Respiratory Muscle Training in the ICU: IMT vs Diaphragmatic NMES

NCT07571642 | Completed

• 1 other identifier: 60116787-020/46004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubated ICU Patients

Keywords

mechanical ventilation; NMES; inspiratory muscle training; physical functions

Outcome Measures

Primary Outcomes (2)

• Inspiratory muscle strength

  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

  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

Secondary Outcomes (4)

• Mechanical Ventilatory Parameters - Tidal Volumes

  Baseline, 1 hour before extubation

• Mechanical Ventilatory Parameter - Minute Ventilation

  Baseline, 1 hour before extubation

• Length of time intubated

  12 hours after extubation

• Hospital stay length

  2 hours after discharge

Study Arms (2)

Inspiratory Muscle Training (IMT)

ACTIVE COMPARATOR

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.

Procedure: Inspiratory muscle training (IMT)

Neuromuscular electric stimulation (NMES)

EXPERIMENTAL

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.

Procedure: Diaphragmatic Neuromuscular Electric Stimulation (NMES)

Interventions

Inspiratory muscle training (IMT) PROCEDURE

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.

Inspiratory Muscle Training (IMT)

Diaphragmatic Neuromuscular Electric Stimulation (NMES) PROCEDURE

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).

Neuromuscular electric stimulation (NMES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ali Yalman: lead

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, 31060, Turkey (Türkiye)

Location

Related Publications (3)

• Leite MA, Osaku EF, Albert J, Costa CRLM, Garcia AM, Czapiesvski FDN, Ogasawara SM, Bertolini GRF, Jorge AC, Duarte PAD. Effects of Neuromuscular Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients: A Pilot Study. Crit Care Res Pract. 2018 Jul 8;2018:4298583. doi: 10.1155/2018/4298583. eCollection 2018.

  PMID: 30123586 BACKGROUND

• Dos Santos FV, Cipriano G Jr, Vieira L, Guntzel Chiappa AM, Cipriano GBF, Vieira P, Zago JG, Castilhos M, da Silva ML, Chiappa GR. Neuromuscular electrical stimulation combined with exercise decreases duration of mechanical ventilation in ICU patients: A randomized controlled trial. Physiother Theory Pract. 2020 May;36(5):580-588. doi: 10.1080/09593985.2018.1490363. Epub 2018 Oct 15.

  PMID: 30321084 BACKGROUND

• Denehy L, de Morton NA, Skinner EH, Edbrooke L, Haines K, Warrillow S, Berney S. A physical function test for use in the intensive care unit: validity, responsiveness, and predictive utility of the physical function ICU test (scored). Phys Ther. 2013 Dec;93(12):1636-45. doi: 10.2522/ptj.20120310. Epub 2013 Jul 25.

  PMID: 23886842 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Proffesor

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: May 6, 2026
• Study Start: March 5, 2020
• Primary Completion: October 20, 2021
• Study Completion: November 23, 2021
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)