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Lung TransplantationNCT06249334

Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation

A study testing Whole-body electrical stimulation and Routine physical therapy in people with Lung Transplantation and Electric Stimulation, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 the effects of whole-body electrical stimulation (WB-EMS) in the rehabilitation of patients undergoing lung transplantation. This is a randomized clinical trial with patients from the inpatient unit of Dom Vicente Scherer Hospital of Irmandade Santa Casa de Misericórdia from Porto Alegre… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lung Transplantation, Electric Stimulation
What is being tested?
Whole-body electrical stimulation and Routine physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteBrazil
Study dates
20 Dec 2024to Aug 2025
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing unilateral or bilateral lung transplantation;
  • Admitted to the intensive care unit and without invasive ventilatory support;
  • Hemodynamically stable;
  • Time less than or equal to 7 days between lung transplantation and the beginning of rehabilitation protocols.

Who cannot join

  • Patients with severe psychomotor agitation;
  • Recent acute myocardial infarction (24 hours) and / or uncontrolled arrhythmias;
  • Temporary transcutaneous pacemaker;
  • Stroke after lung transplantation;
  • Decompensated heart failure;
  • Uncontrolled hypertension (systolic blood pressure > 230 mmHg and diastolic blood pressure > 120 mmHg) or mean arterial pressure <60 mmHg;
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  • Patients who present important hemodynamic changes during training;
  • Peripheral vascular changes in the lower limbs such as untreated deep vein thrombosis;
  • In a feverish state;
  • Patients with epidermal lesions on the thighs that make it impossible to place self-adhesive electrodes for electrical stimulation;
  • Patients with acute renal failure.

Trial locations and contacts

1 site in 1 country.

Jociane Schardong, PhD contact

+55 55981348114

joci_fisioufsm@yahoo.com.br

Rodrigo DM Plentz, PhD contact

+55 5199113651

roplentz@yahoo.com.br

Brazil1 site
  • Federal University of Health Sciences of Porto Alegre

    Porto Alegre, Rio Grande Do Sul (RS), 90050170

    Jociane DM Schardong, PhD, +5555981348114, joci_fisioufsm@yahoo.com.br

Other trials in Brazil

About this study

Official title: Whole-Body Electrical Stimulation in Patients Undergoing Lung Transplantation: Randomized Clinical Trial

This study aims to evaluate the effects of whole-body electrical stimulation (WB-EMS) in the rehabilitation of patients undergoing lung transplantation. This is a randomized clinical trial with patients from the inpatient unit of Dom Vicente Scherer Hospital of Irmandade Santa Casa de Misericórdia from Porto Alegre (ISCMPA) who will be allocated to a control group (which will receive physiotherapy from routine) or intervention group (which will receive physiotherapy from routine and WB-EMS). Interventions with WB-EMS will occur every day from the moment of extubation until hospital discharge (15 sessions per patient). Assessments will be carried out pre-lung transplantation, after extubation, during intervention protocols and at the time of hospital discharge.

Read the detailed description

Patients on the lung transplant list may experience post-procedure complications that culminate in a higher risk of mortality, which are related to primary and chronic graft dysfunction and infections. These complications are partly responsible for prolonged immobility, sarcopenia, decline in functional capacity and deterioration in quality of life. There is evidence that physical rehabilitation, mainly through exercise, improves the physical capacity and quality of life of transplant patients. However, not all patients are able to perform this type of activity due to low tolerance for it. In this sense, WB-EMS can be an alternative for early rehabilitation. This study aims to evaluate the effects of WB-EMS in the rehabilitation of patients undergoing lung transplantation.

Patients will be selected from the Pulmonary Rehabilitation Center of Pereira Filho Hospital prior to lung transplantation and the following assessments will be carried out: muscle architecture and quality (ultrasound), peripheral muscle strength (dynamometry of lower and upper limbs, Medical Research Council scale and 10-repetition sit-and-stand test), respiratory muscle strength (manovacuometry) and functional capacity (six-minute walk test). After the transplant, with the patient admitted to the intensive care unit, and after being extubated, blood sample will be collected to measure muscle damage, also it will be evaluated the muscle architecture and quality, peripheral muscle strength (only using the Medical Research Council scale) and respiratory muscle strength. Prior to hospital discharge, muscle architecture and quality, peripheral muscle strength (dynamometry of lower and upper limbs, Medical Research Council scale and 10-repetition sit-and-stand test), respiratory muscle strength, functional capacity, and muscle damage will be reassessed, along with the length of hospital stay.

During the training period, the safety of the therapy will be assessed by monitoring cardiorespiratory parameters, muscle pain (analogic visual scale) and fatigue (Borg subjective perceived exertion scale).

Patients will be randomized to the control group (GC) (which will receive physiotherapy from routine) or the intervention group (GI), which will perform whole-body electrical stimulation using the equipment ReCARE® (Visuri, Minas Gerais, Brazil), in addition to routine physiotherapy. After extubation, patients will begin the protocol for 15 sessions and will be reevaluated, therefore the protocol begins in the intensive care unit and will be completed in the inpatient unit.

Being tested
Whole-body electrical stimulation, Routine physical therapy
Keywords
Lung transplantation, Electric stimulation, Randomized Controlled Trial

What participants receive

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

  • Whole-body electrical stimulationOther

    Also called Whole-body electromyostimulation

    The protocol with whole-body electrical stimulation will begin in the intensive care unit and will be completed in the inpatient unit. To stimulate all proposed muscle groups, self-adhesive electrodes will be positioned bilaterally on the quadriceps femoris, tibialis anterior, biceps brachii and lower rectus abdominis muscles. The frequency of 75 Hz will be adopted and the intensity will be adjusted to cause visible muscle contraction. The progression of the therapy protocol will occur throughout the sessions aiming to reach 20 minutes of therapy and 80 contractions.

