Clinical trial NCT05033197: Physical Activity, Cognition, Motor Skills, and Well-beings
Official title: 1.1.1 Full Study Title: Impacts of Brain-Boosting Coordinated Aerobic Physical Activity Interventions on Cognition, Motor Skill Competence, Aerobic Fitness, Daily Physical Activity, and Psychological Well-beings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 347
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study used 2 arms, quasi experimental study design with one intervention group and one control group. The intervention group included fourth-grade students of two fourth-grade classes taught by the physical education teacher who received the coordinated-bilateral ball skills (CBBS) intervention training at each of the five elementary schools. The control group included fourth-grade students of other two fourth-grade classes taught by the physical education teacher who did not receive the CBBS intervention training at each of the five elementary schools.
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in D2 Test of Attention being assessed
timeFrame: Baseline and post-intervention test (immediately after the intervention)
measure: Change in Progressive Aerobic Cardiovascular Endurance Run (PACER)® test being assessed
timeFrame: Baseline and post-intervention test (immediately after the intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Weiyun Chen
role: PRINCIPAL_INVESTIGATOR
References: