- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06788106
Effect of Aerobic Exercise With Synchronous Music on Functions Among Medical Students
Effect of Different Aerobic Exercise Intensities With Synchronous Music on Psychophysiological, Attentional, Executive Functions and Brain Functional Connectivity Among Medical Students in Jiangsu Province, China
Study Overview
Status
Conditions
Detailed Description
The study is divided into three parts. Cross sectional study design will be used for Study 1 and Study 2. Experimental study with randomised controlled trial (RCT) will be used for Study 3.
Study-1: Validity and Reliability test of the questionnaire for Chinese population Four scales were selected: the Brief Multidimensional Students' Life Satisfaction Scale - college version (BMSLSS-C), the Positive Thinking Skills Scale (PTSS), Attentional Function Index (AFI), the Executive Functions scale for University settings (UEF).
By using the Brislin (1982) method, firstly, the translation of the questionnaire from English to Chinese first needs to be finished. The translated version needs to be adapted to Chinese culture before implementation. Specifically, a bilingual person will translate all parts of the above questionnaire from English to Chinese. Another bilingual person will translate the translated questionnaire from Chinese into English. The English versions of the two materials will be compared for equivalence, they will be reviewed and finalized by a panel of five experts with experience in sports science, sports psychology, health psychology, and physical education. Then the questionnaire will be distributed through the web-based questionnaire platform.
In the data processing stage, first, the reliability and validity of the three questionnaires will need to be checked, because only with the reliability and validity of the scales, the data will be of analytical value, and the results of the study can be accurately and reliably obtained. For reliability, the magnitude of Cronbach's alpha coefficient, which reflects the degree of internal consistency of the questionnaire, is commonly used as a measure. A Cronbach's alpha coefficient greater than 0.7, according to the general criteria, means that the scale passes the reliability test, and its internal consistency is satisfactory; when the Cronbach's alpha coefficient is greater than 0.8, it means that the scale has good reliability; when the reliability of the scale is below 0.7, the scale needs to be revised at that time. However, in addition to reliability, the validity of the scale needs to be further tested.
Next, validity will be tested using confirmatory factor analysis (CFA) by using Mplus. The CFA model will be constructed separately according to the different dimensions of each scale, the fit indicators for the overall fit measurement were CMIN/DF, RMR, RMSEA, GFI, AGFI, NFI, TLI, and CFI. In addition, the convergent validity of the scale needs to be analyzed. The main indicator of convergent validity is the average variance extracted (AVE), the larger the AVE, the more common the measures are and the better they reflect the same type of problem.
Next, the stability of the translated version of questionnaires employed the test-retest method. An additional 70 participants will be recruited from the 500 participants to re-do the questionnaires after 7 days. This is to compare the stability of the test-retest for the seven questionnaires.
Study-2: Structural equation modeling and path hypothesis validation To test the hypotheses, the full valid sample data are brought into the software Amos, the path hypothesis is tested using the maximum likelihood estimation (ML) method. When using structural equation modeling for model estimation, the overall fit of the model is a test of the extent to which the theoretically constructed conceptual model matches the survey data. The analysis will be conducted using Amos 23.0.
Study-3: Exploring the possible effects of different intensity aerobic training with synchronous music.
Experimental intervention stage, all the selected subjects are divided into four research conditions. Three groups were intervened under aerobic training with synchronous music of different intensities for 8 weeks, and another group served as a control group without intervention. Three aerobic training intervention groups are divided into low-intensity group, moderate-intensity group, and high-intensity group. Defining aerobic training with different intensities based on different MET values. The relationship between MET value and exercise intensity is as follows, less than 3METs belong to low-intensity training, 3-5.9METs belong to moderate-intensity training, greater than 7 METs belong to high-intensity training. The intensity of aerobic training during groups intervention is adjusted through Treadmill Test.
About synchronous music, It is selected using the music tempo according to the exercise intensity as suggested. The music for fast tempo range is 140-150bpm, moderate tempo is 110-120bpm, and slow tempo is 70-80bpm. This study will select 20 pieces of music according to moderate rhythm. After the selection, the 20 songs will be scored by 10 participants using the affect grid and Brunel Music Rating Scale-3, and the highest three song tracks will be selected. To ensure that the intensity of the aerobic exercise is in line with the tempo of the music, we use a DJ beat regulator to do this. When the music plays, the study design and controls for environmental factors are standardized. It is necessary to determine the mode of delivery, frequency /length of time according to the research content when designing music intervention, which is a primary problem on the music variables can be solved. The mode of delivery of music intervention is choose, and the music will be trimmed according to the exercise programme through headphones by the participant.
