DepressionNCT04708691
Effects of Aerobic Exercise Modulation on Brain Physiology and Cognition in Young Adults With Depression
A study testing Aerobic exercise in people with Depression, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Major depressive depression (MDD) affects a quarter of young adults and is associated with marked global burden in this population. Recently, growing literature has shown that cognitive dysfunction is common in young adults with depression. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2020to Apr 2023
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of major depressive disorder by a board-certified psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
- Total score of the 17-item Hamilton Rating Scale for Depression (HAM-D) less than 7
- Aged between 18 to 35 years
- Right handedness
Who cannot join
- A major depressive episode within the past three months
- Pacemaker or deep brain stimulation
- Metal implants in the head or neck area
- Other major mental disorders including autism spectrum disorders, mental retardation, psychotic disorders, bipolar disorders, obsessive-compulsive disorder, and neurocognitive disorders
- Alcohol or other illicit substance abuse
- Neurological diseases involving the central nervous system
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- Major debilitating systemic diseases
- Pregnancy
- Breast feeding
- Cigarette smoker
- Color blindness
- Take part in another study within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Kuo Hsiao-I, MDPHD, 02-33668137, hikuo@ntu.edu.tw
About this study
Official title: Effects of Aerobic Exercise Modulation on Brain Physiology and Cognition
Major depressive depression (MDD) affects a quarter of young adults and is associated with marked global burden in this population. Recently, growing literature has shown that cognitive dysfunction is common in young adults with depression. There is a vast amount of evidence indicating aerobic exercise has positive effects on cognitive function in healthy as well as in subjects with depression. The results might be dependent on neuroplastic changes induced by aerobic exercise. Nevertheless, the neurocognitive mechanisms of aerobic exercise in young adults with depression has not received systematic investigation. In addition, the association between the underlying brain physiology and cognitive performance has not been explored so far. In this project, the investigators aim to explore the relevance of a single session of aerobic exercise for human brain physiology and the impact of respective physiological effects on cognitive processes in young adults with depression.
Read the detailed description
The study are interested in the physiological foundation of the impact of aerobic exercise on cognitive performance in youth MDD subjects. Combined application of neurophysiological intervention and recording tools, including non-invasive brain stimulation, is suited to explore the impact of aerobic exercise on brain physiology and cognition in humans. We will apply transcranial magnetic stimulation (TMS) to obtain evoked potentials with electromyography (EMG) to explore cortical excitability. In the same participants, we will combine motor learning, working memory, and attention task to explore the association between the physiological effect of aerobic exercise and respective cognitive alterations. This project aims to explore the impact of aerobic exercise on cortical excitability and cognitive performance, and the association between these phenomena in youth MDD subjects. The study will improve our understanding of the role of aerobic exercise in cortical excitability, an important physiological basis for cognitive processes in humans, the underlying physiological mechanisms with regard to the aerobic exercise, and their functional relevance in youth MDD subjects.
- Conditions
- Depression
- Being tested
- Aerobic exercise
- Keywords
- Depression, Neurophysiology, Cognition
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | aerobic exercise for 30 mins Receives: Other: Aerobic exercise |
| Control | No intervention | sitting for 30 mins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical excitability
TMS measurment
Measured: 4 weeks
Secondary outcomes (1)
Cognitive task
Serial reaction time task, 3-back letter task
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 May 2020
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuo Hsiao-I, PHD, Principal investigator, Assistant Professor, National Taiwan UniversityKuo Hsiao-I, Principal investigator, Assistant Professor, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708691
- Sponsor's protocol ID
- 201911100RIND
- Status last verified
- May 2021
- First submitted
- 12 Jan 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise Modulation on Brain Physiology and Cognition
- ClinicalTrials.gov ID
- NCT04708691
- Acronym / sponsor ID
- 201911100RIND
- Conditions
- Depression
- Keywords
- Depression, Neurophysiology, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 14 Jan 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.
Major depressive depression (MDD) affects a quarter of young adults and is associated with marked global burden in this population. Recently, growing literature has shown that cognitive dysfunction is common in young adults with depression. There is a vast amount of evidence indicating aerobic exercise has positive effects on cognitive function in healthy as well as in subjects with depression. The results might be dependent on neuroplastic changes induced by aerobic exercise. Nevertheless, the neurocognitive mechanisms of aerobic exercise in young adults with depression has not received systematic investigation. In addition, the association between the underlying brain physiology and cognitive performance has not been explored so far. In this project, the investigators aim to explore the relevance of a single session of aerobic exercise for human brain physiology and the impact of respective physiological effects on cognitive processes in young adults with depression.
Detailed description
The study are interested in the physiological foundation of the impact of aerobic exercise on cognitive performance in youth MDD subjects. Combined application of neurophysiological intervention and recording tools, including non-invasive brain stimulation, is suited to explore the impact of aerobic exercise on brain physiology and cognition in humans. We will apply transcranial magnetic stimulation (TMS) to obtain evoked potentials with electromyography (EMG) to explore cortical excitability. In the same participants, we will combine motor learning, working memory, and attention task to explore the association between the physiological effect of aerobic exercise and respective cognitive alterations. This project aims to explore the impact of aerobic exercise on cortical excitability and cognitive performance, and the association between these phenomena in youth MDD subjects. The study will improve our understanding of the role of aerobic exercise in cortical excitability, an important physiological basis for cognitive processes in humans, the underlying physiological mechanisms with regard to the aerobic exercise, and their functional relevance in youth MDD subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Other: Aerobic exerciseaerobic exercise for 30 mins |
| Control | No intervention | –sitting for 30 mins |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of major depressive disorder by a board-certified psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
- Total score of the 17-item Hamilton Rating Scale for Depression (HAM-D) less than 7
- Aged between 18 to 35 years
- Right handedness
Key exclusion criteria (12 listed)
- A major depressive episode within the past three months
- Pacemaker or deep brain stimulation
- Metal implants in the head or neck area
- Other major mental disorders including autism spectrum disorders, mental retardation, psychotic disorders, bipolar disorders, obsessive-compulsive disorder, and neurocognitive disorders
- Alcohol or other illicit substance abuse
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 |
|---|---|---|
| Aerobic exerciseaerobic exercise | Other | Aerobic exercise |
Primary outcome
Cortical excitability
Time frame: 4 weeks
TMS measurment
1 secondary outcome
Cognitive task
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
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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.
Kuo Hsiao-I, PHD principal investigator
Assistant Professor, National Taiwan University
Kuo Hsiao-I principal investigator
Assistant Professor, National Taiwan 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 Aerobic exercise in people with Depression, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 10 Sep 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuo Hsiao-I, PhD (02-33668137, hikuo@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical excitability (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2021.