Mindfulness-based Stress Reduction Combined With Aerobic Training in Cardiac Rehabilitation After Percutaneous Coronary Intervention: A Dual Impact on Kinesiophobia and Heart Rate Variability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Depression Symptoms
研究概览
简要总结
To evaluate the effectiveness of mindfulness-based stress reduction (MBSR) combined with aerobic training on treatment adherence, kinesiophobia, heart rate variability (HRV), exercise tolerance, and psychological stress response in patients with coronary heart disease (CHD) post-percutaneous coronary intervention (PCI).
Post-PCI patients (n = 150) were randomly assigned to an observation group (receiving combined MBSR and aerobic training) and a control group (receiving aerobic training only). Treatment adherence, the Tampa Scale for Kinesiophobia-Heart (TSK-SV Heart), HRV parameters, exercise tolerance, and psychological stress responses were assessed before and after the intervention. Psychological assessments included the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Confirmed diagnosis of coronary heart disease (CHD)
- •Successful percutaneous coronary intervention (PCI) procedure
- •No contraindications to rehabilitation exercise
- •Provision of written informed consent by the patient and their legal guardian
排除标准
- •Coexisting severe organic disease (e.g., severe valvular disease, advanced kidney or liver failure)
- •Malignancy (active or history of cancer within recent years)
- •Cognitive impairment (sufficient to preclude understanding or compliance with mindfulness-based stress reduction or exercise instructions)
研究组 & 干预措施
observation group
receiving combined MBSR and aerobic training
干预措施: observation group (Behavioral)
control group
receiving aerobic training only
结局指标
主要结局
Change in Depression Symptoms
时间窗: Baseline (pre-intervention) and immediately post-intervention (after 8 weeks).
The SDS is a 20-item self-rating scale used to assess the severity of depressive symptoms. Each item is scored on a 4-point Likert scale. Total scores range from 20 to 80. Scores below 53 are considered normal; higher scores indicate more severe depression. The sample size calculation (n=150) was based on an estimated effect size (Cohen's d) of 0.54 for this measure.
次要结局
- Change in Standard Deviation of Average Normal-to-Normal RR Intervals in 5-minute Segments(Baseline and post-intervention (8 weeks).)
- Change in Anxiety Symptoms(Baseline and post-intervention (8 weeks).)
- Change in Treatment Adherence Score(Baseline and post-intervention (8 weeks).)
- Change in Kinesiophobia Level(Baseline and post-intervention (8 weeks).)
- Change in Standard Deviation of Normal-to-Normal RR Intervals(Baseline and post-intervention (8 weeks).)
研究者
Haifeng Fan
Principal Investigator
Linyi People's Hospital