Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2026-02-17 @ 5:04 PM
Study NCT ID:
NCT03793504
Status:
COMPLETED
Last Update Posted:
2020-07-16
First Post:
2019-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardio-Respiratory Response of a Training Session Versus an Adapted Physical Activity Session
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2019-01-02', 'studyFirstSubmitQcDate': '2019-01-03', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compare heart rate between a training session on cycle or treadmill and a training session on Nintendo WII', 'timeFrame': 'one day', 'description': 'heart rate (pulse per minute) at the end of each session'}], 'secondaryOutcomes': [{'measure': 'compare dyspnea between a training session on cycle or treadmill and a training session on nintendo WII', 'timeFrame': 'one day', 'description': 'dyspnea (borg scale) at the end of each session'}, {'measure': 'compare lower limb muscle fatigue between a training session on cycle or treadmill and a training session on nintendo WII', 'timeFrame': 'one day', 'description': 'lower limb muscle fatigue (borg scale) at the end of each session'}, {'measure': 'compare pulse oxymetry (SpO2) between a training session on cycle or treadmill and a training session on nintendo WII', 'timeFrame': 'one day', 'description': 'SpO2 at the end of each session'}, {'measure': 'Compare the felt pleasure between a training session on cycle or treadmill and a training session on nintendo WII', 'timeFrame': 'one day', 'description': 'felt pleasure (likert scale) at the end of each session'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary rehabilitation', 'exercise', 'physical activity'], 'conditions': ['Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'the aim of this study is to show that training session with nintendo WII requires the same cardiorespiratory demand than training session on ergocycle or treadmill, traditionally used in pulmonary rehabilitation program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with pulmonary disease admitted in pulmonary rehabilitation unit of CHU Brest', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with pulmonary disease\n\nExclusion Criteria:\n\n* exacerbation of the pulmonary disease\n* Weight \\>150Kg\n* Refusal to participate\n* People in pre and post surgical rehabilitation'}, 'identificationModule': {'nctId': 'NCT03793504', 'acronym': 'WIIRR', 'briefTitle': 'Cardio-Respiratory Response of a Training Session Versus an Adapted Physical Activity Session', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Cardio-Respiratory Response of an Exercise Training Session With Ergocycle or Treadmill Compared to an Adapted Physical Activity Session on a Wii, in Patients With Pulmonary Disease', 'orgStudyIdInfo': {'id': 'WIIRR (29BRC18.0250)'}}, 'contactsLocationsModule': {'locations': [{'zip': '29672', 'city': 'Morlaix', 'country': 'France', 'facility': 'CH Morlaix', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}], 'overallOfficials': [{'name': 'Marc BEAUMONT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}