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NCT Number: NCT07310992

Effect of Meditation as an Adjunct to Cardiac Rehabilitation

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.

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Key information

Conditions

High Blood Pressure (& [Essential Hypertension]) Cardiovascular Diseases Essential Hypertension Hypertension Meditation Training Rehabilitation Exercise Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meditation

Behavioral

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.

Standard Cardiac Rehabilitation

Procedure

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.

Primary outcomes

  1. Quality of Life Scores (EuroQol EQ-5D Visual Analogue Scale)

    Time frame: Baseline and Week 12

    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.

Secondary outcomes

  1. Change in Systolic and Diastolic Blood Pressure

    Time frame: Baseline and Week 12

    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.

  2. Rate of Rehabilitation Adherence

    Time frame: Through study completion, an average of 12 weeks

Sponsors and collaborators

Lead sponsor

Instituto Dante Pazzanese de Cardiologia

Other

Registry information

Official study title

The Effect of Meditation Practice Combined With Cardiac Rehabilitation on Improving Quality of Life and Controlling Blood Pressure.

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 30, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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