NCT05033197

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
347

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

August 17, 2021

Last Update Submit

August 29, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Change in Progressive Aerobic Cardiovascular Endurance Run (PACER)® test being assessed

    A valid FITNESSGRAM PACER® 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)

Study Arms (1)

CBBS intervention group

EXPERIMENTAL

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.

Behavioral: CBBS intervention

Interventions

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.

CBBS intervention group

Eligibility Criteria

Age9 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Having illness.
  • Being injured.
  • Having physical or mental impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Weiyun Chen

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Director of Physical Activity and Health Lab

Study Record Dates

First Submitted

August 17, 2021

First Posted

September 2, 2021

Study Start

September 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations