Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation

Federal University of Health Science of Porto Alegre

Status: Not yet enrolling

Conditions: Lung Transplantation; Electric Stimulation

Treatments: Other: Whole-body electrical stimulation; Other: Routine physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06249334

WBES_LT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Whole-body electrical stimulation (WB-EMS)

Experimental group

Description:

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.

Treatment:

Other: Whole-body electrical stimulation

Routine physical therapy

Active Comparator group

Description:

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.

Treatment:

Other: Routine physical therapy