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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Arjumand Bano, MS
- Numéro de téléphone: +92 305 9551883
- E-mail: arjumand.bano@riphah.edu.pk
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Partial Pressure of Oxygen (PaO₂)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Left Ventricular Ejection Fraction (LVEF)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Arjumand Bano, MS, Riphah International University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- REC/RCR & AHS/25/0322
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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