Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation

NCT06249334 | Not Yet Recruiting DMC

• 1 other identifier: WBES_LT
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Transplantation; Electric Stimulation

Keywords

Lung transplantation; Electric stimulation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• Safety of whole-body electrical stimulation.

  Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.

• Safety of whole-body electrical stimulation.

  Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.

• Safety of whole-body electrical stimulation.

  Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.

• Muscle pain.

  Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.

• Safety of whole-body electrical stimulation.

  Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.

Study Arms (2)

Whole-body electrical stimulation (WB-EMS)

EXPERIMENTAL

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

Routine physical therapy

ACTIVE COMPARATOR

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

Interventions

Whole-body electrical stimulation OTHER

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.

Also known as: Whole-body electromyostimulation

Whole-body electrical stimulation (WB-EMS)

Routine physical therapy OTHER

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.

Routine physical therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande Do Sul (RS), 90050170, Brazil

Location

Related Publications (1)

• Garlet AB, Plentz RDM, Righi NC, Schardong J. Whole-body electrical stimulation in patients undergoing lung transplantation in Southern Brazil: study protocol of a single-center randomized controlled trial. Trials. 2025 Dec 5;27(1):23. doi: 10.1186/s13063-025-09177-y.

  PMID: 41350869 DERIVED

Study Officials

• Jociane Schardong, PhD

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jociane Schardong, PhD

CONTACT

+55 55981348114; joci_fisioufsm@yahoo.com.br

Rodrigo DM Plentz, PhD

CONTACT

+55 5199113651; roplentz@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 29, 2023
• First Posted: February 8, 2024
• Study Start: December 20, 2024
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-02

Locations

BR (1)