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

NCT01300442 | Unknown Phase 1 DMC

• 1 other identifier: DC1901-PNPD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

chronic obstructive pulmonary disease; diaphragm; electrical stimulation; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Respiratory pattern

  During the session of transcutaneous electrical diaphragmatic stimulation

Study Arms (2)

Control

EXPERIMENTAL

The transcutaneous electrical diaphragmatic stimulation will be applied in healthy and COPD subjects.

Other: TEDS in healthy patients

Chronic Obstructive Pulmonary Disease

EXPERIMENTAL

The intervention will be the TEDS in patients with Chronic Obstructive Pulmonary Disease (COPD)

Other: TEDS in COPD patients

Interventions

TEDS in COPD patients OTHER

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®).

Chronic Obstructive Pulmonary Disease

TEDS in healthy patients OTHER

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®).

Control

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stable COPD (diagnosed by accepted criteria)
• Healthy patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

UFSCar

São Carlos, São Paulo, 13565-905, Brazil

RECRUITING

Related Publications (1)

• Cancelliero-Gaiad KM, Ike D, Pantoni CB, Mendes RG, Borghi-Silva A, Costa D. Acute effects of transcutaneous electrical diaphragmatic stimulation on respiratory pattern in COPD patients: cross-sectional and comparative clinical trial. Braz J Phys Ther. 2013 Nov-Dec;17(6):547-55. doi: 10.1590/S1413-35552012005000121. Epub 2013 Nov 14.

  PMID: 24271095 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirceu Costa, PhD

  UFSCar

  STUDY DIRECTOR

Central Study Contacts

Dirceu Costa, PhD

CONTACT

55-11-3665-9325; dirceu@ufscar.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 21, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 21, 2011

Record last verified: 2011-01

Locations

BR (1)