Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-14 @ 6:19 AM
Study NCT ID:
NCT03286660
Status:
COMPLETED
Last Update Posted:
2017-09-18
First Post:
2017-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3 Minutes Chair Rise Test (3CRT) in Patients With 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-13', 'studyFirstSubmitDate': '2017-09-09', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of number of rise during 3 minutes Chair Rise Test (3CRT)', 'timeFrame': 'At Baseline, at 2 and 8 weeks.', 'description': 'The change of total number of rise during a 3 minutes Chair Rise Test (3CRT) from baseline'}], 'secondaryOutcomes': [{'measure': 'Change of number of rise during 1 minute Chair Rise Test (1CRT)', 'timeFrame': 'At Baseline, at 2 and 8 weeks.', 'description': 'The change of total number of rise during a 1 minutes Chair Rise Test (3CRT) from baseline'}, {'measure': 'Change of Time to perform 5 sit to stand', 'timeFrame': 'At Baseline, at 2 and 8 weeks.', 'description': 'The change of Time to perform 5 sit to stand from baseline'}, {'measure': 'The change of Total score for the DIsability RElated to COPD Tool (DIRECT)', 'timeFrame': 'At Baseline and at 8 weeks.', 'description': 'Total Score'}, {'measure': 'Difference in physiological response (SpO2 and HR) during the 3 Chair Rise Tests (3CRT-1CRT-5STS)', 'timeFrame': 'At Baseline, at 2 and 8 weeks.', 'description': 'End SpO2 - End Heart Rate'}, {'measure': 'Change in endurance time at constant power on cyclo ergometer,', 'timeFrame': 'At Baseline, at 2 and 8 weeks.', 'description': 'The change of endurance time from baseline'}, {'measure': 'Change of Voluntary Quadriceps force output', 'timeFrame': 'At Baseline, at 2 and 8 weeks.', 'description': 'Change of Voluntary quadriceps force measurements (Mean of 3 maximal measurements) from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise tests', 'COPD', 'Rehabilitation'], 'conditions': ['Evaluations', 'Rehabilitation', 'COPD']}, 'referencesModule': {'references': [{'pmid': '30774324', 'type': 'DERIVED', 'citation': 'Levesque J, Antoniadis A, Li PZ, Herengt F, Brosson C, Grosbois JM, Bernady A, Bender A, Favre M, Guerder A, Surpas P, Similowski T, Aguilaniu B. Minimal clinically important difference of 3-minute chair rise test and the DIRECT questionnaire after pulmonary rehabilitation in COPD patients. Int J Chron Obstruct Pulmon Dis. 2019 Jan 22;14:261-269. doi: 10.2147/COPD.S187567. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside specialized centers.\n\nIn order to monitor the eventual decline of patients in the course of their RHB management, Chair Rise Tests (3CRT-1CRT-5STS) and short questionnaires were developed (CAT-DIRECT). The goal of this prospective, multicenter, real-life study is to compare the change in several functional function tests and questionnaires of quality of life and dyspnea related to daily activities. In addition, MCIDs of the 3CRT and the DIRECT questionnaire (Disability Related to COPS Tool) were specified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with COPD Gold II to IV\n* Patient admitted for a rehabilitation program in real life\n* Person affiliated to the Social Security or beneficiary of such a scheme\n* Informed and written consent by patient or legal representative\n\nExclusion Criteria:\n\n* Patient limited by reduced locomotor activity or joint pain that compromises their participation in a rehabilitation program\n* Patients with a performance less than 250 meters during 6MWT\n* Non-stable cardiac disease\n* Any other lung disease than COPD\n* Person subject to a legal protection measure'}, 'identificationModule': {'nctId': 'NCT03286660', 'acronym': '3CRT', 'briefTitle': '3 Minutes Chair Rise Test (3CRT) in Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Chair Rise Tests for a Simplified Evaluation of Functional Response After a Rehabilitation Program in Patients COPD.', 'orgStudyIdInfo': {'id': '2013_58'}, 'secondaryIdInfos': [{'id': '2014-A00856-41', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'COPD patients', 'description': 'All convenient COPD patients admitted in real life for a rehabilitation program were included.\n\nExercises consist on a Chair Rise Tests and short questionnaire were added to the usual tools for the evaluation.', 'interventionNames': ['Diagnostic Test: Chair Rise Tests and short questionnaire']}], 'interventions': [{'name': 'Chair Rise Tests and short questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'Exercises consist on a Chair Rise Tests and short questionnaire It is a functional test evaluating the number of chair rise over a given time and / or frequency.\n\nThis test is combined with a questionnaire to collect quantitative and qualitative information:\n\n* dyspnea and muscular fatigue at rest before the start of the test and at the end of the exercise\n* Saturation at rest, and at the end of the exercise\n* the number of total a chair rise', 'armGroupLabels': ['COPD patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Calmette, CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Bernard AGUILANIU, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Grenoble Alps'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, {'name': "HYLAB, Physiopathologie de l'exercice", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}