Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06167811
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-10-23
Brief Title:
Acute Effect of Whole-body Electrical Stimulation in ILD Patients
Sponsor:
Federal University of Health Science of Porto Alegre
Organization:
Federal University of Health Science of Porto Alegre
Study Overview
Official Title:
Acute Effect of Whole-body Electrical Stimulation in ILD Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None