Exercise TrainingNCT05294354
Acute Exercise Type and Cognitive Function: An Event-related Potential Study
A study testing aerobic exercise group (AE), aerobic exercise with virtual reality group (AE-VR) and combined exercise group (CE) in people with Exercise Training and Neurocognitive Function, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
This study aims to examine the effects of different types of acute exercise on cognitive functions in healthy adults. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training, Neurocognitive Function
- What is being tested?
- aerobic exercise group (AE), aerobic exercise with virtual reality group (AE-VR) and combined exercise group (CE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2022to Mar 2023
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- no major psychiatric illness or physical disease
- able to do 30-minutes moderate exercise
- normal or corrected-to-normal vision
- right-handed
- moderate exercise ≤ 150 min/week
Who cannot join
- any neurological, respiratory, vascular, metabolic, or brain-relative disease
- any physical limitation or injury
- any wounds on the scalp
- have experience of using technology products
- regular engagement in exercise training programs
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Education and Sport Sciences, National Taiwan Normal University
Taipei, 106
Yu-Kai Chang, Ph.D., 0980321731, yukaichangnew@gmail.com
About this study
Official title: Effects of Different Types of Acute Exercise on Cognitive Function: An Event-related Potential Study
This study aims to examine the effects of different types of acute exercise on cognitive functions in healthy adults.
Read the detailed description
Acute exercise, a single session of exercise, has been shown to enhance cognitive functions. The meta-analysis research has suggested that such benefits might depend upon the types of exercise. However, the predominant types of exercise examined within this area of research are aerobic and resistance exercises. The effects of other types of exercises on cognitive functions are poorly understood. Accordingly, this study is going to examine the effects of different types of acute exercise [i.e., aerobic exercise (AE), aerobic exercise with virtual reality (AE-VR), and combined exercise (CE)] on cognitive functions.
140-180 healthy young adults will be recruited and then randomly assigned to the AE, AE-VR, CE, and Control groups for a 35-minute intervention. Cardiovascular fitness will be assessed beforehand. Additionally, Stroop tasks and several questionnaires will be conducted before and after the intervention. The targeted primary outcomes are changes in cognitive behavior performance (assessed by the Stroop tasks) and neuroelectrical indices (e.g., P3 of event-related potential). The secondary outcomes are the changes in exercise enjoyment, motivation, and emotion.
- Conditions
- Exercise Training, Neurocognitive Function
- Being tested
- aerobic exercise group (AE), aerobic exercise with virtual reality group (AE-VR), combined exercise group (CE), Control group
- Keywords
- virtual reality, multi-domain exercise, executive function, inhibitory control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise group (AE)Behavioural
The participants will ride the cycle ergometer for 35 minutes. The training consisted of a 5-minute warm-up period followed by 25 minutes of moderate exercise and a 5-minute recovery.
aerobic exercise with virtual reality group (AE-VR)Behavioural
The participants will receive the 3D VR training program and ride the cycle ergometer at the same time. The training protocol is similar to the aerobic exercise group.
combined exercise group (CE)Behavioural
The intervention consists of 5-minutes aerobic warm-up, 25-minutes bodyweight exercise, and 5-minutes mindfulness meditation for recovery. The participants will follow the video to do the program.
Control groupBehavioural
Participants will watch a 35-min video about exercise science.
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise group (AE) | Experimental | 35-min cycling at moderate intensity (50-60% heart rate reserve). Receives: Behavioral: aerobic exercise group (AE) |
| aerobic exercise with virtual reality group (AE-VR) | Experimental | 35-min cycling at moderate intensity (50-60% heart rate reserve) with 3D virtual reality. Receives: Behavioral: aerobic exercise with virtual reality group (AE-VR) |
| combined exercise group (CE) | Experimental | This 35-min exercise combines aerobic, bodyweight exercise, and meditation. Receives: Behavioral: combined exercise group (CE) |
| control group | Active comparator | It has a 35-minute video about exercise science. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition performance: Changes in Stroop test performance
The computerized Stroop test will be administrated to assess participants' cognitive functions, and their changes in reaction time and accuracy will be examined.
Measured: 30 minutes each at the pretest and posttest
Changes in neuroelectrical activities
The neuroelectrical activities during the computerized cognitive tasks will be recorded. The changes in the event-related potential (e.g., P3) will be analyzed.
Measured: 30 minutes each at the pretest and posttest
Secondary outcomes (3)
Changes in physical activity enjoyment
The Chinese version of the physical activity enjoyment scale (PACES) questionnaire, with a total of 13 items, will be used to examine the changes in physical activity enjoyment. Participants will rate "how you feel at the moment about the exercise you have been doing" using a 7- point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it).
Measured: 5-10 minutes each at the pretest and posttest
Changes in motivation
The Chinese version of the Motivation for Future Use questionnaire will be used. The scale consists of 3 items and each item is scored on a Likert-type scale that ranges from 1 to 7, with higher scores indicating a higher level of motivation.
Measured: 3-5 minutes each at the pretest and posttest
Changes in emotion
The Chinese version of the positive and negative affect schedule (PANAS) will be used to assess the changes in emotion levels. It is a self-reporting questionnaire consisting of two 10-item scales and each item is scored on a Likert-type scale that ranges from 1 (not at all) to 5 (very much).
