ExerciseNCT04847128
The Effect of Exercise on Anxiety and Cognition in Students at University
A study testing Chronic aerobic exercise in people with Exercise and Anxiety, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Anxiety, Depression
- What is being tested?
- Chronic aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2021to 9 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Undergraduate and graduate students aged 18 to 35 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Afflicated Hospital Xian Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: The Effect of Exercise on Anxiety and Cognition in Students at University: A Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Exercise, Anxiety, Depression, Cognition
- Being tested
- Chronic aerobic exercise
- Medical subject headings
- Motor Activity, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic aerobic exerciseBehavioural
Also called Workout
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Participants receive exercise intervention 3 times weekly for 8 weeks. Receives: Behavioral: Chronic aerobic exercise |
| Arm II | No intervention | Participants keep sedentary life without exercise for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start16 Mar 2021
- Primary completion18 Oct 2021
- Study completion9 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Li, MD., PhD., Principal investigator, First Afflicated Hospital Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847128
- Sponsor's protocol ID
- XJTU1AF2020LSK-276
- Status last verified
- Jan 2022
- First submitted
- 6 Apr 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After 12/01/2023, by email requirement
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):841. doi: 10.3390/jcm8060841.
PubMed 31212854Pedersen 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.
PubMed 22473333Lourenco 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.
PubMed 30617325Moon 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.
PubMed 27345423Horowitz 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.
PubMed 32646997Rosenberg 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.
PubMed 26595653Ng 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.
PubMed 28917364de 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.
PubMed 29054748
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Anxiety and Cognition in Students at University: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04847128
- Acronym / sponsor ID
- XJTU1AF2020LSK-276
- Conditions
- Exercise, Anxiety, Depression, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 9 Jan 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Behavioral: Chronic aerobic exerciseParticipants receive exercise intervention 3 times weekly for 8 weeks. |
| Arm II | No intervention | –Participants keep sedentary life without exercise for 8 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Undergraduate and graduate students aged 18 to 35 years.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic aerobic exerciseAlso: WorkoutParticipants 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. | Behavioural | Arm I |
Primary outcome
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.
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Background: PubMed 31212854Christiansen 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.
- Background: PubMed 22473333Pedersen 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.
- Background: PubMed 30617325Lourenco 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.
- Background: PubMed 27345423Moon 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.
- Background: PubMed 32646997Horowitz 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.
- Background: PubMed 26595653Rosenberg 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.
- Background: PubMed 28917364Ng 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.
- Background: PubMed 29054748de 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.
- Individual participant dataSharing planned: Yes. After 12/01/2023, by email requirement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Li, MD., PhD. principal investigator
First Afflicated Hospital Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic aerobic exercise in people with Exercise and Anxiety, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847128, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.