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Acute Effect of Whole-body Electrical Stimulation in COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole-body electrical stimulation
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Whole-body electrical stimulation, Protocol 1

    Whole-body electrical stimulation, Protocol 2

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Peripheral oxygen saturation
    Peripheral oxygen saturation will be assessed by pulse oximetry
    Peripheral oxygen saturation
    Peripheral oxygen saturation will be assessed by pulse oximetry
    Peripheral oxygen saturation
    Peripheral oxygen saturation will be assessed by pulse oximetry
    Respiratory rate
    Respiratory rate will be assessed by respiratory rate count for one minute
    Respiratory rate
    Respiratory rate will be assessed by respiratory rate count for one minute
    Respiratory rate
    Respiratory rate will be assessed by respiratory rate count for one minute
    Heart rate
    Heart rate will be assessed by pulse oximetry
    Heart rate
    Heart rate will be assessed by pulse oximetry
    Heart rate
    Heart rate will be assessed by pulse oximetry
    Systolic blood pressure
    Systolic blood pressure will be assessed through sphygmomanometer
    Systolic blood pressure
    Systolic blood pressure will be assessed through sphygmomanometer
    Diastolic blood pressure
    Diastolic blood pressure will be assessed through sphygmomanometer
    Diastolic blood pressure
    Diastolic blood pressure will be assessed through sphygmomanometer
    Dyspnea and Fatigue
    Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
    Dyspnea and Fatigue
    Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
    Dyspnea and Fatigue
    Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
    Autonomic control
    Autonomic control will be assessed through variability heart rate
    Autonomic control
    Autonomic control will be assessed through variability heart rate
    Adverse events
    Occurrence of adverse events will be assessed through patient report
    Adverse events
    Occurrence of adverse events will be assessed through patient report
    Adverse events
    Occurrence of adverse events will be assessed through patient report
    Adverse events
    Occurrence of adverse events will be assessed through patient report

    Secondary Outcome Measures

    Muscle damage
    Assessed through the serum level of creatine kinase (CK)
    Muscle damage
    Assessed through the serum level of creatine kinase (CK)
    Muscle damage
    Assessed through the serum level of creatine kinase (CK)
    Muscle damage
    Assessed through the serum level of creatine kinase (CK)
    Muscle damage
    Assessed through the serum level of creatine kinase (CK)
    Muscle fatigue
    Assessed through the serum lactate level
    Muscle fatigue
    Assessed through the serum lactate level
    Muscle fatigue
    Assessed through the serum lactate level
    Muscle fatigue
    Assessed through the serum lactate level
    Delayed onset muscle pain
    Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain.
    Delayed onset muscle pain
    Assessed by visual numerical scale
    Delayed onset muscle pain
    Assessed by visual numerical scale
    Delayed onset muscle pain
    Assessed by visual numerical scale
    Delayed onset muscle pain
    Assessed by visual numerical scale
    Peripheral muscle strength
    Assessed by dynamometry
    Peripheral muscle strength
    Assessed by dynamometry

