NCT07910006Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
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)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- Universitas Padjadjaran
- Diseases
- COPD
- NCT number
- NCT07910006
What you commit to
- Study type: Interventional
- Planned participants: 45
- From Oct 2026 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of systemic (oral) corticosteroids or history of use within 4 weeks prior to enrollment.
Other illness
- Recent thoracic or abdominal surgery, pneumothorax, or a history of spontaneous pneumothorax.
- 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.
Other
- Participation in other structured respiratory muscle training or pulmonary rehabilitation programs that may confound the study results.
- Presence of skin lesions, open wounds, or active dermatitis in the intended electrode placement areas.
Who the study is looking for
- 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.
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine Universitas Padjadjaran Coordinator of this site? Confirm its status | Bandung | Indonesia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.