Clinical trial NCT06761963: Chronic Effect of Whole-body Electrical Stimulation in COPD Patients
Official title: Chronic Effect of Whole-body Electrical Stimulation in COPD Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Santa Casa de Porto Alegre
First posted: 2025-01-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial. Patients with chronic obstructive pulmonary disease (COPD) GOLD III or IV will undergo 16 sessions of Whole-body Electrical Stimulation (WB-EMS) or pulmonary rehabilitation (PR), twice a week. WB-EMS will be performed in association with squats, biceps and triceps exercises, climbing up and down a step, and abdominal exercises. There will be a progression in the number of muscle contractions after the fourth (from 64 to 96) and tenth sessions (96 to 120). PR will consist of upper and lower limb strengthening exercises. Both groups will perform aerobic exercise (essential component of the pulmonary rehabilitation program). Peripheral muscle strength (dynamometry), respiratory muscle strength (maximum inspiratory and expiratory pressure), muscle thickness (ultrasound), functional capacity (6MWT), quality of life (Saint George's Respiratory Questionnaire), inflammatory profile (PCR, IL-6 e IL-10, TNFα), oxidative stress (protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate) will be assessed before and after the 16 sessions.

Detailed description: Patients with chronic obstructive pulmonary disease (COPD) will undergo a 16-session whole-body electrical stimulation (WB-EMS) protocol or a pulmonary rehabilitation program, twice a week, for eight weeks. The 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. Symmetrical pulsed biphasic current will be used, pulse width of 400 µs, frequency of 75 Hz. In the first two weeks, the contraction time will be five seconds and the rest time will be 10 seconds, the session will last 16 minutes, resulting in 64 muscle contractions. In weeks 3, 4 and 5, the contraction time will be five seconds and the rest time will be five seconds, the session will last 16 minutes, resulting in 96 muscle contractions. In weeks 6, 7 and 8, the contraction time will be five seconds and the rest time will be five seconds. The session will last 20 minutes, resulting in 120 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometric position to familiarize themselves with the electrical current. After that, a series of squats, biceps and triceps exercises (using a proprioception stick), abdominal exercises and climbing up and down a step will be performed. At the end of each session, patients will do aerobic exercise (bicycle or treadmill). Pulmonary rehabilitation will consist of muscle strengthening exercises, using weights, ankle weights and weight training equipment. Squats, biceps and triceps exercises (with weights), knee flexion and extension (equipment with weights) and stretching will be performed. At the end of each session, patients will do aerobic exercise (bicycle or treadmill). Peripheral muscle strength (dynamometry), respiratory muscle strength (maximum inspiratory and expiratory pressure), muscle thickness (ultrasound), functional capacity (6MWT), quality of life (Saint George's Respiratory Questionnaire), inflammatory profile (PCR, IL-6 e IL-10, TNFα), oxidative stress (protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate) will be assessed before and after the 16 sessions.

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 muscle strength
timeFrame: Baseline
measure: Peripheral muscle strength
timeFrame: Two months
Secondary outcomes:
measure: Maximum inspiratory pressure
timeFrame: Baseline
measure: Maximum inspiratory pressure
timeFrame: Two months
measure: Maximum expiratory pressure
timeFrame: Baseline
measure: Maximum expiratory pressure
timeFrame: Two months
measure: Muscle thickness
timeFrame: Baseline
measure: Muscle thickness
timeFrame: Two months
measure: Functional capacity
timeFrame: Baseline
measure: Functional capacity
timeFrame: Two months
measure: Quality of life
timeFrame: Baseline
measure: Quality of life
timeFrame: Two months
measure: Inflammatory profile
timeFrame: Baseline
measure: Inflammatory profile
timeFrame: Two months
measure: Oxidative stress
timeFrame: Baseline
measure: Oxidative stress
timeFrame: Two months
Other outcomes:
Locations:
Study officials:
References: