Acute Effect of Whole-body Electrical Stimulation in COPD Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Whole-body electrical stimulation

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Federal University of Health Sciences of Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Whole-body electromyostimulation
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: Whole-body electromyostimulation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Investigators: Principal Investigator: Jociane Schardong, Federal University of Health Sciences of Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: WBES_COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No