Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-25 @ 12:35 AM
Study NCT ID:
NCT02878551
Status:
COMPLETED
Last Update Posted:
2021-03-09
First Post:
2016-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Benefits of a Prehabilitation Program : Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-05', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minutes walk test', 'timeFrame': '7 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Cancer']}, 'descriptionModule': {'briefSummary': 'The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". In the present pilot trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old\n* Affiliated with a social security system\n* Having indicated their non-opposition\n* Must undergo a surgical intervention within a period of at least one month after the completion of the initial inclusion assessment and / or chemotherapy and / or radiotherapy\n\nNon-inclusion criteria:\n\n* Refusal of participation\n* Pregnant or breastfeeding woman\n* Inability to walk or initial physical assessment\n* Patient under guardianship or curatorship\n* Inability to complete questionnaires\n\nExclusion criteria:\n\n* Cognitive disorders detected by the geriatric consultation\n* Lost\n* Death before surgery or chemotherapy or radiotherapy\n* Shortened preoperative preparation time (\\<18 days)'}, 'identificationModule': {'nctId': 'NCT02878551', 'acronym': 'PrehabPilote', 'briefTitle': 'Evaluation of the Benefits of a Prehabilitation Program : Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Evaluation of the Benefits of a Program of Prehabilitation: Pilot Study', 'orgStudyIdInfo': {'id': '2016/29'}, 'secondaryIdInfos': [{'id': '2016-A00981-50', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prehabilitation program', 'description': 'Multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being', 'interventionNames': ['Other: Prehabilitation program']}], 'interventions': [{'name': 'Prehabilitation program', 'type': 'OTHER', 'description': 'multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being', 'armGroupLabels': ['Prehabilitation program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Morgan Le Guen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Foch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}