This study is a randomized controlled trial designed to evaluate the effects of combined diaphragmatic and abdominal neuromuscular electrical stimulation (NMES) on arterial blood gases, pulmonary function, left ventricular ejection fraction, and functional capacity in patients following percutaneous coronary intervention (PCI). A total of 42 participants will be randomly allocated into two groups: an intervention group receiving NMES along with standard cardiac rehabilitation, and a control group receiving standard rehabilitation alone. The intervention will be administered for 30 minutes per session, five days per week, over a period of two weeks. Outcome measures will include arterial blood gas parameters (PaO₂, PaCO₂, SaO₂), spirometry indices (FVC, FEV₁, PEFR), ejection fraction assessed by echocardiography, and functional capacity measured using the 6-minute walk test. Assessments will be conducted at baseline and post-intervention. The study aims to determine whether NMES can serve as an effective adjunct to conventional cardiac rehabilitation in improving respiratory and functional outcomes in post-PCI patients.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
42
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.
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.
Partial Pressure of Oxygen (PaO₂)
Measurement of arterial partial pressure of oxygen using arterial blood gas analysis.
Time frame: Baseline and after 2 weeks of intervention
Partial Pressure of Carbon Dioxide (PaCO₂)
Measurement of arterial partial pressure of carbon dioxide using arterial blood gas analysis.
Time frame: Baseline and after 2 weeks of intervention
Arterial Oxygen Saturation (SaO₂)
Measurement of arterial oxygen saturation using arterial blood gas analysis.
Time frame: Baseline and after 2 weeks of intervention
Forced Vital Capacity (FVC)
Assessment of forced vital capacity using spirometry.
Time frame: Baseline and after 2 weeks of intervention
Forced Expiratory Volume in 1 Second (FEV₁)
Assessment of forced expiratory volume in 1 second using spirometry.
Time frame: Baseline and after 2 weeks of intervention
Peak Expiratory Flow Rate (PEFR)
Assessment of peak expiratory flow rate using spirometry.
Time frame: Baseline and after 2 weeks of intervention
Left Ventricular Ejection Fraction (LVEF)
Measurement of cardiac function using echocardiography (Simpson's biplane method).
Time frame: Baseline and after 2 weeks
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