- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05033197
Physical Activity, Cognition, Motor Skills, and Well-beings
August 29, 2021 updated by: Weiyun Chen, University of Michigan
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
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.
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
347
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CBBS intervention group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in D2 Test of Attention being assessed
Time Frame: Baseline and post-intervention test (immediately after the intervention)
|
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
Time Frame: Baseline and post-intervention test (immediately after the intervention)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Weiyun Chen, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
August 17, 2021
First Submitted That Met QC Criteria
August 29, 2021
First Posted (Actual)
September 2, 2021
Study Record Updates
Last Update Posted (Actual)
September 2, 2021
Last Update Submitted That Met QC Criteria
August 29, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- HUM00149529
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Motor Activity
-
University of MiamiRecruiting
-
University of MiamiCompleted
-
University of Massachusetts, AmherstActive, not recruiting
-
Pamukkale UniversityActive, not recruitingPhysical Activity | Motor DevelopmentTurkey (Türkiye)
-
Applied Science & Performance InstituteCompletedHealth Behavior | Nutrition, Healthy | Activity, MotorUnited States
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)CompletedMotor Activity | Motor NeuroplasticityUnited States
-
University of Texas, El PasoNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingPhysical Activity | Activity TrackersUnited States
Clinical Trials on CBBS intervention
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
Nottingham Trent UniversityUnknownOverweight and ObesityUnited Kingdom
-
University of Southern DenmarkTrygFonden, DenmarkUnknownObesity | Overweight | Metabolic Syndrome | ChildrenDenmark
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedStage 0a Bladder Cancer AJCC v8 | Stage 0is Bladder Cancer AJCC v8 | Stage I Bladder Cancer AJCC v8United States
-
University of FloridaCompletedSensitivityUnited States
-
Ohio State University Comprehensive Cancer CenterCompleted
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnCancer Survivor | Peripheral Sensory Neuropathy
-
Vanderbilt UniversityCompletedMath Learning Disability | Reading Learning DisabilityUnited States
-
Universidad de ExtremaduraDiputación Provincial de BadajozRecruitingHealth Education | Gamification in Health EducationSpain