Acute Effect of Whole-body Electrical Stimulation in COPD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Acute Effect of Whole-body Electrical Stimulation in COPD Patients: a Crossover Randomized Clinical Trial

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Whole-body electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COPD GOLD 3 and 4; Age between 18 and 80 years; Ability to ambulate. Exclusion Criteria: Cognitive dysfunction that prevents assessments from being carried out, as well as inability to understand and 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 deep vein thrombosis; Disabling osteoarticular or musculoskeletal disease; Uncontrolled diabetes (glycemia > 300mg/dL); Patients with cancer and/or undergoing cancer treatment; Patients with systemic lupus erythematosus or other autoimmune disease; Artificial cardiac pacemaker; Epilepsy; Hemophilia; Liver and kidney diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole-body electrical stimulation, Protocol 1<br>A whole body electrical stimulation session. Symmetrical biphasic current will be used, pulse width of 400µs, frequency of 75Hz, contraction time of five seconds, rest time of 10 seconds, for eight minutes, totaling 32 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometry to become familiar with the electrical current. Then with the use of a stick (for proprioception), a series of biceps exercises and a series of triceps exercises, a series of sit-ups and a squat, a series of step ups and downs, and a series of plantings. | Other: Whole-body electrical stimulation<br>* 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.<br>* Other names: Whole-body electromyostimulation;|
| Experimental: Whole-body electrical stimulation, Protocol 2<br>A whole body electrical stimulation session. Symmetrical biphasic current will be used, pulse width of 400µs, frequency of 75Hz, contraction time of five seconds, rest time of 10 seconds, for 16 minutes, totaling 64 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometry to become familiar with the electrical current. Then with the use of a stick (for proprioception), a series of biceps exercises and a series of triceps exercises, a series of sit-ups and a squat, a series of step ups and downs, and a series of plantings. | Other: Whole-body electrical stimulation<br>* 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.<br>* Other names: Whole-body electromyostimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral oxygen saturation | Peripheral oxygen saturation will be assessed by pulse oximetry | Baseline | 
| Peripheral oxygen saturation | Peripheral oxygen saturation will be assessed by pulse oximetry | Protocol 1: minute four; Protocol 2: minute eight | 
| Peripheral oxygen saturation | Peripheral oxygen saturation will be assessed by pulse oximetry | Immediately after the session | 
| Respiratory rate | Respiratory rate will be assessed by respiratory rate count for one minute | Baseline | 
| Respiratory rate | Respiratory rate will be assessed by respiratory rate count for one minute | Protocol 1: minute four; Protocol 2: minute eight | 
| Respiratory rate | Respiratory rate will be assessed by respiratory rate count for one minute | Immediately after the session | 
| Heart rate | Heart rate will be assessed by pulse oximetry | Baseline | 
| Heart rate | Heart rate will be assessed by pulse oximetry | Protocol 1: minute four; Protocol 2: minute eight | 
| Heart rate | Heart rate will be assessed by pulse oximetry | Immediately after the session | 
| Systolic blood pressure | Systolic blood pressure will be assessed through sphygmomanometer | Baseline | 
| Systolic blood pressure | Systolic blood pressure will be assessed through sphygmomanometer | Immediately after the session | 
| Diastolic blood pressure | Diastolic blood pressure will be assessed through sphygmomanometer | Baseline | 
| Diastolic blood pressure | Diastolic blood pressure will be assessed through sphygmomanometer | Immediately after the session | 
| Dyspnea and Fatigue | Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale | Baseline | 
| Dyspnea and Fatigue | Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale | Protocol 1: minute four; Protocol 2: minute eight | 
| Dyspnea and Fatigue | Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale | Immediately after the session | 
| Autonomic control | Autonomic control will be assessed through variability heart rate | Baseline | 
| Autonomic control | Autonomic control will be assessed through variability heart rate | Up to 10 minutes after the session | 
| Adverse events | Occurrence of adverse events will be assessed through patient report | Immediately after the session | 
| Adverse events | Occurrence of adverse events will be assessed through patient report | 24 hours after the session | 
| Adverse events | Occurrence of adverse events will be assessed through patient report | 48 hours after the session | 
| Adverse events | Occurrence of adverse events will be assessed through patient report | 72 hours after the session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle damage | Assessed through the serum level of creatine kinase (CK) | Baseline | 
| Muscle damage | Assessed through the serum level of creatine kinase (CK) | Immediately after the session | 
| Muscle damage | Assessed through the serum level of creatine kinase (CK) | 24 hours after the session | 
| Muscle damage | Assessed through the serum level of creatine kinase (CK) | 48 hours after the session | 
| Muscle damage | Assessed through the serum level of creatine kinase (CK) | 72 hours after the session | 
| Muscle fatigue | Assessed through the serum lactate level | Baseline | 
| Muscle fatigue | Assessed through the serum lactate level | Immediately after the session | 
| Muscle fatigue | Assessed through the serum lactate level | 3 minutes after the session | 
| Muscle fatigue | Assessed through the serum lactate level | 6 minutes after the session | 
| 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 | 
| Delayed onset muscle pain | Assessed by visual numerical scale | Immediately after the session | 
| Delayed onset muscle pain | Assessed by visual numerical scale | 24 hours after the session | 
| Delayed onset muscle pain | Assessed by visual numerical scale | 48 hours after the session | 
| Delayed onset muscle pain | Assessed by visual numerical scale | 72 hours after the session | 
| Peripheral muscle strength | Assessed by dynamometry | Baseline | 
| Peripheral muscle strength | Assessed by dynamometry | Up to 40 minutes after the session |