Acute Effect of Whole-body Electrical Stimulation in COPD Patients

NCT05885152 | Completed

• 1 other identifier: WBES_COPD
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (22)

• Peripheral oxygen saturation

  Peripheral oxygen saturation will be assessed by pulse oximetry

  Baseline

• Peripheral oxygen saturation

  Peripheral oxygen saturation will be assessed by pulse oximetry

  Protocol 1: minute four; Protocol 2: minute eight

• Peripheral oxygen saturation

  Peripheral oxygen saturation will be assessed by pulse oximetry

  Immediately after the session

• Respiratory rate

  Respiratory rate will be assessed by respiratory rate count for one minute

  Baseline

• Respiratory rate

  Respiratory rate will be assessed by respiratory rate count for one minute

  Protocol 1: minute four; Protocol 2: minute eight

• Respiratory rate

  Respiratory rate will be assessed by respiratory rate count for one minute

  Immediately after the session

• Heart rate

  Heart rate will be assessed by pulse oximetry

  Baseline

• Heart rate

  Heart rate will be assessed by pulse oximetry

  Protocol 1: minute four; Protocol 2: minute eight

• Heart rate

  Heart rate will be assessed by pulse oximetry

  Immediately after the session

• Systolic blood pressure

  Systolic blood pressure will be assessed through sphygmomanometer

  Baseline

• Systolic blood pressure

  Systolic blood pressure will be assessed through sphygmomanometer

  Immediately after the session

• Diastolic blood pressure

  Diastolic blood pressure will be assessed through sphygmomanometer

  Baseline

• Diastolic blood pressure

  Diastolic blood pressure will be assessed through sphygmomanometer

  Immediately after the session

• Dyspnea and Fatigue

  Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale

  Baseline

• Dyspnea and Fatigue

  Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale

  Protocol 1: minute four; Protocol 2: minute eight

• Dyspnea and Fatigue

  Dyspnea and Fatigue will be assessed through Borg's perceived exertion scale

  Immediately after the session

• Autonomic control

  Autonomic control will be assessed through variability heart rate

  Baseline

• Autonomic control

  Autonomic control will be assessed through variability heart rate

  Up to 10 minutes after the session

• Adverse events

  Occurrence of adverse events will be assessed through patient report

  Immediately after the session

• Adverse events

  Occurrence of adverse events will be assessed through patient report

  24 hours after the session

• Adverse events

  Occurrence of adverse events will be assessed through patient report

  48 hours after the session

• Adverse events

  Occurrence of adverse events will be assessed through patient report

  72 hours after the session

Secondary Outcomes (16)

• Muscle damage

  Baseline

• Muscle damage

  Immediately after the session

• Muscle damage

  24 hours after the session

• Muscle damage

  48 hours after the session

• Muscle damage

  72 hours after the session

Study Arms (2)

Whole-body electrical stimulation, Protocol 1

EXPERIMENTAL

A whole body electrical stimulation session. Symmetrical biphasic current will be used, pulse width of 400µs, frequency of 75Hz, contraction time of five seconds, rest time of 10 seconds, for eight minutes, totaling 32 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometry to become familiar with the electrical current. Then with the use of a stick (for proprioception), a series of biceps exercises and a series of triceps exercises, a series of sit-ups and a squat, a series of step ups and downs, and a series of plantings.

Other: Whole-body electrical stimulation

Whole-body electrical stimulation, Protocol 2

EXPERIMENTAL

A whole body electrical stimulation session. Symmetrical biphasic current will be used, pulse width of 400µs, frequency of 75Hz, contraction time of five seconds, rest time of 10 seconds, for 16 minutes, totaling 64 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometry to become familiar with the electrical current. Then with the use of a stick (for proprioception), a series of biceps exercises and a series of triceps exercises, a series of sit-ups and a squat, a series of step ups and downs, and a series of plantings.

Other: Whole-body electrical stimulation

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.

Also known as: Whole-body electromyostimulation

Whole-body electrical stimulation, Protocol 1; Whole-body electrical stimulation, Protocol 2

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

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Jociane Schardong

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: June 1, 2023
• Study Start: July 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)