Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-05 @ 3:02 PM
Study NCT ID:
NCT06220851
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2024-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Handgrip Strength and Air Trapping in Patients with Stable 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'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-01-23', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between handgrip strength and air trapping in COPD patients', 'timeFrame': 'At day 1 of the study', 'description': 'This correlation will be reported as correlation coefficient (R).'}], 'secondaryOutcomes': [{'measure': 'The best cutoff value of handgrip strength for predicting air trapping in COPD patients', 'timeFrame': 'At day 1 of the study', 'description': 'The best cutoff value will be determined by the area under the Receiver Operator Characteristic curve (ROC).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic obstructive pulmonary disease', 'handgrip strength', 'air trapping', 'lung volume', 'correlation'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate the relationship between handgrip strength and air trapping in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:\n\n• Is handgrip strength correlated with air trapping in COPD patients? Participants will perform handgrip strength test and lung volume measurement.', 'detailedDescription': 'This is a cross-sectional study in COPD patients. COPD patients aged 40 years or older were included. Handgrip strength test and lung volume measurement will be tested in each patient. Handgrip strength will be measured using a hand dynamometer. Lung volume will be assessed using a body plethysmograph.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients aged 40 years or older who are confirmed diagnosis by spirometry (postbronchodilator FEV1/FVC \\<0.7) and smoking history 10 pack-years or more.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40 years or older\n* Postbronchodilator FEV1/FVC \\<0.7\n* \\>10 pack-year smoking history\n\nExclusion Criteria:\n\n* COPD exacerbation within 3 months\n* Inability to perform handgrip strength test or lung volume measurement'}, 'identificationModule': {'nctId': 'NCT06220851', 'briefTitle': 'Correlation Between Handgrip Strength and Air Trapping in Patients with Stable Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'Correlation Between Handgrip Strength and Air Trapping in Patients with Stable Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'MTU-EC-IM-0-209/65'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD', 'description': 'COPD patients aged 40 years or older with a postbronchodilator ratio of forced expiratory volume at one second (FEV1) to forced vital capacity (FVC) \\<0.7.', 'interventionNames': ['Diagnostic Test: Handgrip strength']}], 'interventions': [{'name': 'Handgrip strength', 'type': 'DIAGNOSTIC_TEST', 'description': 'Handgrip strength will be measured by 3 efforts.', 'armGroupLabels': ['COPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12120', 'city': 'Pathum Thani', 'state': 'Changwat Pathum Thani', 'country': 'Thailand', 'facility': 'Thammasat University Faculty of Medicine', 'geoPoint': {'lat': 14.01346, 'lon': 100.53049}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Individual patient data (IPD) and documents will be available for sharing immediately after publication for a period of 2 years.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Narongkorn Saiphoklang, MD', 'investigatorAffiliation': 'Thammasat University'}}}}