HealthyNCT05689606
Cortical Excitability, Cognitive Functions, and Peripheral Signaling Molecules
A study testing Exercise in people with Healthy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
It is widely known that exercise creates structural and functional changes in the brain. Synaptic plasticity develops through exercise, thus improving brain functions. It is suggested that skeletal muscle contraction and peripheral signal molecules secreted from various tissues, especially skeletal muscle, contribute… Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2022to 1 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being right-handed
- Aged between 20 and 30 years
- Being sedentary
Who cannot join
- having intracranial implants
- history of psychiatric or neurological disease, seizure, any serious medical condition or pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship of Cortical Excitability, Cognitive Functions, and Peripheral Signaling Molecules Following Acute Exercise
It is widely known that exercise creates structural and functional changes in the brain. Synaptic plasticity develops through exercise, thus improving brain functions. It is suggested that skeletal muscle contraction and peripheral signal molecules secreted from various tissues, especially skeletal muscle, contribute to exercise's effect on the brain's structure and function. These signals synthesized and released from skeletal muscle are called myokines. Brain-derived neurotrophic factor (BDNF) and Cathepsin B are two of these myokines, which have been reported to cross the blood-brain barrier following secretion in the periphery and affect the structure and functions of the brain. Transcranial magnetic stimulation (TMS) allows to evaluate the synaptic plasticity responses of the motor cortex to exercise, while cognitive function responses are evaluated via cognitive tests. Additionally, exercise type and intensity influence the responses of cortical excitability and cognitive function. This research proposal aims to investigate how acute high-intensity intermittent exercise (HIIT) changes primary motor cortex (M1) excitability, M1-related cognitive functions, and peripheral BDNF and Cathepsin B levels in healthy sedentary adults and to investigate the relationship between these neurophysiological parameters. All parameters will be measured before and after the acute exercise. M1 excitability will be evaluated through resting motor threshold, short interval intracortical inhibition, and input-output curve measurements. Cognitive functions will be evaluated through mental rotation and working memory tasks, and peripheral signal responses will be measured by serum levels of BDNF and Cathepsin B. Our hypotheses are: 1) Acute HIIT will increase peripheral BDNF and CTSB level, cortical excitability, and M1-specific cognitive function performance. 2) M1 excitability, cognitive function performance, and peripheral BDNF and CTSB increase will be related following exercise. Our findings will have the potential to be a guide for the integration of exercise into daily life and will provide cortical and peripheral data on the neurophysiological basis of the relationship between exercise and cognition.
Read the detailed description
Participants Twenty-eight healthy young adults (female|male:14|14) aged 20-30 years will have participated in the study.
Participants will be at least undergraduate students, right-handed dominant, exercising <150 minutes per week in the last six months. Before the experiment, the participants will be evaluated for their background, family history, and whether they have any health complaints that prevent them from exercising.
With the adult transcranial magnetic stimulation safety screening questionnaire, participants in the risk group for brain stimulation, those with intracranial implants and contraindications, and those with a history of any psychiatric or neurological disease, seizures, any serious medical condition, or pregnancy will be excluded. The hand preference questionnaire will evaluate hand preference, and physical activity status will be evaluated by the short version of the international physical activity questionnaire. The cardiorespiratory fitness will be assessed with the graded maximal exercise stress test. The N-back test is a continuous performance test used to assess working memory capacity. The mental rotation test will evaluate the mental rotation score. The research team designed both tests.
Transcranial magnetic stimulation will be used to assess corticomotor excitability. Resting Motor Threshold (RMT), Short Interval Intracortical Inhibition (SICI), and input-output curve measurements will be performed on all participants in our study for the TMS study.
BDNF and CTSB measurements of the participants will be made both at baseline and following the acute exercise.
HIIT exercise lasting 23 minutes will be performed on the bicycle ergometer. Participants will make 3 visits to the laboratory. First session: Cardiorespiratory fitness assessment, all questionnaires. Second session: TMS analyses, cognitive assessments, HIIT, myokine assessments Third session: TMS analyses, cognitive assessments, control (watching a nature documentary).
The second and third sessions will be performed by cross-over design. Data analysis will be performed with two-way repeated ANOVA to determine the effect of within-group factors (control and HIIT) and time (PRE and POST) on corticospinal excitability and other parameters. When the effect size was calculated as ɳp2 >0.26, the sample size was calculated a priori as n = 22. Considering possible data losses, the number of participants was determined as 28.
- Conditions
- Healthy
- Being tested
- Exercise
- Keywords
- HIIT, TMS, BDNF, Cathepsin B, cognitive performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise includes acute high-intensity interval training.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The exercise group performs acute high-intensity interval training. Receives: Behavioral: Exercise |
| Control group | No intervention | The Control group includes the same participants. In this session, they do not exercise, and they watch a nature documentary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting motor threshold
The amount of transcranial magnetic stimulation machine output necessary to produce a motor-evoked potential that exceeds a defined peak-to-peak amplitude. Lower scores mean a better outcome.
