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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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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
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|
| 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. |
|
| Rate of Rehabilitation Adherence |
| Through study completion, an average of 12 weeks |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |