Effects of Transcutaneous Electrical Diaphragmatic Stimulation on Respiratory Variables in COPD Patients

Study Overview
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Brief Summary
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Transcutaneous electrical diaphragmatic stimulation (TEDS) has been used to improve respiratory muscle strength in patients with respiratory muscles weakness. However, this physiotherapeutic resource has not been studied in chronic obstructive pulmonary disease (COPD) yet. The objective of this study is to evaluate the respiratory pattern during the session of TEDS besides its effect in respiratory muscle strength and in spirometric variables as much healthy patients as in COPD patients. Methods: healthy and COPD patients are selected and submitted to TEDS treatment. The plethysmographic analysis (LifeShirt System - VivoMetric), respiratory muscle strength and spirometry will be made. The hypothesis is that the TEDS can helps COPD patients that shows respiratory muscle weakness.

Official Title
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Fundamentation of TEDS Protocol in Healthy Subjects and Its Application in COPD Patients

Conditions
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COPD

Intervention / Treatment
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* Other: TEDS in COPD patients
* Other: TEDS in healthy patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stable COPD (diagnosed by accepted criteria) Healthy patients Exclusion Criteria: FOR THE COPD PATIENTS: Over 80 years of age History of recent exacerbation Patients with pacemakers Uncontrolled arterial hypertension Requiring home oxygen therapy. FOR THE HEALTHY PATIENTS: Pulmonary diseases Cardiovascular diseases Orthopedic diseases Neurologic diseases.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>The transcutaneous electrical diaphragmatic stimulation will be applied in healthy and COPD subjects. | Other: TEDS in healthy patients<br>* For the TEDS (transcutaneous electrical diaphragmatic stimulation) the electrical current is pulsed, biphasic and symmetric, with the following parameters: frequency of 30 Hertz; 0.4ms phase width, rise time of 0.7 seconds; respiratory rate of 14 rpm; intensity is the minimum necessary to obtain diaphragm muscle contraction. Four silicone-carbon electrodes (3x5cm) were placed on the skin with gel and micropore tape. Two electrodes were located on each side of the thorax, specifically in the 3rd intercostal space near the xyphoid region and in the 7th intercostal space, on the mid-axillary line. Each session had duration of approximately 30 minutes and the subjects were instructed to co-ordinate breathing with the pulsing of the electrical current.<br>* Other names: The equipment is the Dualpex 961 model Phrenics (Quark®).;|
| Experimental: Chronic Obstructive Pulmonary Disease<br>The intervention will be the TEDS in patients with Chronic Obstructive Pulmonary Disease (COPD) | Other: TEDS in COPD patients<br>* For the TEDS (transcutaneous electrical diaphragmatic stimulation) the electrical current is pulsed, biphasic and symmetric, with the following parameters: frequency of 30 Hertz; 0.4ms phase width, rise time of 0.7 seconds; respiratory rate of 14 rpm; intensity is the minimum necessary to obtain diaphragm muscle contraction. Four silicone-carbon electrodes (3x5cm) were placed on the skin with gel and micropore tape. Two electrodes were located on each side of the thorax, specifically in the 3rd intercostal space near the xyphoid region and in the 7th intercostal space, on the mid-axillary line. Each session had duration of approximately 30 minutes and the subjects were instructed to co-ordinate breathing with the pulsing of the electrical current.<br>* Other names: The equipment is the Dualpex 961 model Phrenics (Quark®).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle strength and spirometry | Respiratory muscle strength: maximal inspiratory pressure (cH2O) and maximal expiratory pressure (cH2O) by manovacuometer (Gerar®) Spirometry by Spirometer EasyOne® | 06 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory pattern | Inductance pletismography by LifeShirt® (VivoMetrics). The variables are: inspiratory tidal volume (ViVol); expiratory tidal volume (VeVol); minute ventilation (VE) in liters; inspiratory time (Ti); expiratory time (Te); total breath time (Tt) in seconds; phase relation during inspiration (PhRIB); phase relation during expiration (PhREB); phase relation of the entire breath (PhRTB) and phase angle (PhAng) in percentage (%). | During the session of transcutaneous electrical diaphragmatic stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic obstructive pulmonary disease, diaphragm, electrical stimulation, pulmonary rehabilitation