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Not yet recruitingNCT07629037Updated Jun 5, 2026

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

An interventional study of Neuromuscular Electrical Stimulation (NMES) and Standard Cardiac Rehabilitation in Percutaneous Coronary Intervention, sponsored by Riphah International University. Not yet recruiting. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Percutaneous Coronary Intervention

Keywords

  • Cardiac Rehab Coronary Stent
03

In context

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • 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.

    Device: Neuromuscular Electrical Stimulation (NMES)

  • Active comparator
    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).

    Other: Standard Cardiac Rehabilitation

Interventions

  • DeviceNeuromuscular Electrical Stimulation (NMES)

    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

  • OtherStandard Cardiac Rehabilitation

    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.

06

What researchers measure

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

  5. Forced Expiratory Volume in 1 Second (FEV₁)

    Assessment of forced expiratory volume in 1 second using spirometry.

    Time frame: Baseline and after 2 weeks of intervention

  6. Peak Expiratory Flow Rate (PEFR)

    Assessment of peak expiratory flow rate 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

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07629037
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jun 5, 2026
Start date
May 28, 2026 (estimated)
Primary completion
Jun 28, 2026 (estimated)
Completion
Jun 29, 2026 (estimated)
Last update
Jun 5, 2026

Study contacts

Arjumand Bano, MS
Contact
arjumand.bano@riphah.edu.pk
+92 305 9551883
Arjumand Bano, MS
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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