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Not yet recruitingNCT07536347PNF/IMT/MVUpdated Apr 17, 2026

Effect of Adding PNF to IMT on Weaning Off MV

An interventional study of threshold inspiratory muscle training + conventional chest physiotherapy and proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy in Weaning From Mechanical Ventilation, sponsored by Beni-Suef University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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:

  1. intervention group 1:include 31 mechanically ventilated patients will receive inspiratory muscle training along with Conventional rehabilitation program plus medical treatment.
  2. 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.
  3. Control group: include 31 mechanically ventilated patients will receive Conventional rehabilitation program plus medical treatment.

Instrumentations:

A) Evaluation:

All the following will be measured for all patients who will participate in this study

  1. ICU length of stay.
  2. 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
  3. Maximum inspiratory pressure
  4. Laboratory investigation:

    - Arterial Blood Gases (ABG): for measurement of Pao2, Partial pressure of CO2 (Paco2), Hco3 and PH

  5. Sonar parameters:

    - Diaphragmatic excursion.

  6. APHACH II score
  7. Shallow breathing index.
  8. Lung compliance: - Static and dynamic
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Conditions studied

  • Weaning From Mechanical Ventilation

Keywords

  • proprioceptive neuromuscular facilitation
  • weaning
  • Inspiratory muscle training
  • diaphragmatic excretion
03

In context

Lead sponsor

Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
93 participants (estimated)

Study arms

  • Active comparator
    group (A) threshold inspiratory muscle training

    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.

    Device: threshold inspiratory muscle training + conventional chest physiotherapy

  • Active comparator
    group (B) PNF training + IMT

    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.

    Device: proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy

  • Active comparator
    group(C) Conventional Chest Physiotherapy only

    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.

    Other: Conventional Chest Physiotherapy

Interventions

  • Devicethreshold inspiratory muscle training + conventional chest physiotherapy

    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.

  • Deviceproprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy

    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.

  • OtherConventional Chest Physiotherapy

    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.

06

What researchers measure

Primary outcomes

  1. • Time to Successful weaning

    Successful weaning: defined as sustained spontaneous breathing \>48 hours post-extubation without need for reintubation or non-invasive ventilation.

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

  2. • 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")

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

  3. • 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.

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

Secondary outcomes

  1. • ICU length of stay

    The number of days from ICU admission to ICU discharge

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

  2. 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

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

  3. 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

    Time frame: From enrollment to the end of treatment (an average of 7 to 14 days)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07536347
Lead sponsor
Beni-Suef University
Responsible party
Mohammed Shaaban Attya Abd-Alhafez (demonstrator, Beni-Suef University) — Principal investigator
First posted
Apr 17, 2026
Start date
Apr 25, 2026 (estimated)
Primary completion
Oct 25, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Apr 17, 2026

Study contacts

Mohammed SH Attya, master degree
Contact
mohammedbnshaaban2@gmail.com
+201158268850
Mahmoud I Mahmoud, lecturer
Contact
Mahmoud.ibrahim@pt.bsu.edu.eg
00201142998414
Sherine H Mehani, professor
principal investigator · Beni-Suef University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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