Intubated ICU PatientsNCT07571642

Respiratory Muscle Training in the ICU: IMT vs Diaphragmatic NMES

A study testing Diaphragmatic Neuromuscular Electric Stimulation (NMES) and Inspiratory muscle training (IMT) in people with Intubated ICU Patients, run by Ali Yalman at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Intubated ICU Patients
What is being tested?: Diaphragmatic Neuromuscular Electric Stimulation (NMES) and Inspiratory muscle training (IMT)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 5 Mar 2020to 23 Nov 2021
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

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Hatay Mustafa Kemal University
Hatay, 31060

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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 51 patients were randomized by block randomization to the IMT (n=26) or NMES (n=25) group. The study was completed by 32 patients: IMT (n=16) and NMES (n=16). In the IMT group, 6 participants refused treatment and 4 did not complete the treatment; in the NMES group, 4 participants refused treatment and 5 did not complete the treatment. 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.

Conditions: Intubated ICU Patients
Being tested: Diaphragmatic Neuromuscular Electric Stimulation (NMES), Inspiratory muscle training (IMT)
Keywords: mechanical ventilation, NMES, inspiratory muscle training, physical functions

What participants receive

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

Diaphragmatic Neuromuscular Electric Stimulation (NMES)Procedure or surgery
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).
Inspiratory muscle training (IMT)Procedure or surgery
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.

Study groups in NCT07571642
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Diaphragmatic Neuromuscular Electric Stimulation (NMES)

What is being measured

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

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.
Measured: 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.
Measured: Baseline, 1 hour before discharge

Secondary outcomes (4)

Mechanical Ventilatory Parameters - Tidal Volumes
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).
Measured: Baseline, 1 hour before extubation
Mechanical Ventilatory Parameter - Minute Ventilation
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)
Measured: Baseline, 1 hour before extubation
Length of time intubated
The duration of intubation for the participants was reported in days.
Measured: 12 hours after extubation
Hospital stay length
The duration of hospital stay was reported in days
Measured: 2 hours after discharge

Timeline

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

5 Mar 202023 Nov 2021

First posted6 May 2026
Study start5 Mar 2020
Primary completion20 Oct 2021
Study completion23 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Intubated ICU PatientsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07571642
Sponsor's protocol ID: 60116787-020/46004
Status last verified: May 2026
First submitted: 11 Apr 2026
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 30123586
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.
PubMed 30321084
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.
PubMed 23886842

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing the Effects of Inspiratory Muscle Training and Diaphragmatic Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07571642
Acronym / sponsor ID: 60116787-020/46004
Conditions: Intubated ICU Patients
Keywords: mechanical ventilation, NMES, inspiratory muscle training, physical functions
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Ali YalmanUniversity, hospital or other
Study start: 5 Mar 2020 (actual)
Primary completion: 20 Oct 2021 (actual)
Study completion: 23 Nov 2021 (actual)
First posted: 6 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Inspiratory Muscle Training (IMT)	Active comparator	Procedure: 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.
Neuromuscular electric stimulation (NMES)	Experimental	Procedure: Diaphragmatic 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diaphragmatic 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).	Procedure or surgery	Neuromuscular electric stimulation (NMES)
Inspiratory 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.	Procedure or surgery	Inspiratory Muscle Training (IMT)

Primary outcome

Inspiratory muscle strength
Time frame: 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.
Physical Functions
Time frame: 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.

4 secondary outcomes

Mechanical Ventilatory Parameters - Tidal Volumes
Time frame: Baseline, 1 hour before extubation
Mechanical Ventilatory Parameter - Minute Ventilation
Time frame: Baseline, 1 hour before extubation
Length of time intubated
Time frame: 12 hours after extubation
Hospital stay length
Time frame: 2 hours after discharge

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Background: PubMed 30123586Leite 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.
Background: PubMed 30321084Dos 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.
Background: PubMed 23886842Denehy 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Diaphragmatic Neuromuscular Electric Stimulation (NMES) and Inspiratory muscle training (IMT) in people with Intubated ICU Patients, run by Ali Yalman at 1 site in Turkey (Türkiye).

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 4 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: finished, as of the sponsor's last update on 13 Oct 2026. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inspiratory muscle strength (time frame: Baseline, 1 hour before extubation, 1 hour before discharge). The study lists 2 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 NCT07571642, which also lists 3 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 13 Oct 2026.