Lung Transplantation Clinical Trial
Official title:
Effect of an Electrostimulation Program in Lung Transplant Recipients During Their Stay in the Intensive Critical Care Unit. Experimental Study
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)
Status | Recruiting |
Enrollment | 58 |
Est. completion date | June 30, 2024 |
Est. primary completion date | December 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario 12 de Octubre | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid | Hospital Universitario 12 de Octubre |
Spain,
De Brandt J, Spruit MA, Hansen D, Franssen FM, Derave W, Sillen MJ, Burtin C. Changes in lower limb muscle function and muscle mass following exercise-based interventions in patients with chronic obstructive pulmonary disease: A review of the English-lang — View Citation
Janaudis-Ferreira T, Mathur S, Deliva R, Howes N, Patterson C, Räkel A, So S, Wickerson L, White M, Avitzur Y, Johnston O, Heywood N, Singh S, Holdsworth S. Exercise for Solid Organ Transplant Candidates and Recipients: A Joint Position Statement of the C — View Citation
Maury G, Langer D, Verleden G, Dupont L, Gosselink R, Decramer M, Troosters T. Skeletal muscle force and functional exercise tolerance before and after lung transplantation: a cohort study. Am J Transplant. 2008 Jun;8(6):1275-81. doi: 10.1111/j.1600-6143. — View Citation
Shah S, Darekar B, Salvi S, Kowale A. Quadriceps strength in patients with chronic obstructive pulmonary disease. Lung India. 2019 Sep-Oct;36(5):417-421. doi: 10.4103/lungindia.lungindia_27_19. — View Citation
Zhang L, Hu W, Cai Z, Liu J, Wu J, Deng Y, Yu K, Chen X, Zhu L, Ma J, Qin Y. Early mobilization of critically ill patients in the intensive care unit: A systematic review and meta-analysis. PLoS One. 2019 Oct 3;14(10):e0223185. doi: 10.1371/journal.pone.0 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variation of muscle mass in the quadriceps | 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. | 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). | |
Secondary | Mobility assessment according to ICU-Mobility scale (IMS) | 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). | Each day in the morning and afternoon, until discharge from ICU (up to 14 days). | |
Secondary | Leg strength according to Chair and Stand test | Leg strength assessment before transplantation and at discharge from ICU (up to 14 days), using Chair and Stand test | Up to 6 months prior to transplantation and at ICU discharge (up to 14 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02581111 -
Naloxone for Optimizing Hypoxemia Of Lung Donors
|
Phase 2/Phase 3 | |
Recruiting |
NCT02177916 -
Patient Education Study to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation
|
N/A | |
Not yet recruiting |
NCT01394835 -
Safety and Efficacy of Inhaled Alpha-1 Antitrypsin in Preventing Bronchiolitis Obliterable Syndrome in Lung Transplant Recipients
|
Phase 2 | |
Completed |
NCT01204970 -
Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients
|
N/A | |
Not yet recruiting |
NCT01162148 -
Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation
|
N/A | |
Active, not recruiting |
NCT00980967 -
Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study
|
N/A | |
Completed |
NCT00531921 -
Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival
|
N/A | |
Recruiting |
NCT00163696 -
Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease
|
N/A | |
Completed |
NCT00177684 -
Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
|
Phase 3 | |
Completed |
NCT00163891 -
Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients
|
N/A | |
Completed |
NCT03668483 -
Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx
|
N/A | |
Not yet recruiting |
NCT02855372 -
Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT)
|
N/A | |
Completed |
NCT01212406 -
Vitamin D in Bronchiolitis Obliterans Syndrome
|
Phase 4 | |
Completed |
NCT01211509 -
Montelukast in Bronchiolitis Obliterans Syndrome
|
Phase 4 | |
Not yet recruiting |
NCT00808600 -
Empowerment of Lung and Heart-lung Transplant Patients
|
N/A | |
Completed |
NCT00553397 -
Live Lung Donor Retrospective Study
|
N/A | |
Completed |
NCT00402805 -
Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
|
Phase 4 | |
Completed |
NCT00701922 -
Surveillance Study of Viral Infections Following Lung Transplantation
|
N/A | |
Terminated |
NCT00235651 -
Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients
|
Phase 3 | |
Active, not recruiting |
NCT02936505 -
Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.
|
N/A |