Lung Transplantation Clinical Trial
Official title:
Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation: Randomized Clinical Trial
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.
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Health Sciences of Porto Alegre | Porto Alegre | Rio Grande Do Sul (RS) |
Lead Sponsor | Collaborator |
---|---|
Federal University of Health Science of Porto Alegre | Irmandade Santa Casa de Misericórdia de Porto Alegre |
Brazil,
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. |
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