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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMES + Standard Cardiac Rehabilitation | Experimental | 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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| Standard Cardiac Rehabilitation | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Partial Pressure of Oxygen (PaO₂) | Measurement of arterial partial pressure of oxygen using arterial blood gas analysis. | 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. | Baseline and after 2 weeks of intervention |
| Arterial Oxygen Saturation (SaO₂) | Measurement of arterial oxygen saturation using arterial blood gas analysis. | Baseline and after 2 weeks of intervention |
| Forced Vital Capacity (FVC) | Assessment of forced vital capacity using spirometry. | Baseline and after 2 weeks of intervention |
| Forced Expiratory Volume in 1 Second (FEV₁) | Assessment of forced expiratory volume in 1 second using spirometry. | Baseline and after 2 weeks of intervention |
| Peak Expiratory Flow Rate (PEFR) | Assessment of peak expiratory flow rate using spirometry. | Baseline and after 2 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF) | Measurement of cardiac function using echocardiography (Simpson's biplane method). | Baseline and after 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arjumand Bano, MS | Contact | +92 305 9551883 | arjumand.bano@riphah.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Arjumand Bano, MS | Riphah International University | Principal Investigator |
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Participants will be randomly assigned into two parallel groups: an intervention group receiving neuromuscular electrical stimulation (NMES) along with standard cardiac rehabilitation, and a control group receiving standard cardiac rehabilitation alone. Both groups will be followed simultaneously and outcomes will be compared after the intervention period.
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Due to the nature of the intervention, participants and care providers cannot be blinded. However, outcome assessors will be blinded to group allocation to minimize assessment bias.
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| Standard Cardiac Rehabilitation | Other | 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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