Electrostimulation Program for Lung Transplant Recipients in the ICU

NCT ID: NCT05410522

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Lung Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental lung transplant

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.

Group Type EXPERIMENTAL

EMS Program

Intervention Type 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.

Control lung transplant

Electro stimulation therapy will not be performed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario 12 de Octubre

OTHER

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Virginia Díaz-Teruel, MsD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre

Ignacio Zaragoza-García, PhD

Role: STUDY_DIRECTOR

Universidad Complutense de Madrid

Locations

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Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ignacio Zaragoza García, PhD

Role: CONTACT

+34913941346

Facility Contacts

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Virginia Díaz Teruel, MsD

Role: primary

+34913908000 ext. 1280

References

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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.

Reference Type RESULT
PMID: 28580854 (View on PubMed)

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.

Reference Type RESULT
PMID: 31464214 (View on PubMed)

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.

Reference Type RESULT
PMID: 18444941 (View on PubMed)

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.

Reference Type RESULT
PMID: 31581205 (View on PubMed)

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.

Reference Type RESULT
PMID: 31461743 (View on PubMed)

Other Identifiers

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CuidReaTxLung01

Identifier Type: -

Identifier Source: org_study_id

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