Meditation as a Stress Management Strategy in Cardiac Rehabilitation for Coronary Artery Disease Patients: A Pilot Randomized Controlled Trial (MED-CR-CAD)
9 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Lisbon, Portugal
- Cardiovascular Rehabilitation Centre of the University of Lisbon (CRECUL)
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Perceived Stress (PSS-10)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Anxiety (Beck Anxiety Inventory, BAI)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2021
Primaire voltooiing (Werkelijk)
1 juni 2023
Studie voltooiing (Werkelijk)
1 juni 2023
Studieregistratiedata
Eerst ingediend
9 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 juni 2026
Eerst geplaatst (Werkelijk)
15 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
9 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CCUL-MED-CR-2021
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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