Chronic Effect of Whole-body Electrical Stimulation in COPD Patients

NCT06761963 | Not Yet Recruiting DMC

• 1 other identifier: WBES_COPD_2
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Maximum inspiratory pressure

  Baseline

• Maximum inspiratory pressure

  Two months

• Maximum expiratory pressure

  Baseline

• Maximum expiratory pressure

  Two months

• Muscle thickness

  Baseline

Study Arms (2)

whole-body electrical stimulation

EXPERIMENTAL

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

Rehabilitation

OTHER

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

Interventions

Whole-body electrical stimulation OTHER

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.

whole-body electrical stimulation

Rehabilitation OTHER

Pulmonary rehabilitation program.

Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COPD GOLD 3 and 4;
• Age between 18 and 80 years;
• Ability to ambulate.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Santa Casa de Porto Alegre: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Jociane Schardong

CONTACT

+55 55981348114; joci_fisioufsm@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: January 7, 2025
• Study Start: January 20, 2025
• Primary Completion: March 20, 2025
• Study Completion: April 10, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share