Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT06442059
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2024-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Variables and Dyspnea and Fear of Movement in Chronic Obstructive Pulmonary Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}, {'id': 'D004417', 'term': 'Dyspnea'}], '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': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kinesiophobia Level Due to Dyspnea', 'timeFrame': '12 moon', 'description': "It will be evaluated with the Breathlessness Beliefs Questionnaire (BBQ).BBQ; It is a scale consisting of 11 questions that evaluates the person's kinesiophobia and anxiety due to breathlessness. Patients give scores to each question ranging from 1 (strongly disagree) to 5 (strongly agree). High scores indicate high levels of kinesiophobia and anxiety due to breathlessness."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic obstructive pulmonary disease, kinesiophobia, physical performance, dyspnea'], 'conditions': ['COPD', 'Kinesiophobia Due to Dyspnea']}, 'descriptionModule': {'briefSummary': 'Patients diagnosed with COPD who applied to the Pulmonary Diseases Department of Kırıkkale Yüksek İhtisas Hospital will be included in the study. The aim of our study: It is aimed to investigate the effect of fear of movement due to dyspnea on respiratory function, muscle strength, physical performance and balance in Chronic Obstructive Pulmonary Disease Patients.', 'detailedDescription': 'At Kırıkkale Yüksek İhtisas Hospital, individuals with COPD who meet the inclusion and exclusion criteria and volunteer to participate in the study will be included. The number of patients to be included in our study will be determined by power analysis.\n\nSociodemographic information (Age, Gender, Body Mass Index, Smoking history) of the individuals included in the research will be recorded.\n\nRegarding COPD symptoms:\n\nWhether the cough is productive or non-productive, its frequency and period Presence of sputum, type, amount, color, presence of hemoptysis, Presence of chest pain, Presence of peripheral edema, You will be asked about the presence of resting and/or exertional dyspnea, orthopnea, paroxysmal nocturnal dyspnea (PND).\n\n1. Respiratory Muscle Strength: It will be measured using an electronic, mobile, intraoral pressure measuring device.\n2. Peripheral Muscle Strength Evaluation: Quadriceps muscle strength will be evaluated using a dynomometer.\n3. Physical Performance: A 6-minute walk test will be used to determine the physical fitness levels of individuals.\n4. Balance Level: Mini-BEST Test will be used to determine the balance level\n5. Kinesiophobia Level Due to Dyspnea:\n\nIt will be evaluated with the Breathlessness Beliefs Questionnaire (BBQ). When the literature was examined, no study was found that examined all of these factors together in patients with COPD. Existing studies have shown that the effects of variables are different and it is stated that more studies are needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'At Kırıkkale Yüksek İhtisas Hospital, individuals with COPD who meet the inclusion and exclusion criteria and volunteer to participate in the study will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with COPD Be clinically stable for the last four weeks Not using antibiotics for the last four weeks being over 45 years old, Volunteering to participate in the study\n\nExclusion Criteria:\n\n* Not being able to cooperate with the evaluations to be made, Having any physical disability that may affect walking and balance Having severe neuromuscular, musculoskeletal and rheumatological problems accompanying COPD'}, 'identificationModule': {'nctId': 'NCT06442059', 'briefTitle': 'Clinical Variables and Dyspnea and Fear of Movement in Chronic Obstructive Pulmonary Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kırıkkale University'}, 'officialTitle': 'Examination of the Relationship Between Clinical Variables and Dyspnea and Fear of Movement in Chronic Obstructive Pulmonary Patients', 'orgStudyIdInfo': {'id': 'Kırıkkaleu-Caglanyetim'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'copd', 'description': 'Patients over the age of 45 who have been diagnosed with COPD and whose clinical condition is stable', 'interventionNames': ['Other: Kinesiophobia Level Due to Dyspnea']}], 'interventions': [{'name': 'Kinesiophobia Level Due to Dyspnea', 'type': 'OTHER', 'description': 'Kinesiophobia Level Due to Dyspnea', 'armGroupLabels': ['copd']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71100', 'city': 'Kırıkkale', 'state': 'Kırıkkale', 'country': 'Turkey (Türkiye)', 'facility': 'Saniye Aydoğan Arslan', 'geoPoint': {'lat': 39.84528, 'lon': 33.50639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kırıkkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assoc. prof. Dr.', 'investigatorFullName': 'Saniye Aydoğan Arslan', 'investigatorAffiliation': 'Kırıkkale University'}}}}