Chronic Obstructive Pulmonary Disease
Conditions
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.
Interventions
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.
Sponsors
Federal University of Health Science of Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Immediately after the session | Occurrence of adverse events will be assessed through patient report |
| Systolic blood pressure | Baseline | Systolic blood pressure will be assessed through sphygmomanometer |
| Diastolic blood pressure | Baseline | Diastolic blood pressure will be assessed through sphygmomanometer |
| Dyspnea and Fatigue | Baseline | Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale |
| Autonomic control | Baseline | Autonomic control will be assessed through variability heart rate |
| Peripheral oxygen saturation | Baseline | Peripheral oxygen saturation will be assessed by pulse oximetry |
| Respiratory rate | Baseline | Respiratory rate will be assessed by respiratory rate count for one minute |
| Heart rate | Baseline | Heart rate will be assessed by pulse oximetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle fatigue | Baseline | Assessed through the serum lactate level |
| Delayed onset muscle pain | Baseline | Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain. |
| Peripheral muscle strength | Baseline | Assessed by dynamometry |
| Muscle damage | Baseline | Assessed through the serum level of creatine kinase (CK) |
Countries
Brazil
Outcome results
None listed