NCT06562478 Effects of Zazen Meditation in Patients With Acute Myocardial Infarction - Randomized Clinical Trial
| NCT ID | NCT06562478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Heart Rate Variability |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2025-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2024-02-05 with a primary completion date of 2025-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: Coronary Artery Disease (CAD) remains the leading cause of death in Brazil, with literature indicating that in patients post-acute myocardial infarction, reduced Heart Rate Variability (HRV) has been established as a risk factor. One of the studied practices to aid in rehabilitation is meditation, believed to alter physiological aspects related to stress such as respiratory rate, oxygen consumption, carbon dioxide production, and systolic blood pressure, suggesting a better sympathetic-vagal balance. Objective: To assess the effects of Zazen meditation practice on heart rate variability in patients with recent acute and chronic myocardial infarction. Methodology: Randomized Clinical Trial. Chronic assessments will include: HRV with Polar H10 heart rate monitor, Quality of Life assessment with SF36 Quality of Life and Health questionnaire, Spiritual assessment with WHOQOL SR Spirituality, Religiosity, and Personal Beliefs questionnaire, Biochemical Parameters with ultra-sensitive PCR and cortisol, Ventricular Ejection Fraction (VEF), and 6-minute Walk Test (6MWT). Acute assessments will include: HRV with Polar H10 heart rate monitor, before and after a meditation session, in time and frequency domains. Sample size calculation was performed using Winpepi software version 11.43, with a power of 80% and significance level of 5%, determining a sample of 44 individuals. For intra-group differences analysis, ANOVA for repeated measures and/or its non-parametric counterpart, Friedman Test, will be used. For proportion analysis and comparison, Chi-square Test will be used. Expected Results: It is expected that the findings will contribute to a better understanding of the potential benefits that a meditation intervention may bring to patients who have experienced acute myocardial infarction.
Eligibility Criteria
Inclusion Criteria: * Recent acute myocardial infarction * Both sexes * \>18 years old * Availability to attend the hospital at least twice a week during the study period * Agree to the study and sign the Free and Informed Consent Form. Exclusion Criteria: * Unstable angina * Extensive residual myocardial ischemia (at rest or on exertion) * Inadequate blood pressure response during exercise * Congestive heart failure class III or IV * Severe lung disease * Difficulty or inability to walk * Pacemaker * Participation in other clinical trials
Contact & Investigator
Rosane M Nery, PhD
PRINCIPAL INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Frequently Asked Questions
Who can join the NCT06562478 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Rate Variability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06562478 currently recruiting?
Yes, NCT06562478 is actively recruiting participants. Contact the research team at rosane.nery@gmail.com for enrollment information.
Where is the NCT06562478 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT06562478 clinical trial?
NCT06562478 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Rosane M Nery, PhD at Hospital de Clínicas de Porto Alegre. The trial plans to enroll 44 participants.