Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-02-03 @ 12:59 PM
Study NCT ID:
NCT03704935
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2018-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2018-10-10', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minutes walking distance', 'timeFrame': '10 years', 'description': '6 minutes walking distance'}], 'secondaryOutcomes': [{'measure': 'health-related quality of life', 'timeFrame': '10 years', 'description': 'health-related quality of life : VQ-11 questionnaire'}, {'measure': 'Forced expiratory volume in 1 seconde', 'timeFrame': '10 years', 'description': 'Forced expiratory volume in 1 seconde : FEV1'}, {'measure': 'BODE index', 'timeFrame': '10 years', 'description': 'BODE index'}, {'measure': 'death', 'timeFrame': '10 years', 'description': 'death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary rehabilitation', 'Maintenance program', 'Cohort', 'Microenvironment', 'Long-term benefits'], 'conditions': ['Chronic Respiratory Disease']}, 'descriptionModule': {'briefSummary': 'Chronic respiratory diseases are characterized by a progressive and long term deline. Pulmonary rehabilitation (exercise training and therapeutic education) can improve several disease outcomes like dyspnea, exercise tolerance and health-related quality of life. After an inpatient PR program, maintenance program can stabilize the disease outcomes. However, maintenance program are heterogeneous and long term benefits (\\>36 month) have been observed in only one study, which is not feasible in France. A realistic maintenance program as proposed by the French Air+R network (http://airplusr.com/wordpress/) has only demonstrated benefits after 12 month. In addition, the time course of patients may be heterogeneous, with differens clusters that could be influenced by the clinical, functional and systemic determinants. In particular, the cellular muscle microenvironment could be deleterious for the muscle function in patients, caused by a "spill-over" of inflammatory pulmonary molecules in the systemic milieu.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a chronic respiratory disease (COPD, Asthma, bronchiectasis , Fibrosis, Sleep Apnea, …) undergoing pulmonary rehabilitation (maintenance or inpatient)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPatients with a chronic respiratory disease (COPD, Asthma, bronchiectasis , Fibrosis, Sleep Apnea, …) undergoing pulmonary rehabilitation (maintenance or inpatient)\n\nExclusion criteria:\n\nContraindication to exercise training'}, 'identificationModule': {'nctId': 'NCT03704935', 'acronym': 'LTAir+R', 'briefTitle': 'Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program in Patients With a Chronic Respiratory Disease: Time Course and Determinants', 'orgStudyIdInfo': {'id': 'RECHMPL18_0317'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Department of clinical Physiology - University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Farés Gouzi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}