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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Arjumand Bano, MS
- Telefonnummer: +92 305 9551883
- E-post: arjumand.bano@riphah.edu.pk
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Partial Pressure of Oxygen (PaO₂)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Left Ventricular Ejection Fraction (LVEF)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Arjumand Bano, MS, Riphah International University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- REC/RCR & AHS/25/0322
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