High Blood Pressure (& [Essential Hypertension])NCT07310992
Effect of Meditation as an Adjunct to Cardiac Rehabilitation
A study testing Meditation and Standard Cardiac Rehabilitation in people with High Blood Pressure (& [Essential Hypertension]) and Meditation Training, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Blood Pressure (& [Essential Hypertension]), Meditation Training, Rehabilitation Exercise
- What is being tested?
- Meditation and Standard Cardiac Rehabilitation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Mar 2026to 15 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012909
GUACIRA GRECCA, MD, 55 11 995444126, guagrecca@gmail.com
About this study
Official title: The Effect of Meditation Practice Combined With Cardiac Rehabilitation on Improving Quality of Life and Controlling Blood Pressure.
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.
- Conditions
- High Blood Pressure (& [Essential Hypertension]), Meditation Training, Rehabilitation Exercise
- Being tested
- Meditation, Standard Cardiac Rehabilitation
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
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 RehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Meditation + Rehabilitation | Experimental | 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. Receives: Behavioral: Meditation |
| Active Comparator: Standard Rehabilitation | Active comparator | 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. Receives: Procedure: Standard Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scores (EuroQol EQ-5D Visual Analogue Scale)
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.
Measured: Baseline and Week 12
Secondary outcomes (2)
Change in Systolic and Diastolic Blood Pressure
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.
Measured: Baseline and Week 12
Rate of Rehabilitation Adherence
Measured: Through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start3 Mar 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood Pressure (& [Essential Hypertension])Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1 - Control Group Name: Standard Cardiac Rehabilitation Description: Participants undergo 60 minutes of aerobic and resistance training, twice per week, for 12 weeks, with optimized medical therapy. Intervention Type: Behavioral / Exercise Duration: 12 weeks Arm 2 - Meditation Group (Intervention Group) Name: Cardiac Rehabilitation + Meditation Description: Participants undergo 60 minutes of aerobic and resistance training + 15 minutes of guided mindfulness meditation at the end of each session, twice per week, for 12 weeks, with optimized medical therapy. Intervention Type: Behavioral / Meditation (Mindfulness) Duration: 12 weeks
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guacira Grecca, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310992
- Sponsor's protocol ID
- 91829725.6.0000.5462
- Status last verified
- Aug 2026
- First submitted
- 16 Dec 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Meditation Practice Combined With Cardiac Rehabilitation on Improving Quality of Life and Controlling Blood Pressure.
- ClinicalTrials.gov ID
- NCT07310992
- Acronym / sponsor ID
- 91829725.6.0000.5462
- Conditions
- High Blood Pressure (& [Essential Hypertension]), Meditation Training, Rehabilitation Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 30 Dec 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1 - Control Group Name: Standard Cardiac Rehabilitation Description: Participants undergo 60 minutes of aerobic and resistance training, twice per week, for 12 weeks, with optimized medical therapy. Intervention Type: Behavioral / Exercise Duration: 12 weeks Arm 2 - Meditation Group (Intervention Group) Name: Cardiac Rehabilitation + Meditation Description: Participants undergo 60 minutes of aerobic and resistance training + 15 minutes of guided mindfulness meditation at the end of each session, twice per week, for 12 weeks, with optimized medical therapy. Intervention Type: Behavioral / Meditation (Mindfulness) Duration: 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Experimental: Meditation + Rehabilitation | Experimental | Behavioral: MeditationParticipants 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. |
| Active Comparator: Standard Rehabilitation | Active comparator | Procedure: Standard Cardiac RehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| MeditationParticipants 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. | Behavioural | Experimental: Meditation + Rehabilitation |
| Standard Cardiac RehabilitationParticipants 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. | Procedure or surgery | Active Comparator: Standard Rehabilitation |
Primary outcome
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.
2 secondary outcomes
Change in Systolic and Diastolic Blood Pressure
Time frame: Baseline and Week 12
Rate of Rehabilitation Adherence
Time frame: Through study completion, an average of 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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.
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 and Standard Cardiac Rehabilitation in people with High Blood Pressure (& [Essential Hypertension]) and Meditation Training, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Aug 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Scores (EuroQol EQ-5D Visual Analogue Scale) (time frame: Baseline and Week 12). 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 26 Aug 2026.