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Clinical Trials/NCT04847128
NCT04847128CompletedNot Applicable

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

First Affiliated Hospital Xi'an Jiaotong University1 site in 1 country272 target enrollmentStarted: March 16, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
272
Locations
1
Primary Endpoint
Changes in the Self-rating Anxiety Scale (SAS) after intervention and at follow-up

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

The outcome assessors and statisticians were blinded to group allocations.

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
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.

Arms & Interventions

Arm I

Experimental

Participants receive exercise intervention 3 times weekly for 8 weeks.

Intervention: Chronic aerobic exercise (Behavioral)

Arm II

No Intervention

Participants keep sedentary life without exercise for 8 weeks.

Outcomes

Primary Outcomes

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

  • 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))
  • 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))
  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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