Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-03 @ 6:25 AM
Study NCT ID:
NCT00623532
Status:
COMPLETED
Last Update Posted:
2009-05-19
First Post:
2008-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention Study of Mind-Body Physical Activity in Frail Institutionalized Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-18', 'studyFirstSubmitDate': '2008-02-15', 'studyFirstSubmitQcDate': '2008-02-15', 'lastUpdatePostDateStruct': {'date': '2009-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MOS SF-12'}], 'secondaryOutcomes': [{'measure': 'Timed Up and Go test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tertiary prevention of disability'], 'conditions': ['Aging', 'Frailty']}, 'referencesModule': {'references': [{'pmid': '20101011', 'type': 'DERIVED', 'citation': 'Dechamps A, Diolez P, Thiaudiere E, Tulon A, Onifade C, Vuong T, Helmer C, Bourdel-Marchasson I. Effects of exercise programs to prevent decline in health-related quality of life in highly deconditioned institutionalized elderly persons: a randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):162-9. doi: 10.1001/archinternmed.2009.489.'}]}, 'descriptionModule': {'briefSummary': 'Few previous studies have explored the effects of mind body approaches on health-related quality of life (HRQoL) in frail elderly. Cognition and action are an inseparable whole while functioning. A new intervention-based approach using familiarity based movements and a non-judgmental approach was labeled "cognition-action." The investigators aimed to explore the effects of two different mind-body exercise types on (HRQoL) in frail institutionalized elderly.\n\nThe investigators\' main hypothesis is that adaptated physical activity in frail institutionalized elderly can improve HRQoL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 65 and older\n* Institutionalized\n* Ability to get up alone or with technical or human help if necessary and ability to understand basic motor commands\n* Have given a signed consent\n\nExclusion Criteria:\n\n* Terminally ill and bedridden patients\n* Unable or unwilling to sign the consent\n* Have participated in a study in the past 3 month'}, 'identificationModule': {'nctId': 'NCT00623532', 'briefTitle': 'Intervention Study of Mind-Body Physical Activity in Frail Institutionalized Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Association de Recherche Gerontologique'}, 'officialTitle': 'A Randomized Interventional Study of a Cognition-Action Physical Activity and Adapted Tai-Chi in Frail Institutionalized Elderly', 'orgStudyIdInfo': {'id': 'AGR-2006-01-Etude MARGE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CA', 'description': 'Cognition and action are an inseparable whole while functioning, a new intervention based approach using familiarity based movements and non judgmental approach was labeled "cognition-action".', 'interventionNames': ['Behavioral: Mind-body exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AT', 'description': 'Adapted Tai Chi is based on Tai Chi like movements', 'interventionNames': ['Behavioral: Adapted Tai-chi']}, {'type': 'NO_INTERVENTION', 'label': 'C', 'description': 'Control'}], 'interventions': [{'name': 'Mind-body exercises', 'type': 'BEHAVIORAL', 'armGroupLabels': ['CA']}, {'name': 'Adapted Tai-chi', 'type': 'BEHAVIORAL', 'armGroupLabels': ['AT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33604', 'city': 'Bordeaux', 'state': 'Gironde', 'country': 'France', 'facility': 'Hopital Xavier Arnozan, CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association de Recherche Gerontologique', 'class': 'OTHER'}, 'collaborators': [{'name': "Conseil Régional d'Aquitaine (France)", 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Isabelle Bourdel-Marchasson/ Professor (MD-PhD)', 'oldOrganization': 'Pole of Gerontology-CHU of Bordeaux/ CNRS 5536 University V Segalent Bordeaux 2'}}}}