Percutaneous Coronary InterventionNCT07629037
Effects of Diaphragmatic and Abdominal Neuromuscular Electrical Stimulation in Post-PCI Patients
A study testing Neuromuscular Electrical Stimulation (NMES) and Standard Cardiac Rehabilitation in people with Percutaneous Coronary Intervention, run by Riphah International University.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Neuromuscular Electrical Stimulation (NMES) and Standard Cardiac Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2026to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- Neuromuscular Electrical Stimulation (NMES), Standard Cardiac Rehabilitation
- Keywords
- Cardiac Rehab Coronary Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical Stimulation (NMES)Device
Also called Diaphragmatic NMES; Abdominal 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.
Standard Cardiac RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Standard Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial Pressure of Oxygen (PaO₂)
Measurement of arterial partial pressure of oxygen using arterial blood gas analysis.
Measured: 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.
Measured: Baseline and after 2 weeks of intervention
Arterial Oxygen Saturation (SaO₂)
Measurement of arterial oxygen saturation using arterial blood gas analysis.
Measured: Baseline and after 2 weeks of intervention
Forced Vital Capacity (FVC)
Assessment of forced vital capacity using spirometry.
Measured: Baseline and after 2 weeks of intervention
Forced Expiratory Volume in 1 Second (FEV₁)
Assessment of forced expiratory volume in 1 second using spirometry.
Measured: Baseline and after 2 weeks of intervention
Peak Expiratory Flow Rate (PEFR)
Assessment of peak expiratory flow rate using spirometry.
Measured: 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).
Measured: Baseline and after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start28 May 2026 (estimated)
- Primary completion28 Jun 2026 (estimated)
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjumand Bano, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629037
- Sponsor's protocol ID
- REC/RCR & AHS/25/0322
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragmatic and Abdominal Neuromuscular Electrical Stimulation on Arterial Blood Gases, Pulmonary Function, Ejection Fraction and Functional Capacity in Post-PCI Patients
- ClinicalTrials.gov ID
- NCT07629037
- Acronym / sponsor ID
- REC/RCR & AHS/25/0322
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- Cardiac Rehab Coronary Stent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 May 2026 (estimated)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| NMES + Standard Cardiac Rehabilitation | Experimental | Device: Neuromuscular Electrical Stimulation (NMES)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. |
| Standard Cardiac Rehabilitation | Active comparator | Other: Standard Cardiac RehabilitationParticipants 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). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Electrical Stimulation (NMES)Also: Diaphragmatic NMES; Abdominal NMESA 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. | Device | NMES + Standard Cardiac Rehabilitation |
| Standard Cardiac RehabilitationA structured cardiac rehabilitation program including aerobic exercise, breathing exercises, and patient education delivered according to institutional protocols, without the use of neuromuscular electrical stimulation. | Other | Standard Cardiac Rehabilitation |
Primary outcome
Partial Pressure of Oxygen (PaO₂)
Time frame: Baseline and after 2 weeks of intervention
Measurement of arterial partial pressure of oxygen using arterial blood gas analysis.
Partial Pressure of Carbon Dioxide (PaCO₂)
Time frame: Baseline and after 2 weeks of intervention
Measurement of arterial partial pressure of carbon dioxide using arterial blood gas analysis.
Arterial Oxygen Saturation (SaO₂)
Time frame: Baseline and after 2 weeks of intervention
Measurement of arterial oxygen saturation using arterial blood gas analysis.
Forced Vital Capacity (FVC)
Time frame: Baseline and after 2 weeks of intervention
Assessment of forced vital capacity using spirometry.
Forced Expiratory Volume in 1 Second (FEV₁)
Time frame: Baseline and after 2 weeks of intervention
Assessment of forced expiratory volume in 1 second using spirometry.
Peak Expiratory Flow Rate (PEFR)
Time frame: Baseline and after 2 weeks of intervention
Assessment of peak expiratory flow rate using spirometry.
1 secondary outcome
Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline and after 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Percutaneous Coronary Intervention
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arjumand Bano, MS principal investigator
Riphah International University
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation (NMES) and Standard Cardiac Rehabilitation in people with Percutaneous Coronary Intervention, run by Riphah International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arjumand Bano, MS (+92 305 9551883, arjumand.bano@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial Pressure of Oxygen (PaO₂) (time frame: Baseline and after 2 weeks of intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.