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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05033197
Other study ID # HUM00149529
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date December 1, 2019

Study information

Verified date August 2021
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this quasi-experimental study design was to examine effects of the coordinated-bilateral ball skills (CBBS) intervention on cognitive functions and aerobic fitness in elementary school students. The hypotheses of the study were: students in the intervention group will show a significant higher level of cognitive functions and aerobic fitness compared to the control students.


Description:

Fourth-grade students at 5 elementary schools were recruited to participate. At each participating school, two fourth-grade classes were assigned to the CBBS intervention group and other two fourth-grade classes were assigned to the control group. The students in the intervention group received two, 30-min CBBS physical education (PE) lessons taught by the physical education teacher who were trained in implementation of the two CBBS lessons per week for 16 weeks. In contrast, the students in the control group received regular two PE lessons per week for 16 weeks taught by the other physical education teacher who were not be involved in the CBBS intervention training. All participating students who returned their parent/guardian' signed consent form were pre-tested and post-tested (immediately after the 16-week intervention) in cognitive functions and aerobic fitness. Descriptive statistics and linear mixed models were performed to analyze the data. All data analysis were conducted in Physical Activity and Health Lab of the School of Kinesiology at University of Michigan


Recruitment information / eligibility

Status Completed
Enrollment 347
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 10 Years
Eligibility Inclusion Criteria: - Being fourth-grade students in the class taught by either the intervention PE teacher or the comparison PE teacher. - Consent/assent to participate in the study. - Being able to complete all outcome measures without physical, cognitive, and mental constrains. Exclusion Criteria: - Having illness. - Being injured. - Having physical or mental impairment.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CBBS intervention
The CBBS intervention group received the 16-week intervention, including 16 CBBS lessons in basketball unit (two 40-minute lessons/week, 8 weeks) and 16 CBBS lessons in soccer unit (two 40-minute lessons/week, 8 weeks) during the 2018-2019 school year.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in D2 Test of Attention being assessed The d2 Test of Attention is a standardized paper and pencil letter-cancellation test that measures neuropsychology performance of the students in the areas of sustained and selective attention and concentration Baseline and post-intervention test (immediately after the intervention)
Primary Change in Progressive Aerobic Cardiovascular Endurance Run (PACER)® test being assessed A valid FITNESSGRAM PACERĀ® test (15-meter version for school-aged children) was used to assess students' cardiorespiratory endurance during a PE lesson in the school gymnasium. Baseline and post-intervention test (immediately after the intervention)
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