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Lung TransplantationNCT05410522

Electrostimulation Program for Lung Transplant Recipients in the ICU

A study testing EMS Program in people with Lung Transplantation, run by Universidad Complutense de Madrid at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Transplantation
What is being tested?
EMS Program
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteSpain
Study dates
9 May 2022to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Ignacio Zaragoza García, PhD contact

+34913941346

izaragoz@ucm.es

Spain1 site, 1 recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Virginia Díaz Teruel, MsD, +34913908000 ext. 1280, vdiazt@salud.madrid.org

    Recruiting

Other trials in Spain

About this study

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)

Read the 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.

Being tested
EMS Program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMS ProgramDevice

    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.

Study groups in NCT05410522
Study groupRoleWhat they receive
Experimental lung transplantExperimentalThe 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.
Receives: Device: EMS Program
Control lung transplantNo interventionElectro stimulation therapy will not be performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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).

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

  2. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start9 May 2022
  3. Primary completion21 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05410522
Sponsor's protocol ID
CuidReaTxLung01
Status last verified
May 2022
First submitted
25 May 2022
Last updated
8 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28580854

  • 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.

    PubMed 31464214

  • 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.

    PubMed 18444941

  • 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.

    PubMed 31581205

  • 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.

    PubMed 31461743

Questions about this trial

What is this clinical trial studying?

A study testing EMS Program in people with Lung Transplantation, run by Universidad Complutense de Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ignacio Zaragoza García, PhD (+34913941346, izaragoz@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation of muscle mass in the quadriceps (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05410522, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.

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