Effects of Zazen Meditation in Patients With Acute Myocardial Infarction - Randomized Clinical Trial

NCT06562478 | Recruiting

• 1 other identifier: 2019-0506
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Rate Variability; Acute Myocardial Infarction

Keywords

Myocardial Infarction; heart rate variability

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  Assessed using the Polar H10 heart rate monitor, before and after a meditation session to evaluate acute effects, and before and after 24 sessions to evaluate chronic effects.

  up to 12 weeks

Secondary Outcomes (5)

• Assessment of Quality of Life through the Quality of Life and Health Questionnaire

  up to 12 weeks

• Assessment of Spirituality through the Spirituality, Religiosity, and Personal Beliefs

  up to 12 weeks

• Blood Tests

  up to 12 weeks

• Echocardiography

  up to 12 weeks

• Six-Minute Walk Test

  up to 12 weeks

Study Arms (2)

Meditation Intervention

ACTIVE COMPARATOR

Aspects of Zazen will be addressed. In the first session, the practice will be conducted for a duration of 5 minutes. In the second session, the duration will be extended to 10 minutes, aiming to provide adaptation for the participants. In the third session, the practice will last for 15 minutes, during which heart rate variability will be measured using the Polar H10 chest strap and the Elite HRV mobile app, both before and after the practice, to assess acute effects. At the end of the 24 sessions, the chronic effects of the practices will be evaluated in the same manner.

Behavioral: Zazen Meditation

Documentary Control

ACTIVE COMPARATOR

Neutral documentary on quality of life, for 30 minutes twice a week. Both groups will undergo intervention twice a week for 3 months, totaling 24 sessions. In the third session, heart rate variability assessment will be conducted to observe the acute effects of the method.

Behavioral: Zazen Meditation

Interventions

Zazen Meditation BEHAVIORAL

The sessions will last a maximum of 40 minutes in total, comprising 10 minutes of introduction with general practice instructions, followed by 15 minutes of Zazen meditation practice. The final 15 minutes will be allocated for participants to provide feedback on the session.

Documentary Control; Meditation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Rosane M Nery, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosane M Nery, PhD

CONTACT

+555133597634; rosane.nery@gmail.com

Sabrina Rodrigues da Silva, Ms

CONTACT

+555133597634; sabrina.ed.fis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: August 20, 2024
• Study Start: February 5, 2024
• Primary Completion: January 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)