The Effect of Meditation Practice Combined With Cardiac Rehabilitation on Improving Quality of Life and Controlling Blood Pressure.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 主要终点
- Quality of Life Scores (EuroQol EQ-5D Visual Analogue Scale)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Meditation (Behavioral)
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.
干预措施: Standard Cardiac Rehabilitation (Procedure)
结局指标
主要结局
Quality of Life Scores (EuroQol EQ-5D Visual Analogue Scale)
时间窗: 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.
次要结局
- Rate of Rehabilitation Adherence(Through study completion, an average of 12 weeks)
- Change in Systolic and Diastolic Blood Pressure(Baseline and Week 12)
- Rate of Rehabilitation Adherence(Through study completion, an average of 12 weeks)
研究者
Guacira Grecca
Guacira Grecca
Instituto Dante Pazzanese de Cardiologia