Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 9:07 PM
Study NCT ID:
NCT04663256
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2020-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cognitive Stimulation in Older People With Mild Cognitive Impairment
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2020-11-15', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MMSE (mini-mental state examination)', 'timeFrame': 'Baseline-8 weeks', 'description': 'A tool that can be used to systematically and thoroughly assess mental status.'}, {'measure': 'Yesavage Geriatric Depression Scale Adjetivo 1 relating to old people, especially with regard to their healthcare. a geriatric hospital Sustantivo 1 an old person, especially one receiving special care. a rest home for geriatrics.', 'timeFrame': 'Baseline-8 weeks', 'description': 'Hetero-administered questionnaire used to detect depression in people over 65 years of age.'}, {'measure': 'Hamilton Scale for Anxiety.', 'timeFrame': 'Baseline-8 weeks', 'description': 'Hetero-administered scale used for the detection of anxiety, exploring the interruption of the emotional continum and subjective feelings of tension, restlessness or nervousness.'}, {'measure': 'SF-36 (The Short Form-36 Health Survey)', 'timeFrame': 'Baseline-8 weeks', 'description': 'Used extensively for assessing health-related quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', 'Older People']}, 'descriptionModule': {'briefSummary': 'Mild cognitive impairment is becoming one of the most common cynical manifestations that affect older people. That is why there is a need to investigate non-pharmacological interventions that help to improve or maintain this problem.', 'detailedDescription': 'Each week for 12 weeks, GE participants will attend three 60-minute sessions of cognitive exercises. Each session is divided into 10 minutes of memory practice, which includes short-term and long-term memory; 10 minutes of language skills, including vocabulary, comprehension, reading and writing exercises; 10 minutes of calculation, in which arithmetic, similar and different operations are carried out; 10 minutes of praxis and gnosis where drawing and recognition and auditory, tactile, spatial, visual attention were promoted; 10 minutes of orientation where knowledge of space, person and place is developed; and 10 minutes of executive functions in which exercises of organization, planning and problem solving are worked.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With or without dependency to move.\n* People who show mild cognitive impairment.\n* That they were able to carry out the different selected questionnaires.\n\nExclusion Criteria:\n\n* People with visual deficit.\n* People already enrolled in a cognitive program.\n* Score between 24 and 10 in the Mini Cognitive Exam (MEC).'}, 'identificationModule': {'nctId': 'NCT04663256', 'briefTitle': 'Effects of Cognitive Stimulation in Older People With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'University of Jaén'}, 'officialTitle': 'Effectiveness of a Cognitive Stimulation Program on Anxiety, Depression and Quality of Life in People Older Than 70 Years With Mild Cognitive Impairment.', 'orgStudyIdInfo': {'id': 'University of Jaén_2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Stimulation Group', 'description': 'This group receives physical training based on exercises for cognitive stimulation.', 'interventionNames': ['Other: Cognitive stimulation group']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'This group does not receive any treatment.'}], 'interventions': [{'name': 'Cognitive stimulation group', 'type': 'OTHER', 'description': 'Each week for 12 weeks, GE participants attend three 60-minute sessions of cognitive exercises.', 'armGroupLabels': ['Cognitive Stimulation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23330', 'city': 'Jaén', 'country': 'Spain', 'facility': 'U.E.D. Virgen de la Capilla', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jaén', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Agustín Aibar Almazán', 'investigatorAffiliation': 'University of Jaén'}}}}