Measured: 5-10 minutes each at the pretest and posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start20 Mar 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Ting Cheng, National Taiwan Normal University
- Investigators
- Yu-Kai Chang, Principal investigator, Department of Physical Education and Sport Sciences, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294354
- Sponsor's protocol ID
- PACNL_1100301_YTTY
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2022
- Last updated
- 4 Apr 2022
- 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 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Types of Acute Exercise on Cognitive Function: An Event-related Potential Study
- ClinicalTrials.gov ID
- NCT05294354
- Acronym / sponsor ID
- PACNL_1100301_YTTY
- Conditions
- Exercise Training, Neurocognitive Function
- Keywords
- virtual reality, multi-domain exercise, executive function, inhibitory control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 24 Mar 2022 (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.
This study aims to examine the effects of different types of acute exercise on cognitive functions in healthy adults.
Detailed description
Acute exercise, a single session of exercise, has been shown to enhance cognitive functions. The meta-analysis research has suggested that such benefits might depend upon the types of exercise. However, the predominant types of exercise examined within this area of research are aerobic and resistance exercises. The effects of other types of exercises on cognitive functions are poorly understood. Accordingly, this study is going to examine the effects of different types of acute exercise [i.e., aerobic exercise (AE), aerobic exercise with virtual reality (AE-VR), and combined exercise (CE)] on cognitive functions.
140-180 healthy young adults will be recruited and then randomly assigned to the AE, AE-VR, CE, and Control groups for a 35-minute intervention. Cardiovascular fitness will be assessed beforehand. Additionally, Stroop tasks and several questionnaires will be conducted before and after the intervention. The targeted primary outcomes are changes in cognitive behavior performance (assessed by the Stroop tasks) and neuroelectrical indices (e.g., P3 of event-related potential). The secondary outcomes are the changes in exercise enjoyment, motivation, and emotion.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise group (AE) | Experimental | Behavioral: aerobic exercise group (AE)35-min cycling at moderate intensity (50-60% heart rate reserve). |
| aerobic exercise with virtual reality group (AE-VR) | Experimental | Behavioral: aerobic exercise with virtual reality group (AE-VR)35-min cycling at moderate intensity (50-60% heart rate reserve) with 3D virtual reality. |
| combined exercise group (CE) | Experimental | Behavioral: combined exercise group (CE)This 35-min exercise combines aerobic, bodyweight exercise, and meditation. |
| control group | Active comparator | Behavioral: Control groupIt has a 35-minute video about exercise science. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- no major psychiatric illness or physical disease
- able to do 30-minutes moderate exercise
- normal or corrected-to-normal vision
- right-handed
- moderate exercise ≤ 150 min/week
Key exclusion criteria (5 listed)
- any neurological, respiratory, vascular, metabolic, or brain-relative disease
- any physical limitation or injury
- any wounds on the scalp
- have experience of using technology products
- regular engagement in exercise training programs
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 |
|---|---|---|
| aerobic exercise group (AE)The participants will ride the cycle ergometer for 35 minutes. The training consisted of a 5-minute warm-up period followed by 25 minutes of moderate exercise and a 5-minute recovery. | Behavioural | aerobic exercise group (AE) |
| aerobic exercise with virtual reality group (AE-VR)The participants will receive the 3D VR training program and ride the cycle ergometer at the same time. The training protocol is similar to the aerobic exercise group. | Behavioural | aerobic exercise with virtual reality group (AE-VR) |
| combined exercise group (CE)The intervention consists of 5-minutes aerobic warm-up, 25-minutes bodyweight exercise, and 5-minutes mindfulness meditation for recovery. The participants will follow the video to do the program. | Behavioural | combined exercise group (CE) |
| Control groupParticipants will watch a 35-min video about exercise science. | Behavioural | control group |
Primary outcome
Inhibition performance: Changes in Stroop test performance
Time frame: 30 minutes each at the pretest and posttest
The computerized Stroop test will be administrated to assess participants' cognitive functions, and their changes in reaction time and accuracy will be examined.
Changes in neuroelectrical activities
Time frame: 30 minutes each at the pretest and posttest
The neuroelectrical activities during the computerized cognitive tasks will be recorded. The changes in the event-related potential (e.g., P3) will be analyzed.
3 secondary outcomes
Changes in physical activity enjoyment
Time frame: 5-10 minutes each at the pretest and posttest
Changes in motivation
Time frame: 3-5 minutes each at the pretest and posttest
Changes in emotion
Time frame: 5-10 minutes each at the pretest and posttest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- 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.
Yu-Kai Chang principal investigator
Department of Physical Education and Sport Sciences, National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise group (AE), aerobic exercise with virtual reality group (AE-VR) and combined exercise group (CE) in people with Exercise Training and Neurocognitive Function, run by National Taiwan Normal University at 1 site in Taiwan.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Apr 2022. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Kai Chang, Ph.D (+886277493220, yukaichangnew@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition performance: Changes in Stroop test performance (time frame: 30 minutes each at the pretest and posttest). 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 4 Apr 2022.