An interventional study of Chronic aerobic exercise in Exercise, Anxiety and Depression, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Completed at 1 site in China. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-12.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Prevention
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.
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).
4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's enrollment of 272 is above the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive exercise intervention 3 times weekly for 8 weeks.
Behavioral: Chronic aerobic exercise
Participants keep sedentary life without exercise for 8 weeks.
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.
Also known as: Workout
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.
Time frame: 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
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)
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.
Time frame: 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.
Time frame: Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)
Alterations of sera proteome
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
Alterations of gut microbiota
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
Plan to share: Yes — After 12/01/2023, by email requirement
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University