Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT05373732
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2022-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stress Reduction in the Prevention of Left Ventricular Hypertrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}, {'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization was stratified by age, gender, mean arterial pressure, left ventricular mass index (LVMI), and antihypertensive medication. Investigators, data collectors and data management staff were blinded to group assignment. The biostatistician concealed the allocation by conveying the group assignment to the project manager who then informed each participant and instructed them not to reveal it to the research and data collection staff during the course of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, controlled, single-blinded, clinical trial was conducted to compare the effect of Transcendental Meditation (TM) and health education (HE) on left ventricular mass in adult hypertensive African-Americans'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '1998-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-05-09', 'lastUpdatePostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '1998-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'left ventricular mass (LVM)', 'timeFrame': '6 months pre to post', 'description': 'The primary outcome was change in LVMI. LVM was measured by M-mode echocardiography and indexed by body surface area to generate LVMI. \\[18\\] Measurements were obtained at the end-diastole. Interventricular septal thickness, posterior wall thickness, and left ventricle internal dimension were measured.'}], 'secondaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': '0 and 6 months', 'description': 'systolic and diastolic blood pressure'}, {'measure': 'anger expression', 'timeFrame': '0 and 6 months', 'description': 'Speilberger Anger expression scale'}, {'measure': 'perceived stress', 'timeFrame': '0 and 6 months', 'description': 'Perceived Stress Scale, a 5-item subset of the California Self-Evaluation Scale to measure self-esteem, and a personal efficacy scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['left ventricular mass', 'meditation', 'stress reduction'], 'conditions': ['Left Ventricular Hypertrophy', 'High Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '31641325', 'type': 'RESULT', 'citation': 'Schneider RH, Myers HF, Marwaha K, Rainforth MA, Salerno JW, Nidich SI, Gaylord-King C, Alexander CN, Norris KC. Stress Reduction in the Prevention of Left Ventricular Hypertrophy: A Randomized Controlled Trial of Transcendental Meditation and Health Education in Hypertensive African Americans. Ethn Dis. 2019 Oct 17;29(4):577-586. doi: 10.18865/ed.29.4.577. eCollection 2019 Fall.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the effect of stress reduction by Transcendental Meditation (TM) on left ventricular mass compared to a health education control group in pre-hypertensive or hypertensive African-American adults over a six-month intervention period.', 'detailedDescription': 'Left ventricular hypertrophy (LVH) is an independent risk factor for cardiovascular disease (CVD). African Americans have higher rates of LVH and CVD than whites. Substantial evidence indicates that psychological stress contributes to LVH. This randomized controlled trial evaluated the effect of stress reduction with the Transcendental Meditation (TM) technique on left ventricular mass (LVM) in hypertensive African-Americans.\n\nHypertensive African American men and women were tested at baseline for left ventricular mass index (LVMI) by M-mode echocardiography, blood pressure, lifestyle and behavioral factors. Subjects were randomly assigned to either TM or health education (HE) control. After six months intervention, 86 subjects were posttested on all outcomes. Data were analyzed for between-group and within-group differences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: self-identified African-American men and women ages, 20-75 years old, with either prehypertension (systolic blood pressure (SBP) of 120-139 mm Hg and/or diastolic blood pressure (DBP) of 80-89 mm Hg), Stage-1 hypertension (SBP of 140-159 mm Hg and/or DBP of 90-99 mm Hg) or Stage-2 hypertension (SBP of 160-179 and/or DBP of 100-109 mm of Hg), with or without antihypertensive medications -\n\nExclusion Criteria: Patients with a history of stroke, transient cerebral ischemic attack, congestive heart failure, myocardial infarction, angina pectoris or with significant ECG abnormalities, major psychiatric or behavioral disorder such as alcoholism (\\> 28 drinks per week)\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05373732', 'briefTitle': 'Stress Reduction in the Prevention of Left Ventricular Hypertrophy', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi International University'}, 'officialTitle': 'Stress Reduction in the Prevention of Left Ventricular Hypertrophy: A Randomized Controlled Trial of Transcendental Meditation and Health Education in Hypertensive African Americans', 'orgStudyIdInfo': {'id': '2100mdmvc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcendental Meditation', 'description': 'The Transcendental Meditation (TM) technique is described as a simple, natural technique that is practiced twice a day for 20 minutes while sitting comfortably with eyes closed. There are no required changes in lifestyle, beliefs or philosophy. Instruction in the TM technique involves a seven-step course over five sessions (90-minute meetings).', 'interventionNames': ['Behavioral: meditation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education', 'description': 'The health education (HE) intervention provided behavioral instructions for CVD risk factor prevention . This group received written materials, structured presentations, didactic instructions and group support for modifying the major cardiovascular risk factors including salt restriction, weight reduction, aerobic exercise, alcohol and smoking cessation.', 'interventionNames': ['Behavioral: Health education control']}], 'interventions': [{'name': 'meditation', 'type': 'BEHAVIORAL', 'otherNames': ['stress reduction'], 'description': 'meditation practice 20 minutes twice a day at home and attending classes at the clinic.', 'armGroupLabels': ['Transcendental Meditation']}, {'name': 'Health education control', 'type': 'BEHAVIORAL', 'description': 'didactic based classes in CVD risk factor reduction and prevention', 'armGroupLabels': ['Health Education']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert H Schneider, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maharishi International University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'currently available', 'ipdSharing': 'YES', 'description': 'IPD is available on request to authors from other study investigators. Database on Excel is available to be emailed to inquiring investigators', 'accessCriteria': 'contact investigators and request access to database and submit short study proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maharishi International University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Charles Drew University of Medicine and Science', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Dean', 'investigatorFullName': 'Robert Schneider, MD', 'investigatorAffiliation': 'Maharishi International University'}}}}