Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-27 @ 2:04 AM
Study NCT ID:
NCT07302568
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2025-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Gezaixi Interventions on Community-Dwelling Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D000375', 'term': 'Aging'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'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'}, {'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Strength', 'timeFrame': 'From enrollment to the end of intervention at 12 week', 'description': 'Change in muscle strength from baseline to week 12, measured using standardized tests (e.g., handgrip strength with a dynamometer in kilograms, or 30-second chair stand repetitions). Higher values indicate better strength.'}, {'measure': 'Calf Circumference', 'timeFrame': 'rom enrollment to the end of treatment at 12 weeks', 'description': 'Change in calf circumference (centimeters) measured at the widest point of the non-dominant calf using a non-stretchable tape. Larger circumference generally indicates better muscle mass.'}, {'measure': 'SOF Frailty Score', 'timeFrame': 'From enrollment to the end of treatment at 12 week', 'description': 'Change in Study of Osteoporotic Fractures (SOF) frailty score (range 0-3; higher scores indicate greater frailty)'}], 'secondaryOutcomes': [{'measure': 'BSRS-5', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'Change in the 5-item Brief Symptom Rating Scale total score; higher scores indicate more severe psychological distress.'}, {'measure': 'GGDS-5', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'Change in the 5-item Geriatric Depression Scale score; higher scores indicate more depressive symptoms.'}, {'measure': 'SARC-F', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'Description: Change in SARC-F questionnaire score for sarcopenia risk (range 0-10; higher scores indicate higher risk).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Gezaixi (Taiwanese Opera)', 'Resistance Exercise', 'Strength Training', 'Community-Dwelling Older Adults'], 'conditions': ['Frailty', 'Functional Decline', 'Community-Dwelling Older Adults']}, 'descriptionModule': {'briefSummary': 'This interventional study evaluates a 12-week, once-weekly group exercise program combining 60 minutes of progressive strength training and 60 minutes of Taiwanese opera-based activities for community-dwelling adults aged ≥65 in Taipei. The primary aim is to delay frailty and functional decline by improving physical fitness and independence. Primary outcomes are muscle strength, calf circumference, and SOF frailty score; secondary outcomes are BSRS-5, GGDS-5, and SARC-F. The study uses a non-randomized, parallel two-arm design (exercise vs. usual activity), open-label, with assessments at baseline and week 12.', 'detailedDescription': 'Participants attend weekly 120-minute sessions for 12 consecutive weeks at community centers. Strength training targets major muscle groups using body weight, elastic bands, or light dumbbells at moderate intensity (Borg RPE 11-13) with progressive overload. The Taiwanese opera-based segment integrates singing, reciting, acting, and martial arts elements to promote balance, coordination, posture, and endurance. Sessions include warm-up and cool-down. Certified C-level instructors lead classes; adherence and adverse events are monitored each session. Statistical analysis will compare pre-post changes within groups (paired t-tests) and between-group differences in change scores (independent t-tests or ANCOVA adjusting for baseline values). Missing data will be handled primarily using complete case analysis, with sensitivity analyses using linear mixed-effects models under a MAR assumption or multiple imputation as appropriate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥65 years.\n* Community-dwelling older adults residing in Taipei.\n* Able to ambulate independently (with or without assistive device).\n* Able to communicate and provide informed consent.\n\nExclusion Criteria:\n\n* Unstable cardiopulmonary disease or uncontrolled hypertension.\n* Severe cognitive impairment affecting participation.\n* Recent major surgery or fracture within the past 3 months.\n* Any contraindication to moderate-intensity exercise as assessed by the study team.'}, 'identificationModule': {'nctId': 'NCT07302568', 'briefTitle': 'Exercise and Gezaixi Interventions on Community-Dwelling Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'National Taipei University of Nursing and Health Sciences'}, 'officialTitle': 'The Effects of Exercise and Gezaixi (Taiwanese Opera) Interventions on Community-Dwelling Older Adults', 'orgStudyIdInfo': {'id': '202503em021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise with Taiwanese Opera Elements', 'description': 'Weekly 2-hour group sessions for 12 consecutive weeks; 60 minutes progressive strength training plus 60 minutes Taiwanese opera-based activities.', 'interventionNames': ['Behavioral: Strength Training plus Taiwanese Opera-based Activities']}], 'interventions': [{'name': 'Strength Training plus Taiwanese Opera-based Activities', 'type': 'BEHAVIORAL', 'otherNames': ['Opera-integrated Exercise Program for Older Adults'], 'description': 'Group-based exercise delivered at community centers for community-dwelling adults aged ≥65 years. Frequency: once per week. Session length: 120 minutes per session (60 minutes progressive strength training + 60 minutes Taiwanese opera-based activities integrating singing, reciting, acting, and martial arts). Total duration: 12 consecutive weeks.\n\n* Content and progression: Strength training targets major muscle groups (e.g., sit-to-stand, rowing/pulling with elastic bands, hip abduction, calf raises) using body weight, elastic bands, or light dumbbells; intensity targeted at moderate level (Borg RPE 11-13) and progressed by resistance/repetitions as tolerated. The opera-based segment includes rhythmic movement, balance drills, upper-/lower-limb coordination, posture and breathing, and simple choreographed sequences adapted from Taiwanese opera elements. Each session includes \\~10 minutes warm-up and \\~10 minutes cool-down with flexibility and breathing exercises. Approximate group size:', 'armGroupLabels': ['Exercise with Taiwanese Opera Elements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11219', 'city': 'Taipei', 'state': 'Taitau District', 'country': 'Taiwan', 'facility': 'National Taipei University of Nursing and Health Sciences', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taipei University of Nursing and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wu Gueyhau', 'investigatorAffiliation': 'National Taipei University of Nursing and Health Sciences'}}}}