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

NCT04847128 | Completed

• 1 other identifier: XJTU1AF2020LSK-276
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Anxiety; Depression; Cognition

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)

Secondary Outcomes (3)

• 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)

• 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 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)

Other Outcomes (2)

• Alterations of sera proteome

  week 8

• Alterations of gut microbiota

  week 8

Study Arms (2)

Arm I

EXPERIMENTAL

Participants receive exercise intervention 3 times weekly for 8 weeks.

Behavioral: Chronic aerobic exercise

Arm II

NO INTERVENTION

Participants keep sedentary life without exercise for 8 weeks.

Interventions

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.

Also known as: Workout

Arm I

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Undergraduate and graduate students aged 18 to 35 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Afflicated Hospital Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (8)

• 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):841. doi: 10.3390/jcm8060841.

  PMID: 31212854 BACKGROUND

• 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.

  PMID: 22473333 BACKGROUND

• Lourenco MV, Frozza RL, de Freitas GB, Zhang H, Kincheski GC, Ribeiro FC, Goncalves 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.

  PMID: 30617325 BACKGROUND

• 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.

  PMID: 27345423 BACKGROUND

• 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.

  PMID: 32646997 BACKGROUND

• 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.

  PMID: 26595653 BACKGROUND

• 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.

  PMID: 28917364 BACKGROUND

• 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.

  PMID: 29054748 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Anxiety Disorders; Depression

Interventions

Post-Exercise Recovery

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Study Officials

• Yan Li, MD., PhD.

  First Afflicated Hospital Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors and statisticians were blinded to group allocations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 19, 2021
• Study Start: March 16, 2021
• Primary Completion: October 18, 2021
• Study Completion: January 9, 2022
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12/01/2023
• Access Criteria: For scientific research only, not for commercial use

Locations

CN (1)