Acute Effect of Whole-body Electrical Stimulation in ILD Patients

January 15, 2024 updated by: Jociane Schardong, Federal University of Health Science of Porto Alegre
Patients with interstitial lung disease present, in addition to respiratory symptoms, peripheral muscle dysfunction, which contributes to functional impairment. The aimof the study is to investigate the safetyof whole-body electrical stimulation in patients with interstitial lung disease (ILD). Patients Will perform two different EECI protocols, with na intervalo fone week between them. First the patients Will be submitted to the evaluation of the autonomic control. After a blood collection and measurement of muscles trength will be performed. The verification of vital signs: BP, SpO2, HR, FR and the perception of dyspnea and fatigue (BORG) Will occur immediately before and after the EECI session. During the protocol, SpO2, HR, RR and BORG Will be checked. After the session, a new blood collection Will be performed and autonomic control and muscle strength Will be reassessed. After 24, 48 and 72 hours, new blood samples Will be collected and muscle pain Will be measured.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with ILD will be submitted to two whole body electrostimulation protocols, with an interval of one week between them. Miha Bodytec equipment will be properly calibrated, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi and quadratus lumborum muscles. Symmetric pulsed biphasic current will be used, pulse width of 400µs, frequency of 75Hz, contraction time of five seconds, rest time of 10 seconds. Protocol 1 will take eight minutes resulting in 32 muscle contractions, and protocol 2 will take 16 minutes resulting in 64 muscle contractions. Initially, patients will undergo an assessment of autonomic control. Then, blood collection will be performed, the serum lactate level will be checked and muscle strength will be measured. Verification of systolic blood pressure, diastolic blood pressure, peripheral oxygen saturation, heart rate, respiratory rate and perception of dyspnea and fatigue (BORG) will occur immediately before and after the whole body electrical stimulation session. During the protocol, peripheral oxygen saturation, heart rate, respiratory rate and BORG will be checked. After the session, the serum lactate level will be checked, a new blood collection will be performed and autonomic control and muscle strength will be reassessed. After 24, 48 and 72 hours, new blood samples will be collected and muscle pain will be measured.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of interstitial lung disease;
  • Age between 18 and 80 years;
  • Ability to ambulate.

Exclusion Criteria:

