Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT05353556
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2022-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Home-based Inspiratory Muscle Training in Patients With IPF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was designed as a prospective and experimental study. Participants were randomly divided into two groups; a study group and a control group. The study group will perform inspiratory muscle training at 50% of maximal inspiratory pressure (MIP), and the control group received sham training for 8 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2022-04-28', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in inspiratory muscle strength', 'timeFrame': '8 weeks', 'description': 'MIP'}], 'secondaryOutcomes': [{'measure': 'Change in percentages of forced expiratory volume in one second', 'timeFrame': '8 weeks', 'description': 'Lung function tests: Percentages of forced expiratory volume in one second (FEV1).'}, {'measure': 'Change in percentages of forced vital capacity', 'timeFrame': '8 weeks', 'description': 'Lung function tests: Percentages of forced vital capacity (FVC).'}, {'measure': 'Change in diffusing capacity of the lung for carbon monoxide', 'timeFrame': '8 weeks', 'description': 'Lung function tests: Diffusing capacity of the lung for carbon monoxide (DLCO).'}, {'measure': 'Change in Dyspnea', 'timeFrame': '8 weeks', 'description': 'The modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate the severity of dyspnea. Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea.'}, {'measure': 'Change in Functional capacity', 'timeFrame': '8 weeks', 'description': 'Maximal distance in 6 minute walk test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['idiopathic pulmonary fibrosis', 'inspiratory muscle training', 'home-based', 'rehabilitation'], 'conditions': ['Idiopathic Pulmonary Fibrosis', 'IPF']}, 'referencesModule': {'references': [{'pmid': '14969575', 'type': 'BACKGROUND', 'citation': 'Selman M, Thannickal VJ, Pardo A, Zisman DA, Martinez FJ, Lynch JP 3rd. Idiopathic pulmonary fibrosis: pathogenesis and therapeutic approaches. Drugs. 2004;64(4):405-30. doi: 10.2165/00003495-200464040-00005.'}, {'pmid': '18843927', 'type': 'BACKGROUND', 'citation': 'Jastrzebski D, Kozielski J, Zebrowska A. [Pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis with inspiratory muscle training]. Pneumonol Alergol Pol. 2008;76(3):131-41. Polish.'}, {'pmid': '19561392', 'type': 'BACKGROUND', 'citation': 'Kagaya H, Takahashi H, Sugawara K, Kasai C, Kiyokawa N, Shioya T. Effective home-based pulmonary rehabilitation in patients with restrictive lung diseases. Tohoku J Exp Med. 2009 Jul;218(3):215-9. doi: 10.1620/tjem.218.215.'}, {'pmid': '15833676', 'type': 'BACKGROUND', 'citation': 'Tzanakis N, Samiou M, Lambiri I, Antoniou K, Siafakas N, Bouros D. Evaluation of health-related quality-of-life and dyspnea scales in patients with idiopathic pulmonary fibrosis. Correlation with pulmonary function tests. Eur J Intern Med. 2005 Apr;16(2):105-112. doi: 10.1016/j.ejim.2004.09.013.'}, {'pmid': '18811886', 'type': 'BACKGROUND', 'citation': "Peng S, Li Z, Kang J, Hou X. Cross-sectional and longitudinal construct validity of the Saint George's Respiratory Questionnaire in patients with IPF. Respirology. 2008 Nov;13(6):871-9. doi: 10.1111/j.1440-1843.2008.01359.x."}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of the home-based inspiratory muscle training program on lung functions, dyspnea, inspiratory muscle strength, functional capacity and quality of life in patients with idiopathic pulmonary fibrosis. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.', 'detailedDescription': "The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training was set to 50% of each patient's maximal inspiratory pressure measured every week and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosing Idiopathic Pulmonary Fibrosis by a pulmonologist;\n* Aged between 40 and 75 years;\n* Volunteering to research;\n* Stable clinical condition (same medication routine and/or no acute exacerbation in the last for the last 4 weeks).\n\nExclusion Criteria:\n\n* Inability of the participant to understand or perform the procedures proposed during the evaluations or training program.\n* Participating in any pulmonary rehabilitation programs;\n* A previous pneumonectomy or lobectomy operation;\n* Pneumonia in the last 4 weeks;\n* Any pulmonary infection during the study;\n* Requirement for supplemental oxygen therapy while resting.\n* Having Covid-19 disease (during the study or in the past)\n* Orthopaedic or neurological conditions affecting the ability to independent walking'}, 'identificationModule': {'nctId': 'NCT05353556', 'briefTitle': 'Effects of Home-based Inspiratory Muscle Training in Patients With IPF', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Effects of Home-based Inspiratory Muscle Training in Patients With Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'RidvanAktan_2022/04-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Patients who perform inspiratory muscle training (IMT) with %50 loading', 'interventionNames': ['Device: Inspiratory Muscle Training (IMT)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group', 'description': 'Patients who perform Sham IMT', 'interventionNames': ['Device: Sham IMT']}], 'interventions': [{'name': 'Inspiratory Muscle Training (IMT)', 'type': 'DEVICE', 'description': "The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 50% of each patient's maximal inspiratory pressure measured every week and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session.", 'armGroupLabels': ['Study Group']}, {'name': 'Sham IMT', 'type': 'DEVICE', 'description': 'The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device.', 'armGroupLabels': ['Sham Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35330', 'city': 'Izmir', 'state': 'Balcova', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylul University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Rıdvan Aktan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir University of Economics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, PhD', 'investigatorFullName': 'Ridvan Aktan', 'investigatorAffiliation': 'Izmir University of Economics'}}}}