Lung Transplantation
Conditions
Brief summary
This study aims to evaluate rectus femoris muscle mass in lung transplant recipients and the effect of a training program during ICU admission based on the use of electrical muscle stimulation (EMS)
Detailed description
Lung transplantation is so far the only viable therapy for those individuals with a life-threatening chronic respiratory individuals with a chronic respiratory problem that compromises their life in a period of less than two years and the therapeutic options have been exhausted. The investigators are dealing with individuals with a prolonged disease process, characterized mainly by the reduction of their respiratory capacities, which has a great impact on the basic activities of daily living. Pulmonary involvement conditions the mobility of the individual, limiting physical activity and leading to episodes of dyspnea. The aerobic capacity of the patient is very impaired before the transplant, although after the transplant, it continues in levels below normal for their age . This, resulting in episodes of dyspnea impacts on the extraction and utilization of muscular oxygen , which reduces mobility periods. Limitations in physical activity and even mobility prior to physical activity and even mobility limitations prior to transplantation lead these individuals to marked muscular deterioration, which has an impact on both the general physical and psychological levels. The aim of this study is assessment of muscle status in transplant recipients in lung transplant recipients after application of EMS therapy in the ICU.The sample is divided into two groups, a control group that will not receive EMS therapy and a control group that receive it.
Interventions
DEVICEEMS Program
Lower limb electrostimulation therapy is scheduled for lung transplant patients. The therapy consists in the application of 2 daily 30-minute sessions that begin in the first 48 hours post-transplantation and are maintained daily until discharge from the hospital.
Sponsors
Hospital Universitario 12 de Octubre
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admitted to the lung transplant list according to the criteria of the Health System. * Those who attend the rehabilitation consultation of the hospital under study to undergo treatment prior to transplantation. * They must receive the graft at the hospital under study and be admitted to the resuscitation unit at the same center for post-surgical follow-up.
Exclusion criteria
* Those who are rejected from the transplant list or deceased before the implant is performed. * Lack of follow-up by the rehabilitation consultation. * Are receiving treatment with muscle relaxants after admission to the ICU. * Present skin alterations incompatible with EMS. * Contraindications to perform the transplant proposed according to the criteria of the Health System.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of muscle mass in the quadriceps | Up to 6 months prior to transplantation, within 24 hours of admission and every seven days and/or until discharge from the ICU (up to 14 days). | The quadriceps muscle mass of the lung transplant recipient will be measured prior to transplantation and will be monitored in the first 24 hours post-transplant and every 7 days from admission until hospital discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobility assessment according to ICU-Mobility scale (IMS) | Each day in the morning and afternoon, until discharge from ICU (up to 14 days). | Ability to move during ICU admission. IMS is a scale containing 10 items ranging from 0 (no mobility at all) to 10 (walks unaided), which some authors have categorized binary (\< 4 passive/active mobilization in bed and ≥ 4 active mobilization out of bed). |
| Leg strength according to Chair and Stand test | Up to 6 months prior to transplantation and at ICU discharge (up to 14 days) | Leg strength assessment before transplantation and at discharge from ICU (up to 14 days), using Chair and Stand test |
Countries
Spain
Contacts
Primary ContactIgnacio Zaragoza García, PhD
Outcome results
None listed