Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation
NCT ID: NCT06249334
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
26 participants
INTERVENTIONAL
2024-12-20
2025-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Irmandade Santa Casa de Misericórdia de Porto Alegre
OTHER
Federal University of Health Science of Porto Alegre
OTHER
Responsible Party
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Jociane Schardong
Principal Investigator
Principal Investigators
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Jociane Schardong, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Health Sciences of Porto Alegre
Locations
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Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande Do Sul (RS), Brazil
Countries
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Central Contacts
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Facility Contacts
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Jociane DM Schardong, PhD
Role: primary
Other Identifiers
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WBES_LT
Identifier Type: -
Identifier Source: org_study_id