Before and after intervention, the psychological function, attention, executive function, and brain functional connectivity status of the subjects were evaluated through questionnaires, smartwatch, and Functional near-infrared spectroscopy (fNIRS) brain imaging technology. Then analyze the possible effects of different intensities of aerobic training on the psychological state, attention, and executive function of college students based on the results, as well as the correlation with brain functional connectivity.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Le Li, PhD
- Phone Number: 60167557895
- Email: lile@student.usm.my
Study Contact Backup
- Name: Garry KP Kuan, Asso Prof.
- Phone Number: +609 767 7622
- Email: garry@usm.my
Study Locations
-
-
Jiangsu
-
Yancheng, Jiangsu, China, 224005
- Recruiting
- Jiangsu Medical College
-
Contact:
- Le Li
- Phone Number: 0167557895
- Email: lile@student.usm.my
-
Contact:
- Garry KP Kuan
- Phone Number: 097677622
- Email: garry@usm.my
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Medical students willing to participate in aerobic training
- Population of low questionnaire evaluation results
- Subjects achieved a result of 7met or more on the Treadmill Test using the Bruce protocol
- The medical students with low to moderate physical activity level. They are able to exercise, once or twice per week, but are not in the habit of doing so daily
Exclusion Criteria:
- History of major depressive disorder in the past 6 months
- Have a history of alcohol, drug abuse or use of psychiatric drugs
- Have a history of head trauma, neurological disease or other serious illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
without intervention
|
|
|
Experimental: low-intensity with synchronous music group
intervened under low-intensity aerobic training with synchronous music of different intensities for 8 weeks, 3 times one week, 40minites one time.
|
This group will be intervened under low-intensity aerobic training with synchronous music for 8 weeks, 3 times every week, 40 minites each time.
|
|
Experimental: medium-intensity with synchronous music group
intervened under medium-intensity aerobic training with synchronous music of different intensities for 8 weeks, 3 times one week, 40minites one time.
|
This group will be intervened under medium-intensity aerobic training with synchronous music for 8 weeks, 3 times every week, 40 minites each time.
|
|
Experimental: high-intensity with synchronous music group
intervened under high-intensity aerobic training with synchronous music of different intensities for 8 weeks, 3 times one week, 40minites one time.
|
This group will be intervened under high-intensity aerobic training with synchronous music for 8 weeks, 3 times every week, 40 minites each time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological function
Time Frame: up to 30 weeks
|
Brief Multidimensional Students'Life Satisfaction Scale - college version (BMSLSS-C)
|
up to 30 weeks
|
|
Attentional function
Time Frame: up to 30 weeks
|
Attentional Function Index (AFI)
|
up to 30 weeks
|
|
Executive function
Time Frame: up to 30 weeks
|
Executive Functions scale for University settings (UEF)
|
up to 30 weeks
|
|
Brain functional connectivity
Time Frame: up to 30 weeks
|
Functional near-infrared spectroscopy (fNIRS).
Using fNIRS to observe the brain functional connectivity.
The fNIRS device used in this experiment was a portable Nir Smart [two wavelengths: 760 and 850 nm, 16 channels (eight light sources and eight detectors); Danyang Huichuang Medical Equipment Co., Ltd., Danyang, China].
According to the 10-20 international standard lead system, the fNIRS helmet was placed on the head of the participant such that the light poles covered the left and right prefrontal areas of the brain, including eight channels of each of the left and right prefrontal lobes (3 × 4 array of emitter and detection light poles).
|
up to 30 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive Thinking Skills
Time Frame: up to 30 weeks
|
The Positive Thinking Skills Scale (PTSS)
|
up to 30 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Garry KP Kuan, PhD, Universiti Sains Malaysia
Publications and helpful links
General Publications
- Belkhir Y, Rekik G, Chtourou H, Souissi N. Does warming up with different music tempos affect physical and psychological responses? The evidence from a chronobiological study. J Sports Med Phys Fitness. 2022 Jan;62(1):149-156. doi: 10.23736/S0022-4707.21.12093-6. Epub 2021 Feb 8.
- Karageorghis CI, Bigliassi M, Guerin SMR, Delevoye-Turrell Y. Brain mechanisms that underlie music interventions in the exercise domain. Prog Brain Res. 2018;240:109-125. doi: 10.1016/bs.pbr.2018.09.004. Epub 2018 Oct 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USM/JEPeM/KK/24040378
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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