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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05294354
Other study ID # PACNL_1100301_YTTY
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 20, 2022
Est. completion date March 2023

Study information

Verified date April 2022
Source National Taiwan Normal University
Contact Yu-Kai Chang, Ph.D
Phone +886277493220
Email yukaichangnew@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to examine the effects of different types of acute exercise on cognitive functions in healthy adults.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.
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.
Control group
Participants will watch a 35-min video about exercise science.

Locations

Country Name City State
Taiwan Department of Physical Education and Sport Sciences, National Taiwan Normal University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 minutes each at the pretest and posttest
Primary 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. 30 minutes each at the pretest and posttest
Secondary 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). 5-10 minutes each at the pretest and posttest
Secondary 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. 3-5 minutes each at the pretest and posttest
Secondary 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). 5-10 minutes each at the pretest and posttest
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