Clinical trial NCT05885152: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Peripheral oxygen saturation
timeFrame: Baseline
measure: Peripheral oxygen saturation
timeFrame: Protocol 1: minute four; Protocol 2: minute eight
measure: Peripheral oxygen saturation
timeFrame: Immediately after the session
measure: Respiratory rate
timeFrame: Baseline
measure: Respiratory rate
timeFrame: Protocol 1: minute four; Protocol 2: minute eight
measure: Respiratory rate
timeFrame: Immediately after the session
measure: Heart rate
timeFrame: Baseline
measure: Heart rate
timeFrame: Protocol 1: minute four; Protocol 2: minute eight
measure: Heart rate
timeFrame: Immediately after the session
measure: Systolic blood pressure
timeFrame: Baseline
measure: Systolic blood pressure
timeFrame: Immediately after the session
measure: Diastolic blood pressure
timeFrame: Baseline
measure: Diastolic blood pressure
timeFrame: Immediately after the session
measure: Dyspnea and Fatigue
timeFrame: Baseline
measure: Dyspnea and Fatigue
timeFrame: Protocol 1: minute four; Protocol 2: minute eight
measure: Dyspnea and Fatigue
timeFrame: Immediately after the session
measure: Autonomic control
timeFrame: Baseline
measure: Autonomic control
timeFrame: Up to 10 minutes after the session
measure: Adverse events
timeFrame: Immediately after the session
measure: Adverse events
timeFrame: 24 hours after the session
measure: Adverse events
timeFrame: 48 hours after the session
measure: Adverse events
timeFrame: 72 hours after the session
Secondary outcomes:
measure: Muscle damage
timeFrame: Baseline
measure: Muscle damage
timeFrame: Immediately after the session
measure: Muscle damage
timeFrame: 24 hours after the session
measure: Muscle damage
timeFrame: 48 hours after the session
measure: Muscle damage
timeFrame: 72 hours after the session
measure: Muscle fatigue
timeFrame: Baseline
measure: Muscle fatigue
timeFrame: Immediately after the session
measure: Muscle fatigue
timeFrame: 3 minutes after the session
measure: Muscle fatigue
timeFrame: 6 minutes after the session
measure: Delayed onset muscle pain
timeFrame: Baseline
measure: Delayed onset muscle pain
timeFrame: Immediately after the session
measure: Delayed onset muscle pain
timeFrame: 24 hours after the session
measure: Delayed onset muscle pain
timeFrame: 48 hours after the session
measure: Delayed onset muscle pain
timeFrame: 72 hours after the session
measure: Peripheral muscle strength
timeFrame: Baseline
measure: Peripheral muscle strength
timeFrame: Up to 40 minutes after the session
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Jociane Schardong
role: PRINCIPAL_INVESTIGATOR
References: