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Completed

NCT Number: NCT04847128

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

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.

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Key information

Conditions

Exercise Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cognition Depression Mental Disorders Motor Activity

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Afflicated Hospital Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chronic aerobic exercise

Behavioral

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

Primary outcomes

  1. Changes in the Self-rating Anxiety Scale (SAS) after intervention and at follow-up

    Time frame: 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 outcomes

  1. Changes in the Self-rating Depression Scale (SDS) after intervention and at follow-up

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Alterations of sera proteome

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 19, 2021
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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