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Chronic Obstructive Pulmonary DiseaseNCT03844711

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

A study testing Transcutaneous electrical diaphragmatic stimulation (TEDS), Inspiratory Muscle Training (IMT) and Conventional physiotherapy in people with Chronic Obstructive Pulmonary Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Transcutaneous electrical diaphragmatic stimulation (TEDS), Inspiratory Muscle Training (IMT) and Conventional physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
16 Feb 2019to 1 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Unstable ventricular arrhythmia;
  • Unstable angina; Aortic stenosis;
  • Uncontrolled systemic arterial hypertension;
  • Epilepsy;
  • Undergoing hemodialysis;
  • Fever and / or infectious disease;
Show all 12Show fewer
  • Neoplasms;
  • Pacemaker;
  • At the time of the intervention:
  • Oxygen saturation below 90%;
  • Obese patients;
  • Refuse to participate in the survey.

Trial locations and contacts

1 site in 1 country.

Graciele Sbruzzi, Doctor contact

+55(51)33085857

gracielesbruzzi@ufrgs.br

Brazil1 site, 1 recruiting
  • Federal University of Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul

    Graciele Sbruzzi, Doctor

    Recruiting

Other trials in Brazil

About this study

Official title: Transcutaneous Electrical Diaphragmatic Stimulation and Inspiratory Muscle Training in Healthy Individuals and Patients With Chronic Obstructive Pulmonary Disease Exacerbated

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).

Read the 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.

Being tested
Transcutaneous electrical diaphragmatic stimulation (TEDS), Inspiratory Muscle Training (IMT), Conventional physiotherapy
Keywords
Chronic Obstructive Pulmonary Disease, Electrical Stimulation, Respiratory Muscle Training
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous electrical diaphragmatic stimulation (TEDS)Other

    Also called Transcutaneous 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 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.
  • 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.
  • Conventional physiotherapyOther

    • Stage III: It consists of ventilatory exercises, bronchial hygiene techniques, passive, active-assisted or active exercises for upper and lower limbs, and resistance exercises.
Study groups in NCT03844711
Study groupRoleWhat they receive
Transcutaneous electrical diaphragmatic stimulation (TEDS)ExperimentalFor transcutaneous electrical diaphragmatic stimulation, surface electrodes will be used that will be positioned at the transcutaneous motor points of the diaphragm.
Receives: Other: Transcutaneous electrical diaphragmatic stimulation (TEDS); Other: Conventional physiotherapy
Inspiratory Muscle training (IMT)ExperimentalThe training will start with a minimum load of 50% and will be progressed until reaching 60% of the PImax.
Receives: Other: Inspiratory Muscle Training (IMT); Other: Conventional physiotherapy
Conventional physiotherapyActive comparatorThe 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.
Receives: Other: Conventional physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory muscle strength - maximum expiratory pressure (MEP)

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

    Measured: One week

  2. Respiratory muscle strength - maximum inspiratory pressure (MIP)

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

    Measured: One week

  3. 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.

    Measured: One week

  4. 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.

    Measured: One week

  5. 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).

    Measured: One week

  6. 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).

    Measured: One week

  7. 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.

    Measured: One week

  8. 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.

    Measured: One week

Secondary outcomes (10)
  1. Body composition measure (BMI)

    Evaluate the weight of a person in relation to their height.

    Measured: One week

  2. Dyspnea - Modified Medical Research Council (MRC scale)

    Measure of the subjective sensation of dyspnea.

    Measured: One week

  3. Dyspnea - BORG scale

    Measure of the subjective sensation of dyspnea. This is a scale that asks you to rate the difficulty of your breathing. It starts at number0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal

    Measured: One week

  4. Exercise capacity - 6-min walk test (6MWT)

    Distance traveled on the 6MWT.

    Measured: One week

  5. Systolic blood pressure (SBP)

    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.

    Measured: One week

  6. Diastolic blood pressure (DBP)

    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.

    Measured: One week

  7. Heart rate (HR)

    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.

    Measured: One week

  8. Respiratory Rate (RR)

    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.

    Measured: One week

  9. Oxygen Saturation (SpO2)

    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.

    Measured: One week

  10. Length of hospital stay

    Of the patient's electronic medical record.

    Measured: One week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2019
  2. Study start16 Feb 2019
  3. Primary completion1 Aug 2021 (estimated)
  4. Study completion1 Nov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03844711
Sponsor's protocol ID
2018-0078
Status last verified
Apr 2021
First submitted
26 Jan 2019
Last updated
3 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous electrical diaphragmatic stimulation (TEDS), Inspiratory Muscle Training (IMT) and Conventional physiotherapy in people with Chronic Obstructive Pulmonary Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Graciele Sbruzzi, Doctor (+55(51)33085857, gracielesbruzzi@ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory muscle strength - maximum expiratory pressure (MEP) (time frame: One week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.

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