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

• ClinicalTrials.gov Identifier: NCT04847128
• Recruitment Status: Completed
• First Posted: April 19, 2021
• Last Update Posted: January 12, 2022
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Information provided by (Responsible Party): First Affiliated Hospital Xi'an Jiaotong University

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
Exercise; Anxiety; Depression; Cognition	Behavioral: Chronic aerobic exercise	Not Applicable

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 (Clinical Trial)
• 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: March 16, 2021
• Actual Primary Completion Date: October 18, 2021
• Actual Study Completion Date: January 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 Name: 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 [ 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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

China, Shaanxi

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

More Information

Publications:

Christiansen L, Beck MM, Bilenberg N, Wienecke J, Astrup A, Lundbye-Jensen J. Effects of Exercise on Cognitive Performance in Children and Adolescents with ADHD: Potential Mechanisms and Evidence-based Recommendations. J Clin Med. 2019 Jun 12;8(6). pii: E841. doi: 10.3390/jcm8060841. Review.

Pedersen BK, Febbraio MA. Muscles, exercise and obesity: skeletal muscle as a secretory organ. Nat Rev Endocrinol. 2012 Apr 3;8(8):457-65. doi: 10.1038/nrendo.2012.49. Review.

Lourenco MV, Frozza RL, de Freitas GB, Zhang H, Kincheski GC, Ribeiro FC, Gonçalves RA, Clarke JR, Beckman D, Staniszewski A, Berman H, Guerra LA, Forny-Germano L, Meier S, Wilcock DM, de Souza JM, Alves-Leon S, Prado VF, Prado MAM, Abisambra JF, Tovar-Moll F, Mattos P, Arancio O, Ferreira ST, De Felice FG. Exercise-linked FNDC5/irisin rescues synaptic plasticity and memory defects in Alzheimer's models. Nat Med. 2019 Jan;25(1):165-175. doi: 10.1038/s41591-018-0275-4. Epub 2019 Jan 7.

Moon HY, Becke A, Berron D, Becker B, Sah N, Benoni G, Janke E, Lubejko ST, Greig NH, Mattison JA, Duzel E, van Praag H. Running-Induced Systemic Cathepsin B Secretion Is Associated with Memory Function. Cell Metab. 2016 Aug 9;24(2):332-40. doi: 10.1016/j.cmet.2016.05.025. Epub 2016 Jun 23.

Horowitz AM, Fan X, Bieri G, Smith LK, Sanchez-Diaz CI, Schroer AB, Gontier G, Casaletto KB, Kramer JH, Williams KE, Villeda SA. Blood factors transfer beneficial effects of exercise on neurogenesis and cognition to the aged brain. Science. 2020 Jul 10;369(6500):167-173. doi: 10.1126/science.aaw2622.

Rosenberg MD, Finn ES, Scheinost D, Papademetris X, Shen X, Constable RT, Chun MM. A neuromarker of sustained attention from whole-brain functional connectivity. Nat Neurosci. 2016 Jan;19(1):165-71. doi: 10.1038/nn.4179. Epub 2015 Nov 23.

Ng QX, Ho CYX, Chan HW, Yong BZJ, Yeo WS. Managing childhood and adolescent attention-deficit/hyperactivity disorder (ADHD) with exercise: A systematic review. Complement Ther Med. 2017 Oct;34:123-128. doi: 10.1016/j.ctim.2017.08.018. Epub 2017 Aug 31. Review.

de Greeff JW, Bosker RJ, Oosterlaan J, Visscher C, Hartman E. Effects of physical activity on executive functions, attention and academic performance in preadolescent children: a meta-analysis. J Sci Med Sport. 2018 May;21(5):501-507. doi: 10.1016/j.jsams.2017.09.595. Epub 2017 Oct 10. Review.

• Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
• ClinicalTrials.gov Identifier: NCT04847128
• Other Study ID Numbers: XJTU1AF2020LSK-276
• First Posted: April 19, 2021
• Last Update Posted: January 12, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: After 12/01/2023, by email requirement
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: 12/01/2023
• Access Criteria: For scientific research only, not for commercial use

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders