Transcutaneous Electrical Muscle Stimulation In Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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Transcutaneous electrical muscle stimulation (TCEMS) is well established intervention for rehabilitation of clinically stable patients with chronic obstructive pulmonary disease. The investigators have conceived this study to test whether TCEMS is feasible and tolerated by patients experiencing severe physical and psychical challenge of acutely exacerbated COPD.

Official Title
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Transcutaneous Electrical Muscle Stimulation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Transcutaneous electrical muscle stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic obstructive pulmonary disease GOLD stage III or IV acute exacerbation of the disease Exclusion Criteria: contraindications for transcutaneous electrical muscle stimulation

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCEMS<br>Patients who will receive transcutaneous electrical muscle stimulation | Device: Transcutaneous electrical muscle stimulation<br>* On the first hospitalization day patients received lower extremity TCEMS. We used GymnaUniphy device (GymnaUniphy N.V., 2004, 3740 Bilzen, Belgium) with four surface patch electrodes applied over each lower extremity quadriceps muscle. Patients were in the supine position and were advised to relax during sessions. A prespecified program for lower extremity strength training in sessions of 25 minutes, twice a day (first training in the morning, second in the afternoon, with minimal time difference of 6 hours) was performed six days per week during the hospitalization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on the feasibility scale | Patients will be followed from admission until discharge | 10 days (avarage time from admission to discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on the patient satisfaction scale | Patients will be followed from admission until discharge | 10 days (avarage time from admission to discharge) | 
| Number of patients with adverse events as a measure of Safety and tolerability | Patients will be followed from admission until discharge | 10 days (avarage time from admission to discharge) | 
| Health related quality of life on the St. George respiratory questionnaire | Patients will be followed from admission until discharge | 10 days (avarage time from admission to discharge) | 
| Dyspnea on the MRC dyspnea scale | Patients will be followed from admission until discharge | 10 days (avarage time from admission to discharge) | 
| Patient symptom scores on the Functional assessment of chronic illness therapy questionaire | Patients will be followed from admission until discharge | 10 days (avarage time from admission to discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease