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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01300442

Acronym

COPD

Enrollment

Registered

2011-02-21

Start date

2011-02-28

Completion date

2011-05-31

Last updated

2011-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

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

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.

Interventions

OTHERTEDS 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.

OTHERTEDS in healthy patients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 (%).

Countries

Brazil

Contacts

Primary ContactDirceu Costa, PhD

dirceu@ufscar.br55-11-3665-9325

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026