Effect of Meditation as an Adjunct to Cardiac Rehabilitation

NCT07310992 | Not Yet Recruiting

• 1 other identifier: 91829725.6.0000.5462
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

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.

  Baseline and Week 12

Secondary Outcomes (2)

• Change in Systolic and Diastolic Blood Pressure

  Baseline and Week 12

• Rate of Rehabilitation Adherence

  Through study completion, an average of 12 weeks

Study Arms (2)

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.

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.

Procedure: Standard Cardiac Rehabilitation

Interventions

Meditation BEHAVIORAL

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.

Experimental: Meditation + Rehabilitation

Standard Cardiac Rehabilitation PROCEDURE

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.

Active Comparator: Standard Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

Meditation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guacira Grecca

Model Details: 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

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12