NCT06544317

Brief Summary

This study focuses on the effects of physical activity in schools on the cognitive function and physical fitness of children with and without developmental coordination disorder (DCD). Methods: 58 children with DCD participated in an 8-week exercise program. Children's standing broad jump (SBJ), 50m dash, 50m\*8 shuttle run, mental rotation and executive functions were assessed before and after training. A mixed-design analysis of variance (ANOVA) was conducted separately for each performance variable.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

July 19, 2024

Last Update Submit

August 6, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Reaction time (RT) of mental rotation tasks

    The experiment involved simultaneously presenting children with two pictures of "giraffes". The image on the left was fixed as the target, and the image on the right showed angle or mirror differences. The angular disparities were 0°, 60°, 120° or 180°. Through rotation, the children were asked to determine, as quickly and accurately as possible, whether the two images were identical.

    8 weeks

  • Reaction time (RT) of modified Stroop task

    The computerized modified Stroop task includes the following two conditions: a naming (non-execution) and execution condition. In the naming condition, the screen will display a colored "XXX" and the children need to press the key corresponding to the color. In the execution condition, the stimulus will show a distracting-colored word, similar to the classic Stroop, showing Chinese characters in either blue or red; in this test, the children need to press the key corresponding to the color of the word, rather than the meaning of the Chinese character. When the color of the word is consistent with its meaning, the condition is congruent; when the color of the word is inconsistent with its meaning, it is the condition is incongruent.

    8 weeks

  • Standing broad jump

    The SBJ test, which is completed on a flat surface, is used to evaluate the explosive strength of the lower limbs.

    8 weeks

  • 50m sprint

    The 50m sprint test requires students to start in a standing position and complete a 50m sprint with all their strength. The test is conducted twice, and the fastest result is recorded.

    8 weeks

  • 50m*8 shuttle run

    children are required to run back and forth between two points as quickly as possible.

    8 weeks

  • Safety and Tolerability

    There were no safety and adverse events

    8 weeks

Secondary Outcomes (2)

  • Height

    8 weeks

  • Weight

    8 weeks

Other Outcomes (1)

  • Safety and Tolerability

    From enrollment until at least 12 weeks after completion of study treatment

Study Arms (3)

training group

EXPERIMENTAL
Behavioral: physical training

control group

NO INTERVENTION

typically developing

ACTIVE COMPARATOR
Behavioral: physical training

Interventions

All children received a series of 90-minute sessions 3 times a week for 8 weeks of after-school physical training. Each session began with a warm-up (20 min), three or four tasks related to the skill to be developed (aerobic training, resistance training, other activities designed to improve motor skills and balance, stretching and flexibility activities and core strength and posture exercises; 60 min) and a cool-down (10 min). Children were divided into six groups, with the number of children in each group ranging from eight to twelve.

training grouptypically developing

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • DCDQ scores as follows: (8-9 years: \< 56 points; 10-12 years: \< 58 points)
  • one subitem of the MABC-2 rank below 15%
  • age 9 to 11 years old (elementary school age)

You may not qualify if:

  • Children with other mental illness who are unable to exercise
  • IQ \>90
  • ADHD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai University of Medicine and Health Sciences

Shanghai, Pudong, 201318, China

Location

MeSH Terms

Conditions

Motor Skills Disorders

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 19, 2024

First Posted

August 9, 2024

Study Start

August 1, 2024

Primary Completion

December 30, 2024

Study Completion

May 30, 2025

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations