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Acute Effect of Whole-body Electrical Stimulation in ILD Patients

Acute Effect of Whole-body Electrical Stimulation in ILD Patients

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06167811
Enrollment
8
Registered
2023-12-13
Start date
2024-01-20
Completion date
2024-03-31
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ILD

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.

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.

Interventions

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.

Sponsors

Federal University of Health Science of Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Adverse eventsImmediately after the sessionOccurence of adverse events will be assessed through patient report
Systolic blood pressurebaselineSystolic blood pressure will be assessed through sphygmomanometer
Diastolic blood pressurebaselineDiastolic blood pressure will be assessed through sphygmomanometer
Dyspnea and fatiguebaselineDyspnea and fatigue will be assessed through Borg's perceived exertion scale
Autonomic controlbaselineAutonomic control will be assessed through variability heart rate
Peripheral oxygen saturationbaselinePeripheral oxygen saturation will be assessed by pulse oximetry
Respiratory ratebaselineRespiratory rate will be assessed by respiratory rate count for one minute
Heart ratebaselineHeart rate will be assessed by pulse oximetry

Secondary

MeasureTime frameDescription
Muscle fatiguebaselineAssessed through the serum lactate level
Delayed onset muscle painbaselineAssessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain
Peripheral muscle strengthbaselineAssessed by dynamometry
Muscle damageBaselineAssessed through the serum level of creatine kinase (CK)

Contacts

Primary ContactJociane Schardong
joci_fisioufsm@yahoo.com.br55981348114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026