Acute Effect of Whole-body Electrical Stimulation in ILD Patients

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: Not yet recruiting
• Conditions: ILD
• Intervention / Treatment: Other: whole-body electrical stimulation

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: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jociane Schardong; Phone Number: 55981348114; Email: joci_fisioufsm@yahoo.com.br

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Peripheral oxygen saturation	Peripheral oxygen saturation will be assessed by pulse oximetry	Immediately after the session
Respiratory rate	Respiratory rate will be assessed by respiratory rate count for one minute	Immediately after the session
Heart rate	Heart rate will be assessed by pulse oximetry	Immediately after the session
Systolic blood pressure	Systolic blood pressure will be assessed through sphygmomanometer	Immediately after the session
Diastolic blood pressure	Diastolic blood pressure will be assessed through sphygmomanometer	Immediately after the session
Peripheral oxygen saturation	Peripheral oxygen saturation will be assessed by pulse oximetry	baseline
Peripheral oxygen saturation	Peripheral oxygen saturation will be assessed by pulse oximetry	During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Respiratory rate	Respiratory rate will be assessed by respiratory rate count for one minute	baseline
Respiratory rate	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	Heart rate will be assessed by pulse oximetry	baseline
Heart rate	Heart rate will be assessed by pulse oximetry	During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Systolic blood pressure	Systolic blood pressure will be assessed through sphygmomanometer	baseline
Diastolic blood pressure	Diastolic blood pressure will be assessed through sphygmomanometer	baseline
Dyspnea and fatigue	Dyspnea and fatigue will be assessed through Borg's perceived exertion scale	baseline
Dyspnea and fatigue	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	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	Autonomic control will be assessed through variability heart rate	baseline
Autonomic control	Autonomic control will be assessed through variability heart rate	up to 10 minutes after the session
Adverse events	Occurence of adverse events will be assessed through patient report	Immediately after the session
Adverse events	Occurence of adverse events will be assessed through patient report	24 hours after the session
Adverse events	Occurence of adverse events will be assessed through patient report	48 hours after the session
Adverse events	Occurence of adverse events will be assessed through patient report	72 hours after the session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle damage	Assessed through the serum level of creatine kinase (CK)	Baseline
Muscle damage	Assessed through the serum level of creatine kinase (CK)	Immediately after the session
Muscle damage	Assessed through the serum level of creatine kinase (CK)	24 hours after the session
Muscle damage	Assessed through the serum level of creatine kinase (CK)	48 hours after the session
Muscle damage	Assessed through the serum level of creatine kinase (CK)	72 hours after the session
Muscle fatigue	Assessed through the serum lactate level	Immediately after the session
Muscle fatigue	Assessed through the serum lactate level	3 minutes after the session
Muscle fatigue	Assessed through the serum lactate level	6 minutes after the session
Muscle fatigue	Assessed through the serum lactate level	baseline
Delayed onset muscle pain	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	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	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	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	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	Assessed by dynamometry	baseline
Peripheral muscle strength	Assessed by dynamometry	up to 40 minutes after the session

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Investigators: Principal Investigator: Jociane Schardong, Federal University of Health Sciences of Porto Alegre

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2024
• Primary Completion (Estimated): February 23, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID 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