Clinical trial NCT04847128: The Effect of Exercise on Anxiety and Cognition in Students at University
Official title: The Effect of Exercise on Anxiety and Cognition in Students at University: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Anxiety
Depression
Cognition
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: RATIONALE: Exercise may improve the mood and cognition in young people.

PURPOSE: It has been well-known that physical exercise can generally benefit the mental health. However, most evidences that physical exercise improves psychiatric symptoms come from retrospective or cross-sectional studies. Moreover, the studies on the effect of physical exercise in the young adults' mental health were limited. This randomized-controlled trial aims to determinate the effects of a chronic and aerobic exercise on the mood and cognition of young people.

Detailed description: OBJECTIVES: The anxiety and depression symptoms in young people are worth paying attention to, in China and worldwide. Meanwhile, cognitive function is very important for young people's learning and work. This project aims to evaluate the effectiveness of the moderate aerobic exercise to alleviate anxiety and depression in young people.

DESIGN \& METHODS: Undergraduate and graduate students aged 18-35 years will be randomly and evenly assigned to exercise and control groups. Subjects assigned to exercise group will receive an running exercise intervention more than 30 minutes and 3 times per week for 8 weeks. The control group will be advised not to engage in physical activities. Outcome measures include the score of the Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), the response time of Schulte Grid test, and the response time of Stroop Colour-Word Test at baseline and post-intervention in two groups. In addition, these assessments will be followed up at week 20 (3 months after the end of intervention).

Eligibility criteria: Inclusion Criteria:

* Undergraduate and graduate students aged 18 to 35 years.

Exclusion Criteria:

* Heart disease, hypertension, cardiovascular and respiratory system diseases such as asthma and are unable to tolerate the frequency and strength of exercise requirements.
* Any neurological or psychiatric disorders.
* Physical disabilities.
* Severe dysmenorrhea when they couldn't exercise more than 5 days before or after menstruation.
* Color blindness.

Primary outcomes:
measure: Changes in the Self-rating Anxiety Scale (SAS) after intervention and at follow-up
timeFrame: Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)
Secondary outcomes:
measure: Changes in the Self-rating Depression Scale (SDS) after intervention and at follow-up
timeFrame: Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)
measure: Changes in the response times of Schulte Grid after intervention and at follow-up
timeFrame: Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)
measure: Changes in the response time of the Stroop Colour-Word Test after intervention and at follow-up
timeFrame: Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)
Other outcomes:
measure: Alterations of sera proteome
timeFrame: week 8
measure: Alterations of gut microbiota
timeFrame: week 8
Locations:
city: Xi'an
country: China
facility: First Afflicated Hospital Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Afflicated Hospital Xian Jiaotong University
name: Yan Li, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
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