Acute Effect of Whole-body Electrical Stimulation in COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05885152
• Other study ID #: WBES_COPD
• Status: Completed
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2023
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Health Sciences of Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral oxygen saturation	Peripheral oxygen saturation will be assessed by pulse oximetry	Baseline
Primary	Peripheral oxygen saturation	Peripheral oxygen saturation will be assessed by pulse oximetry	Protocol 1: minute four; Protocol 2: minute eight
Primary	Peripheral oxygen saturation	Peripheral oxygen saturation will be assessed by pulse oximetry	Immediately after the session
Primary	Respiratory rate	Respiratory rate will be assessed by respiratory rate count for one minute	Baseline
Primary	Respiratory rate	Respiratory rate will be assessed by respiratory rate count for one minute	Protocol 1: minute four; Protocol 2: minute eight
Primary	Respiratory rate	Respiratory rate will be assessed by respiratory rate count for one minute	Immediately after the session
Primary	Heart rate	Heart rate will be assessed by pulse oximetry	Baseline
Primary	Heart rate	Heart rate will be assessed by pulse oximetry	Protocol 1: minute four; Protocol 2: minute eight
Primary	Heart rate	Heart rate will be assessed by pulse oximetry	Immediately after the session
Primary	Systolic blood pressure	Systolic blood pressure will be assessed through sphygmomanometer	Baseline
Primary	Systolic blood pressure	Systolic blood pressure will be assessed through sphygmomanometer	Immediately after the session
Primary	Diastolic blood pressure	Diastolic blood pressure will be assessed through sphygmomanometer	Baseline
Primary	Diastolic blood pressure	Diastolic blood pressure will be assessed through sphygmomanometer	Immediately after the session
Primary	Dyspnea and Fatigue	Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale	Baseline
Primary	Dyspnea and Fatigue	Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale	Protocol 1: minute four; Protocol 2: minute eight
Primary	Dyspnea and Fatigue	Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale	Immediately after the session
Primary	Autonomic control	Autonomic control will be assessed through variability heart rate	Baseline
Primary	Autonomic control	Autonomic control will be assessed through variability heart rate	Up to 10 minutes after the session
Primary	Adverse events	Occurrence of adverse events will be assessed through patient report	Immediately after the session
Primary	Adverse events	Occurrence of adverse events will be assessed through patient report	24 hours after the session
Primary	Adverse events	Occurrence of adverse events will be assessed through patient report	48 hours after the session
Primary	Adverse events	Occurrence of adverse events will be assessed through patient report	72 hours after the session
Secondary	Muscle damage	Assessed through the serum level of creatine kinase (CK)	Baseline
Secondary	Muscle damage	Assessed through the serum level of creatine kinase (CK)	Immediately after the session
Secondary	Muscle damage	Assessed through the serum level of creatine kinase (CK)	24 hours after the session
Secondary	Muscle damage	Assessed through the serum level of creatine kinase (CK)	48 hours after the session
Secondary	Muscle damage	Assessed through the serum level of creatine kinase (CK)	72 hours after the session
Secondary	Muscle fatigue	Assessed through the serum lactate level	Baseline
Secondary	Muscle fatigue	Assessed through the serum lactate level	Immediately after the session
Secondary	Muscle fatigue	Assessed through the serum lactate level	3 minutes after the session
Secondary	Muscle fatigue	Assessed through the serum lactate level	6 minutes after the session
Secondary	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
Secondary	Delayed onset muscle pain	Assessed by visual numerical scale	Immediately after the session
Secondary	Delayed onset muscle pain	Assessed by visual numerical scale	24 hours after the session
Secondary	Delayed onset muscle pain	Assessed by visual numerical scale	48 hours after the session
Secondary	Delayed onset muscle pain	Assessed by visual numerical scale	72 hours after the session
Secondary	Peripheral muscle strength	Assessed by dynamometry	Baseline
Secondary	Peripheral muscle strength	Assessed by dynamometry	Up to 40 minutes after the session