Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-26 @ 11:49 PM
Study NCT ID:
NCT05805332
Status:
UNKNOWN
Last Update Posted:
2023-04-10
First Post:
2023-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Skeletal Muscle Function Using Ultrasonic Elastography
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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': 'baseline', 'description': '6-minute walking distance (6MWD)'}, {'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': '1 week after pulmonary rehabilitation', 'description': '6-minute walking distance (6MWD)'}, {'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': 'baseline', 'description': 'COPD Assessment Test (CAT) score'}, {'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': '1 week after pulmonary rehabilitation', 'description': 'COPD Assessment Test (CAT) score'}, {'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': 'baseline', 'description': "St. George's Respiratory Questionnaire (SGRQ)"}, {'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': '1 week after pulmonary rehabilitation', 'description': "St. George's Respiratory Questionnaire (SGRQ)"}, {'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': 'baseline', 'description': 'modified Medical Research Council (mMRC) dyspnea scores'}, {'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': '1 week after pulmonary rehabilitation', 'description': 'modified Medical Research Council (mMRC) dyspnea scores'}, {'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': 'baseline', 'description': 'rectus femoris muscle strength via a dynamometer'}, {'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': '1 week after pulmonary rehabilitation', 'description': 'rectus femoris muscle strength via a dynamometer'}, {'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': 'baseline', 'description': '6-30-second sit-to-stand test'}, {'measure': 'Effectiveness of pulmonary rehabilitation training', 'timeFrame': '1 week after pulmonary rehabilitation', 'description': '6-30-second sit-to-stand test'}], 'secondaryOutcomes': [{'measure': 'Forced Expiratory Volume in 1-second(FEV1)', 'timeFrame': 'before pulmonary rehabilitation', 'description': 'Pulmonary function test'}, {'measure': 'Forced Expiratory Volume in 1-second(FEV1)', 'timeFrame': '1 week after pulmonary rehabilitation', 'description': 'Pulmonary function test'}, {'measure': 'Ultrasonic elastic imaging of rectus femoris', 'timeFrame': 'before pulmonary rehabilitation', 'description': 'Ultrasonic elastography of skeletal muscle'}, {'measure': 'Ultrasonic elastic imaging of rectus femoris', 'timeFrame': '1 week after pulmonary rehabilitation', 'description': 'Ultrasonic elastography of skeletal muscle'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The goal of observational study is to evaluation of skeletal muscle function in patients with chronic obstructive pulmonary disease before and after lung rehabilitation training using ultrasonic elastography in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:Evaluation of skeletal muscle function in patients with chronic obstructive pulmonary disease before and after lung rehabilitation training using ultrasonic elastography.\n\nParticipants will undergo pulmonary rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic obstructive pulmonary disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The age is between 40-80 years old\n* Patients with chronic obstructive pulmonary disease who meet the diagnostic criteria of GOLD guideline(2019)\n* There was no acute exacerbation in the past 12 weeks\n\nExclusion Criteria:\n\n* Hypoxemia (oxygen partial pressure is less than 60mmHg or oxygen saturation is less than 88% at rest), or patients who need continuous oxygen inhalation, or patients with any contraindication to exercise test (refer to the American Thoracic Association/American Association of Thoracic Physicians exercise test guidelines)\n* Oral glucocorticoids\n* Receive long-term oxygen therapy prescription\n* Have participated in supervised exercise programs in the past 12 months\n* History of other lung diseases, including pneumoconiosis, bronchiectasis, tuberculosis, primary pulmonary hypertension, pulmonary embolism, interstitial lung disease\n* Diseases that restrict the active exercise ability of participants or involve skeletal, neuromuscular, cardiovascular or metabolic disorders of muscle activity, such as tumors, diabetes, muscle weakness, etc'}, 'identificationModule': {'nctId': 'NCT05805332', 'briefTitle': 'Evaluation of Skeletal Muscle Function Using Ultrasonic Elastography', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Evaluation of Skeletal Muscle Function in Patients With Chronic Obstructive Pulmonary Disease Before and After Lung Rehabilitation Training Using Ultrasonic Elastography', 'orgStudyIdInfo': {'id': '2022-NHLHCRF-LX-01-0202-4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pulmonary rehabilitation', 'interventionNames': ['Other: pulmonary rehabilitation']}], 'interventions': [{'name': 'pulmonary rehabilitation', 'type': 'OTHER', 'description': 'The participants would undergo pulmonary rehabilitation.', 'armGroupLabels': ['pulmonary rehabilitation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mingming Deng, MD', 'role': 'CONTACT', 'email': 'isdeng1017@163.com', 'phone': '86 18801336854'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gang Hou', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}