Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-09 @ 7:52 PM
Study NCT ID:
NCT03302702
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2017-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duration of Exercise Program in Interstitial Lung Diseases.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-01', 'studyFirstSubmitDate': '2017-10-01', 'studyFirstSubmitQcDate': '2017-10-01', 'lastUpdatePostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six minute walk test', 'timeFrame': '6 minute', 'description': 'It was performed in a 30-meter long corridor in accordance with American Thoracic Society criteria'}], 'secondaryOutcomes': [{'measure': 'mMRC', 'timeFrame': '5 minutes', 'description': 'It was used for dyspnea that patients felt during their daily activities.'}, {'measure': 'Pulmonary Function Test', 'timeFrame': '20 minutes', 'description': 'It was used for assessment of lung functions'}, {'measure': 'SGRQ', 'timeFrame': '30 minutes', 'description': 'A disease-specific quality of life scale'}, {'measure': 'SF-36 Health Survey', 'timeFrame': '30 minutes', 'description': 'A health related quality of life scale'}, {'measure': 'Hospital Anxiety and Depression Inventory', 'timeFrame': '20 minutes', 'description': 'It was used for assessment of anxiety and depression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'duration'], 'conditions': ['Interstitial Lung Disease']}, 'descriptionModule': {'briefSummary': 'We aimed to compare the functional results of the 8th week with the results of the 12th week of the exercise programs applied to the patients with ILD.', 'detailedDescription': 'Exercise programs (EP) have been shown to be the effective approach for functional outcomes in interstitial lung diseases (ILD). In many studies, the duration of exercise programs varies between 8-12 weeks. However, the optimal duration of exercise program is still unknown.\n\nWe aimed to compare the results of the 8th week with the results of the 12th week of the PR programs applied to the patients with ILD.\n\nA total of 14 patients with ILD referred to our PR unit \\[11 idiopathic pulmonary fibrosis, 2 sarcoidosis (stage 3 and 4) and 1 nonspecific interstitial pneumonia\\] were included in the study. Pulmonary function test, arterial blood gas analysis, 6- minute walk test, mMRC dyspnea scale, quality of life questionnaires and hospital anxiety depression scale were performed before, at the 8th and 12th weeks after the exercise program applied to the patients twice a week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed the 12 week exercise program\n* Diagnosed with ILD\n\nExclusion Criteria:\n\n* Not completed 12 week exercise program'}, 'identificationModule': {'nctId': 'NCT03302702', 'briefTitle': 'Duration of Exercise Program in Interstitial Lung Diseases.', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': 'A Comparison Trial of Eight Weeks Versus Twelve Weeks of Exercise Program in Interstitial Lung Diseases.', 'orgStudyIdInfo': {'id': 'IKC4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Exercise program', 'description': 'Treatment group', 'interventionNames': ['Other: Exercise program']}], 'interventions': [{'name': 'Exercise program', 'type': 'OTHER', 'description': 'Exercise program including breathing control, pursed-lip breathing, diaphragmatic and thoracic breathing, aerobic and strengthening training', 'armGroupLabels': ['Exercise program']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Katip Celebi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof', 'investigatorFullName': 'Ilknur Naz', 'investigatorAffiliation': 'Izmir Katip Celebi University'}}}}