Targeted NMES to improve breathing and leg/extra muscle strength in COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized three-arm trial, adults with stable COPD will receive either intercostal NMES with pursed-lip breathing, quadriceps NMES with pursed-lip breathing, or sham upper trapezius NMES with pursed-lip breathing, each for 8 weeks (24 sessions total). Primary assessments include diaphragm ultrasound to measure thickening and movement, along with blood tests for IL-6 and IGF-1 to gauge inflammation and muscle growth signals. The trial aims to compare localized respiratory-muscle stimulation with peripheral-muscle stimulation against a sham control to determine differential effects on respiratory and peripheral muscle function. Participants will undergo baseline and post-treatment evaluations, with safety monitoring during the intervention period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Faculty of Medicine Universitas Padjadjaran
  Bandung, West Java, Indonesia Recruiting

Study contacts

• Study coordinator: Dian Marta Sari, Physiatrist
• Email: dian.marta@unpad.ac.id
• Phone: +62 812 2181 227

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.