An interventional study of Inspiratory muscle training and Conventional Chest Physical Therapy in Restrictive Lung Diseases, sponsored by Foundation University Islamabad. Recruiting at 3 sites in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Treatment
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.
Restrictive lung diseases (RLD) (including interstitial lung diseases, idiopathic lung fibrosis, chest wall deformities, and neuromuscular diseases) 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.
Earlier research has highlighted the potential of targeted respiratory interventions, including inspiratory muscle training (IMT) and positive expiratory pressure (PEP), to mitigate these effects; however, evidence in mechanically ventilated RLD populations remains limited.
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.
The project will use a randomized controlled design, collecting both physiological and clinical outcome data, and will follow ethical guidelines for human research.
This project addresses an important clinical problem with substantial gaps in the literature regarding combined inspiratory and expiratory muscle training in ventilated patients and proposes an applied solution poised to advance respiratory care practices in Pakistan, with positive repercussions for patient outcomes, healthcare sustainability, and the national economy.
656 studies on the registry are indexed under Lung Diseases, Interstitial; 241 are open to participants now.
This study's planned enrollment of 30 is below the median of 57 across 362 interventional studies indexed under Lung Diseases, Interstitial.
Browse Lung Diseases, Interstitial studies →Foundation University Islamabad is the lead sponsor of 253 studies on the registry; 140 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
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.
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.
Time frame: From randomization until extubation, or completion of the 7-day intervention period, whichever occurs first; assessed twice daily, up to 7 days
Started Dec 2025 (actual). Primary completion is estimated for Jan 2027, 13 months after the start.
Of 111 non-industry interventional studies with no phase under Lung Diseases, Interstitial, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 44. This study's planned 13 months is below that.
Counting every sponsor, half of 115 studies reached it within 26 months; a quarter within 14 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Foundation University Islamabad →