Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 3:53 AM
Study NCT ID:
NCT07442994
Status:
COMPLETED
Last Update Posted:
2026-03-02
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Tailored Judo Training and Nutritional Counseling on Physical Fitness and Body Composition in Children With Autism: A Study Including Blood Morphology and Genetic Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-27', 'size': 230249, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-20T06:48', 'hasProtocol': True}, {'date': '2024-06-27', 'size': 122170, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-26T05:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The European Physical Fitness Test - EUROFIT', 'timeFrame': '10 months', 'description': 'The European Physical Fitness Test (EUROFIT) will be used to measure the level of physical fitness. The EUROFIT test will be employed to assess various components, including balance (Flamingo Balance Test), hand movement speed (Tapping Test), explosive power (Standing Long Jump), flexibility (Sit and Reach Test), static strength (Handgrip Dynamometry), trunk strength (Sit-Up Test), functional strength (Flexed-Arm Hang), and agility endurance ($10 \\\\times 5$ m Shuttle Run).The results obtained by the subjects in each term will be converted into points, adjusted to the age and gender of the participants, in accordance with the scoring tables developed for Polish children and adolescents. The better the score obtained by the examined person in relation to their age, the higher the level of physical fitness that will be demonstrated. Depending on the specific physical fitness test, subjects will be able to obtain points ranging from 1 to 100.'}, {'measure': 'Body Composition', 'timeFrame': '10 months', 'description': 'Body composition will be evaluated using the bioelectrical impedance analysis (BIA) method. The measurements will be performed with a professional multi-frequency analyzer - Tanita. The following parameters will be recorded for each participant:\n\nFat Mass (FM), Fat-Free Mass (FFM), Total Body Water (TBW), and Skeletal Muscle Mass (SMM). The measurements will be taken in the morning, in a fasting state. Participants will stand barefoot on the analyzer electrodes according to the standardized measurement protocol. Body composition changes will be analyzed with adjustments for age and baseline measurements.'}, {'measure': 'Postural stability', 'timeFrame': '10 months', 'description': "Postural stability will be assessed using the CQStab2P stabilometric platform. The device will record the Center of Pressure (COP) position using six sensors. The measurement will last 30 seconds in a free-standing position (arbitrary, non-forced foot placement) with eyes open, and 30 seconds in a free-standing position with eyes closed. The platform will be placed 10 cm from the wall, and subjects will focus their gaze on a point in front of them. Prior to the measurement, subjects will be rested and will not have performed a warm-up. The analysis of changes in postural stability will be one of the elements evaluating the impact of the intervention on the participants' fitness levels. It will be analyzed whether judo training leads to a reduction in body sway in a standing position, both with eyes open and eyes closed."}], 'secondaryOutcomes': [{'measure': 'Morphology analysis', 'timeFrame': '10 months', 'description': 'The subject will be seated in a comfortable, relaxed position on a prepared chair. The nurse will position the arm downward and proceed with the blood collection procedure. The vein will be punctured, and once blood appears in the test tube, the previously applied tourniquet will be released. Immediately after the procedure, a dry sterile swab will be pressed onto the puncture site until bleeding stops. Following the collection, blood samples will be analyzed for iron, vitamin B12, total protein, magnesium, and folic acid content. These analyses will be conducted by qualified specialists in a professional laboratory.\n\nBlood morphology results will be analyzed in relation to the duration of the training process, changes in physical fitness levels, and body composition parameters.'}, {'measure': 'Genetic Polymorphism Analysis', 'timeFrame': '10 months', 'description': 'Buccal swabs will be collected for genetic polymorphism analysis. The subject will be seated in a comfortable position, and the sample will be obtained by rubbing a sterile swab against the oral mucosa. Immediately following collection, the swabs will be placed in sterile tubes and stored in a portable cooler to maintain the required temperature during transport to the laboratory. The CD38 gene polymorphism will be examined to investigate its potential association with changes in physical fitness, body composition and morphology during adapted judo training. Genetic analyses will be conducted using the Real-Time Polymerase Chain Reaction (Real-Time PCR) method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['JUDO', 'ASD', 'AUTISM SPECTRUM DISORDER', 'PHYSICAL ACTIVITY', 'FITNESS LEVEL', 'GENETIC POLYMORPHISM', 'BODY COMPOSITION', 'NUTRITION CONSULTING', 'morphology'], 'conditions': ['ASD', 'Autism Spectrum Disorder', 'Autism Spectrum Disorder High-Functioning', 'Autism Spectrum']}, 'descriptionModule': {'briefSummary': 'The present research project aims to testing adapted judo training as a form of supportive developmental therapy, combined with nutritional counseling, to influence physical fitness, dietary habits, body composition, body stability, and blood morphology-while accounting for genetic polymorphisms-among children and adolescents with autism spectrum disorder (ASD) who possess functional communication skills and no diagnosed aphasia. The study hypothesizes that a therapeutic intervention consisting of adapted judo training integrated with nutritional guidance will significantly enhance the functional capacity of children and adolescents with ASD.', 'detailedDescription': 'Current research demonstrates that judo training, despite being a contact sport, reduces the severity of symptoms in individuals with autism spectrum disorder (ASD). This suggests that, due to its specific format, judo may serve as a valuable therapeutic intervention for children and adolescents with ASD. Consequently, this study plans to implement adapted judo training as a form of therapy for participants aged 7 to 14. The sessions will be conducted over a 10-month period in integrated training groups, comprising both individuals with ASD and neurotypical peers. The objective of this training program is to analyze the effectiveness of environmental adaptation, the overcoming of resistance to interpersonal contact through contact sports, and to perform a comparative analysis of changes in examined variables between the ASD and non-ASD groups.