Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-20 @ 4:29 PM
Study NCT ID:
NCT02897102
Status:
COMPLETED
Last Update Posted:
2016-09-13
First Post:
2016-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Training Program Based on Abacus and Other Activities in Healthy Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-09-06', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reasoning score change', 'timeFrame': 'After 7 month', 'description': 'Reasoning score change will be measured using the Z-score of Matrix Reasoning subtest of the BETA III'}, {'measure': 'Attention score change', 'timeFrame': 'After 7 month', 'description': 'Attention score change will be measured using the average of the Z-scores of the Codes subtest of the BETA III and the Cogstate Identification Task'}, {'measure': 'Speed of processing score change', 'timeFrame': 'After 7 month', 'description': 'Speed of processing score change will be measured using the Z-score of the Cogstate Detection Task'}, {'measure': 'Working memory score change', 'timeFrame': 'After 7 month', 'description': 'Working memory score change will be measured using the average of the Z-scores of the Cogstate One Back and Two Back tasks'}, {'measure': 'Verbal learning and memory score change', 'timeFrame': 'After 7 month', 'description': 'Verbal learning and memory score change will be measured using the average of the Z-scores of the Cogstate International Shopping List and International Shopping List - Delayed Recall tasks'}, {'measure': 'Visual learning and memory score change', 'timeFrame': 'After 7 month', 'description': 'Visual learning and memory score change will be measured using the average of the Z-scores of the Cogstate Continuous Paired Associate Learning, One Card Learning and Groton Maze Learning Test - Delayed Recall tasks'}, {'measure': 'Executive function score change', 'timeFrame': 'After 7 month', 'description': 'Executive function score change will be measured using the average of the Z-scores of the Cogstate Groton Maze Learning Test and Set Shifting Task'}], 'secondaryOutcomes': [{'measure': 'Motivation', 'timeFrame': 'After 7 months', 'description': 'Evaluated using the self-concept scales of cognitive competence and self-learning'}, {'measure': 'Quality of life', 'timeFrame': 'After 7 months', 'description': 'Evaluated using the control, autonomy, self-realization, and pleasure scale (CASP-19)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the effects of a structured program, which was based on abacus training associated with other activities, administered as weekly group classes over a 7 month period in older adults.', 'detailedDescription': 'Cognitive stimulating activities are often recommended for older adults; however, little is known regarding the effects of these activities on cognition, motivation and quality of life in this population. The aim of this study was to investigate the effects of a structured program, which was based on abacus training associated with other activities, administered as weekly group classes over a 7 month period in older adults. Eighty-eight older adults were enrolled in an open-label controlled clinical trial to evaluate the effects of this training program on cognition, motivation and quality of life. Training had a significant effect over time; the training group maintained their level of performance on verbal learning and memory tasks, whereas the control group exhibited a significant decrease in performance from baseline to post-intervention. The subjects in the training group were more motivated to learn at study entry; however, the training had no significant effect on motivation or quality of life. Abacus training associated with other activities may benefit verbal learning and memory in older adults. Additional studies with longer follow-ups are necessary to determine whether the results of this training will have a positive effect on the lives of older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60 years\n* Score ≥ 26 on the Mini-Mental State Examination\n* Portuguese as a native language.\n\nExclusion Criteria:\n\n* A neurological or serious medical condition that would prevent participation in the study.'}, 'identificationModule': {'nctId': 'NCT02897102', 'briefTitle': 'Effects of a Training Program Based on Abacus and Other Activities in Healthy Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio de Janeiro'}, 'officialTitle': 'Effects of a Training Program Based on Abacus and Other Activities in Healthy Older Adults', 'orgStudyIdInfo': {'id': '257651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The individuals in the control group chose to participate in different group activities: ballroom dancing (5 participants), belly dancing (4 participants), chorus (16 participants), Spanish classes (8 participants) and chorus and Spanish classes (6 participants). The activities were offered once per week in 2 hours classes for 35 weeks and were held between April and November of 2013.', 'interventionNames': ['Other: Different group activities']}, {'type': 'EXPERIMENTAL', 'label': 'Training group', 'description': 'was offered in one weekly class for 2 hours for 35 weeks between April and November of 2013. The first 50 minutes were spent performing exercises with the abacus, with increasing difficulty. One or two of the following activities followed the abacus training: playing games, neurobic and group dynamics.', 'interventionNames': ['Behavioral: Training']}], 'interventions': [{'name': 'Training', 'type': 'BEHAVIORAL', 'description': 'Training program based on abacus and other activities', 'armGroupLabels': ['Training group']}, {'name': 'Different group activities', 'type': 'OTHER', 'description': 'ballroom dancing (5 participants), belly dancing (4 participants), chorus (16 participants), Spanish classes (8 participants) and chorus and Spanish classes (6 participants).', 'armGroupLabels': ['Control group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rogerio Panizzutti', 'investigatorAffiliation': 'Universidade Federal do Rio de Janeiro'}}}}