Coronary Artery DiseaseMED-CR-CADNCT07648368
Meditation as a Stress Management Strategy in Cardiac Rehabilitation for Coronary Artery Disease Patients: A Pilot Randomized Controlled Trial
A study testing Meditation Program and Exercise-based Cardiac Rehabilitation (standard) in people with Coronary Artery Disease and Stress, run by Universidad Rey Juan Carlos at 1 site in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Stress, Anxiety
- What is being tested?
- Meditation Program and Exercise-based Cardiac Rehabilitation (standard)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Cardiovascular Rehabilitation Centre of the University of Lisbon (CRECUL)
Lisbon
About this study
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease, Stress, Anxiety
- Being tested
- Meditation Program, Exercise-based Cardiac Rehabilitation (standard)
- Keywords
- Secondary Prevention, Meditation
- Medical subject headings
- Coronary Artery Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard CR + Meditation | Experimental | 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). Receives: Other: Meditation Program |
| Standard CR | Active comparator | 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. Receives: Other: Exercise-based Cardiac Rehabilitation (standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress (PSS-10)
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.
Measured: baseline and 16 weeks
Secondary outcomes (4)
Anxiety (Beck Anxiety Inventory, BAI)
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).
Measured: baseline and 16 weeks
Depression (Beck Depression Inventory-II, BDI-II)
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)
Measured: baseline and 16 weeks
Health-Related Quality of Life (HeartQoL)
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.
Measured: baseline and 16 weeks
Physical Activity Level (IPAQ-SF)
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.
Measured: baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Jan 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DeAsís-Fernández, Francisco, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648368
- Sponsor's protocol ID
- CCUL-MED-CR-2021
- Acronym
- MED-CR-CAD
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation as a Stress Management Strategy in Cardiac Rehabilitation for Coronary Artery Disease Patients: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07648368
- Acronym / sponsor ID
- MED-CR-CAD / CCUL-MED-CR-2021
- Conditions
- Coronary Artery Disease, Stress, Anxiety
- Keywords
- Secondary Prevention, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard CR + Meditation | Experimental | Other: Meditation ProgramParticipants 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). |
| Standard CR | Active comparator | Other: Exercise-based Cardiac Rehabilitation (standard)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation ProgramA 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. | Other | Standard CR + Meditation |
| Exercise-based Cardiac Rehabilitation (standard)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. | Other | Standard CR |
Primary outcome
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.
4 secondary outcomes
Anxiety (Beck Anxiety Inventory, BAI)
Time frame: baseline and 16 weeks
Depression (Beck Depression Inventory-II, BDI-II)
Time frame: baseline and 16 weeks
Health-Related Quality of Life (HeartQoL)
Time frame: baseline and 16 weeks
Physical Activity Level (IPAQ-SF)
Time frame: baseline and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation Program and Exercise-based Cardiac Rehabilitation (standard) in people with Coronary Artery Disease and Stress, run by Universidad Rey Juan Carlos at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress (PSS-10) (time frame: baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.