Weaning From Mechanical VentilationPNF/IMT/MVNCT07536347
Effect of Adding PNF to IMT on Weaning Off MV
A study testing threshold inspiratory muscle training + conventional chest physiotherapy, proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy and Conventional Chest Physiotherapy in people with Weaning From Mechanical Ventilation, run by Beni-Suef University.
Trial summary
the goal of this clinical trial is to find out the effect of adding proprioceptive neuromuscular facilitation to inspiratory muscle training on weaning off mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning From Mechanical Ventilation
- What is being tested?
- threshold inspiratory muscle training + conventional chest physiotherapy, proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy and Conventional Chest Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults of both sexes
- patients older than 18 years
- Conscious and cooperative
- Hemodynamic stability without significant vasopressor support.
- No continuous sedation.
- Mechanically ventilated due to type 1 or type 2 respiratory failure (RF) for at least 24 hours.
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- Mechanically ventilated in assisted ventilation mode
- Are able to participate in training actively, weanable as regard shallow breathing index.
- presence of weaning criteria as defined in the European Consensus Conference in 2007, including sedation reduction, spontaneous breathing cycles, Partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FiO2) ≥ 150, absence of inotropes or vasopressors at high doses or increasing doses (< 1 mg/h), oxy-hemoglobin saturation (SaO2) > 90% with FiO2≤ 50%, positive end expiratory pressure (PEEP) ≤ 8 cmH2O, temperature between 36 and 39 °C.
Who cannot join
- Hemodynamic or respiratory instability
- Condition that can compromise weaning, such as heart failure.
- Condition that can prevent adequate performance of inspiratory muscle training, such as neuropathy or myopathy.
- Thoracic or abdominal surgery precluding the use of PNF exercises
- Rib fractures
- Current pregnancy
- Cardiac arrest with a guarded neurological prognosis
- Deep coma
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Adding Proprioceptive Neuromuscular Facilitation to Inspiratory Muscle Training on Weaning Off Mechanical Ventilation
the goal of this clinical trial is to find out the effect of adding proprioceptive neuromuscular facilitation to inspiratory muscle training on weaning off mechanical ventilation. the main question it aims to answer is is there a significant difference in the effect of inspiratory muscle training combined with PNF on the duration of weaning in the mechanically ventilated ICU patients.
researchers will compare effect of (Inspiratory muscle training combined with PNF) to (Inspiratory muscle training) and control group.
participants will be mechanically ventilated both sexes patients will be recruited in this study from intensive care unit, their ages older than 18 years. The selected patients will be mechanically ventilated due to respiratory failure and will randomly assigned into three equal groups.
Read the detailed description
type of study: randomized control trial this study is a prospective interventional study one that will be conducted on ninety three mechanically ventilated patients with respiratory failure of both sexes their ages older than 18 years from intensive care unit and will randomly assigned into three equal groups:
- intervention group 1:include 31 mechanically ventilated patients will receive inspiratory muscle training along with Conventional rehabilitation program plus medical treatment.
- intervention group 2: include 31 mechanically ventilated patients will receive inspiratory muscle training combined with proprioceptive neuromuscular facilitation along with Conventional rehabilitation program plus medical treatment.
- Control group: include 31 mechanically ventilated patients will receive Conventional rehabilitation program plus medical treatment.
Instrumentations:
- Evaluation:
All the following will be measured for all patients who will participate in this study
- ICU length of stay.
- Monitoring:
- Mode of ventilation parameters.
- Fiao2
- PEEP
- Tidal Volume
- Respiratory Rate
- The Duration and Type of Weaning:
- Simple
- Prolonged
- Difficult
- The patient vital signs:
- Heart rate
- Respiratory rate
- Oxygen saturation
- Maximum inspiratory pressure
- Laboratory investigation:
- Arterial Blood Gases (ABG): for measurement of Pao2, Partial pressure of CO2 (Paco2), Hco3 and PH
- Sonar parameters:
- Diaphragmatic excursion.
- APHACH II score
- Shallow breathing index.
