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

NCT03844711 | Unknown

• 1 other identifier: 2018-0078
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Electrical Stimulation; Respiratory Muscle Training

Outcome Measures

Primary Outcomes (8)

• Respiratory muscle strength - maximum expiratory pressure (MEP)

  Performed through a manometer in step cmH2O, of the brand Globalmed model MV300. Maximum expiratory pressure.

  One week

• Respiratory muscle strength - maximum inspiratory pressure (MIP)

  Performed through a manometer in step cmH2O, of the brand Globalmed model MV300. Maximum inspiratory pressure.

  One week

• Pulmonary function - forced expiratory volume in the first second

  Pulmonary function through spirometry, that allows to measure forced expiratory volume in the first second. It's the maximum expired volume at the first second of an maximum expiration.

  One week

• Pulmonary function - forced vital capacity

  Pulmonary function through spirometry. Spirometry allows to measure forced vital capacity. It's the air volume expired, quickly, after an inspiration deep maximum.

  One week

• Diaphragm muscle thickness

  Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 Megahertz (MHz) - VIVID i®, GE).

  One week

• Diaphragm muscle mobility

  Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).

  One week

• Electromyography of the diaphragm muscle - Diaphragm Muscle Activation

  Performed through a Portable Electromyograph System (EMG System Brasil Ltda, São José dos Campos) with surface electrodes.

  One week

• Lower Limb Strength - Test Sit to Stand (STS)

  In the measurements, the subjects mill be asked to stand up from a sitting position and then to sit down 5 times as fast as possible. The STS time will be recorded using a stopwatch to the nearest 10th of a second. The timerequired will be accounted for to perform a 5-time-repeated test on a chair.

  One week

Secondary Outcomes (10)

• Body composition measure (BMI)

  One week

• Dyspnea - Modified Medical Research Council (MRC scale)

  One week

• Dyspnea - BORG scale

  One week

• Exercise capacity - 6-min walk test (6MWT)

  One week

• Systolic blood pressure (SBP)

  One week

Study Arms (3)

Transcutaneous electrical diaphragmatic stimulation (TEDS)

EXPERIMENTAL

For transcutaneous electrical diaphragmatic stimulation, surface electrodes will be used that will be positioned at the transcutaneous motor points of the diaphragm.

Other: Transcutaneous electrical diaphragmatic stimulation (TEDS); Other: Conventional physiotherapy

Inspiratory Muscle training (IMT)

EXPERIMENTAL

The training will start with a minimum load of 50% and will be progressed until reaching 60% of the PImax.

Other: Inspiratory Muscle Training (IMT); Other: Conventional physiotherapy

Conventional physiotherapy

ACTIVE COMPARATOR

The protocol of physiotherapy by the physiotherapists of HCPA will be twice a day and consists of ventilatory exercises, bronchial hygiene techniques, passive, active-assisted or active exercises for upper and lower limbs, and resistance exercises.

Other: Conventional physiotherapy

Interventions

Transcutaneous electrical diaphragmatic stimulation (TEDS) OTHER

* 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.

Also known as: Transcutaneous electrical diaphragmatic stimulation

Transcutaneous electrical diaphragmatic stimulation (TEDS)

Inspiratory Muscle Training (IMT) OTHER

\- 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.

Inspiratory Muscle training (IMT)

Conventional physiotherapy OTHER

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

Conventional physiotherapy; Inspiratory Muscle training (IMT); Transcutaneous electrical diaphragmatic stimulation (TEDS)

Eligibility Criteria

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

You may qualify if:

• Stage I: Healthy adults between 18 and 60 years old; Intense phrenic nerve.
• Stage II: Healthy adults between 20 and 60 years old; Intense phrenic nerve.
• Stage III: Adults between 40 and 80 years old; Smoking more than 10 pack-years; Clinical diagnosis of COPD, GOLD 3 and 4; Patients admitted for severe COPD exacerbation (appearance or worsening of dyspnea, appearance or worsening of cough and appearance or increase in sputum that may be purulent), two of which must be present to characterize exacerbation; Intense phrenic nerve.

You may not qualify if:

• Unstable ventricular arrhythmia;
• Unstable angina; Aortic stenosis;
• Uncontrolled systemic arterial hypertension;
• Epilepsy;
• Undergoing hemodialysis;
• Fever and / or infectious disease;
• Neoplasms;
• Pacemaker;
• At the time of the intervention:
• Oxygen saturation below 90%;
• Obese patients;
• Refuse to participate in the survey.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

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

• Graciele Sbruzzi, Doctor

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graciele Sbruzzi, Doctor

CONTACT

+55(51)33085857; gracielesbruzzi@ufrgs.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2019
• First Posted: February 18, 2019
• Study Start: February 16, 2019
• Primary Completion: August 1, 2021
• Study Completion: November 1, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)