  • Cognitive dysfunction that prevents assessments from being carried out, as well as inability tounder standand sign the informed consent form (ICF);
  • Intolerance to the electrostimulator and/or change in skin sensitivity;
  • Patients with stroke sequelae;
  • Recent acute myocardial infarction (two months);
  • Uncontrolled hypertension;
  • New York Heart Association grade IV heart failure or decompensated;
  • Unstable angina or arrhythmia;
  • Peripheral vascular changes in lower limbs such as deepvein thrombosis;
  • Disabling osteoarticular or musculo skeletal disease;
  • Uncontrolled diabetes (glycemia> 300mg/dL);
  • Patients with câncer and/or under going câncer treatment;
  • Patients with systemic disease or other autoimmune disease;
  • Artificial cardiac pace maker;
  • Epilepsy;
  • Hemophilia;
  • Live rand kidney diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: whole-body electrical stimulation, Protocol 1
A whole body electrical stimulation session. Symmetrical biphasic current will be used, pulse width of 400µs, frequency of 75Hz, contraction time of five seconds, rest time of 10 seconds, for eight minutes, totaling 32 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometry to become familiar with the electrical current. Then with the use of a stick (for proprioception), a series of biceps exercises and a series of triceps exercises, a series of sit-ups and a squat, a series of step ups and downs, and a series of plantings.
Other: whole-body electrical stimulation
Performed using Miha Bodytec equipment, properly calibrated, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi and quadratus lumborum muscles.
Other Names:
  • whole-body electromyostimulation
Experimental: whole-body electrical stimulation, Protocol 2
A whole body electrical stimulation session. Symmetrical biphasic current will be used, pulse width of 400µs, frequency of 75Hz, contraction time of five seconds, rest time of 10 seconds, for 16 minutes, totaling 64 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometry to become familiar with the electrical current. Then with the use of a stick (for proprioception), a series of biceps exercises and a series of triceps exercises, a series of sit-ups and a squat, a series of step ups and downs, and a series of plantings.
Other: whole-body electrical stimulation
Performed using Miha Bodytec equipment, properly calibrated, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi and quadratus lumborum muscles.
Other Names:
  • whole-body electromyostimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peripheral oxygen saturation
Time Frame: Immediately after the session
Peripheral oxygen saturation will be assessed by pulse oximetry
Immediately after the session
Respiratory rate
Time Frame: Immediately after the session
Respiratory rate will be assessed by respiratory rate count for one minute
Immediately after the session
Heart rate
Time Frame: Immediately after the session
Heart rate will be assessed by pulse oximetry
Immediately after the session
Systolic blood pressure
Time Frame: Immediately after the session
Systolic blood pressure will be assessed through sphygmomanometer
Immediately after the session
Diastolic blood pressure
Time Frame: Immediately after the session
Diastolic blood pressure will be assessed through sphygmomanometer
Immediately after the session
Peripheral oxygen saturation
Time Frame: baseline
Peripheral oxygen saturation will be assessed by pulse oximetry
baseline
Peripheral oxygen saturation
Time Frame: During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Peripheral oxygen saturation will be assessed by pulse oximetry
During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Respiratory rate
Time Frame: baseline
Respiratory rate will be assessed by respiratory rate count for one minute
baseline
Respiratory rate
Time Frame: During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Respiratory rate will be assessed by respiratory rate count for one minute
During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Heart rate
Time Frame: baseline
Heart rate will be assessed by pulse oximetry
baseline
Heart rate
Time Frame: During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Heart rate will be assessed by pulse oximetry
During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Systolic blood pressure
Time Frame: baseline
Systolic blood pressure will be assessed through sphygmomanometer
baseline
Diastolic blood pressure
Time Frame: baseline
Diastolic blood pressure will be assessed through sphygmomanometer
baseline
Dyspnea and fatigue
Time Frame: baseline
Dyspnea and fatigue will be assessed through Borg's perceived exertion scale
baseline
Dyspnea and fatigue
Time Frame: During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Dyspnea and fatigue will be assessed using a subjective perceived exertion scale ranging from 0 to 10, where 0 indicates no dyspnea and 10 indicates maximum dyspnea.
During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Dyspnea and fatigue
Time Frame: Immediately after the session
Dyspnea and fatigue will be assessed using a subjective perceived exertion scale ranging from 0 to 10, where 0 indicates no dyspnea and 10 indicates maximum dyspnea.
Immediately after the session
Autonomic control
Time Frame: baseline
Autonomic control will be assessed through variability heart rate
baseline
Autonomic control
Time Frame: up to 10 minutes after the session
Autonomic control will be assessed through variability heart rate
up to 10 minutes after the session
Adverse events
Time Frame: Immediately after the session
Occurence of adverse events will be assessed through patient report
Immediately after the session
Adverse events
Time Frame: 24 hours after the session
Occurence of adverse events will be assessed through patient report
24 hours after the session
Adverse events
Time Frame: 48 hours after the session
Occurence of adverse events will be assessed through patient report
48 hours after the session
Adverse events
Time Frame: 72 hours after the session
Occurence of adverse events will be assessed through patient report
72 hours after the session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle damage
Time Frame: Baseline
Assessed through the serum level of creatine kinase (CK)
Baseline
Muscle damage
Time Frame: Immediately after the session
Assessed through the serum level of creatine kinase (CK)
Immediately after the session
Muscle damage
Time Frame: 24 hours after the session
Assessed through the serum level of creatine kinase (CK)
24 hours after the session
Muscle damage
Time Frame: 48 hours after the session
Assessed through the serum level of creatine kinase (CK)
48 hours after the session
Muscle damage
Time Frame: 72 hours after the session
Assessed through the serum level of creatine kinase (CK)
72 hours after the session
Muscle fatigue
Time Frame: Immediately after the session
Assessed through the serum lactate level
Immediately after the session
Muscle fatigue
Time Frame: 3 minutes after the session
Assessed through the serum lactate level
3 minutes after the session
Muscle fatigue
Time Frame: 6 minutes after the session
Assessed through the serum lactate level
6 minutes after the session
Muscle fatigue
Time Frame: baseline
Assessed through the serum lactate level
baseline
Delayed onset muscle pain
Time Frame: baseline
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain
baseline
Delayed onset muscle pain
Time Frame: Immediately after the session
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain
Immediately after the session
Delayed onset muscle pain
Time Frame: 24 hours after the session
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain
24 hours after the session
Delayed onset muscle pain
Time Frame: 48 hours after the session
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain
48 hours after the session
Delayed onset muscle pain
Time Frame: 72 hours after the session
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain
72 hours after the session
Peripheral muscle strength
Time Frame: baseline
Assessed by dynamometry
baseline
Peripheral muscle strength
Time Frame: up to 40 minutes after the session
Assessed by dynamometry
up to 40 minutes after the session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Health Science of Porto Alegre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jociane Schardong, Federal University of Health Sciences of Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WBES_ILD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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