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Respiratory Muscle Training in the ICU: IMT vs Diaphragmatic NMES

2 maggio 2026 aggiornato da: Ali Yalman

Comparing the Effects of Inspiratory Muscle Training and Diaphragmatic Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients: A Randomized Controlled Trial

This study aimed to compare the effects of Inspiratory Muscle Training (IMT) and Diaphragmatic Neuromuscular Electrical Stimulation (NMES) on inspiratory muscle strength, mechanical ventilator parameters, and functional levels in intubated intensive care unit (ICU) patients. Thirty-two intubated patients were divided into two groups: the IMT group and the NMES group. In the IMT group, IMT was administered twice a day in addition to routine physiotherapy. In the NMES group, electrical stimulation was applied to the diaphragm muscle for 40 minutes in addition to routine physiotherapy. The primary outcomes of the study are inspiratory muscle strength and physical function level. The secondary outcomes are mechanical ventilator parameters, extubation time, and length of hospital stay.

Panoramica dello studio

Descrizione dettagliata

This randomized study aimed to compare the effects of Inspiratory Muscle Training (IMT) and Neuromuscular Electrical Stimulation (NMES) on inspiratory muscle strength, mechanical ventilator parameters, and functional levels in intensive care unit (ICU) patients.

A total of 32 mechanically ventilated patients were randomly assigned to either an IMT group (n=16) or an NMES group (n=16). In addition to routine ICU physiotherapy, the IMT group received inspiratory muscle training using Philips Respironics Threshold IMT devices, while the NMES group received stimulation on the diaphragm with Aussie current using surface electrodes.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria

  • Being intubated
  • Conscious state
  • Ability to trigger mechanical ventilation
  • Capability to execute at least one motor command

Exclusion Criteria

  • Any neurological or orthopedic diagnosis or deficits
  • Inability to cooperate with the physiotherapist
  • Hemodynamic instability despite medical treatment
  • Excessive secretions requiring aspiration more than once per hour.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Inspiratory Muscle Training (IMT)
As a result of randomization, the IMT group consisted of 16 participants with a mean age of 70 ± 9.57 years. IMT was administered to the participants twice a day following routine physiotherapy, which included breathing exercises and mobilization.
Routine ICU physiotherapy includes: conventional chest physiotherapy, consisting of diaphragmatic breathing, thoracic expansion exercises, postural drainage, cough training, and in-bed ROM exercises and mobilization. In addition to routine ICU physiotherapy, patients received IMT twice daily with Threshold IMT devices (Respironics, New Jersey, Inc., NJ, USA). The IMT program started at 30% of pretreatment Pimax and was increased by 2H2O daily according to patients' tolerance. A total of 3 sets of 8 repetitions were applied.
Sperimentale: Neuromuscular electric stimulation (NMES)
As a result of randomization, the NMES group consisted of 16 participants with a mean age of 65.31 ± 8.38 years. Following routine intensive care physiotherapy, which included breathing exercises and mobilization, NMES was applied to the diaphragm muscle for 40 minutes.
Routine ICU physiotherapy includes: conventional chest physiotherapy, consisting of diaphragmatic breathing, thoracic expansion exercises, postural drainage, cough training, and in-bed ROM exercises and mobilization. In addition to routine ICU physiotherapy, patients received NMES on the diaphragm with surface electrodes. Electrodes were placed at four channels with two electrodes on both sides of the xiphoid at the level of the intercostal space of the 7th and 8th ribs, superiorly and inferiorly. In addition, two electrodes with two channels were placed superiorly and inferiorly at the midaxillary level of the intercostal space of the 7th and 8th ribs. A total of 4 channels and 8 electrodes were used with modified burst series biphasic current 30 Hz (Aussie current).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Inspiratory muscle strength
Lasso di tempo: Baseline, 1 hour before extubation, 1 hour before discharge
Inspiratory muscle strength (Pimax) was assessed by a desktop spirometer with Pimax module (Pony Fx, COSMED, Rome, Italy). A catheter mount piece was placed in front of the pressure measurement part of spirometer to perform the measurement in intubated participants. Participants were encouraged throughout the measurements to achieve maximum strength and coordination. The measurements were repeated three times, and the average of these values was recorded. To prevent respiratory muscle fatigue, at least a one-minute break was provided between trials. Results were reported in cmH2O units.
Baseline, 1 hour before extubation, 1 hour before discharge
Physical Functions
Lasso di tempo: Baseline, 1 hour before discharge
Physical function levels of patients were evaluated by Physical Function Intensive Care Unit Test-scored (PFIT-s). Physical Function Intensive Care Unit Test-scored has 4 test components; shoulder flexion strength, knee extension strength, sit to stand assistance, step cadence. Before the test, the participant was expected to correctly answer 2 of 5 questions to assessing the cooperation. Participants' vital signs were noted before and after the test. Participants are scored on a total scale ranging from 0 to 10. A score of 0 signifies total dependence and poor muscle strength, whereas a score of 10 represents functional independence and optimal muscle strength.
Baseline, 1 hour before discharge

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mechanical Ventilatory Parameters - Tidal Volumes
Lasso di tempo: Baseline, 1 hour before extubation
Respitatory parameters were assessed by mechanic ventilator (The Engstrom Carestation, GE Health Care 2016). The test procedure; device was switched to CPAP mode, Psupport was set to 10 cmH2O and PEEP was set to 5 cmH2O to overcome the physiological resistance of the ventilator circuit. The patient was instructed to take deep breaths for one minute. As the measurements required patient motivation and coordination, the tests were conducted by providing appropriate verbal commands. Inspiratory tidal volume (TVi) and expiratory tidal volume (TVe) were recorded in milliliters (ml).
Baseline, 1 hour before extubation
Mechanical Ventilatory Parameter - Minute Ventilation
Lasso di tempo: Baseline, 1 hour before extubation
Respitatory parameters were assessed by mechanic ventilator (The Engstrom Carestation, GE Health Care 2016). The test procedure; device was switched to CPAP mode, Psupport was set to 10 cmH2O and PEEP was set to 5 cmH2O to overcome the physiological resistance of the ventilator circuit.The patient was instructed to perform deep breathing for a period of one minute. Since the measurement required patient motivation and coordination, the tests were conducted by providing appropriate verbal commands. Minute ventilation was recorded in liters per minute (L/min)
Baseline, 1 hour before extubation
Length of time intubated
Lasso di tempo: 12 hours after extubation
The duration of intubation for the participants was reported in days.
12 hours after extubation
Hospital stay length
Lasso di tempo: 2 hours after discharge
The duration of hospital stay was reported in days
2 hours after discharge

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 marzo 2020

Completamento primario (Effettivo)

20 ottobre 2021

Completamento dello studio (Effettivo)

23 novembre 2021

Date di iscrizione allo studio

Primo inviato

11 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 maggio 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 60116787-020/46004

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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