Restrictive Lung DiseasesNCT07867730
Effects of Inspiratory Muscle Training and Positive Expiratory Pressure on Mechanically Ventilated Restrictive Lung Disease Patients
A study testing Inspiratory muscle training and Conventional Chest Physical Therapy in people with Restrictive Lung Diseases, run by Foundation University Islamabad at 3 sites in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Restrictive Lung Diseases
- What is being tested?
- Inspiratory muscle training and Conventional Chest Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesPakistan
- Study dates
- 1 Dec 2025to 31 Jan 2027
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan3 sites, 3 recruiting
- Recruiting
Foundation University College of Physical Therapy Islamabad
Islamabad
- Recruiting
Foundation University College of Physical Therapy Islamabad
Rawalpindi
Furqan Ahmed Siddiqi, PhD, 03004414981, principal.fucp@fui.edu.pk
- Recruiting
Foundation University College of Physical Therapy Islamabad
Rawalpindi
Syeda Sumaira Batool, MSPT-CPT, 03328868680, sumira.batool@fui.edu.pk
About this study
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.
Read the detailed description
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.
- Conditions
- Restrictive Lung Diseases
- Being tested
- Inspiratory muscle training, Conventional Chest Physical Therapy
- Keywords
- restrictive lung diseases, interstitial lung diseases, idiopathic lung fibrosis, inspiratory muscle training, PEP devices, mechanical ventilation, Ventilator induced diaphragm dysfunction
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingDevice
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 Chest Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization until extubation, or completion of the 7-day intervention period, whichever occurs first; assessed twice daily, up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Dec 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restrictive Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867730
- Sponsor's protocol ID
- FUCP/IFG/Sumaira
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training and Positive Expiratory Pressure on Mechanically Ventilated Restrictive Lung Disease Patients
- ClinicalTrials.gov ID
- NCT07867730
- Acronym / sponsor ID
- FUCP/IFG/Sumaira
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 9 Oct 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy | Active comparator | Other: Conventional Chest Physical TherapyParticipants in the group A will recieve standard physiotherapy, including passive/active limb exercises, chest percussion, and positioning. Each session will last for 15 minutes. |
| Conventional Physiotherapy Plus Inspiratory Muscle Training and Positive Expiratory Pressure | Experimental | Device: Inspiratory muscle trainingParticipants in Group B will recieve standard physiotherapy along with targeted inspiratory and positive expiratory pressure (PEP) muscle training to enhance respiratory muscle strength. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Inspiratory muscle trainingInspiratory 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. | Device | Conventional Physiotherapy Plus Inspiratory Muscle Training and Positive Expiratory Pressure |
| Conventional Chest Physical TherapyParticipants 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. | Other | Conventional Physiotherapy |
Primary outcome
Lung compliance
Time frame: From randomization until extubation, or completion of the 7-day intervention period, whichever occurs first; assessed twice daily, up to 7 days
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.
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 9 Oct 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training and Conventional Chest Physical Therapy in people with Restrictive Lung Diseases, run by Foundation University Islamabad at 3 sites in Pakistan.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Syeda Sumaira Batool, MS-CPPT (+923328868680, sumaira.batool@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung compliance (time frame: From randomization until extubation, or completion of the 7-day intervention period, whichever occurs first; assessed twice daily, up to 7 days). 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 9 Oct 2026.