Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
Study NCT ID:
NCT04376892
Status:
COMPLETED
Last Update Posted:
2020-05-06
First Post:
2020-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life and Exercise Capacity in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 516}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life questionnaire', 'timeFrame': '20 minutes', 'description': 'St. George Respiratory Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Dyspnea Severity', 'timeFrame': '5 minutes', 'description': 'mMRC'}, {'measure': 'Respiratory Function', 'timeFrame': '20 minutes', 'description': 'Respiratory Function Test'}, {'measure': 'Anxiety Depression', 'timeFrame': '20 minutes', 'description': 'Hospital anxiety and Depression Qustionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['copd', 'quality of life', 'exercise capacity'], 'conditions': ['Copd', 'Quality of Life', 'Exercise Capacity']}, 'referencesModule': {'references': [{'pmid': '32979640', 'type': 'DERIVED', 'citation': 'Hulya S, Ilknur N, Gulru P. Effect of exercise capacity on perception of dyspnea, psychological symptoms and quality of life in patients with chronic obstructive pulmonary disease. Heart Lung. 2020 Nov-Dec;49(6):753-757. doi: 10.1016/j.hrtlng.2020.09.008. Epub 2020 Sep 23.'}]}, 'descriptionModule': {'briefSummary': 'COPD patients will be examined in 4 groups according to their walking distance. Patients walking under 150 meters will be determined as Group 1, those walking between 150-249 meters will be Group 2, those walking between 250-349 meters will be selected as Group 3, and patients with COPD who walk 350 and above will be determined as Group 4. The groups were compared in terms of quality of life, psychological symptoms and dyspnea.', 'detailedDescription': 'Quality of life affects the mortality rate independently in patients with COPD. The treatment applied in COPD does not stop the decrease in lung function, nor does it prolong the survival time. Spirometric evaluations to determine the severity of the disease are not sufficient to explain the perception of patients and their adaptation to their diseases. Therefore, evaluating the quality of life has become an important measure of treatment in COPD patients. Quality of life measurements should be done to minimize the effect of the disease, to help patients better cope with the consequences of an incurable long-term condition, and to determine modifiable factors. Identifying modifiable factors; in personalized treatment adopted in airway diseases in recent years; it is important to be able to apply appropriate pharmacological and non-pharmacological treatments Our aim is to exercise capacity in COPD patients; firstly to investigate the effect on quality of life, then to determine the relationship between emergency admission and hospitalization, dyspnea, psychological symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients', 'genderDescription': 'Above 18', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients completed all tests and qustionnaires\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04376892', 'briefTitle': 'Quality of Life and Exercise Capacity in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': 'The Effect of Exercise Capacity on Quality of Life in COPD Patients', 'orgStudyIdInfo': {'id': 'IKCU2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Exercise capacity under 149 meter', 'interventionNames': ['Other: Quality of life measurement']}, {'label': 'Group 2', 'description': 'Exercise capacity between 150 and 249 meter', 'interventionNames': ['Other: Quality of life measurement']}, {'label': 'Group 3', 'description': 'Exercise capacity between 250 and 349 meter', 'interventionNames': ['Other: Quality of life measurement']}, {'label': 'Group 4', 'description': 'Exercise capacity above 340', 'interventionNames': ['Other: Quality of life measurement']}], 'interventions': [{'name': 'Quality of life measurement', 'type': 'OTHER', 'description': 'Quality of life measurement by St. George Respiratory questionnaire', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Katip Celebi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Ilknur Naz', 'investigatorAffiliation': 'Izmir Katip Celebi University'}}}}