Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT03271112
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2017-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frailty Prevention in Elders From Reunion Island
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilote study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical performance improvement', 'timeFrame': 'Physical performance improvement from baseline to 12 wks', 'description': 'Physical performance is assessed as as balance, walk and strength improvement'}], 'secondaryOutcomes': [{'measure': 'Quality of life score', 'timeFrame': 'SF36 improvement from baseline to 12 wks', 'description': 'Improvement of quality of life assessed by SF36 v1 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frail Elderly Syndrome', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'In Reunion Island, people encounter environmental and social conditions leading to premature ageing and subsequent frailty. Social welfare has developped exercise programs to promote physical activity especially for elderly with higher risk factors of frailty, including low incomes.\n\nThe study evaluates the potent benefit effect of such exercise program on physical performance and frailty improvement in seniors from Reunion Island. All seniors participate to a 12-weeks exercise program especially dedicated to this targeted population needs and ability.', 'detailedDescription': 'Regular physical activity has been shown to slow down sarcopenia, and increase strengh in elders. Nevertheless, senior with low incomes do not usually have access to physical activity areas.\n\nSocial partners are in close relationship with these elders and could promote free exercise programs dedicated to elders classified as "GIR5-6" according to the French scale "AGIRR". The AGIRR scale takes into account several criteria allowing the evaluation of the level of autonomy. The level of autonomy is closely related to frailty and could be reversed since elders have not reach a dependant-state. The "GIR5-6" level means that elderly people are still not dependant but exhibit several frailty risk factors.\n\nThe level of frailty and the physical performance of the participants is assessed by standard geriatric evaluation before the 12-wks exercice program. The improvement of the physical performance is assessed after he 12-wks exercice program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Retired\n* with an autonomy level corresponding to the "GIR 5-6" level of the French "AGIRR scale"\n* informed consent\n\nExclusion Criteria:\n\n* physical activity prohibited\n* under guardianship'}, 'identificationModule': {'nctId': 'NCT03271112', 'acronym': '5P-PILOTE', 'briefTitle': 'Frailty Prevention in Elders From Reunion Island', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Frailty Prevention in Elderly People From Reunion Island: Effects of Adaptated Exercises on Physical Performance', 'orgStudyIdInfo': {'id': '2017/CHU/00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Exercise program', 'description': 'Participation to the 12-wks exercise program', 'interventionNames': ['Other: Exercise program']}], 'interventions': [{'name': 'Exercise program', 'type': 'OTHER', 'description': 'Measurement of physical performance before and after the 12 wks-exercice program', 'armGroupLabels': ['Exercise program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Joseph', 'country': 'Reunion', 'facility': 'Chu Reunion Island', 'geoPoint': {'lat': -21.3777, 'lon': 55.61691}}], 'overallOfficials': [{'name': 'Jean-Marc EYCHENE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hpospitalier Universitaire de La REUNION'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre National de la Recherche Scientifique, France', 'class': 'OTHER'}, {'name': 'Institut de Recherche pour le Developpement', 'class': 'OTHER_GOV'}, {'name': 'General Social Security Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}