Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT07230093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise and Physical Fitness in Children With Specific Learning Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007859', 'term': 'Learning Disabilities'}], 'ancestors': [{'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking is applied in this study; participants, caregivers, and investigators are aware of group assignments.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to one of two groups: the exercise group receives a combined exercise program for 8 weeks, 3 days per week, 45 minutes per session. The control group does not receive any intervention. Assessments of physical fitness parameters-including flexibility, muscular strength, muscular endurance, balance, coordination, speed, and agility-are performed before and after the intervention to evaluate changes.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-09-27', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Balance Performance (Flamingo Balance Test)', 'timeFrame': 'Pre- and post-intervention (8 weeks)', 'description': 'Description: Static balance will be assessed using the Flamingo Balance Test from the Eurofit Test Battery. Participants will stand on one leg on a narrow beam, and the number of falls within 1 minute will be recorded.\n\nTime Frame: Baseline and 8 weeks\n\nUnit of Measure: Number of falls (count)\n\nInterpretation: Lower scores indicate better balance.'}, {'measure': 'Coordination Speed (Plate Tapping Test)', 'timeFrame': 'Before and after intervention (8 weeks)', 'description': 'Description: Coordination and movement speed will be assessed using the Plate Tapping Test from the Eurofit Test Battery. The time required to complete 25 cycles of alternating taps will be recorded.\n\nTime Frame: Baseline and 8 weeks\n\nUnit of Measure: Seconds\n\nInterpretation: Lower scores indicate better performance.'}, {'measure': 'Flexibility (Sit-and-Reach Test)', 'timeFrame': 'Before and after intervention (8 weeks)', 'description': 'Description: Flexibility will be measured using the Sit and Reach Test, which assesses hamstring and lower back flexibility.\n\nTime Frame: Baseline and 8 weeks\n\nUnit of Measure: Centimeters\n\nInterpretation: Higher scores indicate greater flexibility.'}, {'measure': 'Abdominal Muscle Endurance (Sit-Ups Test)', 'timeFrame': 'Before and after intervention (8 weeks)', 'description': 'Description: Abdominal muscle endurance will be assessed using the Sit-Ups Test, recording the number of repetitions completed in 30 seconds.\n\nTime Frame: Baseline and 8 weeks\n\nUnit of Measure: Number of sit-ups (count)\n\nInterpretation: Higher scores indicate better endurance.'}, {'measure': 'Lower Limb Power (Standing Long Jump Test)', 'timeFrame': 'Before and after intervention (8 weeks)', 'description': 'Description: Explosive leg power will be evaluated using the Standing Long Jump Test. The best distance achieved in three trials will be recorded.\n\nTime Frame: Baseline and 8 weeks\n\nUnit of Measure: Centimeters\n\nInterpretation: Higher scores indicate better performance.'}, {'measure': 'Cardiorespiratory Endurance (20 m Shuttle Run Test)', 'timeFrame': 'Before and after intervention (8 weeks)', 'description': 'Description: Aerobic endurance will be assessed using the 20-meter Shuttle Run Test (Eurofit). The number of completed stages will be recorded.\n\nTime Frame: Baseline and 8 weeks\n\nUnit of Measure: Number of completed stages\n\nInterpretation: Higher scores indicate better endurance.'}, {'measure': 'Age', 'timeFrame': 'Baseline (Pre-intervention)', 'description': 'Measurement: Years\n\nDescription: Chronological age of the participant will be recorded.\n\nTime Frame: Baseline (Pre-intervention)'}, {'measure': 'Sex', 'timeFrame': 'Baseline (Pre-intervention)', 'description': 'Measurement: Male / Female (categorical variable)\n\nDescription: Biological sex will be recorded to explore potential differences in physical fitness outcomes.\n\nTime Frame: Baseline (Pre-intervention)'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Baseline (Pre-intervention)', 'description': 'Measurement: kg/m²\n\nDescription: BMI will be calculated using measured body weight and height (BMI = weight \\[kg\\] / height² \\[m²\\]). It will be used as a descriptive and covariate variable in analysis.\n\nInterpretation: Higher or lower BMI values will be examined in relation to physical fitness outcomes.\n\nTime Frame: Baseline (Pre-intervention)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Learning Disability', 'Physical Fitness', 'Combined Exercise', 'Children', 'Exercise Intervention'], 'conditions': ['Learning Disabilities']}, 'descriptionModule': {'briefSummary': 'Specific learning disabilities (SLD) are characterized by difficulties in reading, comprehension, arithmetic, and written expression, often accompanied by impairments in motor skills, balance, and coordination. However, physical difficulties in children with SLD are often overlooked in educational settings, and parental awareness of these issues remains limited.\n\nThis study aims to examine the effect of an 8-week combined exercise program-including balance, strength, and stretching exercises-on the physical fitness of children aged 7-14 years with SLD. Participants will be randomly assigned to either an exercise group or a control group.\n\nThe exercise intervention will be conducted three times per week for 45 minutes per session over eight weeks. Physical fitness will be evaluated through standardized field-based measures of balance, strength, flexibility, and endurance before and after the intervention. Data will be analyzed using SPSS 26.0, employing Wilcoxon, Mann-Whitney U, independent t-test, and paired t-test as appropriate.\n\nThe study is expected to emphasize the importance of physical activity for children with SLD and promote the inclusion of physiotherapy-based exercise programs in individualized support plans.