NCT06788106

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 26, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

January 2, 2025

Last Update Submit

March 24, 2025

Conditions

Keywords

medical studentsmental healthpsychophysiological functionattentional functionexecutive funcionbrain functional connectivity

Outcome Measures

Primary Outcomes (4)

  • Psychological function

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

    up to 30 weeks

  • Attentional function

    Attentional Function Index (AFI)

    up to 30 weeks

  • Executive function

    Executive Functions scale for University settings (UEF)

    up to 30 weeks

  • 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).

    up to 30 weeks

Secondary Outcomes (1)

  • Positive Thinking Skills

    up to 30 weeks

Study Arms (4)

control group

NO INTERVENTION

without intervention

low-intensity with synchronous music group

EXPERIMENTAL

intervened under low-intensity aerobic training with synchronous music of different intensities for 8 weeks, 3 times one week, 40minites one time.

Behavioral: low-intensity aerobic exercise + synchronous music

medium-intensity with synchronous music group

EXPERIMENTAL

intervened under medium-intensity aerobic training with synchronous music of different intensities for 8 weeks, 3 times one week, 40minites one time.

Behavioral: medium-intensity aerobic exercise + synchronous music

high-intensity with synchronous music group

EXPERIMENTAL

intervened under high-intensity aerobic training with synchronous music of different intensities for 8 weeks, 3 times one week, 40minites one time.

Behavioral: high-intensity aerobic exercise + synchronous music

Interventions

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

high-intensity with synchronous music group

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

medium-intensity with synchronous music group

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

low-intensity with synchronous music group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Medical College

Yancheng, Jiangsu, 224005, China

RECRUITING

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Stress, PsychologicalPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Garry KP Kuan, PhD

    Universiti Sains Malaysia

    STUDY DIRECTOR

Central Study Contacts

Garry KP Kuan, Asso Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 22, 2025

Study Start

February 26, 2025

Primary Completion

October 31, 2025

Study Completion

December 21, 2025

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Results to be published

Locations