- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07738809
Effects of Exercise Intervention on Sleep Quality and Emotional Problems in College Students With Depressive Symptoms
Effects of Exercise Intervention on Sleep Quality, Emotional Problems, and Neuroelectrophysiological Mechanisms in College Students With Depressive Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Depressive symptoms are highly prevalent among college students and are frequently accompanied by poor sleep quality, emotional disturbances, impaired executive function, and altered brain activity. Although physical exercise has been recognized as an effective non-pharmacological intervention for improving mental health, the neurophysiological mechanisms underlying these benefits remain unclear.
This study adopts an exploratory randomized controlled design consisting of two consecutive phases. In Phase I, participants will complete a single session of low-to-moderate intensity exercise to investigate immediate changes in emotional state, executive function, resting-state EEG, brain functional connectivity, and event-related potentials (ERP). In Phase II, the same participants will continue to participate in an 8-week exercise intervention to examine the effects of regular exercise on sleep quality, depressive symptoms, emotional problems, executive function, and neurophysiological characteristics.
Behavioral assessments, standardized psychological questionnaires, resting-state EEG, brain functional connectivity analysis, and ERP recordings will be performed before and after intervention. The study will also investigate whether the immediate response to acute exercise is associated with subsequent improvements following long-term exercise intervention, providing evidence for individualized exercise prescriptions and neurophysiological mechanisms of exercise in college students with depressive symptoms.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yongguo Zhu, Professor
- Phone Number: +86 13811265116
- Email: zhuyongguo@cupes.edu.cn
Study Locations
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China
- Shanghai University of Sport
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Contact:
- Yongguo Zhu, Professor
- Phone Number: +86 13811265116
- Email: zhuyongguo@cupes.edu.cn
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Aged 18-23 years.
- Right-handed.
- Non-physical education major.
- No history of psychiatric disorders and no current or previous use of psychotropic medications, hypnotics, or other medications affecting the central nervous system.
- No history of traumatic brain injury or chronic physical diseases.
- No contraindications to physical exercise.
- Participants with a Beck Depression Inventory-II (BDI-II) score >13 will be classified as having depressive symptoms, whereas participants with a BDI-II score ≤13 will be classified as having no depressive symptoms.
Exclusion Criteria:
Vigorous physical exercise, alcohol consumption, caffeine intake, or other stimulating behaviors within 24 hours before testing.
- Withdrawal from the study before completion of EEG recording or behavioral task assessments.
- Participants will be excluded from the final analysis if they fail to complete the required questionnaires or if the collected data do not meet predefined quality control criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Archery Exercise Group
Participants assigned to this group will first complete one supervised session of low-to-moderate intensity archery exercise and will subsequently participate in an 8-week regular archery exercise program.
The acute exercise session consists of a 5-minute warm-up, 20 minutes of archery exercise, and a 5-minute cool-down.
The 8-week intervention will be conducted three times per week, with at least 48 hours between sessions.
Exercise intensity will be maintained at 50%-75% of age-predicted maximum heart rate and monitored using heart rate and ratings of perceived exertion.
Psychological questionnaires, behavioral tasks, resting-state EEG, and task-related ERP assessments will be completed before and after the acute session and before and after the 8-week intervention.
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Participants perform a standardized archery exercise program consisting of an acute exercise session followed by an 8-week supervised training program.
The acute session includes a 5-minute warm-up, 20 minutes of archery exercise, and a 5-minute cool-down.
The long-term intervention is conducted three times per week for 8 weeks at moderate exercise intensity.
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Active Comparator: Control Group
Participants assigned to this group will complete an equal-duration seated rest or non-exercise control activity during the acute experiment.
During the subsequent 8-week period, participants will maintain their usual lifestyle and attend the laboratory three times per week at the same scheduled times as the exercise group to complete 30 minutes of seated rest or another non-exercise control activity.
Psychological questionnaires, behavioral tasks, resting-state EEG, and task-related ERP assessments will be completed at the same assessment time points as those in the archery exercise group.
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Participants continue their usual daily activities without participating in the archery exercise intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms measured by the Beck Depression Inventory-II (BDI-II)
Time Frame: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II).
Changes in depressive symptom severity following acute and long-term archery exercise interventions will be evaluated.
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Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
Changes in sleep quality after acute and long-term archery exercise interventions will be evaluated.
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Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Resting-state EEG functional connectivity
Time Frame: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Resting-state EEG functional connectivity will be analyzed using phase synchronization metrics to evaluate neural changes associated with archery exercise interventions.
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Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
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Collaborators and Investigators
Investigators
- Principal Investigator: Yongguo Zhu, Professor, Capital University of Physical Education and Sports
Study record dates
Study Major Dates
Study Start (Estimated)
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
- 2026A137
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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