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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06167811
Other study ID # WBES_ILD
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 20, 2024
Est. completion date March 31, 2024

Study information

Verified date January 2024
Source Federal University of Health Science of Porto Alegre
Contact Jociane Schardong
Phone 55981348114
Email joci_fisioufsm@yahoo.com.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 8
Est. completion date March 31, 2024
Est. primary completion date February 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Outcome

Type Measure Description Time frame Safety issue
Primary Peripheral oxygen saturation Peripheral oxygen saturation will be assessed by pulse oximetry baseline
Primary Peripheral oxygen saturation Peripheral oxygen saturation will be assessed by pulse oximetry During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Primary Peripheral oxygen saturation Peripheral oxygen saturation will be assessed by pulse oximetry Immediately after the session
Primary Respiratory rate Respiratory rate will be assessed by respiratory rate count for one minute baseline
Primary 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
Primary Respiratory rate Respiratory rate will be assessed by respiratory rate count for one minute Immediately after the session
Primary Heart rate Heart rate will be assessed by pulse oximetry baseline
Primary Heart rate Heart rate will be assessed by pulse oximetry During the procedure: Protocol 1: minute four; Protocol 2: minute eight
Primary Heart rate Heart rate will be assessed by pulse oximetry Immediately after the session
Primary Systolic blood pressure Systolic blood pressure will be assessed through sphygmomanometer baseline
Primary Systolic blood pressure Systolic blood pressure will be assessed through sphygmomanometer Immediately after the session
Primary Diastolic blood pressure Diastolic blood pressure will be assessed through sphygmomanometer baseline
Primary Diastolic blood pressure Diastolic blood pressure will be assessed through sphygmomanometer Immediately after the session
Primary Dyspnea and fatigue Dyspnea and fatigue will be assessed through Borg's perceived exertion scale baseline
Primary 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
Primary 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
Primary Autonomic control Autonomic control will be assessed through variability heart rate baseline
Primary Autonomic control Autonomic control will be assessed through variability heart rate up to 10 minutes after the session
Primary Adverse events Occurence of adverse events will be assessed through patient report Immediately after the session
Primary Adverse events Occurence of adverse events will be assessed through patient report 24 hours after the session
Primary Adverse events Occurence of adverse events will be assessed through patient report 48 hours after the session
Primary Adverse events Occurence of adverse events will be assessed through patient report 72 hours after the session
Secondary Muscle damage Assessed through the serum level of creatine kinase (CK) Baseline
Secondary Muscle damage Assessed through the serum level of creatine kinase (CK) Immediately after the session
Secondary Muscle damage Assessed through the serum level of creatine kinase (CK) 24 hours after the session
Secondary Muscle damage Assessed through the serum level of creatine kinase (CK) 48 hours after the session
Secondary Muscle damage Assessed through the serum level of creatine kinase (CK) 72 hours after the session
Secondary Muscle fatigue Assessed through the serum lactate level baseline
Secondary Muscle fatigue Assessed through the serum lactate level Immediately after the session
Secondary Muscle fatigue Assessed through the serum lactate level 3 minutes after the session
Secondary Muscle fatigue Assessed through the serum lactate level 6 minutes after the session
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Peripheral muscle strength Assessed by dynamometry baseline
Secondary Peripheral muscle strength Assessed by dynamometry up to 40 minutes after the session
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