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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Universidade Federal de Sao Carlos.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT01300442
First received: February 18, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
COPD
 Other: TEDS in COPD patients
Other: TEDS in healthy patients
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Fundamentation of TEDS Protocol in Healthy Subjects and Its Application in COPD Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Federal de Sao Carlos:

Primary Outcome Measures:
  • Respiratory muscle strength and spirometry [ Time Frame: 06 weeks ] [ Designated as safety issue: Yes ]
    Respiratory muscle strength: maximal inspiratory pressure (cH2O) and maximal expiratory pressure (cH2O) by manovacuometer (Gerar®) Spirometry by Spirometer EasyOne®


Secondary Outcome Measures:
  • Respiratory pattern [ Time Frame: During the session of transcutaneous electrical diaphragmatic stimulation ] [ Designated as safety issue: Yes ]
    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 (%).


Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control
The transcutaneous electrical diaphragmatic stimulation will be applied in healthy and COPD subjects.
 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.
Other Name: The equipment is the Dualpex 961 model Phrenics (Quark®).
Experimental: Chronic Obstructive Pulmonary Disease
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.
Other Name: The equipment is the Dualpex 961 model Phrenics (Quark®).

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300442

Contacts
Contact: Dirceu Costa, PhD 55-11-3665-9325 dirceu@ufscar.br

Locations
Brazil
UFSCar Recruiting
São Carlos, São Paulo, Brazil, 13565-905
Contact: Dirceu Costa, PhD     55 - 11 - 3665-9325     dirceu@ufscar.br    
Principal Investigator: Dirceu Costa, PhD            
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Dirceu Costa, PhD UFSCar
  More Information

No publications provided

Responsible Party: Dr. Dirceu Costa, PNPD / CNPq
ClinicalTrials.gov Identifier: NCT01300442     History of Changes
Other Study ID Numbers: DC1901-PNPD
Study First Received: February 18, 2011
Last Updated: February 18, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal de Sao Carlos:
chronic obstructive pulmonary disease
diaphragm
electrical stimulation
pulmonary rehabilitation

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013