Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-01 @ 4:14 PM
Study NCT ID:
NCT07104435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-22
First Post:
2025-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Recreation to Enhance Function in Aging
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088544', 'term': 'Exergaming'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in performance on the Stroop Color-Word Test', 'timeFrame': 'From enrollment to study end at 24 weeks', 'description': 'Change in score on the Stroop Color-Word Test'}, {'measure': 'Performance on the Trail Making Test', 'timeFrame': 'From baseline to study end at 24 weeks', 'description': 'Change in score on the Trail Making Test'}], 'secondaryOutcomes': [{'measure': 'Performance on Four Stage Balance Test', 'timeFrame': 'From baseline to study end at 24 weeks', 'description': 'Change in score on the Four Stage Balance Test'}, {'measure': 'Performance on the Six-Minute Walk Test', 'timeFrame': 'From baseline to study end at 24 weeks', 'description': 'Change in score on the Six-Minute Walk Test'}, {'measure': 'Dual-Task Ability', 'timeFrame': 'From baseline to study end at 24 weeks', 'description': 'Change in scores on the Timed Up and Go Test: Dual Task'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Functional Impairment', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This aim of this study is to examine the therapeutic impacts of a group-based recreational program that delivers guided visual artmaking and dual-task exergaming, to older adults. Outcomes of interest include cognitive function (attention, task-switching, interference inhibition), physical function (balance, walking, lower-limb strength), and dual-task performance. Key implementation outcomes including intervention fidelity, feasibility, and acceptability will be explored to inform design of future community-based intervention programs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have no more than MCI (Montreal Cognitive Assessment score ≥ 24 points)\n* Have no contraindications to exercise guided by the American College of Sports Medicine (ACSM)\n* Fluent in English\n\nExclusion Criteria:\n\n* Have a condition that would prevent safe participation in the exercise, as determined by the Physical Activity Readiness Questionnaire for Older Adults\n* Have severe neurological disease.\n* Have severe psychiatric illness.\n* Have a likelihood of withdrawing from the study due to severe illness or a life expectancy of \\< 6 mo.\n* Having a lower or upper limb amputation'}, 'identificationModule': {'nctId': 'NCT07104435', 'briefTitle': 'Community Recreation to Enhance Function in Aging', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'A Community-Based Recreation Program to Improve Function and Quality of Life in Older Adults', 'orgStudyIdInfo': {'id': '1193595'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No artmaking, no exergaming'}, {'type': 'EXPERIMENTAL', 'label': 'Artmaking and Exergaming', 'description': 'Weekly group-based visual artmaking and dual-task exergaming', 'interventionNames': ['Other: Artmaking and exergaming']}], 'interventions': [{'name': 'Artmaking and exergaming', 'type': 'OTHER', 'description': 'Weekly visual artmaking and exergaming', 'armGroupLabels': ['Artmaking and Exergaming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14223', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nikhil Satchidanand', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}