NCT01300442

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universidade Federal de Sao Carlos · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• COPD

Interventions

Type	Name	Description
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.
OTHER	TEDS in healthy 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.

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2011-02-21
• Last updated: 2011-02-21

Locations

1 site across 1 country: Brazil