\n\nPrimary Outcome Question: Does an 8-week combined exercise program improve balance, strength, flexibility, and endurance-key components of physical fitness-in children with specific learning disabilities compared to a control group?', 'detailedDescription': 'The term "Learning Disability" refers to difficulties in achieving expected academic performance in specific areas despite normal intelligence. In Turkey, learning disabilities encompass difficulties in one or more cognitive processes necessary for understanding and using language, either written or spoken. These difficulties may manifest in listening, speaking, reading, writing, spelling, attention, or mathematical operations.\n\nChildren with Specific Learning Disabilities (SLD) often experience not only academic difficulties but also deficits in motor skills, balance, and coordination. Physical fitness, defined as the ability to perform daily activities efficiently and safely, depends on multiple parameters including flexibility, muscular strength, muscular endurance, balance, coordination, speed, and agility. Regular exercise can improve these parameters, supporting children\'s physical, social, and cognitive development.\n\nDespite the importance of physical fitness, studies on exercise interventions in SLD children are limited and mostly focus on balance. There is a lack of research investigating comprehensive combined exercise programs addressing multiple fitness components simultaneously.\n\nThe aim of this study is to examine the effects of a combined exercise program on physical fitness parameters in children with SLD aged 7-14 years. The primary objectives are:\n\nTo improve flexibility, muscular strength, muscular endurance, balance, coordination, speed, and agility.\n\nTo prevent deficits in gross and fine motor skills commonly observed in children with SLD.\n\nTo increase parental awareness of the importance of physical exercise in children with learning disabilities.\n\nTo provide a home-based exercise guide for children and parents to promote sustainable physical activity.\n\nThis randomized controlled study will be conducted in Bartın, Turkey, with 18 participants diagnosed with SLD according to official assessments. Participants will be randomly assigned to the exercise group, which will receive the combined exercise program, or to the control group, which will not receive intervention. Physical fitness parameters will be measured before and after the intervention to evaluate changes.\n\nThe combined exercise program consists of 8 weeks of progressive training, three times per week, 45 minutes per session, including warm-up, main exercise, and cool-down phases. Exercises target all major muscle groups and incorporate strength, flexibility, balance, coordination, speed, and agility components.\n\nHypothesis: H0: "Combined exercise training has a significant positive effect on the physical fitness parameters of children with SLD." The novelty of this study lies in addressing physical fitness comprehensively in SLD children, beyond academic interventions, and promoting sustainable exercise habits. Results are expected to contribute to both the scientific literature and practical guidance for education and rehabilitation programs for children with learning disabilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Exercise Group: Children aged 7-14 years diagnosed with Specific Learning Difficulty (SLD), with signed parental consent and child assent form\n* Control Group: Children aged 7-14 years without SLD (healthy), with signed parental consent and child assent form\n\nExclusion Criteria:\n\n* Children with physical disabilities preventing participation\n* Children unable to cooperate with the assessments'}, 'identificationModule': {'nctId': 'NCT07230093', 'briefTitle': 'Exercise and Physical Fitness in Children With Specific Learning Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'Bartın Unıversity'}, 'officialTitle': 'The Effect of Combined Exercise Training on Physical Fitness Parameters in Children With Specific Learning Disabilities', 'orgStudyIdInfo': {'id': '2025-SBB-0230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Group', 'description': 'Participants receive a combined exercise program for 8 weeks, 3 days per week, 45 minutes per session. Physical fitness parameters-including flexibility, muscular strength, muscular endurance, balance, coordination, speed, and agility-are assessed before and after the intervention.', 'interventionNames': ['Behavioral: Combined Exercise Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants do not receive any intervention. Physical fitness parameters-including flexibility, muscular strength, muscular endurance, balance, coordination, speed, and agility-are assessed at the same time points as the exercise group.'}], 'interventions': [{'name': 'Combined Exercise Program', 'type': 'BEHAVIORAL', 'description': 'Participants perform a combined exercise program for 8 weeks, 3 days per week, 45 minutes per session. Physical fitness parameters-including flexibility, muscular strength, muscular endurance, balance, coordination, speed, and agility-are assessed before and after the intervention. This program aims to improve gross and fine motor skills, balance, coordination, and overall physical fitness in children with specific learning difficulties.', 'armGroupLabels': ['Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74100', 'city': 'Bartın', 'state': 'Bartın', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Meryem Sevim, Dr.', 'role': 'CONTACT', 'email': 'msevim@bartin.edu.tr', 'phone': '+905536104510'}], 'facility': 'Bartın University, Vocational School of Health Services', 'geoPoint': {'lat': 41.63583, 'lon': 32.3375}}], 'centralContacts': [{'name': 'Meryem Sevim, PhD', 'role': 'CONTACT', 'email': 'fzt.meryemsevim@outlook.com', 'phone': '+905536104510'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bartın Unıversity', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, PhD, Lecturer, Department of Physiotherapy', 'investigatorFullName': 'Meryem Sevim', 'investigatorAffiliation': 'Bartın Unıversity'}}}}