Acute Effect of Whole-body Electrical Stimulation in ILD Patients

NCT06167811 | Unknown

• 1 other identifier: WBES_ILD
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ILD

Outcome Measures

Primary Outcomes (22)

• 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

• 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

  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

• 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

  baseline

• Heart rate

  Heart rate will be assessed by pulse oximetry

  During the procedure: Protocol 1: minute four; Protocol 2: minute eight

• 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

  baseline

• 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

  baseline

• Diastolic blood pressure

  Diastolic blood pressure will be assessed through sphygmomanometer

  Immediately after the session

• 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 Outcomes (16)

• Muscle damage

  Baseline

• Muscle damage

  Immediately after the session

• Muscle damage

  24 hours after the session

• Muscle damage

  48 hours after the session

• Muscle damage

  72 hours after the session

Study Arms (2)

whole-body electrical stimulation, Protocol 1

EXPERIMENTAL

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

whole-body electrical stimulation, Protocol 2

EXPERIMENTAL

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

Interventions

whole-body electrical stimulation OTHER

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.

Also known as: whole-body electromyostimulation

whole-body electrical stimulation, Protocol 1; whole-body electrical stimulation, Protocol 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Officials

• Jociane Schardong

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jociane Schardong

CONTACT

55981348114; joci_fisioufsm@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: December 13, 2023
• Study Start: January 20, 2024
• Primary Completion: February 23, 2024
• Study Completion: March 31, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share