[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659632":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":35,"overallOfficials":13,"centralContacts":45,"locations":55,"responsibleParty":89,"collaborators":13,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":13,"eligibilityCriteria":96,"healthyVolunteers":93,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":13,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":58,"whyStopped":13,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Foundation University Islamabad","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"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",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","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.\n\nThe control group will recieve standard physiotherapy, including passive\u002Factive limb exercises, chest percussion, and positioning. Each session will last for 15 minutes.","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","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).\n\nMechanical ventilation, while vital, is associated with ventilator-induced diaphragmatic dysfunction (VIDD), leading to rapid muscle atrophy and impeding patient recovery.\n\nEarlier 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.\n\nThis 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.\n\nThe project will use a randomized controlled design, collecting both physiological and clinical outcome data, and will follow ethical guidelines for human research.\n\nThis 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.",[23,29],{"label":24,"type":25,"description":26,"interventionNames":27},"Conventional Physiotherapy","ACTIVE_COMPARATOR","Participants in the group A will recieve standard physiotherapy, including passive\u002Factive limb exercises, chest percussion, and positioning. Each session will last for 15 minutes.",[28],"Other: Conventional Chest Physical Therapy",{"label":30,"type":31,"description":32,"interventionNames":33},"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.",[34],"Device: Inspiratory muscle training",[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":13},"DEVICE","Inspiratory muscle training","Inspiratory Muscle Training (IMT):\n\nPatients 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%.\n\nPositive Expiratory Pressure (PEP) Training:\n\nPatients 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.",[30],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":13},"Conventional Chest Physical Therapy","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.",[24],[46,51],{"name":47,"role":48,"phone":49,"phoneExt":13,"email":50},"Syeda Sumaira Batool, MS-CPPT","CONTACT","+923328868680","sumaira.batool@fui.edu.pk",{"name":52,"role":48,"phone":53,"phoneExt":13,"email":54},"Qurat Ul Ain Khalid, MS-MSKPT","+923028939996","quratulain.khalid@fui.edu.pk",[56,68,80],{"facility":57,"status":58,"city":59,"state":13,"zip":13,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":13},"Foundation University College of Physical Therapy Islamabad","RECRUITING","Islamabad","Pakistan","PK",{"type":63,"coordinates":64},"Point",[65,66],73.04329,33.72148,{"lat":66,"lon":65},{"facility":57,"status":58,"city":69,"state":13,"zip":13,"country":60,"countryCode":61,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Rawalpindi",{"type":63,"coordinates":71},[72,73],73.0479,33.59733,{"lat":73,"lon":72},[76],{"name":77,"role":48,"phone":78,"phoneExt":13,"email":79},"Furqan Ahmed Siddiqi, PhD","03004414981","principal.fucp@fui.edu.pk",{"facility":57,"status":58,"city":69,"state":13,"zip":13,"country":60,"countryCode":61,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},{"type":63,"coordinates":82},[72,73],{"lat":73,"lon":72},[85],{"name":86,"role":48,"phone":87,"phoneExt":13,"email":88},"Syeda Sumaira Batool, MSPT-CPT","03328868680","sumira.batool@fui.edu.pk",{"type":90,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659632","effects-of-inspiratory-muscle-training-and-positive-expiratory-pressure-on-mechanically-ventilated-restrictive-lung-disease-patients-100659632",false,"NCT07867730","Effects of Inspiratory Muscle Training and Positive Expiratory Pressure on Mechanically Ventilated Restrictive Lung Disease Patients","Inclusion Criteria:\n\n* Patients aged between 18 and 60 years.\n* Diagnosed with restrictive lung disease (RLD), including interstitial lung diseases, idiopathic pulmonary fibrosis, chest wall deformities, or neuromuscular diseases.\n* Admitted to the ICU and requiring invasive mechanical ventilation for more than 48 hours.\n* Glasgow Coma Scale score over 13, inspiratory pressures below -20 cmH2O, oxygen saturation above 90%, tidal volumes exceeding 5ml\u002Fkg, respiratory rates under 35 breaths per minute\n* Hemodynamically stable at the time of enrolment (as determined by the treating physician).\n\nExclusion Criteria:\n\n* Pre-existing chronic obstructive pulmonary disease (COPD) or other primary obstructive pathologies.\n* Hemodynamic instability (e.g., requiring high-dose vasopressors).\n* Active pneumothorax or untreated bronchopleural fistula.\n* History of cranial or facial trauma, recent thoracic or abdominal surgery contraindicating the intervention.\n* Pre-existing cognitive impairment or inability to comprehend and cooperate with the training protocol.","ALL","18 Years","60 Years",{"count":101,"type":102},30,"ESTIMATED","INTERVENTIONAL",[105],"NA","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.\n\nThis 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.",[108],"Restrictive Lung Diseases",[110,111,112,113,114,115,116],"restrictive lung diseases","interstitial lung diseases","idiopathic lung fibrosis","inspiratory muscle training","PEP devices","mechanical ventilation","Ventilator induced diaphragm dysfunction","2026-10-07",{"date":119,"type":120},"2026-10-09","ACTUAL",{"date":122,"type":120},"2025-12-01",{"date":124,"type":102},"2027-01-31",{"name":5,"class":6},3]