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IRCT20260519069455N3 IRCT 2026-10-29 Faculty of Sport Sciences and Health, University of Tehran The Effect of Different Exercise Interventions on Motor and Cognitive Skills in Obese Children with Learning Disabilities The Effect of Cognitive–Motor Training Intervention and Active Video Games on Motor Skills, Executive Function, and Selective Attention in Obese Children with Learning Disabilities 2026-11-06 anticipated 45 Recruiting https://irct.ir/trial/94390 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting 45 eligible children, the participants were allocated to three equal groups using a block randomization method: a cognitive-motor training group, an active video game group, and a control group. Microsoft Excel and the rand function were used to perform the randomization. Ultimately, 15 participants were assigned to each group. Unit of randomization: The unit of randomization was the individual; that is, each child was treated as an independent unit and assigned to one of the three study groups. Randomization strata: Stratified randomization was not used, and participants were allocated without stratification based on variables such as age, sex, or body mass index. Randomization tool: Microsoft Excel and the rand function were used to perform the random allocation process. Method of generating the randomization sequence: The allocation sequence was generated using Microsoft Excel, and participants were assigned to the three study groups according to the resulting sequence. The allocation process aimed to establish three equal groups, with 15 participants in each group. Allocation concealment: Allocation concealment as a separate procedure was not specified in the available information regarding the study implementation. N/A Overweight with a learning disability. Intervention 1: Intervention group: Intervention Group 1: Participants in the cognitive–motor training program attended three sessions per week for eight weeks, with each session lasting 45 minutes. The training sessions were conducted in the school setting under the researcher’s supervision and involved combined cognitive–motor activities designed to simultaneously engage executive functions, including attention, working memory, and response inhibition, as well as gross and fine motor skills, balance, hand–eye coordination, and reaction speed. Outcome measures were assessed before the intervention began and after completion of the eight-week program. Intervention 2: Intervention Group 2: Participants in the active video game program attended three sessions per week for eight weeks, with each session lasting 45 minutes. The sessions were conducted in the school setting using an Xbox One Kinect console under the researcher’s supervision. The selected games were designed to engage gross and fine motor skills, hand–eye coordination, reaction speed, and decision-making. Outcome measures were assessed before the intervention began and after completion of the eight-week program. Intervention 3: Control group: Participants in this group did not receive cognitive–motor training or active video game interventions during the eight-week study period. Outcome measures were assessed at baseline and again after eight weeks, following the same assessment procedures used for the two intervention groups. Yes - There is a plan to make this available What will be shared: The data obtained from this study will be available for sharing in anonymized form after removing participants’ identifying and confidential information, in accordance with research ethics principles. Data from pre- and post-intervention assessments, including gross and fine motor skills, response inhibition, working memory, cognitive flexibility, and selective attention, along with the data dictionary and descriptions of the variables, will be made available upon request to qualified researchers, subject to approval by the principal investigator. Requests will be submitted and reviewed through correspondence with the principal investigator. Identifiable information about the children and other confidential information will not be shared with third parties. The data will be used solely for scientific and research purposes, in compliance with ethical principles and confidentiality requirements. When: Six months after publishing the paper To whom: Researchers Conditions: Requests for access to the data must be submitted by qualified researchers through correspondence with the principal investigator. 2. Each request must specify the scientific and research purpose, the research questions to be addressed, and the intended statistical analyses. 3. Access to the data is subject to review and approval by the principal investigator. 4. The data may be used solely for approved scientific and research purposes. Secondary statistical analyses, including descriptive and inferential analyses relevant to the research objectives, are permitted, provided that they comply with research ethics principles and confidentiality requirements. 5. Re-identification of participants, attempts to determine their identities, or linkage of the data to identifiable information are strictly prohibited. 6. Transferring or sharing the data with third parties without the authorization of the principal investigator is not permitted. 7. Any publication of findings derived from the data must comply with research ethics principles and appropriately cite the original study. 8. No identifiable or confidential information relating to participants will be provided to requesters. Where to obtain: Maryam khalaji How to obtain: Researchers wishing to access the anonymized study data must submit a request to the principal investigator by email. The request should include the applicant’s name and institutional affiliation, the purpose of the request, the research questions, and the planned analyses. The principal investigator will review the request to ensure that the proposed use is consistent with the study objectives, research ethics principles, and confidentiality requirements. Applicants may be contacted if additional information or clarification is required. Following approval, the anonymized data and relevant documentation, including the data dictionary and variable descriptions, will be provided electronically via email or another mutually agreed secure method. The process is expected to take approximately 2–4 weeks from receipt of a complete request, depending on the complexity of the request and the time required for review. No personally identifiable or confidential participant information will be shared. Comments:
public Maryam Khalaji
Faculty of Sport Sciences and Health, University of Tehran, North Kargar Street, Tehran, Iran.