    Full Information

    First Posted
    April 6, 2023
    Last Updated
    May 31, 2023
    Sponsor
    Federal University of Health Science of Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05885152
    Brief Title
    Acute Effect of Whole-body Electrical Stimulation in COPD Patients
    Official Title
    Acute Effect of Whole-body Electrical Stimulation in COPD Patients: a Crossover Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    September 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Health Science of Porto Alegre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    8 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Whole-body electrical stimulation, Protocol 1
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Whole-body electrical stimulation, Protocol 2
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Whole-body electrical stimulation
    Other Intervention Name(s)
    Whole-body electromyostimulation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Peripheral oxygen saturation
    Description
    Peripheral oxygen saturation will be assessed by pulse oximetry
    Time Frame
    Baseline
    Title
    Peripheral oxygen saturation
    Description
    Peripheral oxygen saturation will be assessed by pulse oximetry
    Time Frame
    Protocol 1: minute four; Protocol 2: minute eight
    Title
    Peripheral oxygen saturation
    Description
    Peripheral oxygen saturation will be assessed by pulse oximetry
    Time Frame
    Immediately after the session
    Title
    Respiratory rate
    Description
    Respiratory rate will be assessed by respiratory rate count for one minute
    Time Frame
    Baseline
    Title
    Respiratory rate
    Description
    Respiratory rate will be assessed by respiratory rate count for one minute
    Time Frame
    Protocol 1: minute four; Protocol 2: minute eight
    Title
    Respiratory rate
    Description
    Respiratory rate will be assessed by respiratory rate count for one minute
    Time Frame
    Immediately after the session
    Title
    Heart rate
    Description
    Heart rate will be assessed by pulse oximetry
    Time Frame
    Baseline
    Title
    Heart rate
    Description
    Heart rate will be assessed by pulse oximetry
    Time Frame
    Protocol 1: minute four; Protocol 2: minute eight
    Title
    Heart rate
    Description
    Heart rate will be assessed by pulse oximetry
    Time Frame
    Immediately after the session
    Title
    Systolic blood pressure
    Description
    Systolic blood pressure will be assessed through sphygmomanometer
    Time Frame
    Baseline
    Title
    Systolic blood pressure
    Description
    Systolic blood pressure will be assessed through sphygmomanometer
    Time Frame
    Immediately after the session
    Title
    Diastolic blood pressure
    Description
    Diastolic blood pressure will be assessed through sphygmomanometer
    Time Frame
    Baseline
    Title
    Diastolic blood pressure
    Description
    Diastolic blood pressure will be assessed through sphygmomanometer
    Time Frame
    Immediately after the session
    Title
    Dyspnea and Fatigue
    Description
    Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
    Time Frame
    Baseline
    Title
    Dyspnea and Fatigue
    Description
    Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
    Time Frame
    Protocol 1: minute four; Protocol 2: minute eight
    Title
    Dyspnea and Fatigue
    Description
    Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale
    Time Frame
    Immediately after the session
    Title
    Autonomic control
    Description
    Autonomic control will be assessed through variability heart rate
    Time Frame
    Baseline
    Title
    Autonomic control
    Description
    Autonomic control will be assessed through variability heart rate
    Time Frame
    Up to 10 minutes after the session
    Title
    Adverse events
    Description
    Occurrence of adverse events will be assessed through patient report
    Time Frame
    Immediately after the session
    Title
    Adverse events
    Description
    Occurrence of adverse events will be assessed through patient report
    Time Frame
    24 hours after the session
    Title
    Adverse events
    Description
    Occurrence of adverse events will be assessed through patient report
    Time Frame
    48 hours after the session
    Title
    Adverse events
    Description
    Occurrence of adverse events will be assessed through patient report
    Time Frame
    72 hours after the session
    Secondary Outcome Measure Information:
    Title
    Muscle damage
    Description
    Assessed through the serum level of creatine kinase (CK)
    Time Frame
    Baseline
    Title
    Muscle damage
    Description
    Assessed through the serum level of creatine kinase (CK)
    Time Frame
    Immediately after the session
    Title
    Muscle damage
    Description
    Assessed through the serum level of creatine kinase (CK)
    Time Frame
    24 hours after the session
    Title
    Muscle damage
    Description
    Assessed through the serum level of creatine kinase (CK)
    Time Frame
    48 hours after the session
    Title
    Muscle damage
    Description
    Assessed through the serum level of creatine kinase (CK)
    Time Frame
    72 hours after the session
    Title
    Muscle fatigue
    Description
    Assessed through the serum lactate level
    Time Frame
    Baseline
    Title
    Muscle fatigue
    Description
    Assessed through the serum lactate level
    Time Frame
    Immediately after the session
    Title
    Muscle fatigue
    Description
    Assessed through the serum lactate level
    Time Frame
    3 minutes after the session
    Title
    Muscle fatigue
    Description
    Assessed through the serum lactate level
    Time Frame
    6 minutes after the session
    Title
    Delayed onset muscle pain
    Description
    Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain.
    Time Frame
    Baseline
    Title
    Delayed onset muscle pain
    Description
    Assessed by visual numerical scale
    Time Frame
    Immediately after the session
    Title
    Delayed onset muscle pain
    Description
    Assessed by visual numerical scale
    Time Frame
    24 hours after the session
    Title
    Delayed onset muscle pain
    Description
    Assessed by visual numerical scale
    Time Frame
    48 hours after the session
    Title
    Delayed onset muscle pain
    Description
    Assessed by visual numerical scale
    Time Frame
    72 hours after the session
    Title
    Peripheral muscle strength
    Description
    Assessed by dynamometry
    Time Frame
    Baseline
    Title
    Peripheral muscle strength
    Description
    Assessed by dynamometry
    Time Frame
    Up to 40 minutes after the session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jociane Schardong
    Phone
    +55 55 98134-8114
    Email
    joci_fisioufsm@yahoo.com.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jociane Schardong
    Organizational Affiliation
    Federal University of Health Sciences of Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Acute Effect of Whole-body Electrical Stimulation in COPD Patients

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