Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:32 PM
Study NCT ID:
NCT07452302
Status:
COMPLETED
Last Update Posted:
2026-03-05
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mixed PE Program Using Sports Games and Ball Sports in Left-Behind Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors responsible for physical fitness testing were blinded to group allocation. Participants and the physical education teacher delivering the intervention were not blinded due to the nature of the study design.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned in a 1:1 ratio to either a mixed training group (MTG) or a usual physical education control group (CONG). Both groups received physical education during the same 12-week period. The MTG received a structured mixed intervention combining cooperative sports games and ball sports, while the CONG followed the standard school curriculum. No crossover occurred between groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-01', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mental Health Test (MHT) Total Score', 'timeFrame': 'Baseline and Week 12 (Immediately Post-Intervention)', 'description': 'The Mental Health Test (MHT) is a standardized self-report instrument used to assess psychological status in school-aged children. The total score reflects overall psychological difficulty, with higher scores indicating greater levels of psychological problems.'}], 'secondaryOutcomes': [{'measure': 'Interpersonal Anxiety (MHT Subscale Score)', 'timeFrame': 'Baseline and Week 12 (Immediately Post-Intervention)', 'description': 'Interpersonal Anxiety is a subscale of the Mental Health Test (MHT) assessing social anxiety and interpersonal stress. Higher scores indicate greater levels of interpersonal anxiety.'}, {'measure': 'Self-Blame Tendency (MHT Subscale Score)', 'timeFrame': 'Baseline and Week 12 (Immediately Post-Intervention)', 'description': 'Self-Blame Tendency is a subscale of the Mental Health Test (MHT) evaluating self-directed negative attribution patterns. Higher scores indicate greater self-blame.'}, {'measure': 'Vital Capacity (mL)', 'timeFrame': 'Baseline and Week 12 (Immediately Post-Intervention)', 'description': 'Vital capacity measured in milliliters using standardized school-based pulmonary function testing procedures.'}, {'measure': '50-Meter Dash Time (seconds)', 'timeFrame': 'Baseline and Week 12 (Immediately Post-Intervention)', 'description': 'Time required to complete a 50-meter sprint, recorded in seconds.'}, {'measure': '8×50-Meter Shuttle Run Time (seconds)', 'timeFrame': 'Baseline and Week 12 (Immediately Post-Intervention)', 'description': 'Total time required to complete eight 50-meter shuttle runs, recorded in seconds.'}, {'measure': 'Rope Skipping Performance (repetitions per minute)', 'timeFrame': 'Baseline and Week 12 (Immediately Post-Intervention)', 'description': 'Number of rope skipping repetitions completed within one minute.'}, {'measure': 'Sit-Ups Performance (repetitions per minute)', 'timeFrame': 'Baseline and Week 12 (Immediately Post-Intervention)', 'description': 'Number of sit-ups completed within one minute.'}, {'measure': 'Sit-and-Reach Distance (centimeters)', 'timeFrame': 'Baseline and Week 12 (Immediately Post-Intervention)', 'description': 'Maximum forward reach distance measured in centimeters using a standardized sit-and-reach test.'}, {'measure': 'Body Mass Index (kg/m²)', 'timeFrame': 'Baseline and Week 12 (Immediately Post-Intervention)', 'description': 'Body mass index calculated from measured height and weight (kg/m²).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['left-behind children', 'school-based intervention', 'physical education', 'sports games', 'ball sports', 'randomized controlled trial', 'child mental health', 'aerobic fitness', 'social interaction', 'cooperative play'], 'conditions': ['Mental Health', 'Physical Fitness', 'Left-Behind Children']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial evaluates whether a 12-week school-based physical education program that combines cooperative sports games and ball sports can improve mental health and physical fitness in rural left-behind children. Left-behind children are those who remain in rural areas while one or both parents migrate for work. These children may experience social and emotional challenges in addition to physical health concerns.\n\nForty sixth-grade boarding students who met the criteria for left-behind children were randomly assigned to either a mixed training group or a usual physical education control group. The intervention was delivered during regular school physical education classes three times per week, 90 minutes per session, for 12 weeks. Each session included cooperative physical games designed to promote peer interaction, followed by structured soccer or basketball training activities.\n\nMental health was assessed using the Mental Health Test (MHT), and physical fitness was evaluated using standardized school-based tests including lung function, running performance, flexibility, and coordination. Outcomes were measured before and after the intervention.\n\nThe study aims to determine whether optimizing the structure of routine school physical education can provide a feasible and scalable strategy to support both psychological well-being and physical development in vulnerable child populations.', 'detailedDescription': "This study is a single-center, parallel-group randomized controlled trial conducted in a rural primary boarding school in China. The objective was to evaluate the effects of a structured 12-week mixed physical education intervention integrating cooperative sports games and ball sports on mental health and physical fitness in left-behind children.