Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT07136818
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2025-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
From Blueprint to Practice: An Innovative Dynamic 9-Box Grid Improves Exercise Participation and Aerobic Capacity in Graduate Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-09', 'size': 84586, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-20T13:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Aerobic Capacity (12-min run distance)', 'timeFrame': 'Baseline, Week 5 (mid-intervention), Week 9 (post-intervention).', 'description': 'Description: Distance run in meters during standardized 12-minute field test.\n\nMeasurement Tool: GPS-tracked outdoor run (Keep App + Huawei Band 6).'}], 'secondaryOutcomes': [{'measure': 'Exercise Self-Efficacy (SEE-C Scale)', 'timeFrame': 'Timeframe: Baseline and Week 9.', 'description': "Description: Confidence in maintaining exercise habits (0-90 scale).\n\nMeasurement Tool: Chinese Self-Efficacy for Exercise Scale (Cronbach's α=0.75)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Improving Low Exercise Engagement', 'Addressing Sedentary Behaviors', 'Enhancing Aerobic Capacity', 'Bridging the Gap Between Exercise Intention and Action']}, 'descriptionModule': {'briefSummary': 'This study aims to develop and validate an innovative dynamic 9-square grid management model to improve aerobic capacity (AC) and physical activity participation among graduate students. The model integrates real-time exercise volume (quantified via smart wearable devices) and aerobic capacity (assessed by 12-minute run tests) into a two-dimensional grid, stratifying participants into five tiers for differentiated interventions.\n\nUsing a 2 × 3 mixed-design (feedback frequency: weekly vs. monthly; time points: baseline/mid/post-intervention), 32 healthy graduate students are randomized into two groups:\n\nWeekly feedback (dynamic position updates + tailored optimization strategies).\n\nMonthly feedback (position updates at monthly intervals).\n\nKey components include:\n\nMultimodal assessment: Objective exercise metrics (Huawei Band 6), AC (12-min run), psychological scales (Exercise Identity Scale, Self-Efficacy for Exercise Scale).\n\nTiered intervention: Customized strategies based on grid positioning (e.g., "Star Talent" optimization vs. "Urgent Attention" support).\n\nPrimary outcomes: Changes in AC, total exercise volume (TEV), exercise identity, and self-efficacy.\n\nThe study seeks to determine whether weekly dynamic feedback outperforms monthly feedback in sustaining behavioral change and enhancing physiological adaptation. Ethical approval was obtained from Anqing Normal University (AQNU2024110).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Graduate students aged between 18 and 30 years.\n* Completion of the Physical Activity Readiness Questionnaire (PAR-Q) to confirm readiness for exercise.\n* Completion of a sociodemographic questionnaire (including age, gender, and education level).\n* Confirmation of absence of exercise contraindications (e.g., conditions that may prevent safe participation in physical activity).\n* Confirmation of absence of cardiovascular disease.\n* Confirmation of absence of recent lower-limb injuries (occurring within the past 3 months or less).\n* Confirmation of absence of chest pain symptoms.\n* Ability to provide written informed consent for voluntary participation.\n\nExclusion Criteria:\n\n* Presence of exercise contraindications identified through the PAR-Q or clinical evaluation.\n* History or diagnosis of cardiovascular disease (e.g., heart conditions, stroke, or related disorders).\n* Recent lower-limb injuries (e.g., fractures, sprains, or surgeries) within the past 3 months.\n* Experience of chest pain symptoms (e.g., angina or discomfort during physical exertion).\n* Inability to complete the required questionnaires or assessments due to cognitive or language barriers.\n* Presence of any uncontrolled chronic condition that could interfere with exercise participation, as determined by the researchers during screening.'}, 'identificationModule': {'nctId': 'NCT07136818', 'briefTitle': 'From Blueprint to Practice: An Innovative Dynamic 9-Box Grid Improves Exercise Participation and Aerobic Capacity in Graduate Students', 'organization': {'class': 'OTHER', 'fullName': 'Hainan Normal University'}, 'officialTitle': 'From Blueprint to Practice: an Innovative Dynamic 9-Box Grid for Enhancing Exercise Adherence and Aerobic Capacity in Graduate Students', 'orgStudyIdInfo': {'id': 'AQNU2024110'}, 'secondaryIdInfos': [{'id': '21BTY074', 'type': 'OTHER_GRANT', 'domain': 'National Social Science Founda'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weekly Feedback Group', 'description': 'Dynamic placement in a 9-grid matrix (based on aerobic capacity + total exercise volume) updated weekly.', 'interventionNames': ['Behavioral: Dynamic 9-Square Grid Health Management with Weekly Feedback']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Monthly Feedback Group', 'description': 'Comparison group testing low-frequency feedback.', 'interventionNames': ['Behavioral: Dynamic 9-Square Grid Health Management with Monthly Feedback']}], 'interventions': [{'name': 'Dynamic 9-Square Grid Health Management with Weekly Feedback', 'type': 'BEHAVIORAL', 'description': 'A dual-axis management system categorizing participants into a 3x3 grid based on aerobic capacity (12-min run test) and total exercise volume (smart-device tracked). Includes weekly personalized feedback, tiered exercise prescriptions, and goal recalibration. Arm 1 receives updates every 7 days.', 'armGroupLabels': ['Weekly Feedback Group']}, {'name': 'Dynamic 9-Square Grid Health Management with Monthly Feedback', 'type': 'BEHAVIORAL', 'description': 'Identical grid framework as Arm 1 (aerobic capacity + exercise volume assessment), but with monthly (30-day) feedback cycles. Participants receive delayed optimization strategies and tier adjustments once per calendar month, simulating conventional health programs."', 'armGroupLabels': ['Monthly Feedback Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '571158', 'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'Hainan Normal University', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}]}, 'ipdSharingStatementModule': {'url': 'https://www.openclinica.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '1 January 2030;', 'ipdSharing': 'YES', 'description': 'Aerobic capacity test results；Smart wearable exercise data；Cloud-synced TEV metrics (intensity/duration/frequency)；Aggregated weekly values；Psychological scales (EIS/SEE-C)；Encrypted survey responses；Baseline demographics；Limited metadata (age/BMI)。', 'accessCriteria': 'Academic researchers affiliated with accredited institutions Regulatory bodies (e.g., ethics committees) Peer reviewers for journal publication validation\n\nAccess Process:\n\nStep 1: Submit research proposal via OpenClinica Platform Step 2: Institutional ethics approval documentation required Step 3: Data Use Agreement (DUA) signing with corresponding authors'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hainan Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}