Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-04 @ 3:44 PM
Study NCT ID:
NCT06703359
Status:
RECRUITING
Last Update Posted:
2024-12-02
First Post:
2024-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Properties of the 6-Minute Stepper Test for Mortality in 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Two-year mortality', 'timeFrame': 'From the 6-Minute Stepper Test to two years thereafter', 'description': 'Vital status (alive or deceased) will be collected from the database of the French National Institute of Statistics and Economic Studies (INSEE): https://arbre.app/insee.'}, {'measure': 'Five-year mortality', 'timeFrame': 'From the 6-Minute Stepper Test to five years thereafter', 'description': 'Vital status (alive or deceased) will be collected from the database of the French National Institute of Statistics and Economic Studies (INSEE): https://arbre.app/insee.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Six-minute stepper test', 'Pulmonary rehabilitation', 'Exercise testing'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'Retrospective study aimed to answer the following research questions :\n\n* What are the predictive properties of the 6-minute stepper in COPD for 2-year mortality in individuals with COPD ?\n* What are the predictive properties of the 6-minute stepper in COPD for 5-year mortality in invididuals with COPD ?', 'detailedDescription': 'Method: retrospective study with external validation.\n\nThe medical records of all patients referred for pulmonary rehabilitation at ADIR Association, France, between 2015 and 2023 will be screened for eligibility. Demographic data and performance during the 6-Minute Stepper Test will be collected directly from the patients\' medical records.\n\nCollected data include: age, weight, height, body-mass index, sex, long-term oxygen therapy, long-term non-invasive ventilation, oxygen uptake (from cardiopulmonary exercise testing), peak power output (from cardiopulmonary exercise testing), pulmonary function testing, disease stage according to the Global Initiative for Chronic Obstructive Lung Disease classification, modified Medical Research Council dyspnea score, smoking status, quality of life, number of disease exacerbations prior to the pulmonary rehabilitation program, number of pulmonary rehabilitation programs performed during the follow-up period, and performance during the 6-Minute Stepper Test.\n\nVital status (alive or deceased) will be collected from the database of the French National Institute of Statistics and Economic Studies (INSEE): https://arbre.app/insee. This variable will be collected during the first quarter of 2025.\n\nA receiver operator curve analysis will be performed to determine the statistical threshold value (number of steps) with the best sensitivity and specificity for predicting all-cause mortality at 2 and 5 years.\n\nPatients will then be divided into two groups based on the established threshold, and a Cox regression model will be used to determine the hazard ratio for mortality at 2 and 5 years.\n\nInvidiual participant data from a prospective study will be used to assess the external validity of established thresholds.(https://pubmed.ncbi.nlm.nih.gov/27216848/).\n\nStatistical analysis :\n\nContinuous data will be expressed as mean (standard deviation), median (interquartile range), and categorical data as number (percentage). The distribution of data will be assessed using the Shapiro-Wilk test.\n\nTo determine the statistical threshold value of the 6-Minute Stepper Test with the best sensitivity and specificity for 2-year and 5-year mortality, receivor operator curves (95% confience interval) will be generated.\n\nPatients will then be divided into two groups (based on the threshold value). The characteristics of the two groups will be compared using Fisher\'s exact test (categorical data), the independent Student\'s t-test (parametric data), or the Mann-Whitney U test (non-parametric data).\n\nA Cox proportional hazards regression model will be used to calculate the "crude" and "adjusted" hazard ratio (95% confidence interval) for 2-year and 5-year mortality. The adjusted model will include the following variables: sex, age, FEV1 (L), modified Medical Research Council dyspnea score, BMI. Sensitivity analysis will be porformed adding smoking status, long term oxygen use and number of pulmonary rehabilitation during the follow-up.\n\nThe external validity of the model will be assessed using individual pariticipant data from a previously published study (https://pubmed.ncbi.nlm.nih.gov/27216848/).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with COPD referred for pulmonary rehabilitation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years;\n* Covered by a social security scheme;\n* COPD (all stages);\n* Referred for pulmonary rehabilitation;\n* Completed a 6-Minute Stepper Test at the start of their program.\n\nNon-inclusion Criteria:\n\n* Patients under guardianship or legal supervision;\n* Pregnant or breastfeeding women.\n\nExclusion Criteria:\n\n* Not applicable.'}, 'identificationModule': {'nctId': 'NCT06703359', 'acronym': 'SixSTeM-COPD', 'briefTitle': 'Predictive Properties of the 6-Minute Stepper Test for Mortality in COPD', 'organization': {'class': 'OTHER', 'fullName': 'ADIR Association'}, 'officialTitle': 'Evaluation of the Predictive Properties of the 6-Minute Stepper Test for Long-term Mortality in Patients with COPD', 'orgStudyIdInfo': {'id': 'SixSTeM-COPD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD referred for pulmonary rehabilitation.', 'description': 'Included participant were referred for pulmonary. During their baseline assessment, they performed the 6-Minute Stepper Test and were then followed for 5 years.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Tristan Bonnevie, PhD', 'role': 'CONTACT', 'email': 't.bonnevie@adir-hautenormandie.com', 'phone': '+33235592970'}, {'name': 'Tristan Bonnevie, PhD', 'role': 'CONTACT'}], 'facility': 'ADIR Association', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Tristan Bonnevie, PhD', 'role': 'CONTACT', 'email': 't.bonnevie@adir-hautenormandie.com', 'phone': '+33232592970'}], 'overallOfficials': [{'name': 'Tristan Bonnevie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ADIR Association'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will be made available after publication.', 'ipdSharing': 'YES', 'description': 'Data will be made available upon reasonnable request for research purpose after publication. Request should be send to t.bonnevie@adir-hautenormandie.com', 'accessCriteria': 'Data will be made available upon request to t.bonnevie@adir-hautenormandie.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ADIR Association', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}