Electrostimulation Program for Lung Transplant Recipients in the ICU

NCT05410522 | Unknown

• 1 other identifier: CuidReaTxLung01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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)

Conditions

Lung Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mobility assessment according to ICU-Mobility scale (IMS)

  Each day in the morning and afternoon, until discharge from ICU (up to 14 days).

• Leg strength according to Chair and Stand test

  Up to 6 months prior to transplantation and at ICU discharge (up to 14 days)

Study Arms (2)

Experimental lung transplant

EXPERIMENTAL

The training time will be 30 minutes in the morning and 30 minutes in the afternoon with a total daily work time of 60 minutes. The frequency of work will be different in each session, seeking in the morning routine a vascularization and improvement of muscle trophism and in the afternoon an aerobic endurance, activation of the working capacity of the tonic muscles to improve the stabilizing muscles and postural fitness.

Device: EMS Program

Control lung transplant

NO INTERVENTION

Electro stimulation therapy will not be performed.

Interventions

EMS Program DEVICE

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.

Experimental lung transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Hospital Universitario 12 de Octubre: collaborator

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Related Publications (5)

• 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-language literature. Chron Respir Dis. 2018 May;15(2):182-219. doi: 10.1177/1479972317709642. Epub 2017 Jun 5.

  PMID: 28580854 RESULT

• 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.

  PMID: 31464214 RESULT

• 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.1600-6143.2008.02209.x. Epub 2008 Apr 29.

  PMID: 18444941 RESULT

• 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.0223185. eCollection 2019.

  PMID: 31581205 RESULT

• Janaudis-Ferreira T, Mathur S, Deliva R, Howes N, Patterson C, Rakel 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 Canadian Society of Transplantation and CAN-RESTORE. Transplantation. 2019 Sep;103(9):e220-e238. doi: 10.1097/TP.0000000000002806.

  PMID: 31461743 RESULT

Study Officials

• Virginia Díaz-Teruel, MsD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

• Ignacio Zaragoza-García, PhD

  Universidad Complutense de Madrid

  STUDY DIRECTOR

Central Study Contacts

Ignacio Zaragoza García, PhD

CONTACT

+34913941346; izaragoz@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 8, 2022
• Study Start: May 9, 2022
• Primary Completion: December 21, 2023
• Study Completion: June 30, 2024
• Last Updated: June 8, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)