Chronic Obstructive Pulmonary Disease (COPD)NMES in COPDNCT07910006
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
A study testing Neuromuscular Electric Stimulation and Exercise in people with Chronic Obstructive Pulmonary Disease (COPD) and Respiratory Muscle Dysfunction, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn if targeted neuromuscular electrical stimulation (NMES) can treat respiratory and peripheral muscle weakness in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction, Muscle Weakness
- What is being tested?
- Neuromuscular Electric Stimulation and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2026to Mar 2028
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with stable Chronic Obstructive Pulmonary Disease (COPD), GOLD spirometric grade 2-4 (post-bronchodilator FEV1/FVC <0.70 with FEV1 <80% predicted), confirmed by a pulmonologist.
- Age between 40 and 85 years old.
- Willing to participate in the study and sign the written informed consent form.
Who cannot join
- Recent thoracic or abdominal surgery, pneumothorax, or a history of spontaneous pneumothorax.
- Participation in other structured respiratory muscle training or pulmonary rehabilitation programs that may confound the study results.
- Presence of neuromuscular, bulbar, laryngeal, or other disorders that may independently impair respiratory muscle function.
- Use of a cardiac pacemaker or any metal/electronic implant at the intended stimulation area.
- Diagnosis of heart failure classified as NYHA (New York Heart Association) class III-IV.
- Presence of skin lesions, open wounds, or active dermatitis in the intended electrode placement areas.
- Current use of systemic (oral) corticosteroids or history of use within 4 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Faculty of Medicine Universitas Padjadjaran
Bandung, West Java
About this study
Official title: COMPARATIVE EFFECTS OF TARGETED NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) ON RESPIRATORY AND PERIPHERAL MUSCLES IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD): A MULTIMODAL ASSESSEMENT USING DIAPHRAGM ULTRASOUND AND PLASMA BIOMARKERS (IL-6 AND IGF-1)
The goal of this clinical trial is to learn if targeted neuromuscular electrical stimulation (NMES) can treat respiratory and peripheral muscle weakness in patients with chronic obstructive pulmonary disease (COPD). The main questions it aims to answer are:
- Does targeted NMES improve diaphragm thickening fraction and excursion as measured by diaphragm ultrasound?
- What are the comparative effects of targeted NMES on plasma biomarkers, specifically Interleukin-6 (IL-6) and Insulin-like Growth Factor-1 (IGF-1)? Researchers will compare three groups: the first intervention group receiving intercostal NMES combined with Pursed-Lip Breathing (PLB), the second intervention group receiving quadriceps NMES combined with PLB, and a control group receiving sham upper trapezius NMES combined with PLB, to see if targeted NMES provides superior improvements in respiratory and peripheral muscle function.
Read more
Participants will:
- Undergo baseline screening, including a diaphragm ultrasound and a blood draw for plasma biomarkers (IL-6 and IGF-1)
- Be randomly assigned to one of the three groups to receive either intercostal NMES, quadriceps NMES, or sham upper trapezius NMES, all combined with Pursed-Lip Breathing exercises
- Complete a post-intervention assessment involving repeat ultrasound imaging and biomarker analysis to evaluate muscle and systemic changes
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic airflow limitation and progressive respiratory and peripheral muscle dysfunction. While pulmonary rehabilitation is a cornerstone of management, severe breathlessness often limits a patient's exercise tolerance. Neuromuscular Electrical Stimulation (NMES) offers an alternative modality to train specific muscle groups without inducing severe dyspnea. However, the comparative efficacy of stimulating respiratory muscles versus peripheral muscle groups requires deeper investigation using precise physiological and biochemical markers.
This study utilizes a three-arm randomized controlled design to evaluate and compare the localized and systemic effects of targeted NMES. The mechanical properties of the respiratory system will be monitored using diaphragm ultrasound, focusing on active contractility and movement. Concurrently, systemic inflammation and muscle anabolic responses will be analyzed through plasma biomarkers to understand the underlying biomolecular pathways.
Upon meeting the eligibility criteria and providing written informed consent, the 45 participants will be randomly assigned to one of three study arms in a 1:1:1 ratio. All participants will undergo a standardized baseline assessment. Following the allocation, each group will complete their designated 8-week intervention protocol consisting of 3 sessions per week (total of 24 sessions) concurrently with Pursed-Lip Breathing (PLB) training. A comprehensive post-intervention reassessment will be conducted immediately following the final session to determine the comparative physiological and biochemical outcomes.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction, Muscle Weakness
- Being tested
- Neuromuscular Electric Stimulation, Exercise
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Neuromuscular Electrical Stimulation, NMES, Diaphragm Ultrasound, Diaphragm Excursion, Thickening Fraction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electric StimulationDevice
Neuromuscular Electrical Stimulation (NMES) is a procedure that uses small electrical impulses delivered through electrodes on the skin to stimulate motor nerves and cause passive muscle contractions.
ExerciseOther
Pursed-lip breathing is a simple respiratory exercise that involves inhaling slowly through your nose and exhaling gently through tightly puckered or "pursed" lips (as if whistling or blowing out a candle).
| Study group | Role | What they receive |
|---|---|---|
| Intercostal NMES + PLB | Experimental | Participants receive targeted NMES to the intercostal muscles combined with Pursed-Lip Breathing (PLB) exercises. The protocol is administered 3 times per week for 8 weeks. Receives: Device: Neuromuscular Electric Stimulation; Other: Exercise |
| Quadriceps NMES + PLB | Experimental | Participants receive targeted NMES to the quadriceps muscles combined with Pursed-Lip Breathing (PLB) exercises. The protocol is administered 3 times per week for 8 weeks. Receives: Device: Neuromuscular Electric Stimulation; Other: Exercise |
| Sham NMES + PLB | Placebo comparator | Participants receive sham NMES to the upper trapezius muscles combined with Pursed-Lip Breathing (PLB) exercises. The protocol is administered 3 times per week for 8 weeks. Receives: Device: Neuromuscular Electric Stimulation; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Excursion (DE)
Measured via B-mode or M-mode transabdominal ultrasound during quiet and deep breathing to evaluate the distance the diaphragm travels vertically. A higher excursion value indicates better diaphragmatic mobility.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Diaphragm Thickening Fraction (TF)
Calculated using the formula: [(Thickness at end-inspiration - Thickness at end-expiration) / Thickness at end-expiration] x 100%. Measured via high-frequency linear ultrasound at the zone of apposition to assess diaphragmatic contractile function.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Secondary outcomes (2)
Change in Plasma Interleukin-6 (IL-6) Levels
Measured via Enzyme-Linked Immunosorbent Assay (ELISA) from venous blood samples to evaluate systemic inflammatory profiles. Decreased levels indicate a reduction in systemic inflammation.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Change in Plasma Insulin-like Growth Factor-1 (IGF-1) Levels
Measured via Enzyme-Linked Immunosorbent Assay (ELISA) from venous blood samples to evaluate muscle anabolic activity and systemic growth factor response. Increased levels indicate an improved anabolic state.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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
- This study utilizes a prospective, randomized, 3-arm parallel-group design with a 1:1:1 allocation ratio. Eligible participants with Chronic Obstructive Pulmonary Disease (COPD) will be randomly allocated into one of three parallel groups upon completion of the baseline assessment: Experimental Group 1 (Intercostal NMES + PLB), Experimental Group 2 (Quadriceps NMES + PLB), or the Placebo Control Group (Sham Upper Trapezius NMES + PLB). All participants will undergo their respective protocols concurrently for a duration of 8 weeks, with identical assessment time points at baseline (Week 0) and post-intervention (Week 8) to compare localized respiratory, peripheral, and systemic biomarkers across the arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Collaborators
- Maranatha Christian University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910006
- Sponsor's protocol ID
- IKFR-202609.01
- Other IDs
- 004/PEG-PRJ/SL/UKM/X/2026
- Acronym
- NMES in COPD
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available to protect participant privacy
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE EFFECTS OF TARGETED NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) ON RESPIRATORY AND PERIPHERAL MUSCLES IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD): A MULTIMODAL ASSESSEMENT USING DIAPHRAGM ULTRASOUND AND PLASMA BIOMARKERS (IL-6 AND IGF-1)
- ClinicalTrials.gov ID
- NCT07910006
- Acronym / sponsor ID
- NMES in COPD / IKFR-202609.01
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction, Muscle Weakness
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Neuromuscular Electrical Stimulation, NMES, Diaphragm Ultrasound, Diaphragm Excursion, Thickening Fraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Collaborators
- Maranatha Christian University
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 2 Nov 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.
The goal of this clinical trial is to learn if targeted neuromuscular electrical stimulation (NMES) can treat respiratory and peripheral muscle weakness in patients with chronic obstructive pulmonary disease (COPD). The main questions it aims to answer are:
- Does targeted NMES improve diaphragm thickening fraction and excursion as measured by diaphragm ultrasound?
- What are the comparative effects of targeted NMES on plasma biomarkers, specifically Interleukin-6 (IL-6) and Insulin-like Growth Factor-1 (IGF-1)? Researchers will compare three groups: the first intervention group receiving intercostal NMES combined with Pursed-Lip Breathing (PLB), the second intervention group receiving quadriceps NMES combined with PLB, and a control group receiving sham upper trapezius NMES combined with PLB, to see if targeted NMES provides superior improvements in respiratory and peripheral muscle function.
Participants will:
- Undergo baseline screening, including a diaphragm ultrasound and a blood draw for plasma biomarkers (IL-6 and IGF-1)
- Be randomly assigned to one of the three groups to receive either intercostal NMES, quadriceps NMES, or sham upper trapezius NMES, all combined with Pursed-Lip Breathing exercises
- Complete a post-intervention assessment involving repeat ultrasound imaging and biomarker analysis to evaluate muscle and systemic changes
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic airflow limitation and progressive respiratory and peripheral muscle dysfunction. While pulmonary rehabilitation is a cornerstone of management, severe breathlessness often limits a patient's exercise tolerance. Neuromuscular Electrical Stimulation (NMES) offers an alternative modality to train specific muscle groups without inducing severe dyspnea. However, the comparative efficacy of stimulating respiratory muscles versus peripheral muscle groups requires deeper investigation using precise physiological and biochemical markers.
This study utilizes a three-arm randomized controlled design to evaluate and compare the localized and systemic effects of targeted NMES. The mechanical properties of the respiratory system will be monitored using diaphragm ultrasound, focusing on active contractility and movement. Concurrently, systemic inflammation and muscle anabolic responses will be analyzed through plasma biomarkers to understand the underlying biomolecular pathways.
Upon meeting the eligibility criteria and providing written informed consent, the 45 participants will be randomly assigned to one of three study arms in a 1:1:1 ratio. All participants will undergo a standardized baseline assessment. Following the allocation, each group will complete their designated 8-week intervention protocol consisting of 3 sessions per week (total of 24 sessions) concurrently with Pursed-Lip Breathing (PLB) training. A comprehensive post-intervention reassessment will be conducted immediately following the final session to determine the comparative physiological and biochemical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study utilizes a prospective, randomized, 3-arm parallel-group design with a 1:1:1 allocation ratio. Eligible participants with Chronic Obstructive Pulmonary Disease (COPD) will be randomly allocated into one of three parallel groups upon completion of the baseline assessment: Experimental Group 1 (Intercostal NMES + PLB), Experimental Group 2 (Quadriceps NMES + PLB), or the Placebo Control Group (Sham Upper Trapezius NMES + PLB). All participants will undergo their respective protocols concurrently for a duration of 8 weeks, with identical assessment time points at baseline (Week 0) and post-intervention (Week 8) to compare localized respiratory, peripheral, and systemic biomarkers across the arms.
| Arm | Type | Receives |
|---|---|---|
| Intercostal NMES + PLB | Experimental | Device: Neuromuscular Electric Stimulation, Other: ExerciseParticipants receive targeted NMES to the intercostal muscles combined with Pursed-Lip Breathing (PLB) exercises. The protocol is administered 3 times per week for 8 weeks. |
| Quadriceps NMES + PLB | Experimental | Device: Neuromuscular Electric Stimulation, Other: ExerciseParticipants receive targeted NMES to the quadriceps muscles combined with Pursed-Lip Breathing (PLB) exercises. The protocol is administered 3 times per week for 8 weeks. |
| Sham NMES + PLB | Placebo comparator | Device: Neuromuscular Electric Stimulation, Other: ExerciseParticipants receive sham NMES to the upper trapezius muscles combined with Pursed-Lip Breathing (PLB) exercises. The protocol is administered 3 times per week for 8 weeks. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with stable Chronic Obstructive Pulmonary Disease (COPD), GOLD spirometric grade 2-4 (post-bronchodilator FEV1/FVC <0.70 with FEV1 <80% predicted), confirmed by a pulmonologist.
- Age between 40 and 85 years old.
- Willing to participate in the study and sign the written informed consent form.
Key exclusion criteria (7 listed)
- Recent thoracic or abdominal surgery, pneumothorax, or a history of spontaneous pneumothorax.
- Participation in other structured respiratory muscle training or pulmonary rehabilitation programs that may confound the study results.
- Presence of neuromuscular, bulbar, laryngeal, or other disorders that may independently impair respiratory muscle function.
- Use of a cardiac pacemaker or any metal/electronic implant at the intended stimulation area.
- Diagnosis of heart failure classified as NYHA (New York Heart Association) class III-IV.
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 Electric StimulationNeuromuscular Electrical Stimulation (NMES) is a procedure that uses small electrical impulses delivered through electrodes on the skin to stimulate motor nerves and cause passive muscle contractions. | Device | Intercostal NMES + PLB, Quadriceps NMES + PLB, Sham NMES + PLB |
| ExercisePursed-lip breathing is a simple respiratory exercise that involves inhaling slowly through your nose and exhaling gently through tightly puckered or "pursed" lips (as if whistling or blowing out a candle). | Other | Intercostal NMES + PLB, Quadriceps NMES + PLB, Sham NMES + PLB |
Primary outcome
Diaphragm Excursion (DE)
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Measured via B-mode or M-mode transabdominal ultrasound during quiet and deep breathing to evaluate the distance the diaphragm travels vertically. A higher excursion value indicates better diaphragmatic mobility.
Diaphragm Thickening Fraction (TF)
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Calculated using the formula: [(Thickness at end-inspiration - Thickness at end-expiration) / Thickness at end-expiration] x 100%. Measured via high-frequency linear ultrasound at the zone of apposition to assess diaphragmatic contractile function.
2 secondary outcomes
Change in Plasma Interleukin-6 (IL-6) Levels
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Change in Plasma Insulin-like Growth Factor-1 (IGF-1) Levels
Time frame: Baseline (Week 0) and post-intervention (Week 8)
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 2 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available to protect participant privacy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electric Stimulation and Exercise in people with Chronic Obstructive Pulmonary Disease (COPD) and Respiratory Muscle Dysfunction, run by Universitas Padjadjaran at 1 site in Indonesia.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Dian Marta Sari, Physiatrist (+62 812 2181 227, dian.marta@unpad.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm Excursion (DE) (time frame: Baseline (Week 0) and post-intervention (Week 8)). The study lists 2 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 2 Nov 2026.