Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation

Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation: Randomized Clinical Trial

This study aims to evaluate the effects of whole-body electrical stimulation (WB-EMS) in the rehabilitation of patients undergoing lung transplantation. This is a randomized clinical trial with patients from the inpatient unit of Dom Vicente Scherer Hospital of Irmandade Santa Casa de Misericórdia from Porto Alegre (ISCMPA) who will be allocated to a control group (which will receive physiotherapy from routine) or intervention group (which will receive physiotherapy from routine and WB-EMS). Interventions with WB-EMS will occur every day from the moment of extubation until hospital discharge (15 sessions per patient). Assessments will be carried out pre-lung transplantation, after extubation, during intervention protocols and at the time of hospital discharge.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Transplantation; Electric Stimulation
• Intervention / Treatment: Other: Whole-body electrical stimulation; Other: Routine physical therapy

Detailed Description

Patients on the lung transplant list may experience post-procedure complications that culminate in a higher risk of mortality, which are related to primary and chronic graft dysfunction and infections. These complications are partly responsible for prolonged immobility, sarcopenia, decline in functional capacity and deterioration in quality of life. There is evidence that physical rehabilitation, mainly through exercise, improves the physical capacity and quality of life of transplant patients. However, not all patients are able to perform this type of activity due to low tolerance for it. In this sense, WB-EMS can be an alternative for early rehabilitation. This study aims to evaluate the effects of WB-EMS in the rehabilitation of patients undergoing lung transplantation.

Patients will be selected from the Pulmonary Rehabilitation Center of Pereira Filho Hospital prior to lung transplantation and the following assessments will be carried out: muscle architecture and quality (ultrasound), peripheral muscle strength (dynamometry of lower and upper limbs, Medical Research Council scale and 10-repetition sit-and-stand test), respiratory muscle strength (manovacuometry) and functional capacity (six-minute walk test). After the transplant, with the patient admitted to the intensive care unit, and after being extubated, blood sample will be collected to measure muscle damage, also it will be evaluated the muscle architecture and quality, peripheral muscle strength (only using the Medical Research Council scale) and respiratory muscle strength. Prior to hospital discharge, muscle architecture and quality, peripheral muscle strength (dynamometry of lower and upper limbs, Medical Research Council scale and 10-repetition sit-and-stand test), respiratory muscle strength, functional capacity, and muscle damage will be reassessed, along with the length of hospital stay.

During the training period, the safety of the therapy will be assessed by monitoring cardiorespiratory parameters, muscle pain (analogic visual scale) and fatigue (Borg subjective perceived exertion scale).

Patients will be randomized to the control group (GC) (which will receive physiotherapy from routine) or the intervention group (GI), which will perform whole-body electrical stimulation using the equipment ReCARE® (Visuri, Minas Gerais, Brazil), in addition to routine physiotherapy. After extubation, patients will begin the protocol for 15 sessions and will be reevaluated, therefore the protocol begins in the intensive care unit and will be completed in the inpatient unit.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jociane Schardong, PhD; Phone Number: +55 55981348114; Email: joci_fisioufsm@yahoo.com.br
• Study Contact Backup: Name: Rodrigo DM Plentz, PhD; Phone Number: +55 5199113651; Email: roplentz@yahoo.com.br

Study Locations

• Brazil
  • Rio Grande do Sul (RS)
    • Porto Alegre, Rio Grande do Sul (RS), Brazil, 90050170
      • Federal University of Health Sciences of Porto Alegre
      • Contact: Jociane DM Schardong, PhD; Phone Number: +5555981348114; Email: joci_fisioufsm@yahoo.com.br

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients undergoing unilateral or bilateral lung transplantation;
• Admitted to the intensive care unit and without invasive ventilatory support;
• Hemodynamically stable;
• Time less than or equal to 7 days between lung transplantation and the beginning of rehabilitation protocols.

Exclusion Criteria:

• Patients with severe psychomotor agitation;
• Recent acute myocardial infarction (24 hours) and / or uncontrolled arrhythmias;
• Temporary transcutaneous pacemaker;
• Stroke after lung transplantation;
• Decompensated heart failure;
• Uncontrolled hypertension (systolic blood pressure > 230 mmHg and diastolic blood pressure > 120 mmHg) or mean arterial pressure <60 mmHg;
• Patients who present important hemodynamic changes during training;
• Peripheral vascular changes in the lower limbs such as untreated deep vein thrombosis;
• In a feverish state;
• Patients with epidermal lesions on the thighs that make it impossible to place self-adhesive electrodes for electrical stimulation;
• Patients with acute renal failure.

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 (WB-EMS); WB-EMS will be performed with ReCare® equipment (Visuri, Minas Gerais, Brazil). Patients will perform sessions once a day, totaling a maximum of 15 sessions. In addition to the WB-EMS protocol, the patients will receive routine physiotherapy at the hospital.	Other: Whole-body electrical stimulation; The protocol with whole-body electrical stimulation will begin in the intensive care unit and will be completed in the inpatient unit. To stimulate all proposed muscle groups, self-adhesive electrodes will be positioned bilaterally on the quadriceps femoris, tibialis anterior, biceps brachii and lower rectus abdominis muscles. The frequency of 75 Hz will be adopted and the intensity will be adjusted to cause visible muscle contraction. The progression of the therapy protocol will occur throughout the sessions aiming to reach 20 minutes of therapy and 80 contractions.; Other Names: Whole-body electromyostimulation
Active Comparator: Routine physical therapy; Patients in the control group (active comparator) will receive routine hospital physical therapy until the moment of hospital discharge. No intervention with electrical stimulation will be performed in this group.	Other: Routine physical therapy; The protocol will be based on knee and hip flexion and extension movements; hip adduction and abduction; flexion and extension of shoulders, elbows and wrists; shoulder abduction and adduction; respecting the range of each joint. Volunteers will also perform transfers from lying to sitting and standing positions. Respiratory conduct will be based on ventilation patterns, bronchial hygiene maneuvers and cough.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric quadriceps muscle strength.	Isometric quadriceps muscle strength will be evaluated using a portable dynamometer.	Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
Lower limb muscle strength.	Lower limb strength will be carried out using the 10-repetition sit-and-stand test (SST).	Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
Mortality.	Mortality will be assessed by counting the number of deaths occurring in the study and after hospital discharge.	Mortality will be assessed after 30 days, after 60 days and up to 1 year after lung transplantation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of whole-body electrical stimulation.	Safety of whole-body electrical stimulation will be assessed by measuring peripheral oxygen saturation.	Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.
Safety of whole-body electrical stimulation.	Safety of whole-body electrical stimulation will be assessed by measuring heart rate.	Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.
Safety of whole-body electrical stimulation.	Safety of whole-body electrical stimulation will be assessed by measuring blood pressure.	Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.
Muscle pain.	Muscle pain will be measured with the analogic visual scale (AVS). This scale classifies pain from 0 (not at all) to 10 (maximum).	Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.
Safety of whole-body electrical stimulation.	Safety of whole-body electrical stimulation will be assessed by perceived exertion with the modified Borg Scale.This scale classifies effort from 0 (nothing at all) to 10 (maximum).	Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.
Isometric muscle strength of the elbow flexors.	The muscle strength of the upper limbs will be assessed through isometric contraction of the elbow flexor muscles with a portable dynamometer.	Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
Upper limb muscle strength.	Palmar handgrip will also be assessed using an analog hydraulic dynamometer.	Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
Overall muscle strength.	To assess global muscle strength, the Medical Research Council (MRC) scale will be used. The total score ranges from 0 (quadriplegia) to 60 points (preserved muscle strength).	Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).
Respiratory muscle strength.	Respiratory muscle strength will be measured using the digital manovacuometer.	Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).
Muscle architecture.	The muscle architecture will be evaluated for the acquisition of ultrasound images of the vastus lateralis, rectus femoris, biceps brachii and rectus abdominis muscles, using a high-resolution ultrasound.	Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).
Functional capacity.	Functional capacity will be assessed using the six-minute walk test (6MWT).	Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
Muscle damage.	Muscle damage will be assessed by dosage of creatine phosphokinase.	On the first day post extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).
Muscle damage.	Muscle damage will be assessed by dosage of lactate dehydrogenase.	On the first day post extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).
Length of hospital stay.	Length of hospital stay will be based on the number of days between the date of admission and hospital discharge.	From randomization to discharge or death from any cause, whichever comes first, assessed up to 3 months.

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Collaborators: Irmandade Santa Casa de Misericórdia de Porto Alegre
• Investigators: Principal Investigator: Jociane Schardong, PhD, Federal University of Health Sciences of Porto Alegre

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Lung transplantation; Electric stimulation
• Other Study ID Numbers: WBES_LT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No