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Completed

NCT Number: NCT07648368

Meditation as a Stress Management Strategy in Cardiac Rehabilitation for Coronary Artery Disease Patients: A Pilot Randomized Controlled Trial

The aim of this pilot randomized controlled trial was to evaluate whether adding a 16-week structured meditation intervention to a long-term (phase III) cardiac rehabilitation program reduces perceived stress and improves anxiety, depression, and health-related quality of life in patients with stable coronary artery disease. Patients were randomized 1:1 to standard cardiac rehabilitation plus meditation (experimental group) or standard cardiac rehabilitation alone (control group). The meditation intervention consisted of four weekly 90-minute group sessions followed by 12 weeks of daily individual practice supported by weekly follow-up calls. Outcomes were assessed at baseline and after 16 weeks.

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Key information

Conditions

Coronary Artery Disease Anxiety Anxiety Disorders Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Mental Disorders Myocardial Ischemia Stress Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Rehabilitation Centre of the University of Lisbon (CRECUL)

Lisbon, Portugal

About this study

Despite advances in cardiac care, psychological stress, anxiety, and depression remain common in patients with coronary artery disease (CAD) and contribute to worse cardiovascular outcomes. Exercise-based cardiac rehabilitation (CR) programs are effective in reducing physical risk factors but often do not adequately address the psychological burden of CAD. Mind-body interventions such as meditation have been suggested as cost-effective adjuncts to CR, but evidence in long-term phase III CR programs remains limited.

This pilot randomized controlled trial was designed to evaluate the additive effect of a structured meditation intervention combining Karuna (compassion) and Metta (loving-kindness) practices, integrated into a long-term CR program. The intervention included four weekly 90-minute group sessions led by a physiotherapist trained in meditation techniques, followed by 12 weeks of daily individual practice (20 minutes/day) supported by recorded video material and weekly follow-up telephone calls. Outcomes were measured at baseline (M0) and after 16 weeks (M1), using validated psychometric instruments administered by telephone interview by a blinded health professional.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years (male or female).
  • Clinically stable coronary artery disease, documented by previous myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, or angina pectoris.
  • Active participation in the long-term cardiac rehabilitation program for at least 3 months.
  • Access to a smartphone, tablet, or computer for telephone follow-up and meditation video materials.
  • Written informed consent.

Exclusion criteria

  • Cognitive impairment that prevents informed consent or questionnaire completion.
  • Symptomatic heart failure.
  • Cardiac implantable defibrillators or resynchronization devices.
  • Lack of access to the technology required for the intervention.

Treatment and study plan

Meditation Program

Other

A 16-week structured meditation program added to standard cardiac rehabilitation. During the first month, participants attended four weekly 90-minute group sessions led by a physiotherapist trained in meditation techniques. Each session included: (1) a 30-minute thought-sharing and Q&A moment; (2) a 30-minute conscious breathing protocol combining diaphragmatic abdominal breathing in a 1:2 inhale-to-exhale ratio and heart-focused breathing; and (3) a 30-minute guided meditation combining Karuna (compassion) and Metta (loving-kindness) practices. During the subsequent 12 weeks, participants practised individually for 20 minutes per day, supported by a recorded video by the same instructor and weekly follow-up telephone calls to maintain engagement and address questions.

Exercise-based Cardiac Rehabilitation (standard)

Other

Standard long-term (phase III) exercise-based cardiac rehabilitation program delivered three times per week (60 minutes per session) on non-consecutive days, supervised by exercise physiologists. Each session included a 10-minute warm-up and cool-down. Moderate continuous aerobic training was prescribed at 40-75% of heart rate reserve for 20-25 minutes per session using cycle ergometers or treadmills. Resistance training was performed after the aerobic component (1-2 sets of 8-12 repetitions at approximately 60-80% of one-repetition maximum, with 2-3 minutes rest between sets), according to European Society of Cardiology guidelines. Heart rate was monitored with a chest band.

Primary outcomes

  1. Perceived Stress (PSS-10)

    Time frame: baseline and 16 weeks

    The Perceived Stress Scale is a 10-item self-report questionnaire (score range 0-40) assessing the extent to which life events over the previous month are perceived as unpredictable, uncontrollable, and overloading. Higher scores indicate greater perceived stress.

Secondary outcomes

  1. Anxiety (Beck Anxiety Inventory, BAI)

    Time frame: baseline and 16 weeks

    21-item self-report measure of anxiety symptom severity, score range 0-63. Severity categories: minimal (0-7), mild (8-15), moderate (16-25), severe (26-63).

  2. Depression (Beck Depression Inventory-II, BDI-II)

    Time frame: baseline and 16 weeks

    21-item self-report measure of depressive symptom severity, score range 0-63. Severity categories: minimal (0-13), mild (14-19), moderate (20-28), severe (29-63)

  3. Health-Related Quality of Life (HeartQoL)

    Time frame: baseline and 16 weeks

    14-item disease-specific HRQoL questionnaire for ischaemic heart disease, providing Physical (10 items), Emotional (4 items), and Global scores. Higher scores indicate better HRQoL.

  4. Physical Activity Level (IPAQ-SF)

    Time frame: baseline and 16 weeks

    International Physical Activity Questionnaire - Short Form. 9-item self-report measure categorizing participants into low, moderate, or high physical activity levels based on the past 7 days.

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Acronym: MED-CR-CAD

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2026
Registry last updated
Jun 15, 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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