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Clinical Trial Summary

Patients with chronic respiratory diseases present in addition to respiratory symptoms, peripheral muscle dysfunction, which contributes to functional impairment. The aim of the study is to investigate the safety of whole-body electrical stimulation in patients with chronic obstructive pulmonary disease (COPD). Patients will perform two whole body electrostimulation protocols, with an interval of one week between them. The primary outcome will be the safety of electrical stimulation through peripheral oxygen saturation, respiratory rate, systolic blood pressure, diastolic blood pressure, heart rate, dyspnea and fatigue (Borg subjective perceived exertion scale), autonomic control (rate variability cardiac arrest) and occurrence of adverse events. Secondary outcomes will be muscle damage assessed by serum creatine kinase level, muscle fatigue assessed by serum lactate level, delayed onset muscle soreness assessed by visual numerical scale, and peripheral muscle strength by dynamometry.


Clinical Trial Description

Patients with COPD 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 Design


Related Conditions & MeSH terms


NCT number NCT05885152
Study type Interventional
Source Federal University of Health Science of Porto Alegre
Contact
Status Completed
Phase N/A
Start date July 1, 2023
Completion date September 1, 2023

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