?
- Mindfulness Meditation, Yoga and Exercise, Relaxation, and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cardiovascular Disease, Stress, Anxiety, Depression
- Being tested
- Mindfulness Meditation, Yoga, Exercise, Relaxation, and Health Education
- Keywords
- Mindfulness, Meditation, Yoga, Inflammatory Markers
- Medical subject headings
- Cardiovascular Diseases, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
Also called MBSR
The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.
YogaBehavioural
The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.
Exercise, Relaxation, and Health EducationBehavioural
Also called Progressive muscle relaxation
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation | Active comparator | Not described Receives: Behavioral: Mindfulness Meditation |
| Yoga | Active comparator | Not described Receives: Behavioral: Yoga |
| Conventional Stress Reduction | Active comparator | Not described Receives: Behavioral: Exercise, Relaxation, and Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in inflammatory markers
Measured: within 26 weeks of enrollment
Secondary outcomes (1)
change in psychological and physiological markers of anxiety, depression, and cardiovascular disease
Measured: within 26 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Fox, The Cleveland Clinic
- Investigators
- Joan EB Fox, Ph.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696852
- Sponsor's protocol ID
- BHBI-1201
- Status last verified
- Sep 2012
- First submitted
- 11 Jun 2008
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness and Yoga on Heart Rate Variability and Immune Markers
- ClinicalTrials.gov ID
- NCT00696852
- Acronym / sponsor ID
- BHBI-1201
- Conditions
- Cardiovascular Disease, Stress, Anxiety, Depression
- Keywords
- Mindfulness, Meditation, Yoga, Inflammatory Markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation | Active comparator | Behavioral: Mindfulness Meditation |
| Yoga | Active comparator | Behavioral: Yoga |
| Conventional Stress Reduction | Active comparator | Behavioral: Exercise, Relaxation, and Health Education |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness MeditationAlso: MBSRThe yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises. | Behavioural | Mindfulness Meditation |
| YogaThe yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises. | Behavioural | Yoga |
| Exercise, Relaxation, and Health EducationAlso: Progressive muscle relaxationThe 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. | Behavioural | Conventional Stress Reduction |
Primary outcome
change in inflammatory markers
Time frame: within 26 weeks of enrollment
1 secondary outcome
change in psychological and physiological markers of anxiety, depression, and cardiovascular disease
Time frame: within 26 weeks from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan EB Fox, Ph.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation, Yoga and Exercise, Relaxation, and Health Education in people with Cardiovascular Disease and Stress, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in inflammatory markers (time frame: within 26 weeks of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.