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

NCT07629037 | Not Yet Recruiting

• 1 other identifier: REC/RCR & AHS/25/0322
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Percutaneous Coronary Intervention

Keywords

Cardiac Rehab Coronary Stent

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (1)

• Left Ventricular Ejection Fraction (LVEF)

  Baseline and after 2 weeks

Study Arms (2)

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.

Device: Neuromuscular Electrical Stimulation (NMES)

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).

Other: Standard Cardiac Rehabilitation

Interventions

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.

Also known as: Diaphragmatic NMES; Abdominal NMES

NMES + Standard Cardiac Rehabilitation

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.

Standard Cardiac Rehabilitation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Officials

• Arjumand Bano, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arjumand Bano, MS

CONTACT

+92 305 9551883; arjumand.bano@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: June 5, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): June 29, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share