Transcutaneous Electrical Diaphragmatic Stimulation and Inspiratory Muscle Training in Patients With COPD Exacerbated

NCT03844711 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-05-03

No results posted yet for this study

Summary

Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic airflow limitation, a qualification of impairment of respiratory muscle function, including hyperinflation and muscle weakness. Thus, pulmonary rehabilitation is indicated for patients and is recommended for even the most severe cases. However some patients do not conclude conventional rehabilitation protocols, due to exercise intolerance, are then an electrical estimation and muscle training respiratory adjuvant treatments for patients. and little has been explored about the effects and methodologies of using transcutaneous electrical diaphragmatic stimulation (TEDS) in healthy subjects. The objective of this study on stage I is to evaluate the acute effect of transcutaneous electrical diaphragmatic stimulation on respiratory muscle strength, cardiac variability, thickness, resistance, mobility and diaphragmatic activation comparing different frequencies of electrical stimulation in healthy individuals. The objective of this study on stage II is to evaluate the effects of transcutaneous electrical diaphragmatic stimulation, compared to inspiratory muscle training on respiratory muscle strength, security of the technics, thickness and diaphragmatic function in healthy individuals.The objective of this study on stage III is to evaluate the effects of transcutaneous electrical diaphragmatic stimulation, compared to IMT on respiratory muscle strength, lung function, thickness and diaphragmatic function in patients with exacerbated chronic obstructive pulmonary disease. The study was approved by the Research Ethics Committee of the Hospital de Clinicas of Porto Alegre (CAEE: 80271517.2.0000.5327).

Conditions

Interventions

OTHER

Transcutaneous electrical diaphragmatic stimulation (TEDS)

* Stage I: In the first day (group 1) the parameters will be with 30 Hz frequency and the second day (group 2) will be with 80 Hz, with one-day interval between interventions. The TEDS will be applied with symmetrical biphasic pulsed current, pulse width 0.4 ms, rise time of 1 second (s), 1s lift, 2 s descent, maintaining respiratory rate of 15 rpm, intensity required to obtain visible muscle contraction, for 20 minutes or until muscle fatigue. * Stage II and III:The TEDS will be applied with symmetrical biphasic pulsed current, the parameters will be with 30 Hz frequency, pulse width 0.4 ms, rise time of 1 second (s), 1s lift, 2 s descent, maintaining respiratory rate of 15 rpm, intensity required to obtain visible muscle contraction, for 20 minutes or until muscle fatigue.

OTHER

Inspiratory Muscle Training (IMT)

\- Stage II and III: The training will start with a minimum load of 50% and will be progressed until reaching 60% of the PImax. Inspiratory muscle training will start with a minimum load of 50% and progress to 60% of the MIP. The patients will perform daily training, being two sets of 30 breaths, one in the morning and one in the afternoon.

OTHER

Conventional physiotherapy

\- Stage III: It consists of ventilatory exercises, bronchial hygiene techniques, passive, active-assisted or active exercises for upper and lower limbs, and resistance exercises.

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Graciele Sbruzzi, Doctor · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-16
Primary Completion
2021-08-01
Completion
2021-11-01

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03844711 on ClinicalTrials.gov