NCT06761963Not yet recruiting
Chronic Effect of Whole-body Electrical Stimulation in COPD Patients
Source: ClinicalTrials.gov · Last updated 7 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 4 Nov 2024
- Start date
- 20 Jan 2025
- Primary completion date
- 20 Mar 2025
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Diseases
- COPD
- NCT number
- NCT06761963
What you commit to
- Study type: Interventional
- Planned participants: 16
- From 20 Jan 2025 to the primary completion date, 20 Mar 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Liver and kidney diseases.
Other
- 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;
- Hemophilia;
Who the study is looking for
- Diagnosis of COPD GOLD 3 and 4;
- Age between 18 and 80 years;
- Ability to ambulate.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.