Clinical trial NCT03844711: Transcutaneous Electrical Diaphragmatic Stimulation and Inspiratory Muscle Training in Patients With COPD Exacerbated
Official title: Transcutaneous Electrical Diaphragmatic Stimulation and Inspiratory Muscle Training in Healthy Individuals and Patients With Chronic Obstructive Pulmonary Disease Exacerbated
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Electrical Stimulation
Respiratory Muscle Training
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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, 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 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, the Stage II and is a randomized crossover clinical trial, to be performed at the Exercise Physiology Laboratory (LAFIEX) of Hospital de Clínicas de Porto Alegre (HCPA). Healthy individuals aged between 20 and 60 years, fully aware and cooperative, randomized into two groups will be included: one group that will perform TEDS and another that will perform IMT in a single session. TEDS will be applied with symmetrical biphasic pulsed current, frequency 30 Hertz (Hz), pulse width 0.5 ms, rise time of 1 second, sustain of 1s, descent of 2 s, maintaining respiratory rate of 15 rpm, intensity necessary to obtain muscle contraction visible, for 30 minutes or until muscle fatigue, daily. The IMT will be performed with the PowerBreath device with a charge of 50-60% of the PImax, for 30 breaths and Stage III 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria (all stages):

* 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.

Primary outcomes:
measure: Respiratory muscle strength - maximum expiratory pressure (MEP)
timeFrame: One week
measure: Respiratory muscle strength - maximum inspiratory pressure (MIP)
timeFrame: One week
measure: Pulmonary function - forced expiratory volume in the first second
timeFrame: One week
measure: Pulmonary function - forced vital capacity
timeFrame: One week
measure: Diaphragm muscle thickness
timeFrame: One week
measure: Diaphragm muscle mobility
timeFrame: One week
measure: Electromyography of the diaphragm muscle - Diaphragm Muscle Activation
timeFrame: One week
measure: Lower Limb Strength - Test Sit to Stand (STS)
timeFrame: One week
Secondary outcomes:
measure: Body composition measure (BMI)
timeFrame: One week
measure: Dyspnea - Modified Medical Research Council (MRC scale)
timeFrame: One week
measure: Dyspnea - BORG scale
timeFrame: One week
measure: Exercise capacity - 6-min walk test (6MWT)
timeFrame: One week
measure: Systolic blood pressure (SBP)
timeFrame: One week
measure: Diastolic blood pressure (DBP)
timeFrame: One week
measure: Heart rate (HR)
timeFrame: One week
measure: Respiratory Rate (RR)
timeFrame: One week
measure: Oxygen Saturation (SpO2)
timeFrame: One week
measure: Length of hospital stay
timeFrame: One week
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Graciele Sbruzzi, Doctor
role: PRINCIPAL_INVESTIGATOR
References: