Clinical trial NCT06249334: Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation
Official title: Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Transplantation
Electric Stimulation
Keywords: Lung transplantation
Electric stimulation
Randomized Controlled Trial
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Irmandade Santa Casa de Misericórdia de Porto Alegre
First posted: 2024-02-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Isometric quadriceps muscle strength.
timeFrame: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
measure: Lower limb muscle strength.
timeFrame: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
measure: Mortality.
timeFrame: Mortality will be assessed after 30 days, after 60 days and up to 1 year after lung transplantation.
Secondary outcomes:
measure: Safety of whole-body electrical stimulation.
timeFrame: Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.
measure: Safety of whole-body electrical stimulation.
timeFrame: Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.
measure: Safety of whole-body electrical stimulation.
timeFrame: Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.
measure: Muscle pain.
timeFrame: Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.
measure: Safety of whole-body electrical stimulation.
timeFrame: Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.
measure: Isometric muscle strength of the elbow flexors.
timeFrame: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
measure: Upper limb muscle strength.
timeFrame: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
measure: Overall muscle strength.
timeFrame: Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).
measure: Respiratory muscle strength.
timeFrame: Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).
measure: Muscle architecture.
timeFrame: Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).
measure: Functional capacity.
timeFrame: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).
measure: Muscle damage.
timeFrame: On the first day post extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).
measure: Muscle damage.
timeFrame: On the first day post extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).
measure: Length of hospital stay.
timeFrame: From randomization to discharge or death from any cause, whichever comes first, assessed up to 3 months.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande do Sul (RS)
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Jociane Schardong, PhD
role: PRINCIPAL_INVESTIGATOR
References: