A Phase 1/2 interventional study of TEDS in COPD patients and TEDS in healthy patients in COPD, sponsored by Universidade Federal de Sao Carlos. Status unknown at 1 site in Brazil. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-21.
Sponsored by Universidade Federal de Sao Carlos · Phase 1/2, Interventional, and Treatment
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.
Universidade Federal de Sao Carlos is the lead sponsor of 85 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
The transcutaneous electrical diaphragmatic stimulation will be applied in healthy and COPD subjects.
Other: TEDS in healthy patients
The intervention will be the TEDS in patients with Chronic Obstructive Pulmonary Disease (COPD)
Other: TEDS in COPD patients
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.
Also known as: The equipment is the Dualpex 961 model Phrenics (Quark®).
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.
Also known as: The equipment is the Dualpex 961 model Phrenics (Quark®).
Respiratory muscle strength and spirometry
Respiratory muscle strength: maximal inspiratory pressure (cH2O) and maximal expiratory pressure (cH2O) by manovacuometer (Gerar®) Spirometry by Spirometer EasyOne®
Time frame: 06 weeks
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 (%).
Time frame: During the session of transcutaneous electrical diaphragmatic stimulation
This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Universidade Federal de Sao Carlos