Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation

Lung Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06249334
• Other study ID #: WBES_LT
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: February 2024
• Source: Federal University of Health Science of Porto Alegre
• Contact: Jociane Schardong, PhD
• Phone: +55 55981348114
• Email: joci_fisioufsm[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electric Stimulation
• Lung Transplantation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Health Sciences of Porto Alegre	Porto Alegre	Rio Grande Do Sul (RS)

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Irmandade Santa Casa de Misericórdia de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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.