Mindfulness meditation added to cardiac rehabilitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial tests whether adding 15 minutes of voice-guided mindfulness meditation to a 12-week cardiac rehabilitation program improves blood pressure control, perceived quality of life, and adherence compared with standard rehabilitation alone. Participants are adults with cardiovascular disease starting a Phase II rehab program and are randomized to receive either standard rehab with meditation or standard rehab without meditation. Both groups complete aerobic and resistance training plus optimized medical therapy; the intervention group adds the meditation sessions twice weekly. The study uses a pragmatic design to assess real-world applicability within an established rehabilitation setting. Primary outcomes center on cardiovascular risk factors and patient-reported well-being.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto Dante Pazzanese de Cardiologia
  São Paulo, São Paulo, Brazil Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.