Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
NCT Number: NCT05885152
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Whole-body electromyostimulation
Time frame: Baseline
Peripheral oxygen saturation will be assessed by pulse oximetry
Time frame: Protocol 1: minute four; Protocol 2: minute eight
Peripheral oxygen saturation will be assessed by pulse oximetry
Time frame: Immediately after the session
Peripheral oxygen saturation will be assessed by pulse oximetry
Time frame: Baseline
Respiratory rate will be assessed by respiratory rate count for one minute
Time frame: Protocol 1: minute four; Protocol 2: minute eight
Respiratory rate will be assessed by respiratory rate count for one minute
Time frame: Immediately after the session
Respiratory rate will be assessed by respiratory rate count for one minute
Time frame: Baseline
Heart rate will be assessed by pulse oximetry
Time frame: Protocol 1: minute four; Protocol 2: minute eight
Heart rate will be assessed by pulse oximetry
Time frame: Immediately after the session
Heart rate will be assessed by pulse oximetry
Time frame: Baseline
Systolic blood pressure will be assessed through sphygmomanometer
Time frame: Immediately after the session
Systolic blood pressure will be assessed through sphygmomanometer
Time frame: Baseline
Diastolic blood pressure will be assessed through sphygmomanometer
Time frame: Immediately after the session
Diastolic blood pressure will be assessed through sphygmomanometer
Time frame: Baseline
Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
Time frame: Protocol 1: minute four; Protocol 2: minute eight
Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
Time frame: Immediately after the session
Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
Time frame: Baseline
Autonomic control will be assessed through variability heart rate
Time frame: Up to 10 minutes after the session
Autonomic control will be assessed through variability heart rate
Time frame: Immediately after the session
Occurrence of adverse events will be assessed through patient report
Time frame: 24 hours after the session
Occurrence of adverse events will be assessed through patient report
Time frame: 48 hours after the session
Occurrence of adverse events will be assessed through patient report
Time frame: 72 hours after the session
Occurrence of adverse events will be assessed through patient report
Time frame: Baseline
Assessed through the serum level of creatine kinase (CK)
Time frame: Immediately after the session
Assessed through the serum level of creatine kinase (CK)
Time frame: 24 hours after the session
Assessed through the serum level of creatine kinase (CK)
Time frame: 48 hours after the session
Assessed through the serum level of creatine kinase (CK)
Time frame: 72 hours after the session
Assessed through the serum level of creatine kinase (CK)
Time frame: Baseline
Assessed through the serum lactate level
Time frame: Immediately after the session
Assessed through the serum lactate level
Time frame: 3 minutes after the session
Assessed through the serum lactate level
Time frame: 6 minutes after the session
Assessed through the serum lactate level
Time frame: Baseline
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain.
Time frame: Immediately after the session
Assessed by visual numerical scale
Time frame: 24 hours after the session
Assessed by visual numerical scale
Time frame: 48 hours after the session
Assessed by visual numerical scale
Time frame: 72 hours after the session
Assessed by visual numerical scale
Time frame: Baseline
Assessed by dynamometry
Time frame: Up to 40 minutes after the session
Assessed by dynamometry
Federal University of Health Science of Porto Alegre
Other
Acute Effect of Whole-body Electrical Stimulation in COPD Patients: a Crossover Randomized Clinical Trial
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