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

Primary Purpose

Exercise, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chronic aerobic exercise
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Exercise

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • First Afflicated Hospital Xian Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm I

Arm II

Arm Description

Participants receive exercise intervention 3 times weekly for 8 weeks.

Participants keep sedentary life without exercise for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 6, 2021
Last Updated
January 9, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT04847128
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
October 18, 2021 (Actual)
Study Completion Date
January 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Anxiety, Depression, Cognition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessors and statisticians were blinded to group allocations.
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Participants receive exercise intervention 3 times weekly for 8 weeks.
Arm Title
Arm II
Arm Type
No Intervention
Arm Description
Participants keep sedentary life without exercise for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Chronic aerobic exercise
Other Intervention Name(s)
Workout
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the Self-rating Anxiety Scale (SAS) after intervention and at follow-up
Description
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.
Time Frame
Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)
Secondary Outcome Measure Information:
Title
Changes in the Self-rating Depression Scale (SDS) after intervention and at follow-up
Description
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.
Time Frame
Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)
Title
Changes in the response times of Schulte Grid after intervention and at follow-up
Description
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.
Time Frame
Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)
Title
Changes in the response time of the Stroop Colour-Word Test after intervention and at follow-up
Description
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.
Time Frame
Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)
Other Pre-specified Outcome Measures:
Title
Alterations of sera proteome
Description
Using a proteomic analysis to compare the levels of proteins in the serum of participants between two groups after an 8-week exercise intervention.
Time Frame
week 8
Title
Alterations of gut microbiota
Description
Using a shotgun metagenomic analysis to identify the alterations of gut microbiota in participants between two groups of after an 8-week exercise intervention.
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Li, MD., PhD.
Organizational Affiliation
First Afflicated Hospital Xian Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Afflicated Hospital Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After 12/01/2023, by email requirement
IPD Sharing Time Frame
12/01/2023
IPD Sharing Access Criteria
For scientific research only, not for commercial use
Citations:
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31212854
Citation
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Citation
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The Effect of Exercise on Anxiety and Cognition in Students at University

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