Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT03866018
Status:
UNKNOWN
Last Update Posted:
2019-03-07
First Post:
2019-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contribution of Physical Activity to Self-esteem and Motivation in Older Adults With Minor to Major Cognitive Disorders Such as Alzheimer's Disease or Related Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-05', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of patient self-esteem', 'timeFrame': 'At 4 months', 'description': 'Rosenberg self-esteem scale'}, {'measure': 'Improvement of patient motivation', 'timeFrame': 'At 4 months', 'description': 'EAD scale'}, {'measure': 'Improvement of patient apathy', 'timeFrame': 'At 4 months', 'description': 'Apathy inventory'}], 'secondaryOutcomes': [{'measure': 'Quantitative assessment of physical activity', 'timeFrame': 'At 4 months', 'description': 'questionnaire for caregivers'}, {'measure': 'Patient satisfaction', 'timeFrame': 'At 4 months', 'description': 'satisfaction questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Disorders']}, 'descriptionModule': {'briefSummary': "Alzheimer's disease is the leading cause of dementia in people over 60 years of age. It is characterized by a decline in memory, learning ability and other cognitive domains (language, gnosis, praxis, attention), with a gradual progression of cognitive and behavioral symptoms. Because of the difficulties it causes in carrying out daily living activities, it has a very significant impact on the autonomy of patients suffering from it.\n\nTo date, there are various non-drug strategies available to manage these difficulties. Thus, in recent years, more and more studies have shown the benefits that can be gained by several patients care including physical activity, on cognitive function and general quality of life of the elderly people without cognitive impairment but also for patients suffering from Alzheimer's disease or a related pathology.\n\nThe objective of this study is to evaluate the effectiveness of adapted physical activity on self-esteem and motivation in patients with neurocognitive disorders. Stimulation groups are proposed within the Claude Pompidou Institute. Within these groups we offer an adapted physical activity program that we have developed in our department. More specifically, it is a study that aims to evaluate the impact of physical activity on the self-esteem and motivation of patients who perform these exercises for 12 weeks, at the rate of one hour per week.\n\nThe interest of this study lies in the validation of the effectiveness of such patient care, which would make it possible to promote its dissemination and strengthen the accessibility of this type of non-drug management to elderly people suffering from neurocognitive disorders.", 'detailedDescription': "Alzheimer's disease is the leading cause of dementia in people over 60 years of age. It is characterized by a decline in memory, learning ability and other cognitive domains (language, gnosis, praxis, attention), with a gradual progression of cognitive and behavioral symptoms. Because of the difficulties it causes in carrying out daily living activities, it has a very significant impact on the autonomy of patients suffering from it.\n\nTo date, there are various non-drug strategies available to manage these difficulties. Thus, in recent years, more and more studies have shown the benefits that can be gained by several patients care including physical activity, on cognitive function and general quality of life of the elderly people without cognitive impairment but also for patients suffering from Alzheimer's disease or a related pathology.\n\nThe objective of this study is to evaluate the effectiveness of adapted physical activity on self-esteem and motivation in patients with neurocognitive disorders. Stimulation groups are proposed within the Claude Pompidou Institute. Within these groups we offer an adapted physical activity program that we have developed in our department. More specifically, it is a study that aims to evaluate the impact of physical activity on the self-esteem and motivation of patients who perform these exercises for 12 weeks, at the rate of one hour per week.\n\nThe interest of this study lies in the validation of the effectiveness of such patient care, which would make it possible to promote its dissemination and strengthen the accessibility of this type of non-drug management to elderly people suffering from neurocognitive disorders."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female ≥ 60 years old\n* MMSE score between 4 and 26 / 30\n* Diagnosis of minor to major NeuroCognitive Disorder of the Alzheimer type or multiple etiology;\n* Subject without a major hearing or visual impairment;\n* Subject not presenting any contraindications to the practice of adapted physical activity;\n* Subject affiliated to Social Security System;\n* Signing informed consent\n\nExclusion Criteria:\n\n* \\< 60 years\n* Medical indications: Recent or unstable cardiovascular events: ECG changes, unstable angina, uncontrolled arrhythmia, 3rd degree BAV, acute heart failure.\n* MMSE score \\< 4\n* Subject already engaged in appropriate physical activity\n* Subject with a perceptual disorder (AMD, deafness...)\n* Subject with a motor disability\n* Subject under guardianship, curatorship or safeguard of justice\n* Persons deprived of their liberty (administrative or judicial)'}, 'identificationModule': {'nctId': 'NCT03866018', 'acronym': 'APAMA', 'briefTitle': "Contribution of Physical Activity to Self-esteem and Motivation in Older Adults With Minor to Major Cognitive Disorders Such as Alzheimer's Disease or Related Disorders", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': "Contribution of Physical Activity to Self-esteem and Motivation in Older Adults With Minor to Major Cognitive Disorders Such as Alzheimer's Disease or Related Disorders", 'orgStudyIdInfo': {'id': '18-AOI-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adapted physical activity', 'description': 'Patients will participate in an adapted physical activity workshop.', 'interventionNames': ['Other: Adapted physical activity']}], 'interventions': [{'name': 'Adapted physical activity', 'type': 'OTHER', 'description': '12 sessions of one hour of adapted physical activity.', 'armGroupLabels': ['Adapted physical activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Nice', 'country': 'France', 'facility': 'Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Cindy MENEZ', 'role': 'CONTACT', 'email': 'menez.c@chu-nice.fr', 'phone': '+33(0)4.92.03.47.63'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}