- Lung compliance: - Static and dynamic
- Conditions
- Weaning From Mechanical Ventilation
- Being tested
- threshold inspiratory muscle training + conventional chest physiotherapy, proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy, Conventional Chest Physiotherapy
- Keywords
- proprioceptive neuromuscular facilitation, weaning, Inspiratory muscle training, diaphragmatic excretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
threshold inspiratory muscle training + conventional chest physiotherapyDevice
threshold inspiratory muscle training: threshold inspiratory muscle training in addition to conventional chest physiotherapy. The TIMT device will be connected to an endotracheal tube and will be verified to be reliable for inspiratory muscle training. With patient in 45 supine position, he will instructed to exhale slowly, empty the air in the lungs and then inhale deeply and vigorously as fast as possible. The MIP will recorded. The inspiratory resistance is set at 50% of MIP. When the heart rate, pulse oxygen, and respiratory rate are relatively stable during inspiratory training, the inspiratory resistance will be increased by 1-2 cm H2O per day. the resistance will be adjusted every day to be 50% of the new maximum inspiratory pressure then 1-2 cm H2O added. Each patient performed 6 breaths × five sets × twice daily × 5 days/ week. Until patients are weaned from mechanical ventilation.
proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapyDevice
PNF training: in the form of rhythmic initiation technique (RIT) and initial stretch technique (IST) in addition to TIMT plus Conventional Chest Physiotherapy. The RIT performed to teach coordination of motion and to establish the correct breathing pattern. The IST applied to reinforce the strength of inspiratory muscles. Its main aim is to facilitate the initiation of motion . PNF techniques include two sessions per day, 5 days/week until patients are weaned from mechanical ventilation. Including four 90-second manual stimulations each (upper ribs, lower ribs, sternum, and diaphragm). After every stimulation the patient rested for one minute.
Conventional Chest PhysiotherapyOther
Conventional Chest Physiotherapy only: two sessions per day, 5 days/week which included Vibration, Percussion, hyperinflation, and suctioning if indicated until patients are weaned from mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| group (A) threshold inspiratory muscle training | Active comparator | threshold inspiratory muscle training: threshold inspiratory muscle training in addition to conventional chest physiotherapy. The TIMT device will be connected to an endotracheal tube and will be verified to be reliable for inspiratory muscle training. With patient in 45 supine position, he will instructed to exhale slowly, empty the air in the lungs and then inhale deeply and vigorously as fast as possible. The MIP will recorded. The inspiratory resistance is set at 50% of MIP. When the heart rate, pulse oxygen, and respiratory rate are relatively stable during inspiratory training, the inspiratory resistance will be increased by 1-2 cm H2O per day. the resistance will be adjusted every day to be 50% of the new maximum inspiratory pressure then 1-2 cm H2O added. Each patient performed 6 breaths × five sets × twice daily × 5 days/ week. Until patients are weaned from mechanical ventilation. Receives: Device: threshold inspiratory muscle training + conventional chest physiotherapy |
| group (B) PNF training + IMT | Active comparator | PNF training: in the form of rhythmic initiation technique (RIT) and initial stretch technique (IST) in addition to TIMT plus Conventional Chest Physiotherapy. The RIT performed to teach coordination of motion and to establish the correct breathing pattern. The IST applied to reinforce the strength of inspiratory muscles. Its main aim is to facilitate the initiation of motion . PNF techniques include two sessions per day, 5 days/week until patients are weaned from mechanical ventilation. Including four 90-second manual stimulations each (upper ribs, lower ribs, sternum, and diaphragm). After every stimulation the patient rested for one minute. Receives: Device: proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy |
| group(C) Conventional Chest Physiotherapy only | Active comparator | Conventional Chest Physiotherapy only: two sessions per day, 5 days/week which included Vibration, Percussion, hyperinflation, and suctioning if indicated until patients are weaned from mechanical ventilation. Receives: Other: Conventional Chest Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Time to Successful weaning
Successful weaning: defined as sustained spontaneous breathing >48 hours post-extubation without need for reintubation or non-invasive ventilation.
Measured: From enrollment to the end of treatment (an average of 7 to 14 days)
• Maximum inspiratory pressure
Maximum inspiratory pressure: to determine the inspiratory muscle strength before and after training. To measure the "negative inspiratory force" (NIF) through the ventilator settings menu (often available under "special procedures" or "lung mechanics")
Measured: From enrollment to the end of treatment (an average of 7 to 14 days)
• Diaphragmatic excursion
Diaphragmatic movement is evaluated using (sonoscape sonar). The right hemidiaphragm is examined by two-dimensional (2D) and M-mode to record diaphragm excursion (displacement). The probe is placed immediately below the right costal margin in the midclavicular line in longitudinal scanning plane with the angle in cephalad direction to make the ultrasound beam perpendicular to the posterior third of the right hemidiaphragm and with the liver serving as an acoustic window.
