An interventional study of Neuromuscular Electric Stimulation and Exercise in Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction and Muscle Weakness, sponsored by Universitas Padjadjaran. Recruiting at 1 site in Indonesia. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Universitas Padjadjaran · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 45 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Universitas Padjadjaran is the lead sponsor of 93 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Neuromuscular Electric Stimulation · Other: Exercise
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.
Device: Neuromuscular Electric Stimulation · Other: Exercise
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.
Device: Neuromuscular Electric Stimulation · Other: Exercise
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.
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).
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.
Time frame: 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.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
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.
Time frame: 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.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Six-Minute Walk Test (6MWT) Distance
Measured by the total distance in meters that a participant can walk quickly on a flat, hard surface in a period of 6 minutes. It evaluates functional exercise capacity.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Modified Medical Research Council (mMRC) Dyspnea Scale
A questionnaire used to rate the baseline dyspnea (breathlessness) on a scale from 0 (breathless only with strenuous exercise) to 4 (too breathless to leave the house). Lower scores indicate less respiratory disability.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
COPD Assessment Test (CAT) Score
An 8-item questionnaire measuring the health status impairment in COPD patients. Scores range from 0 to 40, where higher scores signify a worse health status and severe impact of COPD on the patient's life.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Modified Borg Scale (MBS) for Dyspnea
A categorical scale ranging from 0 (no breathlessness at all) to 10 (maximal breathlessness) used to assess the patient's perceived level of shortness of breath during functional activity or rest.
Time frame: Baseline (Week 0) and post-intervention (Week 8)
Plan to share: No — Individual participant data will not be made publicly available to protect participant privacy
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →
Universitas Padjadjaran