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Psychological StressNCT06788106

Effect of Aerobic Exercise With Synchronous Music on Functions Among Medical Students

A study testing high-intensity aerobic exercise + synchronous music, medium-intensity aerobic exercise + synchronous music and low-intensity aerobic exercise + synchronous music in people with Psychological Stress and Aerobic Exercise, run by Universiti Sains Malaysia at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Researchers invite participants to volunteer to participate in this cross-sectional, interventional study. This research examines the effects of 8-week aerobic exercise of different intensities combining synchronized music on psychology, attention, and executive function among Chinese college students, and also… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
high-intensity aerobic exercise + synchronous music, medium-intensity aerobic exercise + synchronous music and low-intensity aerobic exercise + synchronous music
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteChina
Study dates
26 Feb 2025to 21 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Garry KP Kuan, Asso Prof. contact

+609 767 7622

garry@usm.my

China1 site, 1 recruiting
  • Jiangsu Medical College

    Yancheng, Jiangsu, 224005

    Le Li, 0167557895, lile@student.usm.my

    Garry KP Kuan, 097677622, garry@usm.my

    Recruiting

Other trials in China

About this study

Official title: 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

Researchers invite participants to volunteer to participate in this cross-sectional, interventional study. This research examines the effects of 8-week aerobic exercise of different intensities combining synchronized music on psychology, attention, and executive function among Chinese college students, and also validates the reliability and validity of the Chinese version of Brief College Student Hassles Scale, the Perceived Stress Scale for Medical Students, Brief Multidimensional Students'Life Satisfaction Scale, Positive Thinking Skills Scale, Attentional Function Index, Procrastination Assessment Scale-Student and Behavioral Assessment of the Dysexecutive Syndrome-College version, providing a research basis for aerobic exercise to improve the cognitive function and mental health level of Chinese college students. Participants will be invited to participate in the intervention study, in which participants will be assigned to the intervention group and control group. Participation in this study will last approximately 8 weeks for a total of 24 sessions, 40 minutes each session, and participants will not be forced to participate in this study if they do not wish to. This study will include up to 134 participants who will be assigned to the intervention and control groups in a randomized manner.

Read the 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.

Being tested
high-intensity aerobic exercise + synchronous music, medium-intensity aerobic exercise + synchronous music, low-intensity aerobic exercise + synchronous music
Keywords
medical students, mental health, psychophysiological function, attentional function, executive funcion, brain functional connectivity
Medical subject headings
Stress, Psychological, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high-intensity aerobic exercise + synchronous musicBehavioural

    This group will be intervened under high-intensity aerobic training with synchronous music for 8 weeks, 3 times every week, 40 minites each time.

  • medium-intensity aerobic exercise + synchronous musicBehavioural

    This group will be intervened under medium-intensity aerobic training with synchronous music for 8 weeks, 3 times every week, 40 minites each time.

  • low-intensity aerobic exercise + synchronous musicBehavioural

    This group will be intervened under low-intensity aerobic training with synchronous music for 8 weeks, 3 times every week, 40 minites each time.

Study groups in NCT06788106
Study groupRoleWhat they receive
control groupNo interventionwithout intervention
low-intensity with synchronous music groupExperimentalintervened under low-intensity aerobic training with synchronous music of different intensities for 8 weeks, 3 times one week, 40minites one time.
Receives: Behavioral: low-intensity aerobic exercise + synchronous music
medium-intensity with synchronous music groupExperimentalintervened under medium-intensity aerobic training with synchronous music of different intensities for 8 weeks, 3 times one week, 40minites one time.
Receives: Behavioral: medium-intensity aerobic exercise + synchronous music
high-intensity with synchronous music groupExperimentalintervened under high-intensity aerobic training with synchronous music of different intensities for 8 weeks, 3 times one week, 40minites one time.
Receives: Behavioral: high-intensity aerobic exercise + synchronous music

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychological function

    Brief Multidimensional Students'Life Satisfaction Scale - college version (BMSLSS-C)

    Measured: up to 30 weeks

  2. Attentional function

    Attentional Function Index (AFI)

    Measured: up to 30 weeks

  3. Executive function

    Executive Functions scale for University settings (UEF)

    Measured: up to 30 weeks

  4. Brain functional connectivity

    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).

    Measured: up to 30 weeks

Secondary outcomes (1)
  1. Positive Thinking Skills

    The Positive Thinking Skills Scale (PTSS)

    Measured: up to 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2025
  2. Study start26 Feb 2025
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion21 Dec 2025 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06788106
Sponsor's protocol ID
USM/JEPeM/KK/24040378
Status last verified
Mar 2025
First submitted
2 Jan 2025
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Results to be published

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.

    PubMed 33555672
  • 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.

    PubMed 30390826

Questions about this trial

What is this clinical trial studying?

A study testing high-intensity aerobic exercise + synchronous music, medium-intensity aerobic exercise + synchronous music and low-intensity aerobic exercise + synchronous music in people with Psychological Stress and Aerobic Exercise, run by Universiti Sains Malaysia at 1 site in China.

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 4 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: looking for participants now, as of the sponsor's last update on 26 Mar 2025. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Le Li, PhD (60167557895, lile@student.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychological function (time frame: up to 30 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06788106, which also lists 2 linked publications.

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 26 Mar 2025.

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