Effects of Diaphragmatic and Abdominal Neuromuscular Electrical Stimulation in Post-PCI Patients
Effects of Diaphragmatic and Abdominal Neuromuscular Electrical Stimulation on Arterial Blood Gases, Pulmonary Function, Ejection Fraction and Functional Capacity in Post-PCI Patients
研究概览
地位
条件
详细说明
Percutaneous coronary intervention (PCI) improves coronary blood flow in patients with coronary artery disease; however, many patients continue to experience reduced pulmonary function, impaired gas exchange, decreased cardiac performance, and limited functional capacity after the procedure. These issues are often related to respiratory muscle weakness, immobilization, and altered ventilatory mechanics. Conventional cardiac rehabilitation focuses mainly on aerobic and resistance training, with limited emphasis on respiratory muscle strengthening.
Neuromuscular electrical stimulation (NMES) is a non-invasive technique that induces muscle contractions and may enhance both inspiratory and expiratory muscle function when applied to the diaphragm and abdominal muscles. This study aims to evaluate the effectiveness of combined diaphragmatic and abdominal NMES as an adjunct to standard cardiac rehabilitation in post-PCI patients.
In this randomized controlled trial, 42 hemodynamically stable patients aged 40-75 years will be randomly assigned to either an intervention group (NMES plus standard rehabilitation) or a control group (standard rehabilitation alone). The NMES intervention will be applied for 30 minutes per session, five days per week, for two weeks.
Outcome measures will include arterial blood gases (PaO₂, PaCO₂, SaO₂), pulmonary function (FVC, FEV₁, PEFR), left ventricular ejection fraction, and functional capacity assessed by the 6-minute walk test. Assessments will be conducted at baseline and after the intervention.
This study aims to determine whether NMES can improve respiratory and functional outcomes and serve as an effective adjunct to conventional cardiac rehabilitation in post-PCI patients.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Arjumand Bano, MS
- 电话号码:+92 305 9551883
- 邮箱:arjumand.bano@riphah.edu.pk
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients aged 40-75 years
- Patients who have undergone successful percutaneous coronary intervention (PCI) for stable or acute coronary syndrome
- Hemodynamically stable (no inotropic support, no active arrhythmias)
- Left ventricular ejection fraction (LVEF) ≥ 35%
- Able to perform spirometry and 6-minute walk test (6MWT)
- Willing to participate and provide informed consent
Exclusion Criteria:
- Significant arrhythmias or pacemaker/implantable defibrillator not cleared for NMES
- Severe pulmonary disease (e.g., advanced COPD, pulmonary fibrosis) affecting lung function independently
- Neuromuscular disorders interfering with NMES application
- Recent stroke or severe cognitive impairment limiting participation
- Active infection, sepsis, or systemic inflammatory disease
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:NMES + Standard Cardiac Rehabilitation
Participants in this group will receive combined diaphragmatic and abdominal neuromuscular electrical stimulation (NMES) in addition to standard cardiac rehabilitation.
NMES will be applied using surface electrodes placed over the lower thoracic region (for diaphragmatic stimulation) and abdominal muscles (rectus abdominis and external obliques).
The intervention will be delivered for 30 minutes per session, five days per week, for two weeks, along with routine cardiac rehabilitation including aerobic exercise, breathing exercises, and education.
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A dual-channel electrical stimulation device will be used to deliver stimulation to respiratory muscles.
Surface electrodes will be placed over the lower thoracic region for diaphragmatic stimulation and over the abdominal muscles for expiratory muscle stimulation.
Stimulation parameters will include a frequency of 30-50 Hz, pulse width of 300 µs, and a duty cycle of 5 seconds on and 5 seconds off.
Intensity will be adjusted to achieve visible muscle contraction without discomfort.
Sessions will last 30 minutes, five days per week, for two weeks.
其他名称:
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有源比较器:Standard Cardiac Rehabilitation
Participants in this group will receive standard cardiac rehabilitation only, including aerobic exercise, breathing exercises, and patient education as per institutional protocol, without the use of neuromuscular electrical stimulation (NMES).
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A structured cardiac rehabilitation program including aerobic exercise, breathing exercises, and patient education delivered according to institutional protocols, without the use of neuromuscular electrical stimulation.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Partial Pressure of Oxygen (PaO₂)
大体时间:Baseline and after 2 weeks of intervention
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Measurement of arterial partial pressure of oxygen using arterial blood gas analysis.
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Baseline and after 2 weeks of intervention
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Partial Pressure of Carbon Dioxide (PaCO₂)
大体时间:Baseline and after 2 weeks of intervention
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Measurement of arterial partial pressure of carbon dioxide using arterial blood gas analysis.
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Baseline and after 2 weeks of intervention
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Arterial Oxygen Saturation (SaO₂)
大体时间:Baseline and after 2 weeks of intervention
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Measurement of arterial oxygen saturation using arterial blood gas analysis.
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Baseline and after 2 weeks of intervention
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Forced Vital Capacity (FVC)
大体时间:Baseline and after 2 weeks of intervention
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Assessment of forced vital capacity using spirometry.
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Baseline and after 2 weeks of intervention
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Forced Expiratory Volume in 1 Second (FEV₁)
大体时间:Baseline and after 2 weeks of intervention
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Assessment of forced expiratory volume in 1 second using spirometry.
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Baseline and after 2 weeks of intervention
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Peak Expiratory Flow Rate (PEFR)
大体时间:Baseline and after 2 weeks of intervention
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Assessment of peak expiratory flow rate using spirometry.
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Baseline and after 2 weeks of intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Left Ventricular Ejection Fraction (LVEF)
大体时间:Baseline and after 2 weeks
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Measurement of cardiac function using echocardiography (Simpson's biplane method).
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Baseline and after 2 weeks
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合作者和调查者
调查人员
- 首席研究员:Arjumand Bano, MS、Riphah International University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- REC/RCR & AHS/25/0322
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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