Meditation as a Stress Management Strategy in Cardiac Rehabilitation for Coronary Artery Disease Patients: A Pilot Randomized Controlled Trial (MED-CR-CAD)
9 de junio de 2026 actualizado por: DeAsís-Fernández, Francisco, Universidad Rey Juan Carlos
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Lisbon, Portugal
- Cardiovascular Rehabilitation Centre of the University of Lisbon (CRECUL)
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Standard CR + Meditation
Participants received the standard exercise-based cardiac rehabilitation program plus a 16-week structured meditation intervention.
The meditation component included four weekly 90-minute group sessions during the first month (led by a physiotherapist trained in meditation), followed by 12 weeks of daily individual practice (20 minutes/day) supported by a recorded video and weekly follow-up telephone calls.
Each group session included a thought-sharing moment (30 min), a conscious breathing protocol - diaphragmatic 1:2 and heart-focused breathing (30 min), and a guided Karuna (compassion) and Metta (loving-kindness) meditation (30 min).
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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.
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Comparador activo: Standard CR
Participants received the standard exercise-based cardiac rehabilitation program without the meditation component.
The standard CR program consisted of supervised group exercise sessions three times per week (60 min per session), with combined aerobic and resistance training prescribed according to European Society of Cardiology guidelines.
After completing the 16-week assessment, control-group participants were offered the same breathing and meditation protocol.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perceived Stress (PSS-10)
Periodo de tiempo: baseline and 16 weeks
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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.
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baseline and 16 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Anxiety (Beck Anxiety Inventory, BAI)
Periodo de tiempo: baseline and 16 weeks
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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).
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baseline and 16 weeks
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Depression (Beck Depression Inventory-II, BDI-II)
Periodo de tiempo: baseline and 16 weeks
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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)
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baseline and 16 weeks
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Health-Related Quality of Life (HeartQoL)
Periodo de tiempo: baseline and 16 weeks
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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.
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baseline and 16 weeks
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Physical Activity Level (IPAQ-SF)
Periodo de tiempo: baseline and 16 weeks
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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.
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baseline and 16 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2021
Finalización primaria (Actual)
1 de junio de 2023
Finalización del estudio (Actual)
1 de junio de 2023
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
15 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CCUL-MED-CR-2021
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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