Electrostimulation Program for Lung Transplant Recipients in the ICU

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410522
• Other study ID #: CuidReaTxLung01
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2022
• Source: Universidad Complutense de Madrid
• Contact: Ignacio Zaragoza García, PhD
• Phone: +34913941346
• Email: izaragoz[@]ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Device:
• EMS 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

References & 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-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

Outcome

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)