Effects of Diaphragmatic and Abdominal Neuromuscular Electrical Stimulation in Post-PCI Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Standard Cardiac Rehabilitation

    Other intervention

    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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: NMES + Standard Cardiac RehabilitationExperimental treatment 1 intervention
Group B: Standard Cardiac RehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

Arterial Oxygen Saturation (SaO₂)

Measurement of arterial oxygen saturation using arterial blood gas analysis.

Time frame
Baseline and after 2 weeks of intervention
4

Forced Vital Capacity (FVC)

Assessment of forced vital capacity using spirometry.

Time frame
Baseline and after 2 weeks of intervention

Secondary outcomes

1

Left Ventricular Ejection Fraction (LVEF)

Measurement of cardiac function using echocardiography (Simpson's biplane method).

Time frame
Baseline and after 2 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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