Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:07 AM
Study NCT ID:
NCT07310992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Meditation as an Adjunct to Cardiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arm 1 - Control Group\n\nName: Standard Cardiac Rehabilitation\n\nDescription:\n\nParticipants undergo 60 minutes of aerobic and resistance training, twice per week, for 12 weeks, with optimized medical therapy.\n\nIntervention Type: Behavioral / Exercise Duration: 12 weeks\n\nArm 2 - Meditation Group (Intervention Group)\n\nName: Cardiac Rehabilitation + Meditation\n\nDescription:\n\nParticipants undergo 60 minutes of aerobic and resistance training + 15 minutes of guided mindfulness meditation at the end of each session, twice per week, for 12 weeks, with optimized medical therapy.\n\nIntervention Type: Behavioral / Meditation (Mindfulness) Duration: 12 weeks'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-30', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life Scores (EuroQol EQ-5D Visual Analogue Scale)', 'timeFrame': 'Baseline and Week 12', 'description': "Quality of life is assessed using the EuroQol Five Dimensions Questionnaire (EQ-5D). This instrument includes the EQ Visual Analogue Scale (EQ-VAS), a quantitative measure of the participant's self-rated health status. The EQ-VAS scores range from a minimum of 0 to a maximum of 100, where 0 represents 'the worst health you can imagine' and 100 represents 'the best health you can imagine'. Higher scores indicate better health outcomes and higher quality of life."}], 'secondaryOutcomes': [{'measure': 'Change in Systolic and Diastolic Blood Pressure', 'timeFrame': 'Baseline and Week 12', 'description': 'Assessment of both systolic and diastolic blood pressure parameters using a validated digital oscillometric device. Measurements are recorded in millimeters of mercury (mmHg). Reductions in both systolic and diastolic values indicate clinical improvement.'}, {'measure': 'Rate of Rehabilitation Adherence', 'timeFrame': 'Through study completion, an average of 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Blood Pressure (& [Essential Hypertension])', 'Meditation Training', 'Rehabilitation Exercise']}, 'descriptionModule': {'briefSummary': 'Cardiovascular rehabilitation is a well-established standard of care that significantly reduces morbidity and mortality while improving quality of life. However, integrating behavioral interventions into physical training may offer additional benefits for autonomic regulation and emotional well-being.\n\nThis randomized clinical trial aims to investigate the efficacy of adding a brief, guided mindfulness meditation session to a standard cardiovascular rehabilitation program. The study seeks to determine whether this combined intervention enhances blood pressure control, improves perceived quality of life, and increases patient adherence compared to standard rehabilitation alone.\n\nParticipants newly enrolled in the Cardiac Rehabilitation Service will be randomized into two groups. Both groups will undergo a standard 12-week regimen of aerobic and resistance training combined with optimized medical therapy. The intervention group will additionally receive 15 minutes of voice-guided mindfulness meditation at the end of each exercise session. Key outcome measures include blood pressure variability, quality of life scores (assessed via EQ-5D), and attendance rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes, aged 18 years or older.\n* Newly enrolled in the Phase II Cardiac Rehabilitation Program.\n* Clinically stable condition with medical clearance to perform aerobic and resistance exercises.\n* Diagnosis of cardiovascular disease (e.g., coronary artery disease, post-myocardial infarction, post-cardiac surgery, or stable heart failure) warranting rehabilitation.\n* Willingness and cognitive ability to provide written informed consent.\n* Availability to attend the twice-weekly sessions for the 12-week duration of the study.\n\nExclusion Criteria:\n\n* Current regular practice of meditation, yoga, or other mind-body techniques (defined as formal practice more than once a week in the previous 3 months).\n* Current participation in other psychological or behavioral intervention clinical trials.\n* Severe cognitive impairment or psychiatric disorders that preclude understanding of the meditation instructions or group participation (e.g., dementia, untreated psychosis).\n* Unstable clinical conditions such as unstable angina, uncontrolled arrhythmias, or decompensated heart failure that contraindicate physical exercise.\n* Significant orthopedic or neurological limitations that prevent the performance of the exercise protocol.\n* Refusal to participate in the randomization process.'}, 'identificationModule': {'nctId': 'NCT07310992', 'briefTitle': 'Effect of Meditation as an Adjunct to Cardiac Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Dante Pazzanese de Cardiologia'}, 'officialTitle': 'The Effect of Meditation Practice Combined With Cardiac Rehabilitation on Improving Quality of Life and Controlling Blood Pressure.', 'orgStudyIdInfo': {'id': '91829725.6.0000.5462'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Meditation + Rehabilitation', 'description': 'Participants in this group will undergo the standard cardiac rehabilitation program consisting of 60 minutes of aerobic and resistance training, twice a week for 12 weeks. Additionally, they will participate in a 15-minute voice-guided mindfulness meditation session immediately following each exercise session. Participants also receive optimized medical therapy.', 'interventionNames': ['Behavioral: Meditation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Standard Rehabilitation', 'description': 'Participants in this group will undergo the standard cardiac rehabilitation program consisting of 60 minutes of aerobic and resistance training, twice a week for 12 weeks, along with optimized medical therapy. This group does not receive the guided meditation intervention.', 'interventionNames': ['Procedure: Standard Cardiac Rehabilitation']}], 'interventions': [{'name': 'Meditation', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will undergo the standard cardiac rehabilitation program consisting of 60 minutes of aerobic and resistance training, twice a week for 12 weeks. Additionally, they will participate in a 15-minute voice-guided mindfulness meditation session immediately following each exercise session. Participants also receive optimized medical therapy.', 'armGroupLabels': ['Experimental: Meditation + Rehabilitation']}, {'name': 'Standard Cardiac Rehabilitation', 'type': 'PROCEDURE', 'description': 'Participants in this group will undergo the standard cardiac rehabilitation program consisting of 60 minutes of aerobic and resistance training, twice a week for 12 weeks, along with optimized medical therapy. This group does not receive the guided meditation intervention.', 'armGroupLabels': ['Active Comparator: Standard Rehabilitation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Dante Pazzanese de Cardiologia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Guacira Grecca', 'investigatorFullName': 'Guacira Grecca', 'investigatorAffiliation': 'Instituto Dante Pazzanese de Cardiologia'}}}}