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

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ClinicalTrials.gov Identifier: NCT03844711
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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 (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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Electrical diaphragmatic stimulation Other: Inspiratory muscle training Other: Conventional physiotherapy Not Applicable

Detailed Description:
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 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, lung function, thickness and diaphragmatic function in patients with exacerbated chronic obstructive pulmonary disease. Methods: The Stage I is a cross-over Randomized Controlled Trial (RCT) in the first stage of this research, which will be performed at the Exercise Research Laboratory (LAPEX) of the School of Physical Education, Physiotherapy and Dance of the Universidade Federal do Rio Grande do Sul and Stage II will be an RCT, which will be performed at the Hospitalization Units of Hospital de Clinicas de Porto Alegre (HCPA). In the first stage only healthy individuals will be included, who will be randomized to TEDS, in the first day (group 1) the parameters will be with 30 hertz (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 breaths per minute, intensity required to obtain visible muscle contraction, for 20 minutes or until muscle fatigue. In this stage, heart rate variability, thickness and diaphragmatic mobility by ultrasonography, diaphragmatic activation by electromyography, inspiratory muscle endurance with powerbreath, and respiratory muscle strength by manovacuometry, before and at the end of treatment, the following variables will be measured. In the second stage patients with COPD (GOLD III and IV) hospitalized for exacerbation of the disease, who will be randomized into three groups: one group that will perform TEDS, another will perform IMT and a third group that will only perform conventional physiotherapy. The TEDS will be applied with symmetrical biphasic pulsed current, frequency 30 Hz, pulse width 0.4 ms, rise time of 1 second, sustain of 1s, decrease of 2 s, maintaining respiratory rate (RR) of 15 breaths per minute (rpm), intensity required to obtain visible muscle contraction for 20 minutes or even muscle fatigue daily. The IMT will be performed with the Power Breath device with load referring to 30-60% of PImax, during 30 breaths daily. Conventional physical therapy will be HCPA standard. In this stage, before and at the end of treatment, the following variables will be measured: respiratory muscle strength through manovacuometry, pulmonary function through spirometry, diaphragmatic thickness through echocardiography, diaphragmatic function through respiratory electroneuromyography, Body Mass-Index, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE) Index with mass index (BMI), functional capacity through the six-minute walk test, dyspnoea by the Borg Scale and Medical Research Council (MRC) Scale, cardiovascular variables and time of hospitalization through the electronic medical record. The interventions will be carried out from the patient's hospitalization to the hospital discharge.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcutaneous Electrical Diaphragmatic Stimulation and Inspiratory Muscle Training in Healthy Individuals and Patients With Chronic Obstructive Pulmonary Disease Exacerbated
Actual Study Start Date : February 16, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Electrical diaphragmatic stimulation
For transcutaneous electrical diaphragmatic stimulation, surface electrodes will be used that will be positioned at the transcutaneous motor points of the diaphragm.
Other: Electrical diaphragmatic stimulation
  • 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: 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 Name: Transcutaneous electrical diaphragmatic stimulation

Other: Conventional physiotherapy
It consists of ventilatory exercises, bronchial hygiene techniques, passive, active-assisted or active exercises for upper and lower limbs, and resistance exercises.

Experimental: Inspiratory muscle training
The training will start with a minimum load of 30% and will be progressed until reaching 60% of the PImax.
Other: Inspiratory muscle training
The training will start with a minimum load of 30% and will be progressed until reaching 60% of the PImax. Inspiratory muscle training will start with a minimum load of 30% 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
It consists of ventilatory exercises, bronchial hygiene techniques, passive, active-assisted or active exercises for upper and lower limbs, and resistance exercises.

Active Comparator: Conventional physiotherapy
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
It consists of ventilatory exercises, bronchial hygiene techniques, passive, active-assisted or active exercises for upper and lower limbs, and resistance exercises.




Primary Outcome Measures :
  1. Respiratory muscle strength - maximum expiratory pressure (MEP) [ Time Frame: One week ]
    Performed through a manometer in step cmH2O, of the brand Globalmed model MV300. Maximum expiratory pressure.

  2. Respiratory muscle strength - maximum inspiratory pressure (MIP) [ Time Frame: One week ]
    Performed through a manometer in step cmH2O, of the brand Globalmed model MV300. Maximum inspiratory pressure.

  3. Pulmonary function - forced expiratory volume in the first second [ Time Frame: One week ]
    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.

  4. Pulmonary function - forced vital capacity [ Time Frame: One week ]
    Pulmonary function through spirometry. Spirometry allows to measure forced vital capacity. It's the air volume expired, quickly, after an inspiration deep maximum.

  5. Diaphragm muscle thickness [ Time Frame: One week ]
    Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 Megahertz (MHz) - VIVID i®, GE).

  6. Diaphragm muscle mobility [ Time Frame: One week ]
    Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).

  7. Electromyography of the diaphragm muscle - Diaphragm Muscle Activation [ Time Frame: One week ]
    Performed through a Portable Electromyograph System (EMG System Brasil Ltda, São José dos Campos) with surface electrodes.


Secondary Outcome Measures :
  1. Body composition measure (BMI) [ Time Frame: One week ]
    Evaluate the weight of a person in relation to their height.

  2. Dyspnea - Modified Medical Research Council (MRC scale) [ Time Frame: One week ]
    Measure of the subjective sensation of dyspnea.

  3. Exercise capacity - 6-min walk test (6MWT) [ Time Frame: One week ]
    Distance traveled on the 6MWT.

  4. Systolic blood pressure (SBP) [ Time Frame: One week ]
    Measures the pressure in your blood vessels when your heart beats. Will be measured during each session, using the monitors available on the floors of the HCPA.

  5. Diastolic blood pressure (DBP) [ Time Frame: One week ]
    Measures the pressure in your blood vessels when your heart rests between beats. Will be measured during each session, using the monitors available on the floors of the HCPA.

  6. Heart rate (HR) [ Time Frame: One week ]
    Is the speed of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm). Will be measured during each session, using the monitors available on the floors of the HCPA.

  7. Respiratory Rate (RR) [ Time Frame: One week ]
    Is the number of breaths you take per minute. Will be measured during each session, using the monitors available on the floors of the HCPA.

  8. Oxygen Saturation (SpO2) [ Time Frame: One week ]
    Is a measurement of how much oxygen the red blood cells in the body's arteries are carrying. Will be measured during each session, using the monitors available on the floors of the HCPA.

  9. Length of hospital stay [ Time Frame: One week ]
    Of the patient's electronic medical record.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of COPD, in stages III and IV, according to criteria of the Global Initiative for COPD;
  • Presence of inspiratory muscle weakness characterized by maximal inspiratory pressure (PImax) obtained less than 70% of predicted PImax;
  • Without nerve phrenic injury .

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844711


Contacts
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Contact: Graciele Sbruzzi, Doctor +55(51)33085857 gracielesbruzzi@ufrgs.br

Locations
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Brazil
Federal University of Rio Grande do Sul Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Contact: Graciele Sbruzzi, Doctor         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Graciele Sbruzzi, Doctor Federal University of Rio Grande do Sul

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03844711     History of Changes
Other Study ID Numbers: 2018-0078
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital de Clinicas de Porto Alegre:
Chronic Obstructive Pulmonary Disease
Electrical Stimulation
Respiratory Muscle Training

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