\n\nThe training program will be based on movement-based games and activities designed to influence psychosocial behavior, peer interaction, and the acquisition of new motor skills to enhance functional abilities. Furthermore, it will include components of general physical literacy and judo-specific techniques (e.g., safe falling, displacement, applying and escaping holds, body rotations, and off-balancing/kuzushi). Sessions will be held twice weekly for 60 minutes. The study will enroll 50 participants aged 7-14 with a confirmed ASD diagnosis, possessing at least a "fair" level of communication skills and no diagnosed aphasia, alongside a control group of 50 neurotypical individuals. Therapeutic efficacy regarding physical fitness will be assessed through environmental adaptation tests (evaluating social comfort and cooperation), the EUROFIT Test battery, and stabilometric platform measurements.\n\nIt has been shown that coaches can influence the conscious healthy eating habits of their trainees; however, there is a lack of such data regarding children and adolescents with ASD. A frequent issue in the ASD population is food selectivity, characterized by the consumption of a highly restricted range of accepted food products. This may lead to micronutrient deficiencies as well as weight and growth disturbances. Therefore, this study proposes an innovative scientific intervention involving nutritional counseling conducted in cooperation with legal guardians, based on the collection of dietary habit data. To evaluate micronutrient status, blood morphology will be performed to analyze levels of iron, vitamin B12, protein, magnesium, and folic acid. These results, combined with body composition analysis via bioelectrical impedance (BIA), will facilitate the design of appropriately balanced diets for individual participants.\n\nExisting, though limited, genetic studies in individuals with ASD highlight the importance of identifying targeted, highly effective therapeutic and preventive measures to optimize functional outcomes. Research suggests a correlation between polymorphisms in genes encoding oxytocin receptors or those responsible for its secretion (e.g., the CD38 gene) and the functioning of individuals with ASD. Based on these observations, CD38 gene polymorphisms will be examined in the study participants using real-time PCR genetic analysis. Assessments of physical fitness, body stability, blood morphology, body composition will be conducted at three intervals: baseline (pre-intervention), mid-point, and post-intervention. Genetic polymorphism analysis assessments will be performed once, towards the conclusion of the training process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group ASD: Male and female participants aged 7-14 years with a confirmed diagnosis of autism spectrum disorder (ASD), without intellectual disability and without impairments in language functioning.\n\nGroup non-ASD: Male and female participants aged 7-14 years without ASD, intellectual disability and without impairments in language functioning.\n\nExclusion Criteria:\n\n* judo athlete\n* lack of medical clearance to participate in physical exercise, specifically judo'}, 'identificationModule': {'nctId': 'NCT07442994', 'acronym': 'AdaptedJudoASD', 'briefTitle': 'The Effects of Tailored Judo Training and Nutritional Counseling on Physical Fitness and Body Composition in Children With Autism: A Study Including Blood Morphology and Genetic Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': 'Evaluation of Changes in Physical Fitness and Body Composition Following a Tailored Judo Intervention and Nutritional Counseling in Children and Adolescents With Autism Spectrum Disorder: A Study Incorporating Blood Morphology and Genetic Polymorphism Analysis.', 'orgStudyIdInfo': {'id': 'DEC-2024/08/X/NZ5/00942'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'non - ASD', 'description': 'Children and adolescents without a diagnosed autism spectrum disorder participating in integrated groups alongside children and adolescents with ASD.', 'interventionNames': ['Combination Product: Adapted judo training for children and adeloscence with and without autism spectrum disorder - training in integrated groups']}, {'type': 'EXPERIMENTAL', 'label': 'ASD', 'interventionNames': ['Combination Product: Adapted judo training for children and adeloscence with and without autism spectrum disorder - training in integrated groups']}], 'interventions': [{'name': 'Adapted judo training for children and adeloscence with and without autism spectrum disorder - training in integrated groups', 'type': 'COMBINATION_PRODUCT', 'description': 'The innovation long - term (10 months) intervention conducted in an integration groups, where children and adolecence with ASD train judo, together with their neurotypical peers. The sessions would be implemented over a period of 10 months in combined training groups, ensuring that individuals with ASD and those without such a diagnosis train together. The trainings would take place twice a week for 60 minutes each. This intervention will allow for the examination of changes in physical fitness levels, body composition, and the effects of nutritional counseling following the completion of the adapted judo training program among participants. Analyses of blood morphology and genetic polymorphism will constitute additional, previously unexamined variables related to the potential for functional improvement in individuals with ASD following an intervention conducted in integrated groups.', 'armGroupLabels': ['ASD', 'non - ASD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-871', 'city': 'Poznan', 'state': 'Poznań', 'country': 'Poland', 'facility': 'Poznań University of Physical Education', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Physical Education', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science Centre, Poland', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}