Effect of Meditation as an Adjunct to Cardiac Rehabilitation

Instituto Dante Pazzanese de Cardiologia

Status: Not yet enrolling

Conditions: Meditation Training; High Blood Pressure (& [Essential Hypertension]); Rehabilitation Exercise

Treatments: Procedure: Standard Cardiac Rehabilitation; Behavioral: Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT07310992

91829725.6.0000.5462

Details and patient eligibility

About

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.

This 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.

Participants 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both sexes, aged 18 years or older.
• Newly enrolled in the Phase II Cardiac Rehabilitation Program.
• Clinically stable condition with medical clearance to perform aerobic and resistance exercises.
• Diagnosis of cardiovascular disease (e.g., coronary artery disease, post-myocardial infarction, post-cardiac surgery, or stable heart failure) warranting rehabilitation.
• Willingness and cognitive ability to provide written informed consent.
• Availability to attend the twice-weekly sessions for the 12-week duration of the study.

Exclusion criteria

• 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).
• Current participation in other psychological or behavioral intervention clinical trials.
• Severe cognitive impairment or psychiatric disorders that preclude understanding of the meditation instructions or group participation (e.g., dementia, untreated psychosis).
• Unstable clinical conditions such as unstable angina, uncontrolled arrhythmias, or decompensated heart failure that contraindicate physical exercise.
• Significant orthopedic or neurological limitations that prevent the performance of the exercise protocol.
• Refusal to participate in the randomization process.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Experimental: Meditation + Rehabilitation

Experimental group

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.

Treatment:

Behavioral: Meditation

Active Comparator: Standard Rehabilitation

Active Comparator group

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.

Treatment:

Procedure: Standard Cardiac Rehabilitation