Effect of Adding PNF to IMT on Weaning Off MV

NCT07536347 | Not Yet Recruiting

• 1 other identifier: FPTBSUREC/0101/201024
• Study Type: interventional
• Target: 93
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Weaning From Mechanical Ventilation

Keywords

proprioceptive neuromuscular facilitation; weaning; Inspiratory muscle training; diaphragmatic excretion

Outcome Measures

Primary Outcomes (3)

• • Time to Successful weaning

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

  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")

  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.

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

Secondary Outcomes (3)

• • ICU length of stay

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

• Lung compliance

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

• Classification of patients according to the weaning process

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

Study Arms (3)

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.

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.

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.

Other: Conventional Chest Physiotherapy

Interventions

threshold inspiratory muscle training + conventional chest physiotherapy DEVICE

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.

group (A) threshold inspiratory muscle training

proprioceptive neuromuscular facilitation + threshold inspiratory muscle training + conventional chest physiotherapy DEVICE

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.

group (B) PNF training + IMT

Conventional Chest Physiotherapy OTHER

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.

group(C) Conventional Chest Physiotherapy only

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sherine H Mehani, professor

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed SH Attya, master degree

CONTACT

+201158268850; mohammedbnshaaban2@gmail.com

Mahmoud I Mahmoud, lecturer

CONTACT

00201142998414; Mahmoud.ibrahim@pt.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: April 17, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share