Measured: From enrollment to the end of treatment (an average of 7 to 14 days)
Secondary outcomes (3)
• ICU length of stay
The number of days from ICU admission to ICU discharge
Measured: From enrollment to the end of treatment (an average of 7 to 14 days)
Lung compliance
Lung compliance: Calculated based on the following formula:
Static compliance=Tidal volume / plateau pressure-PEEP Dynamic compliance=Tidal volume / peak inspiratory pressure-PEEP
Measured: From enrollment to the end of treatment (an average of 7 to 14 days)
Classification of patients according to the weaning process
Into 3 Groups:
Simple weaning Patients who proceed from initiation of weaning to successful extubation on the first attempt without difficulty.
Difficult weaning Patients who fail initial weaning and require up to three SBT or as long as 7 days from the first SBT to achieve successful weaning.
Prolonged weaning Patients who fail at least three weaning attempts or require 7 days of weaning after the first SBT
Measured: From enrollment to the end of treatment (an average of 7 to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start25 Apr 2026 (estimated)
- Primary completion25 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning From Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Shaaban Attya Abd-Alhafez, Beni-Suef University
- Investigators
- Sherine H Mehani, professor, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536347
- Sponsor's protocol ID
- FPTBSUREC/0101/201024
- Acronym
- PNF/IMT/MV
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Proprioceptive Neuromuscular Facilitation to Inspiratory Muscle Training on Weaning Off Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07536347
- Acronym / sponsor ID
- PNF/IMT/MV / FPTBSUREC/0101/201024
- Conditions
- Weaning From Mechanical Ventilation
- Keywords
- proprioceptive neuromuscular facilitation, weaning, Inspiratory muscle training, diaphragmatic excretion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 25 Apr 2026 (estimated)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Apr 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.
the goal of this clinical trial is to find out the effect of adding proprioceptive neuromuscular facilitation to inspiratory muscle training on weaning off mechanical ventilation. the main question it aims to answer is is there a significant difference in the effect of inspiratory muscle training combined with PNF on the duration of weaning in the mechanically ventilated ICU patients.
researchers will compare effect of (Inspiratory muscle training combined with PNF) to (Inspiratory muscle training) and control group.
participants will be mechanically ventilated both sexes patients will be recruited in this study from intensive care unit, their ages older than 18 years. The selected patients will be mechanically ventilated due to respiratory failure and will randomly assigned into three equal groups.
Detailed description
type of study: randomized control trial this study is a prospective interventional study one that will be conducted on ninety three mechanically ventilated patients with respiratory failure of both sexes their ages older than 18 years from intensive care unit and will randomly assigned into three equal groups:
- intervention group 1:include 31 mechanically ventilated patients will receive inspiratory muscle training along with Conventional rehabilitation program plus medical treatment.
- intervention group 2: include 31 mechanically ventilated patients will receive inspiratory muscle training combined with proprioceptive neuromuscular facilitation along with Conventional rehabilitation program plus medical treatment.
- Control group: include 31 mechanically ventilated patients will receive Conventional rehabilitation program plus medical treatment.
Instrumentations:
- Evaluation:
All the following will be measured for all patients who will participate in this study
- ICU length of stay.
- Monitoring:
- Mode of ventilation parameters.
- Fiao2
- PEEP
- Tidal Volume
- Respiratory Rate
- The Duration and Type of Weaning:
- Simple
- Prolonged
- Difficult
- The patient vital signs:
- Heart rate
- Respiratory rate
- Oxygen saturation
- Maximum inspiratory pressure
- Laboratory investigation:
- Arterial Blood Gases (ABG): for measurement of Pao2, Partial pressure of CO2 (Paco2), Hco3 and PH
- Sonar parameters:
- Diaphragmatic excursion.
- APHACH II score
- Shallow breathing index.
- Lung compliance: - Static and dynamic
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group (A) threshold inspiratory muscle training | Active comparator | Device: threshold inspiratory muscle training + conventional chest physiotherapythreshold inspiratory muscle training: threshold inspiratory muscle training in addition to conventional chest physiotherapy. The TIMT device will be connected to an endotracheal tube and will be verified to be reliable for inspiratory muscle training. With patient in 45 supine position, he will instructed to exhale slowly, empty the air in the lungs and then inhale deeply and vigorously as fast as possible. The MIP will recorded. The inspiratory resistance is set at 50% of MIP. When the heart rate, pulse oxygen, and respiratory rate are relatively stable during inspiratory training, the inspiratory resistance will be increased by 1-2 cm H2O per day. the resistance will be adjusted every day to be 50% of the new maximum inspiratory pressure then 1-2 cm H2O added. Each patient performed 6 breaths × five sets × twice daily × 5 days/ week. Until patients are weaned from mechanical ventilation. |
| group (B) PNF training + IMT | Active comparator | Device: proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapyPNF training: in the form of rhythmic initiation technique (RIT) and initial stretch technique (IST) in addition to TIMT plus Conventional Chest Physiotherapy. The RIT performed to teach coordination of motion and to establish the correct breathing pattern. The IST applied to reinforce the strength of inspiratory muscles. Its main aim is to facilitate the initiation of motion . PNF techniques include two sessions per day, 5 days/week until patients are weaned from mechanical ventilation. Including four 90-second manual stimulations each (upper ribs, lower ribs, sternum, and diaphragm). After every stimulation the patient rested for one minute. |
| group(C) Conventional Chest Physiotherapy only | Active comparator | Other: Conventional Chest PhysiotherapyConventional Chest Physiotherapy only: two sessions per day, 5 days/week which included Vibration, Percussion, hyperinflation, and suctioning if indicated until patients are weaned from mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults of both sexes
- patients older than 18 years
- Conscious and cooperative
- Hemodynamic stability without significant vasopressor support.
