Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-01 @ 11:23 AM
Study NCT ID:
NCT06921057
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exergames on Muscle and Lung Function in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'forced expiratory volume at 1 sec (L)', 'timeFrame': 'week 0 and week 8', 'description': 'forced expiratory volume at 1sec'}, {'measure': 'forced expiratory volume at 1 sec (%)', 'timeFrame': 'week 0 and week 8', 'description': 'percentage of forced expiratory volume at 1sec predicted value'}, {'measure': 'forced vital capacity(L)', 'timeFrame': 'week 0 and week 8', 'description': 'forced vital capacity'}, {'measure': 'forced vital capacity(%)', 'timeFrame': 'week 0 and week 8', 'description': 'percentage of forced vital capacity predicted value'}, {'measure': 'arm curl test', 'timeFrame': 'week 0 and week 8', 'description': 'measurement upper arm muscle strength'}, {'measure': 'hand grip strength', 'timeFrame': 'week 0 and week 8', 'description': 'measurement upper arm muscle strength'}, {'measure': 'Mini-Mental State Examination', 'timeFrame': 'week 0 and week 8', 'description': 'assessment of cognitive function'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'week 0 and week 8', 'description': 'assessment of cognitive function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to examine the effects of 8-weeks exergames program on pulmonary function, muscle strength and cognitive function in elderly.\n\nParticipants will:\n\nPlay exergame 30min/session, 2 sessions/week or remained regular daily activities for 8 weeks.', 'detailedDescription': 'Subjects who are older than 60 years will be assigned to exergame group or control group randomly.\n\nExergame group: Subjects will receive exergame program 30min/session, 2 sessions/week for 8 weeks.\n\nControl group: Subjects remain regular daily activities for 8 weeks. Both groups receive pre- and post- measurements. The measurements included assessment of muscle strength and lung function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age \\> 60 years,\n2. sufficient cognitive capacity to provide informed consent,\n3. ability to understand and speak Chinese or Taiwanese.\n\nExclusion Criteria:\n\n1. medical conditions prohibiting physical exercise\n2. physical or cognitive disabilities preventing participation in or comprehension of the exergame.'}, 'identificationModule': {'nctId': 'NCT06921057', 'briefTitle': 'Effects of Exergames on Muscle and Lung Function in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung University'}, 'officialTitle': 'Effects of Exergames on Muscle Strength and Lung Function in Elderly', 'orgStudyIdInfo': {'id': '202301151B0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exergame', 'description': 'playing exergame 30 min/session, 2 sessions/ week, for 8 weeks.', 'interventionNames': ['Other: exergame']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'remain regular activities for 8 weeks.'}], 'interventions': [{'name': 'exergame', 'type': 'OTHER', 'description': 'playing exergames', 'armGroupLabels': ['exergame']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Chang Gung University', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'overallOfficials': [{'name': 'Yen-Huey Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '2025/01-2025/06', 'ipdSharing': 'YES', 'description': 'all collected IPD, that underlie results in a publication', 'accessCriteria': 'Data are available from the PI upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Chen Yen-Huey', 'investigatorAffiliation': 'Chang Gung University'}}}}