Effects of Inspiratory Muscle Training and Positive Expiratory Pressure on Mechanically Ventilated Restrictive Lung Disease Patients

NCT07867730 | Recruiting

• 1 other identifier: FUCP/IFG/Sumaira
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

Restrictive lung diseases (RLD) represent a significant cause of morbidity, often necessitating intensive interventions such as mechanical ventilation due to diminished lung compliance (LC) and reduced total lung capacity (TLC). Mechanical ventilation, while vital, is associated with ventilator-induced diaphragmatic dysfunction (VIDD), leading to rapid muscle atrophy and impeding patient recovery. This proposed study aims to evaluate the clinical impact of IMT and PEP on improving respiratory muscle strength, lung compliance and mobilizing secretions (effective cough reflex) in patients with RLD who require mechanical ventilation.

Conditions

Restrictive Lung Diseases

Keywords

restrictive lung diseases; interstitial lung diseases; idiopathic lung fibrosis; inspiratory muscle training; PEP devices; mechanical ventilation; Ventilator induced diaphragm dysfunction

Outcome Measures

Primary Outcomes (1)

• Lung compliance

  It will be assessed daily using ventilator-derived parameters. Static and dynamic compliance values will be recorded directly from the ventilator settings, providing objective measures of lung mechanics improvements throughout the intervention period.

  From randomization until extubation, or completion of the 7-day intervention period, whichever occurs first; assessed twice daily, up to 7 days

Study Arms (2)

Conventional Physiotherapy

ACTIVE COMPARATOR

Participants in the group A will recieve standard physiotherapy, including passive/active limb exercises, chest percussion, and positioning. Each session will last for 15 minutes.

Other: Conventional Chest Physical Therapy

Conventional Physiotherapy Plus Inspiratory Muscle Training and Positive Expiratory Pressure

EXPERIMENTAL

Participants in Group B will recieve standard physiotherapy along with targeted inspiratory and positive expiratory pressure (PEP) muscle training to enhance respiratory muscle strength.

Device: Inspiratory muscle training

Interventions

Inspiratory muscle training DEVICE

Inspiratory Muscle Training (IMT): Patients will be positioned at a 45° angle in bed. The IMT device will be individually calibrated and connected to the endotracheal tube. Initial intensity will be set at 40% of the patient's maximal inspiratory pressure (MIP), progressing daily by 10%. Positive Expiratory Pressure (PEP) Training: Patients will be positioned laterally. The PEP device will be set at 7 cm H₂O resistance and will be connected to the endotracheal tube. Training will continue daily. Sessions will be paused if signs of respiratory or hemodynamic instability appear (e.g., altered respiratory rate, SpO₂, BP, HR, mental status, hemoptysis, arrhythmias, or diaphoresis). In such cases, training intensity will be maintained at the previous level.

Conventional Physiotherapy Plus Inspiratory Muscle Training and Positive Expiratory Pressure

Conventional Chest Physical Therapy OTHER

Participants will receive standard physiotherapy consisting of passive and active range-of-motion exercises for the upper and lower limbs, chest physiotherapy (including chest percussion), and therapeutic positioning. Each treatment session will last 15 minutes and will be administered by a qualified physiotherapist according to the institutional standard of care.

Conventional Physiotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 and 60 years.
• Diagnosed with restrictive lung disease (RLD), including interstitial lung diseases, idiopathic pulmonary fibrosis, chest wall deformities, or neuromuscular diseases.
• Admitted to the ICU and requiring invasive mechanical ventilation for more than 48 hours.
• Glasgow Coma Scale score over 13, inspiratory pressures below -20 cmH2O, oxygen saturation above 90%, tidal volumes exceeding 5ml/kg, respiratory rates under 35 breaths per minute
• Hemodynamically stable at the time of enrolment (as determined by the treating physician).

You may not qualify if:

• Pre-existing chronic obstructive pulmonary disease (COPD) or other primary obstructive pathologies.
• Hemodynamic instability (e.g., requiring high-dose vasopressors).
• Active pneumothorax or untreated bronchopleural fistula.
• History of cranial or facial trauma, recent thoracic or abdominal surgery contraindicating the intervention.
• Pre-existing cognitive impairment or inability to comprehend and cooperate with the training protocol.

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (3)

Foundation University College of Physical Therapy Islamabad

Islamabad, Pakistan

RECRUITING

Foundation University College of Physical Therapy Islamabad

Rawalpindi, Pakistan

RECRUITING

Foundation University College of Physical Therapy Islamabad

Rawalpindi, Pakistan

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Syeda Sumaira Batool, MS-CPPT

CONTACT

+923328868680; sumaira.batool@fui.edu.pk

Qurat Ul Ain Khalid, MS-MSKPT

CONTACT

+923028939996; quratulain.khalid@fui.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial having two groups. One group (interventional group) will receive standard physiotherapy along with targeted inspiratory and positive expiratory pressure (PEP) muscle training to enhance respiratory muscle strength. The control group will recieve standard physiotherapy, including passive/active limb exercises, chest percussion, and positioning. Each session will last for 15 minutes.

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: October 9, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

PA (3)