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RecruitingNCT07310992Updated Aug 26, 2026

Effect of Meditation as an Adjunct to Cardiac Rehabilitation

An interventional study of Meditation and Standard Cardiac Rehabilitation in High Blood Pressure (& [Essential Hypertension]), Meditation Training and Rehabilitation Exercise, sponsored by Instituto Dante Pazzanese de Cardiologia. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Primary conditionEssential HypertensionRegistry: HypertensionReclassifiedWhy we changed it
Registry
Hypertension — the first condition term the registry derived for this study.
ClinicalTrials.gg
Essential Hypertension
Why
  1. The study's listed conditions name Essential Hypertension, a narrower term within Hypertension.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Instituto Dante Pazzanese de Cardiologia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • High Blood Pressure (& [Essential Hypertension])
  • Meditation Training
  • Rehabilitation Exercise

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03

In context

Essential Hypertension Reclassified

478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.

This study's planned enrollment of 80 is below the median of 144 across 406 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Instituto Dante Pazzanese de Cardiologia is the lead sponsor of 20 studies on the registry; 3 are open to participants now.

Compared within Essential Hypertension, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertension. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .
  • Availability to attend the twice-weekly sessions for the 12-week duration of the study.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Experimental: Meditation + Rehabilitation

    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.

    Behavioral: Meditation

  • Active comparator
    Active Comparator: Standard Rehabilitation

    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.

    Procedure: Standard Cardiac Rehabilitation

Interventions

  • BehavioralMeditation

    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.

  • ProcedureStandard Cardiac Rehabilitation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 12

  2. Rate of Rehabilitation Adherence

    Time frame: Through study completion, an average of 12 weeks

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07310992
Lead sponsor
Instituto Dante Pazzanese de Cardiologia
Responsible party
Guacira Grecca (Guacira Grecca, Instituto Dante Pazzanese de Cardiologia) — Principal investigator
First posted
Dec 30, 2025
Start date
Mar 3, 2026
Primary completion
Jan 15, 2027 (estimated)
Completion
Jan 15, 2028 (estimated)
Last update
Aug 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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