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Respiratory Muscle Training in the ICU: IMT vs Diaphragmatic NMES

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07571642
Enrollment
32
Registered
2026-05-06
Start date
2020-03-05
Completion date
2021-11-23
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubated ICU Patients

Keywords

mechanical ventilation, NMES, inspiratory muscle training, physical functions

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.

Detailed description

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.

Interventions

PROCEDUREDiaphragmatic Neuromuscular Electric Stimulation (NMES)

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).

PROCEDUREInspiratory muscle training (IMT)

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.

Sponsors

Ali Yalman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Inspiratory muscle strengthBaseline, 1 hour before extubation, 1 hour before dischargeInspiratory 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.
Physical FunctionsBaseline, 1 hour before dischargePhysical 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.

Secondary

MeasureTime frameDescription
Mechanical Ventilatory Parameters - Tidal VolumesBaseline, 1 hour before extubationRespitatory 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).
Mechanical Ventilatory Parameter - Minute VentilationBaseline, 1 hour before extubationRespitatory 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)
Length of time intubated12 hours after extubationThe duration of intubation for the participants was reported in days.
Hospital stay length2 hours after dischargeThe duration of hospital stay was reported in days

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026