Building Long-term Academic Success Through Ongoing Fun Fitness Program

Reading Disorder Clinical Trial

— BLASTOFF  

Official title:

Building Long-term Academic Success Through Ongoing Fun Fitness Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04113707
• Other study ID #: 19-0180
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the research study is to investigate if daily motor activities, including fitness activities, gross motor skills, fine motor skills, and motor coordination activities result in physiological, cognitive, and behavioral benefits to children at Odyssey Academy. The study will compare students' performance after intervention by comparing an intervention period to a standard care period, and comparing intervention students to students engaged in standard school activities in the area of academic performance.

Description:

The objective of this study is to track if daily participation in motor lab activities for school age children improves their academic performance. Academic performance is associated with motor skills, coordination, and executive function. Our objectives are to determine if daily participation in motor lab activities changes these skills, to better understand these relationships, track outcomes of children participating in motor lab intervention compared to non-intervention and children receiving standard level of care in the school, and to be able to follow the intervention students over time. The specific aims of the study are: 1. To investigate whether gross motor skills, fine motor skills, and physical fitness, predict executive function skills. 2. To determine the relationship between these variables and academic performance. 3. To examine the relationship between participation in motor lab activities and measures of change in fitness, gross motor skills, fine motor skills, executive function, and academic performance. 4. To evaluate if participation in daily motor lab activities predicts fitness level, gross motor skills, fine motor skills, executive function, and academic success at the end of the school year and in the next school year.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

Inclusion Criteria:

• students in grades kindergarten through fourth grade,
• students below grade level in reading
• in Odyssey Academy's reading program

Exclusion Criteria:

• students that are not part of the specialized reading program at Odyssey Academy
• are unwilling to participate in the motor lab intervention
• lack conversational ability in the use of the English language.

Related Conditions & MeSH terms

• Dyslexia
• Reading Disorder

Intervention

Behavioral:
• Motor lab activity
fitness, gross motor, fine motor, and motor coordination activities

Locations

Country	Name	City	State
United States	Odyssey Academy	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Movement Assessment Battery for Children-2 (MABC-2) between 3 time points (baseline, 10 weeks, 20 weeks)	Motor skills test which provides standard scores from 1-19 where higher scores represent better performance.	Baseline, 10 weeks, 20 weeks
Primary	Change in Wechsler Intelligence Scale for Children-5 (WISC-5) between 3 time points (baseline, 10 weeks, 20 weeks)	Measures of executive function which provides scale scores from 1-19 where higher scores represent better performance.	Baseline, 10 weeks, 20 weeks
Primary	Change in Test of Visual Motor Integration (VMI) between 3 time points (baseline, 10 weeks, 20 weeks)	Measures of visual perception and visual motor skills providing scores from 45-155 where higher scores represent better performance.	Baseline, 10 weeks, 20 weeks
Primary	Change in Behavior Rating Inventory of Executive Function - Parent and Teacher Forms between 3 time points (baseline, 10 weeks, 20 weeks)	Measure of behavioral executive function with score within the range of 30-90 where scores >60 represent poorer performance.	Baseline, 10 weeks, 20 weeks
Secondary	Change in Renaissance Star Reading Assessment between 3 time points (baseline, 10 weeks, 20 weeks)	Reading assessment with domain scores ranging from 0-99 where higher scores represent stronger performance.	Baseline, 10 weeks, 20 weeks
Secondary	Change in Fitness Gram between 3 time points (baseline, 10 weeks, 20 weeks)	fitness assessment with scores falling within either healthy fitness zone, needs improvement zone, or health risk zone.	Baseline, 10 weeks, 20 weeks