Acute Effect of Whole-body Electrical Stimulation in COPD Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Whole-body electrical stimulation, Protocol 1 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
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:
|
| Experimental: Whole-body electrical stimulation, Protocol 2 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
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:
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Outcome Measures
Primary Outcome Measures
- Peripheral oxygen saturation [Baseline]
Peripheral oxygen saturation will be assessed by pulse oximetry
- Peripheral oxygen saturation [Protocol 1: minute four; Protocol 2: minute eight]
Peripheral oxygen saturation will be assessed by pulse oximetry
- Peripheral oxygen saturation [Immediately after the session]
Peripheral oxygen saturation will be assessed by pulse oximetry
- Respiratory rate [Baseline]
Respiratory rate will be assessed by respiratory rate count for one minute
- Respiratory rate [Protocol 1: minute four; Protocol 2: minute eight]
Respiratory rate will be assessed by respiratory rate count for one minute
- Respiratory rate [Immediately after the session]
Respiratory rate will be assessed by respiratory rate count for one minute
- Heart rate [Baseline]
Heart rate will be assessed by pulse oximetry
- Heart rate [Protocol 1: minute four; Protocol 2: minute eight]
Heart rate will be assessed by pulse oximetry
- Heart rate [Immediately after the session]
Heart rate will be assessed by pulse oximetry
- Systolic blood pressure [Baseline]
Systolic blood pressure will be assessed through sphygmomanometer
- Systolic blood pressure [Immediately after the session]
Systolic blood pressure will be assessed through sphygmomanometer
- Diastolic blood pressure [Baseline]
Diastolic blood pressure will be assessed through sphygmomanometer
- Diastolic blood pressure [Immediately after the session]
Diastolic blood pressure will be assessed through sphygmomanometer
- Dyspnea and Fatigue [Baseline]
Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
- Dyspnea and Fatigue [Protocol 1: minute four; Protocol 2: minute eight]
Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
- Dyspnea and Fatigue [Immediately after the session]
Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
- Autonomic control [Baseline]
Autonomic control will be assessed through variability heart rate
- Autonomic control [Up to 10 minutes after the session]
Autonomic control will be assessed through variability heart rate
- Adverse events [Immediately after the session]
Occurrence of adverse events will be assessed through patient report
- Adverse events [24 hours after the session]
Occurrence of adverse events will be assessed through patient report
- Adverse events [48 hours after the session]
Occurrence of adverse events will be assessed through patient report
- Adverse events [72 hours after the session]
Occurrence of adverse events will be assessed through patient report
Secondary Outcome Measures
- Muscle damage [Baseline]
Assessed through the serum level of creatine kinase (CK)
- Muscle damage [Immediately after the session]
Assessed through the serum level of creatine kinase (CK)
- Muscle damage [24 hours after the session]
Assessed through the serum level of creatine kinase (CK)
- Muscle damage [48 hours after the session]
Assessed through the serum level of creatine kinase (CK)
- Muscle damage [72 hours after the session]
Assessed through the serum level of creatine kinase (CK)
- Muscle fatigue [Baseline]
Assessed through the serum lactate level
- Muscle fatigue [Immediately after the session]
Assessed through the serum lactate level
- Muscle fatigue [3 minutes after the session]
Assessed through the serum lactate level
- Muscle fatigue [6 minutes after the session]
Assessed through the serum lactate level
- Delayed onset muscle pain [Baseline]
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain.
- Delayed onset muscle pain [Immediately after the session]
Assessed by visual numerical scale
- Delayed onset muscle pain [24 hours after the session]
Assessed by visual numerical scale
- Delayed onset muscle pain [48 hours after the session]
Assessed by visual numerical scale
- Delayed onset muscle pain [72 hours after the session]
Assessed by visual numerical scale
- Peripheral muscle strength [Baseline]
Assessed by dynamometry
- Peripheral muscle strength [Up to 40 minutes after the session]
Assessed by dynamometry
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of COPD GOLD 3 and 4;
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Age between 18 and 80 years;
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Ability to ambulate.
Exclusion Criteria:
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Cognitive dysfunction that prevents assessments from being carried out, as well as inability to understand and sign the informed consent form (ICF);
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Intolerance to the electrostimulator and/or change in skin sensitivity;
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Patients with stroke sequelae;
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Recent acute myocardial infarction (two months);
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Uncontrolled hypertension;
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New York Heart Association grade IV heart failure or decompensated;
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Unstable angina or arrhythmia;
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Peripheral vascular changes in lower limbs such as deep vein thrombosis;
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Disabling osteoarticular or musculoskeletal disease;
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Uncontrolled diabetes (glycemia > 300mg/dL);
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Patients with cancer and/or undergoing cancer treatment;
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Patients with systemic lupus erythematosus or other autoimmune disease;
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Artificial cardiac pacemaker;
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Epilepsy;
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Hemophilia;
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Liver and kidney diseases.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Federal University of Health Science of Porto Alegre
Investigators
- Principal Investigator: Jociane Schardong, Federal University of Health Sciences of Porto Alegre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WBES_COPD