\n\nEligible participants were sixth-grade students who had been separated from one or both parents for more than six months and met the study's screening criteria for left-behind children. After baseline assessment, participants were randomly allocated in a 1:1 ratio to either the mixed training group (MTG) or the control group (CONG) using block randomization (block size = 4) with allocation concealment via sequentially numbered opaque sealed envelopes. Outcome assessors were blinded to group assignment.\n\nThe intervention was delivered within the routine physical education curriculum (three sessions per week, 90 minutes per session, for 12 weeks). Each session included: (1) a 20-25 minute cooperative game segment emphasizing social interaction and group participation; (2) a 55-60 minute structured soccer or basketball training segment with progressive skill development and small-sided games; and (3) a brief cool-down period. Exercise intensity was staged using target heart rate zones corresponding to approximately 60-85% of age-predicted maximal heart rate.\n\nThe primary outcome measure was the total score of the Mental Health Test (MHT). Secondary outcomes included MHT subscales and standardized physical fitness indicators (vital capacity, 50-m dash, 8×50-m shuttle run, rope skipping, sit-ups, sit-and-reach, and body mass index). All outcomes were assessed at baseline and immediately post-intervention.\n\nData were analyzed using two-way repeated-measures analysis of variance to assess group, time, and interaction effects. The study was conducted in accordance with the Declaration of Helsinki and was approved by the institutional ethics committee."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 12 to 13 years\n* Enrolled in the sixth grade of the participating rural primary school\n* Classified as left-behind children, defined as separation from one or both parents for more than six months due to parental migration for work\n* Boarding-school students during the study period\n* Provided written informed consent from legal guardians and written assent from the child\n\nExclusion Criteria:\n\n* Children from single-parent families or orphans\n* Presence of physical, neurological, or medical conditions that would limit participation in regular physical activity\n* Participation in any structured extracurricular physical training program during the study period'}, 'identificationModule': {'nctId': 'NCT07452302', 'acronym': 'MIXPE-LBC', 'briefTitle': 'Mixed PE Program Using Sports Games and Ball Sports in Left-Behind Children', 'organization': {'class': 'OTHER', 'fullName': 'Anhui Normal University'}, 'officialTitle': 'A 12-Week School-Based Mixed Physical Education Intervention Combining Cooperative Sports Games and Ball Sports to Improve Mental Health and Physical Fitness in Rural Left-Behind Children', 'orgStudyIdInfo': {'id': 'AHNU-MIXPE-LBC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mixed Training Group (MTG)', 'description': 'Participants in this arm received a structured 12-week school-based physical education intervention delivered three times per week (90 minutes per session). Each session included a 20-25 minute cooperative sports game segment followed by 55-60 minutes of structured soccer or basketball training with progressive intensity and small-sided games. The intervention was implemented within the regular physical education curriculum.', 'interventionNames': ['Behavioral: Mixed Physical Education Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Physical Education Control Group (CONG)', 'description': 'Participants in this arm followed the standard school physical education curriculum for 12 weeks. The curriculum primarily included calisthenics and general physical fitness training without structured cooperative sports games or systematic ball sports training.', 'interventionNames': ['Behavioral: Usual Physical Education']}], 'interventions': [{'name': 'Mixed Physical Education Program', 'type': 'BEHAVIORAL', 'description': 'Participants received a structured 12-week school-based physical education program delivered three times per week (90 minutes per session). Each session included a cooperative sports game component (20-25 minutes) designed to promote peer interaction and social engagement, followed by structured soccer or basketball training (55-60 minutes) with progressive skill development and small-sided games. Exercise intensity was staged to achieve approximately 60-85% of age-predicted maximal heart rate. The intervention was implemented within the regular school physical education curriculum.', 'armGroupLabels': ['Mixed Training Group (MTG)']}, {'name': 'Usual Physical Education', 'type': 'BEHAVIORAL', 'description': 'Participants followed the standard school physical education curriculum for 12 weeks, consisting primarily of calisthenics and general physical fitness activities. The curriculum did not include structured cooperative sports games or systematic soccer or basketball training as provided in the experimental intervention.', 'armGroupLabels': ['Usual Physical Education Control Group (CONG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '241000', 'city': 'Wuhu', 'state': 'Anhui', 'country': 'China', 'facility': 'Rural Primary School in J County', 'geoPoint': {'lat': 31.35259, 'lon': 118.42947}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tao Fang', 'investigatorAffiliation': 'Anhui Normal University'}}}}