Chronic Effect of Whole-body Electrical Stimulation in COPD Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Other: Whole-body electrical stimulation; Other: Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jociane Schardong; Phone Number: +55 55981348114; Email: joci_fisioufsm@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: whole-body electrical stimulation; Performed with calibrated Miha Bodytec equipment, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi, and quadratus lumborum. A symmetrical biphasic current, 400µs pulse width, 75Hz frequency will be used. Sixteen sessions will occur twice weekly for eight weeks. In weeks 1-2, contractions last five seconds with 10 seconds rest, for 16 minutes (64 contractions). In weeks 3-5, contractions remain five seconds with five seconds rest, also lasting 16 minutes (96 contractions). In weeks 6-8, contractions/rest stay at five seconds each, lasting 20 minutes (120 contractions). Initial isometric positions familiarize the patient with stimulation, followed by squats, biceps/triceps exercises with a proprioception stick, abdominal exercises, step-up exercises, and aerobic activities (bike/treadmill) to conclude each session.	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.
Other: Rehabilitation; There will be 16 sessions, twice a week, on alternate days, for eight weeks. It 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).	Other: Rehabilitation; Pulmonary rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral muscle strength	Peripheral muscle strength will be assessed by maximum isometric strength of the knee extensor, elbow flexor and palmar flexor muscles using a hand-held dynamometer	Baseline
Peripheral muscle strength	Peripheral muscle strength will be assessed by maximum isometric strength of the knee extensor, elbow flexor and palmar flexor muscles using a hand-held dynamometer	Two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum inspiratory pressure	Maximum inspiratory pressure will be assessed by manovacuometry.	Baseline
Maximum inspiratory pressure	Maximum inspiratory pressure will be assessed by manovacuometry.	Two months
Maximum expiratory pressure	Maximum expiratory pressure will be assessed by manovacuometry.	Baseline
Maximum expiratory pressure	Maximum expiratory pressure will be assessed by manovacuometry.	Two months
Muscle thickness	Muscle thickness will be assessed by the thickness of the quadriceps, biceps and abdominal muscles using ultrasound	Baseline
Muscle thickness	Muscle thickness will be assessed by the thickness of the quadriceps, biceps and abdominal muscles using ultrasound	Two months
Functional capacity	Functional capacity will be assessed by the Six-minute walk test	Baseline
Functional capacity	Functional capacity will be assessed by the Six-minute walk test	Two months
Quality of life	Quality of life will be assessed by the Saint George's Respiratory Questionnaire. Scores range from 0 to 100, with higher scores indicating more limitations	Baseline
Quality of life	Quality of life will be assessed by the Saint George's Respiratory Questionnaire. Scores range from 0 to 100, with higher scores indicating more limitations	Two months
Inflammatory profile	The inflammatory profile will be assessed by the levels of PCR, IL-6 e IL-10, TNFα	Baseline
Inflammatory profile	The inflammatory profile will be assessed by the levels of PCR, IL-6 e IL-10, TNFα	Two months
Oxidative stress	The oxidative stress will be assessed by the measurement of protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate	Baseline
Oxidative stress	The oxidative stress will be assessed by the measurement of protein oxidation, superoxide dismutase and catalase, total hydrogen sulfides, dichlorofluorescein diacetate	Two months

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Collaborators: Santa Casa de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2025
• Primary Completion (Estimated): March 20, 2025
• Study Completion (Estimated): April 10, 2025

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: WBES_COPD_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No