Meditation as a Stress Management Strategy in Cardiac Rehabilitation for Coronary Artery Disease Patients: A Pilot Randomized Controlled Trial

NCT07648368 | Completed

• 1 other identifier: CCUL-MED-CR-2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Coronary Artery Disease; Stress; Anxiety

Keywords

Secondary Prevention; Meditation

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 16 weeks

Secondary Outcomes (4)

• Anxiety (Beck Anxiety Inventory, BAI)

  baseline and 16 weeks

• Depression (Beck Depression Inventory-II, BDI-II)

  baseline and 16 weeks

• Health-Related Quality of Life (HeartQoL)

  baseline and 16 weeks

• Physical Activity Level (IPAQ-SF)

  baseline and 16 weeks

Study Arms (2)

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).

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.

Other: Exercise-based Cardiac Rehabilitation (standard)

Interventions

Meditation Program OTHER

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.

Standard CR + Meditation

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.

Standard CR

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Cardiovascular Rehabilitation Centre of the University of Lisbon (CRECUL)

Lisbon, Portugal

Location

MeSH Terms

Conditions

Coronary Artery Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator / Physiotherapist

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: January 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)