Effects of Diaphragmatic and Abdominal Neuromuscular Electrical Stimulation in Post-PCI Patients
1 de junio de 2026 actualizado por: Riphah International University
Effects of Diaphragmatic and Abdominal Neuromuscular Electrical Stimulation on Arterial Blood Gases, Pulmonary Function, Ejection Fraction and Functional Capacity in Post-PCI Patients
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
42
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Arjumand Bano, MS
- Número de teléfono: +92 305 9551883
- Correo electrónico: arjumand.bano@riphah.edu.pk
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Partial Pressure of Oxygen (PaO₂)
Periodo de tiempo: Baseline and after 2 weeks of intervention
|
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)
Periodo de tiempo: Baseline and after 2 weeks of intervention
|
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)
Periodo de tiempo: Baseline and after 2 weeks of intervention
|
Measurement of arterial oxygen saturation using arterial blood gas analysis.
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Baseline and after 2 weeks of intervention
|
|
Forced Vital Capacity (FVC)
Periodo de tiempo: Baseline and after 2 weeks of intervention
|
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)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline and after 2 weeks of intervention
|
Assessment of peak expiratory flow rate using spirometry.
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Baseline and after 2 weeks of intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF)
Periodo de tiempo: Baseline and after 2 weeks
|
Measurement of cardiac function using echocardiography (Simpson's biplane method).
|
Baseline and after 2 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Arjumand Bano, MS, Riphah International University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
28 de mayo de 2026
Finalización primaria (Estimado)
28 de junio de 2026
Finalización del estudio (Estimado)
29 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
2 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
5 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- REC/RCR & AHS/25/0322
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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