Tehran Iran (Islamic Republic of) 8835173037 +98 21 6111 8865 maryam.khalaji@ut.ac.ir Faculty of Sport Sciences and Health, University of Tehran scientific Daryoush Khajavi
Faculty of Sport Sciences and Health, University of Tehran, North Kargar Street, Tehran, Iran.
Tehran Iran (Islamic Republic of) 8835173037 +98 21 6611 8963 d-khajavi@araku.ac.ir Faculty of sport sciences and health, university of Tehran Iran (Islamic Republic of) Being between 8 and 12 years of age Having a Body Mass Index (BMI) greater than 30 Diagnosis of a learning disorder by a qualified specialist Absence of physical limitations for participating in physical activity Written parental consent 8 years 12 years Both Absence from more than two consecutive sessions Sustaining an injury during the execution of exercises Presence of any serious medical or psychiatric condition that could affect participation or study outcomes Use of medications that may impact cognitive or physical performance (e.g., ADHD stimulants) Participation in other interventional studies within the past six months that could influence the results Unwillingness to continue participation throughout the course of the research Rehabilitation Rehabilitation Other Intervention group: Intervention Group 1: Participants in the cognitive–motor training program attended three sessions per week for eight weeks, with each session lasting 45 minutes. The training sessions were conducted in the school setting under the researcher’s supervision and involved combined cognitive–motor activities designed to simultaneously engage executive functions, including attention, working memory, and response inhibition, as well as gross and fine motor skills, balance, hand–eye coordination, and reaction speed. Outcome measures were assessed before the intervention began and after completion of the eight-week program. Intervention Group 2: Participants in the active video game program attended three sessions per week for eight weeks, with each session lasting 45 minutes. The sessions were conducted in the school setting using an Xbox One Kinect console under the researcher’s supervision. The selected games were designed to engage gross and fine motor skills, hand–eye coordination, reaction speed, and decision-making. Outcome measures were assessed before the intervention began and after completion of the eight-week program. Control group: Participants in this group did not receive cognitive–motor training or active video game interventions during the eight-week study period. Outcome measures were assessed at baseline and again after eight weeks, following the same assessment procedures used for the two intervention groups. 1. Gross Motor Skills: Gross motor skills score based on the relevant subtests of the Bruininks–Oseretsky Test of Motor Proficiency, compared across the three groups at pre-test and post-test following the eight-week intervention.2. Fine Motor Skills: Fine motor skills score based on the relevant subtests of the Bruininks–Oseretsky Test of Motor Proficiency, compared across the three groups at pre-test and post-test following the eight-week intervention.3. Response Inhibition: Performance score on the response inhibition assessment, based on the scoring indicator specified in the study protocol, compared across the three groups at pre-test and post-test.4. Working Memory: Performance score on the working memory assessment, based on the scoring indicator specified in the study protocol, compared across the three groups at pre-test and post-test.5. Cognitive Flexibility: Performance score on the cognitive flexibility assessment, based on the scoring indicator specified in the study protocol, compared across the three groups at pre-test and post-test.6. Selective Attention: Performance score on the Stroop Color–Word Test, based on the scoring indicator specified in the study protocol, compared across the three groups at pre-test and post-test. Timepoint: Pre-test and after 8 weeks of intervention, a post-test was taken. Method of measurement: All primary outcomes, including gross motor skills, fine motor skills, response inhibition, working memory, cognitive flexibility, and selective attention, were measured at two time points: at baseline before the intervention (pre-test) and immediately after completion of the eight-week intervention (post-test). Faculty of Sport Sciences and Health, University of Tehran Approved 2025-09-14 Research Ethics Committee of the Faculty of Sport Sciences and Health, University of Tehran Faculty of Sport Sciences and Health, University of Tehran, North Kargar Street, Between 15th and 16th Streets, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)