- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04708691
Effects of Aerobic Exercise Modulation on Brain Physiology and Cognition in Young Adults With Depression
September 9, 2021 updated by: National Taiwan University Hospital
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kuo Hsiao-I, PhD
- Phone Number: 02-33668137
- Email: hikuo@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Kuo Hsiao-I, MDPHD
- Phone Number: 02-33668137
- Email: hikuo@ntu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria
- 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
Exclusion criteria
- 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
- Major debilitating systemic diseases
- Pregnancy
- Breast feeding
- Cigarette smoker
- Color blindness
- Take part in another study within the last 4 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic exercise
aerobic exercise for 30 mins
|
aerobic exercise
|
No Intervention: Control
sitting for 30 mins
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortical excitability
Time Frame: 4 weeks
|
TMS measurment
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive task
Time Frame: 4 weeks
|
Serial reaction time task, 3-back letter task
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kuo Hsiao-I, PHD, Assistant Professor, National Taiwan University
- Principal Investigator: Kuo Hsiao-I, Assistant Professor, National Taiwan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2020
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
April 1, 2023
Study Registration Dates
First Submitted
January 12, 2021
First Submitted That Met QC Criteria
January 12, 2021
First Posted (Actual)
January 14, 2021
Study Record Updates
Last Update Posted (Actual)
September 10, 2021
Last Update Submitted That Met QC Criteria
September 9, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201911100RIND
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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