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Completed

NCT Number: NCT05885152

Acute Effect of Whole-body Electrical Stimulation in COPD Patients

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole-body electrical stimulation

Other

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

Primary outcomes

  1. Peripheral oxygen saturation

    Time frame: Baseline

    Peripheral oxygen saturation will be assessed by pulse oximetry

  2. Peripheral oxygen saturation

    Time frame: Protocol 1: minute four; Protocol 2: minute eight

    Peripheral oxygen saturation will be assessed by pulse oximetry

  3. Peripheral oxygen saturation

    Time frame: Immediately after the session

    Peripheral oxygen saturation will be assessed by pulse oximetry

  4. Respiratory rate

    Time frame: Baseline

    Respiratory rate will be assessed by respiratory rate count for one minute

  5. Respiratory rate

    Time frame: Protocol 1: minute four; Protocol 2: minute eight

    Respiratory rate will be assessed by respiratory rate count for one minute

  6. Respiratory rate

    Time frame: Immediately after the session

    Respiratory rate will be assessed by respiratory rate count for one minute

  7. Heart rate

    Time frame: Baseline

    Heart rate will be assessed by pulse oximetry

  8. Heart rate

    Time frame: Protocol 1: minute four; Protocol 2: minute eight

    Heart rate will be assessed by pulse oximetry

  9. Heart rate

    Time frame: Immediately after the session

    Heart rate will be assessed by pulse oximetry

  10. Systolic blood pressure

    Time frame: Baseline

    Systolic blood pressure will be assessed through sphygmomanometer

  11. Systolic blood pressure

    Time frame: Immediately after the session

    Systolic blood pressure will be assessed through sphygmomanometer

  12. Diastolic blood pressure

    Time frame: Baseline

    Diastolic blood pressure will be assessed through sphygmomanometer

  13. Diastolic blood pressure

    Time frame: Immediately after the session

    Diastolic blood pressure will be assessed through sphygmomanometer

  14. Dyspnea and Fatigue

    Time frame: Baseline

    Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale

  15. Dyspnea and Fatigue

    Time frame: Protocol 1: minute four; Protocol 2: minute eight

    Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale

  16. Dyspnea and Fatigue

    Time frame: Immediately after the session

    Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale

  17. Autonomic control

    Time frame: Baseline

    Autonomic control will be assessed through variability heart rate

  18. Autonomic control

    Time frame: Up to 10 minutes after the session

    Autonomic control will be assessed through variability heart rate

  19. Adverse events

    Time frame: Immediately after the session

    Occurrence of adverse events will be assessed through patient report

  20. Adverse events

    Time frame: 24 hours after the session

    Occurrence of adverse events will be assessed through patient report

  21. Adverse events

    Time frame: 48 hours after the session

    Occurrence of adverse events will be assessed through patient report

  22. Adverse events

    Time frame: 72 hours after the session

    Occurrence of adverse events will be assessed through patient report

Secondary outcomes

  1. Muscle damage

    Time frame: Baseline

    Assessed through the serum level of creatine kinase (CK)

  2. Muscle damage

    Time frame: Immediately after the session

    Assessed through the serum level of creatine kinase (CK)

  3. Muscle damage

    Time frame: 24 hours after the session

    Assessed through the serum level of creatine kinase (CK)

  4. Muscle damage

    Time frame: 48 hours after the session

    Assessed through the serum level of creatine kinase (CK)

  5. Muscle damage

    Time frame: 72 hours after the session

    Assessed through the serum level of creatine kinase (CK)

  6. Muscle fatigue

    Time frame: Baseline

    Assessed through the serum lactate level

  7. Muscle fatigue

    Time frame: Immediately after the session

    Assessed through the serum lactate level

  8. Muscle fatigue

    Time frame: 3 minutes after the session

    Assessed through the serum lactate level

  9. Muscle fatigue

    Time frame: 6 minutes after the session

    Assessed through the serum lactate level

  10. Delayed onset muscle pain

    Time frame: Baseline

    Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain.

  11. Delayed onset muscle pain

    Time frame: Immediately after the session

    Assessed by visual numerical scale

  12. Delayed onset muscle pain

    Time frame: 24 hours after the session

    Assessed by visual numerical scale

  13. Delayed onset muscle pain

    Time frame: 48 hours after the session

    Assessed by visual numerical scale

  14. Delayed onset muscle pain

    Time frame: 72 hours after the session

    Assessed by visual numerical scale

  15. Peripheral muscle strength

    Time frame: Baseline

    Assessed by dynamometry

  16. Peripheral muscle strength

    Time frame: Up to 40 minutes after the session

    Assessed by dynamometry

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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