- No continuous sedation.
Key exclusion criteria (8 listed)
- Hemodynamic or respiratory instability
- Condition that can compromise weaning, such as heart failure.
- Condition that can prevent adequate performance of inspiratory muscle training, such as neuropathy or myopathy.
- Thoracic or abdominal surgery precluding the use of PNF exercises
- Rib fractures
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 |
|---|---|---|
| threshold inspiratory muscle training + conventional chest physiotherapythreshold inspiratory muscle training: threshold inspiratory muscle training in addition to conventional chest physiotherapy. The TIMT device will be connected to an endotracheal tube and will be verified to be reliable for inspiratory muscle training. With patient in 45 supine position, he will instructed to exhale slowly, empty the air in the lungs and then inhale deeply and vigorously as fast as possible. The MIP will recorded. The inspiratory resistance is set at 50% of MIP. When the heart rate, pulse oxygen, and respiratory rate are relatively stable during inspiratory training, the inspiratory resistance will be increased by 1-2 cm H2O per day. the resistance will be adjusted every day to be 50% of the new maximum inspiratory pressure then 1-2 cm H2O added. Each patient performed 6 breaths × five sets × twice daily × 5 days/ week. Until patients are weaned from mechanical ventilation. | Device | group (A) threshold inspiratory muscle training |
| proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapyPNF training: in the form of rhythmic initiation technique (RIT) and initial stretch technique (IST) in addition to TIMT plus Conventional Chest Physiotherapy. The RIT performed to teach coordination of motion and to establish the correct breathing pattern. The IST applied to reinforce the strength of inspiratory muscles. Its main aim is to facilitate the initiation of motion . PNF techniques include two sessions per day, 5 days/week until patients are weaned from mechanical ventilation. Including four 90-second manual stimulations each (upper ribs, lower ribs, sternum, and diaphragm). After every stimulation the patient rested for one minute. | Device | group (B) PNF training + IMT |
| Conventional Chest PhysiotherapyConventional Chest Physiotherapy only: two sessions per day, 5 days/week which included Vibration, Percussion, hyperinflation, and suctioning if indicated until patients are weaned from mechanical ventilation. | Other | group(C) Conventional Chest Physiotherapy only |
Primary outcome
• Time to Successful weaning
Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)
Successful weaning: defined as sustained spontaneous breathing >48 hours post-extubation without need for reintubation or non-invasive ventilation.
• Maximum inspiratory pressure
Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)
Maximum inspiratory pressure: to determine the inspiratory muscle strength before and after training. To measure the "negative inspiratory force" (NIF) through the ventilator settings menu (often available under "special procedures" or "lung mechanics")
• Diaphragmatic excursion
Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)
Diaphragmatic movement is evaluated using (sonoscape sonar). The right hemidiaphragm is examined by two-dimensional (2D) and M-mode to record diaphragm excursion (displacement). The probe is placed immediately below the right costal margin in the midclavicular line in longitudinal scanning plane with the angle in cephalad direction to make the ultrasound beam perpendicular to the posterior third of the right hemidiaphragm and with the liver serving as an acoustic window.
3 secondary outcomes
• ICU length of stay
Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)
Lung compliance
Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)
Classification of patients according to the weaning process
Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- 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.
Sherine H Mehani, professor principal investigator
Beni-Suef University
Questions about this trial
What is this clinical trial studying?
A study testing threshold inspiratory muscle training + conventional chest physiotherapy, proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy and Conventional Chest Physiotherapy in people with Weaning From Mechanical Ventilation, run by Beni-Suef University.
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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed SH Attya, master degree (+201158268850, mohammedbnshaaban2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Time to Successful weaning (time frame: From enrollment to the end of treatment (an average of 7 to 14 days)). 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?
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 17 Apr 2026.