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

Phase 1

• Conditions: COPD
• Interventions: Other: TEDS in healthy patients; Other: TEDS in COPD patients

• Registration Number: NCT01300442
• Lead Sponsor: Universidade Federal de Sao Carlos

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-02
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-18
• Last Update Submitted: 2011-02-18
• Study First Posted: 2011-02-21
• Last Update Posted: 2011-02-21
• Primary Completion: 2011-04
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	TEDS in healthy patients	The transcutaneous electrical diaphragmatic stimulation will be applied in healthy and COPD subjects.
Chronic Obstructive Pulmonary Disease	TEDS in COPD patients	The intervention will be the TEDS in patients with Chronic Obstructive Pulmonary Disease (COPD)

Primary Outcome Measures

Name	Time	Method
Respiratory muscle strength and spirometry	06 weeks	Respiratory muscle strength: maximal inspiratory pressure (cH2O) and maximal expiratory pressure (cH2O) by manovacuometer (Gerar®) Spirometry by Spirometer EasyOne®

Secondary Outcome Measures

Name	Time	Method
Respiratory pattern	During the session of transcutaneous electrical diaphragmatic stimulation	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 (%).

Trial Locations

Locations (1)

UFSCar; 🇧🇷 São Carlos, São Paulo, Brazil