  • Routine physical therapyOther

    The protocol will be based on knee and hip flexion and extension movements; hip adduction and abduction; flexion and extension of shoulders, elbows and wrists; shoulder abduction and adduction; respecting the range of each joint. Volunteers will also perform transfers from lying to sitting and standing positions. Respiratory conduct will be based on ventilation patterns, bronchial hygiene maneuvers and cough.

Study groups in NCT06249334
Study groupRoleWhat they receive
Whole-body electrical stimulation (WB-EMS)ExperimentalWB-EMS will be performed with ReCare® equipment (Visuri, Minas Gerais, Brazil). Patients will perform sessions once a day, totaling a maximum of 15 sessions. In addition to the WB-EMS protocol, the patients will receive routine physiotherapy at the hospital.
Receives: Other: Whole-body electrical stimulation
Routine physical therapyActive comparatorPatients in the control group (active comparator) will receive routine hospital physical therapy until the moment of hospital discharge. No intervention with electrical stimulation will be performed in this group.
Receives: Other: Routine physical therapy

What is being measured

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

  1. Isometric quadriceps muscle strength.

    Isometric quadriceps muscle strength will be evaluated using a portable dynamometer.

    Measured: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).

  2. Lower limb muscle strength.

    Lower limb strength will be carried out using the 10-repetition sit-and-stand test (SST).

    Measured: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).

  3. Mortality.

    Mortality will be assessed by counting the number of deaths occurring in the study and after hospital discharge.

    Measured: Mortality will be assessed after 30 days, after 60 days and up to 1 year after lung transplantation.

Secondary outcomes (14)
  1. Safety of whole-body electrical stimulation.

    Safety of whole-body electrical stimulation will be assessed by measuring peripheral oxygen saturation.

    Measured: Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.

  2. Safety of whole-body electrical stimulation.

    Safety of whole-body electrical stimulation will be assessed by measuring heart rate.

    Measured: Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.

  3. Safety of whole-body electrical stimulation.

    Safety of whole-body electrical stimulation will be assessed by measuring blood pressure.

    Measured: Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.

  4. Muscle pain.

    Muscle pain will be measured with the analogic visual scale (AVS). This scale classifies pain from 0 (not at all) to 10 (maximum).

    Measured: Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.

  5. Safety of whole-body electrical stimulation.

    Safety of whole-body electrical stimulation will be assessed by perceived exertion with the modified Borg Scale.This scale classifies effort from 0 (nothing at all) to 10 (maximum).

    Measured: Time 0 (pre intervention), after 10 minutes and at 20 minutes from the beginning of the intervention.

  6. Isometric muscle strength of the elbow flexors.

    The muscle strength of the upper limbs will be assessed through isometric contraction of the elbow flexor muscles with a portable dynamometer.

    Measured: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).

  7. Upper limb muscle strength.

    Palmar handgrip will also be assessed using an analog hydraulic dynamometer.

    Measured: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).

  8. Overall muscle strength.

    To assess global muscle strength, the Medical Research Council (MRC) scale will be used. The total score ranges from 0 (quadriplegia) to 60 points (preserved muscle strength).

    Measured: Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).

  9. Respiratory muscle strength.

    Respiratory muscle strength will be measured using the digital manovacuometer.

    Measured: Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).

  10. Muscle architecture.

    The muscle architecture will be evaluated for the acquisition of ultrasound images of the vastus lateralis, rectus femoris, biceps brachii and rectus abdominis muscles, using a high-resolution ultrasound.

    Measured: Time 0 (baseline), on the first day after extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).

  11. Functional capacity.

    Functional capacity will be assessed using the six-minute walk test (6MWT).

    Measured: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).

  12. Muscle damage.

    Muscle damage will be assessed by dosage of creatine phosphokinase.

    Measured: On the first day post extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).

  13. Muscle damage.

    Muscle damage will be assessed by dosage of lactate dehydrogenase.

    Measured: On the first day post extubation and immediately after 15 sessions (totaling a maximum of 3 weeks).

  14. Length of hospital stay.

    Length of hospital stay will be based on the number of days between the date of admission and hospital discharge.

    Measured: From randomization to discharge or death from any cause, whichever comes first, assessed up to 3 months.

Timeline

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

  1. First posted8 Feb 2024
  2. Study start20 Dec 2024 (estimated)
  3. Primary completionApr 2025 (estimated)
  4. Study completionAug 2025 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06249334
Sponsor's protocol ID
WBES_LT
Status last verified
Feb 2024
First submitted
29 Nov 2023
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Garlet AB, Plentz RDM, Righi NC, Schardong J. Whole-body electrical stimulation in patients undergoing lung transplantation in Southern Brazil: study protocol of a single-center randomized controlled trial. Trials. 2025 Dec 5;27(1):23. doi: 10.1186/s13063-025-09177-y.

    PubMed 41350869

Questions about this trial

What is this clinical trial studying?

A study testing Whole-body electrical stimulation and Routine physical therapy in people with Lung Transplantation and Electric Stimulation, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

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 4 inclusion and 11 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 18 Dec 2024. 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 Brazil. 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 Jociane Schardong, PhD (+55 55981348114, joci_fisioufsm@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Isometric quadriceps muscle strength. (time frame: Time 0 (baseline) and immediately after 15 sessions (totaling a maximum of 3 weeks).). The study lists 3 primary outcomes in all. 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 NCT06249334, which also lists 1 linked publication.

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 18 Dec 2024.

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