Motor ActivityNCT05033197
Physical Activity, Cognition, Motor Skills, and Well-beings
A study testing CBBS intervention in people with Motor Activity, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- CBBS intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Having illness.
- Being injured.
- Having physical or mental impairment.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Motor Activity
- Being tested
- CBBS intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBBS interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CBBS intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline and post-intervention test (immediately after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Sep 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiyun Chen, University of Michigan
- Investigators
- Weiyun Chen, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033197
- Sponsor's protocol ID
- HUM00149529
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05033197
- Acronym / sponsor ID
- HUM00149529
- Conditions
- Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| CBBS intervention group | Experimental | Behavioral: CBBS interventionThe 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. |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Having illness.
- Being injured.
- Having physical or mental impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBBS interventionThe 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. | Behavioural | CBBS intervention group |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiyun Chen principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBBS intervention in people with Motor Activity, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in D2 Test of Attention being assessed (time frame: Baseline and post-intervention test (immediately after the intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.