Effects of Aerobic Exercise Modulation on Brain Physiology and Cognition in Young Adults With Depression
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Neurophysiology, Cognition
Eligibility Criteria
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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Aerobic exercise
Control
Arm Description
aerobic exercise for 30 mins
sitting for 30 mins
Outcomes
Primary Outcome Measures
Cortical excitability
TMS measurment
Secondary Outcome Measures
Cognitive task
Serial reaction time task, 3-back letter task
Full Information
NCT ID
NCT04708691
First Posted
January 12, 2021
Last Updated
September 9, 2021
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04708691
Brief Title
Effects of Aerobic Exercise Modulation on Brain Physiology and Cognition in Young Adults With Depression
Official Title
Effects of Aerobic Exercise Modulation on Brain Physiology and Cognition
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Neurophysiology, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
aerobic exercise for 30 mins
Arm Title
Control
Arm Type
No Intervention
Arm Description
sitting for 30 mins
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
aerobic exercise
Primary Outcome Measure Information:
Title
Cortical excitability
Description
TMS measurment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Cognitive task
Description
Serial reaction time task, 3-back letter task
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuo Hsiao-I, PhD
Phone
02-33668137
Email
hikuo@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuo Hsiao-I, PHD
Organizational Affiliation
Assistant Professor, National Taiwan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kuo Hsiao-I
Organizational Affiliation
Assistant Professor, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuo Hsiao-I, MDPHD
Phone
02-33668137
Email
hikuo@ntu.edu.tw
12. IPD Sharing Statement
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Effects of Aerobic Exercise Modulation on Brain Physiology and Cognition in Young Adults With Depression
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