Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-30 @ 7:44 AM
Study NCT ID:
NCT05021068
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2021-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Structure and Mobility in Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}], 'ancestors': [{'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2021-08-19', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spinal Structure and Mobility', 'timeFrame': '15 minutes (single application)', 'description': 'Spinal mouse measurement'}], 'secondaryOutcomes': [{'measure': 'Pulmonary Functions', 'timeFrame': '10 minutes (single application)', 'description': 'Respiratory Function Test'}, {'measure': 'Dyspnea Severity', 'timeFrame': '5 minutes (single application)', 'description': 'Modified Medical Research Dyspnea Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['copd', 'posture', 'respiratory function', 'dyspnea'], 'conditions': ['COPD', 'Postural; Defect', 'Respiratory Function Impaired', 'Dyspnea']}, 'descriptionModule': {'briefSummary': 'In recent studies with musculoskeletal system disorders in chronic respiratory patients, it has been reported that postural control is affected in COPD patients.\n\nThe aim of this study to investigate relationship between spinal structure and mobility an severity of dyspnea in patients with COPD.', 'detailedDescription': 'Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease characterized by irreversible airway limitation. In recent studies with musculoskeletal system disorders in chronic respiratory patients, it has been reported that postural control is affected in COPD patients.It has been observed that balance systems, functional balance tests, posturography, posture assessment systems, force platform and inclinometer measurements are used in studies on postural control assessment in COPD patients.There are a limited number of studies in which devices that objectively present the degree of deviation in spinal curves are used in patients with COPD, and posture and lung volume and capacities are evaluated.\n\nTherefore, the aim of this study is to investigate the changes in spine structure and mobility in COPD patients and to reveal their relationship with static and dynamic lung volumes and capacities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients over 18 years old', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteer to participate in the study\n* Be over 18 years old\n* Being clinically stable\n* Not having a COPD attack in the last 3 months at least\n\nExclusion Criteria:\n\n* Refusing to participate in the research\n* Having had spinal surgery Presence of back and shoulder pain\n* Idiopathic scoliosis\n* Ankylosing spondylitis\n* Presence of respiratory disease other than COPD\n* Difficulty understanding verbal commands'}, 'identificationModule': {'nctId': 'NCT05021068', 'briefTitle': 'Spinal Structure and Mobility in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': 'Investigation of The Relationship Between Spinal Structure and Mobility and Respiratory Functions in Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'IKC1233'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD Patients', 'description': 'The respiratory functions of the participants will be measured in accordance with the ATS-ERS criteria. After measurement; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, total lung capacity (TLC), residual volume (RV), inspiratory capacity (IC), vital capacity (VC) parameters will be recorded.\n\nSpinal structure and mobility will be evaluated with the Spinal Mouse device in the sagittal and frontal planes in standing and sitting positions. For the sagittal plane, the measurements were first in the neutral, then in the maximum flexion and extension positions, for the frontal plane; neutral, right and left lateral flexions will be performed.\n\nPatients will be asked to mark the level of activity that causes dyspnea on the Medical Council Research Scale (MMRC) Dyspnea Score.', 'interventionNames': ['Other: Postural Assessment']}, {'label': 'Control Group', 'description': 'The respiratory functions of the participants will be measured in accordance with the ATS-ERS criteria. After measurement; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, total lung capacity (TLC), residual volume (RV), inspiratory capacity (IC), vital capacity (VC) parameters will be recorded.\n\nSpinal structure and mobility will be evaluated with the Spinal Mouse device in the sagittal and frontal planes in standing and sitting positions. For the sagittal plane, the measurements were first in the neutral, then in the maximum flexion and extension positions, for the frontal plane; neutral, right and left lateral flexions will be performed.\n\nPatients will be asked to mark the level of activity that causes dyspnea on the Medical Council Research Scale (MMRC) Dyspnea Score.', 'interventionNames': ['Other: Postural Assessment']}], 'interventions': [{'name': 'Postural Assessment', 'type': 'OTHER', 'otherNames': ['Respiratory Function Test', 'MMRC Dyspnea measurement'], 'description': 'Spinal mouse measurement', 'armGroupLabels': ['COPD Patients', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35620', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, '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'}}}}