The Effect of Exercise on Anxiety and Cognition in Students at University

Study Overview
=================
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).

Official Title
-----------------
The Effect of Exercise on Anxiety and Cognition in Students at University: A Randomized Controlled Trial

Conditions
-----------------
Exercise, Anxiety, Depression, Cognition

Intervention / Treatment
-----------------
* Behavioral: Chronic aerobic exercise


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Participants receive exercise intervention 3 times weekly for 8 weeks. | Behavioral: Chronic aerobic exercise<br>* Participants in the experimental group will exercise more than 30 minutes each time and 3 times weekly for 8 weeks. The chronic aerobic exercise in the present trial is running. The heart rate is required to 60% -85% of the maximum heart rate during exercise. Maximum heart rate = 220 - age.<br>* Other names: Workout;|
| No Intervention: Arm II<br>Participants keep sedentary life without exercise for 8 weeks. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Self-rating Anxiety Scale (SAS) after intervention and at follow-up | The SAS is organized in 20 items, each with a score from 1 to 4, and a total score from 20 to 80. It will report the anxious mood, physical symptoms, psychomotor behavior and psychological symptoms of participants. Higher scores on the SAS indicate a higher level of anxiety symptoms. | Change from baseline to post-intervention at week 8 and follow up (3 months after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Self-rating Depression Scale (SDS) after intervention and at follow-up | The SDS scale is organized in 20 items, each with a score from 1 to 4, and a total score from 20 to 80. It will report the depressive mood, physical symptoms, psychomotor behavior and psychological symptoms of participants. Higher scores on the SDS indicate a higher level of depressive symptoms. | Change from baseline to post-intervention at week 8 and follow up (3 months after intervention) | 
| Changes in the response times of Schulte Grid after intervention and at follow-up | In Schulte Grid test, the participants will be asked to point out randomly arranged 36 numbers within a 6 × 6 matrix in ascending order. Shorter time to finish the Schulte Grid test indicates a higher level of attention and cognition. | Change from baseline to post-intervention at week 8 and follow up (3 months after intervention) | 
| Changes in the response time of the Stroop Colour-Word Test after intervention and at follow-up | In Stroop Colour-Word test, the participants will be required to naming the colour of words printed in conflicting ink colours while refraining from reading the words (e.g., the word 'green' printed in blue ink). It measures cognitive control and inhibition of concurrent automatic process of word reading, both of which relate to executive functions. Participants will be instructed to name the colour while refraining from reading the words. The response times will be recorded to evaluate the level of attention and cognition. | Change from baseline to post-intervention at week 8 and follow up (3 months after intervention) |