Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-28 @ 10:02 PM
Study NCT ID:
NCT06249334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-18
First Post:
2023-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation
Sponsor:
Federal University of Health Science of Porto Alegre
Organization:
Study Overview
Official Title:
Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation: Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: