Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT03740867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2018-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Cognitive Status Affect Pulmonary Rehabilitation Gains?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After completion of the program, patients will be divided into two groups according to their cognitive status (Group 1: those with poor cognition; Group 2: those with good cognition). The PR gains of the groups will be compared.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2018-11-02', 'studyFirstSubmitQcDate': '2018-11-11', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline the 6 minutes walk distance at 3 months.', 'timeFrame': '3 months', 'description': 'The test was conducted in a 30-m corridor in line with American Thoracic Society (ATS) guidelines. Patients were told that they should walk as fast as they can walk in 6 minutes time.'}, {'measure': 'Change from Baseline the Montreal Cognitive Assessment (MoCA) test score at 3 months.', 'timeFrame': '3 months', 'description': 'It was designed to detect mild cognitive impairment.Thirty items assessing multiple cognitive domains are contained in the MoCA: short-term memory (5 points); visuospatial abilities via clock drawing (3 points), and a cube copy task (1 point); executive functioning via an adaptation of Trail Making Test Part B (1 point), phonemic fluency (1 point), and verbal abstraction (2 points); attention, concentration, and working memory via target detection (1 point), serial subtraction (3 points), digits forward (1 point), and digits backward (1 point); language via confrontation naming with low-familiarity animals (3 points), and repetition of complex sentences (2 points); and orientation to time and place (6 points). The MoCA is scored by obtaining an item total and the authors recommend a clinical cutoff score of 23.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline the modified Medical Council Dyspnea score at 3 months.', 'timeFrame': '3 months', 'description': 'The scale will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.'}, {'measure': 'Change from Baseline the Forced Expiratory Volume in 1 second (FEV1) at 3 months.', 'timeFrame': '3 months', 'description': 'It was conducted using the Sensor Medics model 2400 (Yorba Linda, CA,USA), according to the ATS guidelines.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Impairment', 'pulmonary rehabilitation', 'exercise', 'MOCA', 'aerobic training'], 'conditions': ['Cognitive Impairment', 'Pulmonary Rehabilitation']}, 'descriptionModule': {'briefSummary': 'Pulmonary rehabilitation program with aerobic and strengthening trainings for 3 months will be applied to the candidates for lung transplantation. The program will be designed to be 2 days supervised weekly and 3 day home program. After completion of the program, patients will be divided into two groups according to their cognitive status (Group 1: those with poor cognition; Group 2: those with good cognition). The PR gains of the groups will be compared.', 'detailedDescription': "The fact that cognition is not always included in the assessment routine makes it difficult to clarify which patient group or severity of illness is more affected by this issue. The effect of exercise on cognitive functions is a remarkable issue in recent years. It can also be predicted that cognitive function may be effective on program adaptation in patients who are given home program without supervision. The aim of the investigator's study was to investigate the effect of cognitive status to pulmonary rehabilitation gains in lung transplant candidates.\n\nLung transplantation candidates who refered from Lung Transplantation surgery team will receive the Pulmonary Rehabilitation program for 3-months (2 days at hospital, 3 days at home). Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components. Patient will evaluate at the beginning and end of the program. Demographic information, diagnosis distributions, educational status of patients will be recorded. Exercise capacities are determined by 6 min walk test. The medical research council dyspnea scale is used in determining the dispense levels. Montreal Cognitive Function Assessment (MOCA) is used to determine cognitive functions. Cognitive functions and exercise capacities of the patients before and after the program will be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be listed for lung transplantation,\n* Pulmonary rehabilitation exercise program planned to be taken,\n* Volunteers who have agreed to participate in the work,\n* Patients who can complete the 3-month Pulmonary Rehabilitation program.\n\nExclusion Criteria:\n\n* Failure to complete the planned exercise program for any reason,\n* Not to be literate.'}, 'identificationModule': {'nctId': 'NCT03740867', 'briefTitle': 'Does Cognitive Status Affect Pulmonary Rehabilitation Gains?', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Does Cognitive Status Affect Pulmonary Rehabilitation Gains?', 'orgStudyIdInfo': {'id': 'Cognition_PR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group1', 'description': 'Those with poor cognition (MOCA score\\<23)\n\nThe patients will receive the Pulmonary Rehabilitation program for 3-months (2 days at hospital, 3 days at home). Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components.', 'interventionNames': ['Other: Pulmonary rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Group2', 'description': 'Those with good cognition (MOCA score≥23)\n\nThe patients will receive the Pulmonary Rehabilitation program for 3-months (2 days at hospital, 3 days at home). Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components.', 'interventionNames': ['Other: Pulmonary rehabilitation']}], 'interventions': [{'name': 'Pulmonary rehabilitation', 'type': 'OTHER', 'description': 'Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components.', 'armGroupLabels': ['Group1', 'Group2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34200', 'city': 'Istanbul', 'state': 'Zeytinburnu', 'country': 'Turkey (Türkiye)', 'facility': 'Yedikule Chest Disease Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Esra Pehlivan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saglik Bilimleri Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'esra pehlivan', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}