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

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Completed
CT.gov ID
NCT04847128
Collaborator
(none)
272
1
2
9.8
27.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Chronic aerobic exercise
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
272 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The outcome assessors and statisticians were blinded to group allocations.
Primary Purpose:
Prevention
Official Title:
The Effect of Exercise on Anxiety and Cognition in Students at University: A Randomized Controlled Trial
Actual Study Start Date :
Mar 16, 2021
Actual Primary Completion Date :
Oct 18, 2021
Actual Study Completion Date :
Jan 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

Participants receive exercise intervention 3 times weekly for 8 weeks.

Behavioral: Chronic aerobic exercise
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.
Other Names:
  • Workout
  • No Intervention: Arm II

    Participants keep sedentary life without exercise for 8 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Changes in the Self-rating Anxiety Scale (SAS) after intervention and at follow-up [Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)]

      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

    1. Changes in the Self-rating Depression Scale (SDS) after intervention and at follow-up [Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)]

      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.

    2. Changes in the response times of Schulte Grid after intervention and at follow-up [Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)]

      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.

    3. Changes in the response time of the Stroop Colour-Word Test after intervention and at follow-up [Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)]

      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.

    Other Outcome Measures

    1. Alterations of sera proteome [week 8]

      Using a proteomic analysis to compare the levels of proteins in the serum of participants between two groups after an 8-week exercise intervention.

    2. Alterations of gut microbiota [week 8]

      Using a shotgun metagenomic analysis to identify the alterations of gut microbiota in participants between two groups of after an 8-week exercise intervention.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Afflicated Hospital Xian Jiaotong University Xi'an Shaanxi China 710061

    Sponsors and Collaborators

    • First Affiliated Hospital Xi'an Jiaotong University

    Investigators

    • Principal Investigator: Yan Li, MD., PhD., First Afflicated Hospital Xian Jiaotong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    First Affiliated Hospital Xi'an Jiaotong University
    ClinicalTrials.gov Identifier:
    NCT04847128
    Other Study ID Numbers:
    • XJTU1AF2020LSK-276
    First Posted:
    Apr 19, 2021
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2022