Measured: Change from Baseline resting motor threshold immediately following acute exercise
Short interval intracortical inhibition
The relative amplitude reduction of motor evoked potentials by subthreshold conditioning stimuli.
Measured: Change from Baseline short interval intracortical inhibition immediately following acute exercise
Input output curve
The input-output curve is a sigmoid-shaped relation between the MEP amplitude at incremented TMS intensities. Higher scores mean a better outcome.
Measured: Change from Baseline input output curve immediately following acute exercise
Working memory
The small amount of information that can be held in mind and used in the execution of cognitive tasks. Higher scores mean a better outcome.
Measured: Change from Baseline working memory score immediately following acute exercise
Serum BDNF
Serum level of BDNF. Higher scores mean a better outcome.
Measured: Change from Baseline serum BDNF immediately following acute exercise
Mental rotation
The ability to transform a mental representation of an object so as to accurately predict how the object would look from a different angle. Higher scores mean a better outcome.
Measured: Change from Baseline mental rotation score immediately following acute exercise
Serum Cathepsin B
Serum level of Cathepsin B. Higher scores mean a better outcome.
Measured: Change from Baseline serum Cathepsin B immediately following acute exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start7 Oct 2022
- Primary completion1 Feb 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689606
- Sponsor's protocol ID
- 12091985
- Status last verified
- Aug 2024
- First submitted
- 10 Oct 2022
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Cortical Excitability, Cognitive Functions, and Peripheral Signaling Molecules Following Acute Exercise
- ClinicalTrials.gov ID
- NCT05689606
- Acronym / sponsor ID
- 12091985
- Conditions
- Healthy
- Keywords
- HIIT, TMS, BDNF, Cathepsin B, cognitive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 19 Jan 2023 (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.
It is widely known that exercise creates structural and functional changes in the brain. Synaptic plasticity develops through exercise, thus improving brain functions. It is suggested that skeletal muscle contraction and peripheral signal molecules secreted from various tissues, especially skeletal muscle, contribute to exercise's effect on the brain's structure and function. These signals synthesized and released from skeletal muscle are called myokines. Brain-derived neurotrophic factor (BDNF) and Cathepsin B are two of these myokines, which have been reported to cross the blood-brain barrier following secretion in the periphery and affect the structure and functions of the brain. Transcranial magnetic stimulation (TMS) allows to evaluate the synaptic plasticity responses of the motor cortex to exercise, while cognitive function responses are evaluated via cognitive tests. Additionally, exercise type and intensity influence the responses of cortical excitability and cognitive function. This research proposal aims to investigate how acute high-intensity intermittent exercise (HIIT) changes primary motor cortex (M1) excitability, M1-related cognitive functions, and peripheral BDNF and Cathepsin B levels in healthy sedentary adults and to investigate the relationship between these neurophysiological parameters. All parameters will be measured before and after the acute exercise. M1 excitability will be evaluated through resting motor threshold, short interval intracortical inhibition, and input-output curve measurements. Cognitive functions will be evaluated through mental rotation and working memory tasks, and peripheral signal responses will be measured by serum levels of BDNF and Cathepsin B. Our hypotheses are: 1) Acute HIIT will increase peripheral BDNF and CTSB level, cortical excitability, and M1-specific cognitive function performance. 2) M1 excitability, cognitive function performance, and peripheral BDNF and CTSB increase will be related following exercise. Our findings will have the potential to be a guide for the integration of exercise into daily life and will provide cortical and peripheral data on the neurophysiological basis of the relationship between exercise and cognition.
Detailed description
Participants Twenty-eight healthy young adults (female|male:14|14) aged 20-30 years will have participated in the study.
Participants will be at least undergraduate students, right-handed dominant, exercising <150 minutes per week in the last six months. Before the experiment, the participants will be evaluated for their background, family history, and whether they have any health complaints that prevent them from exercising.
With the adult transcranial magnetic stimulation safety screening questionnaire, participants in the risk group for brain stimulation, those with intracranial implants and contraindications, and those with a history of any psychiatric or neurological disease, seizures, any serious medical condition, or pregnancy will be excluded. The hand preference questionnaire will evaluate hand preference, and physical activity status will be evaluated by the short version of the international physical activity questionnaire. The cardiorespiratory fitness will be assessed with the graded maximal exercise stress test. The N-back test is a continuous performance test used to assess working memory capacity. The mental rotation test will evaluate the mental rotation score. The research team designed both tests.
Transcranial magnetic stimulation will be used to assess corticomotor excitability. Resting Motor Threshold (RMT), Short Interval Intracortical Inhibition (SICI), and input-output curve measurements will be performed on all participants in our study for the TMS study.
BDNF and CTSB measurements of the participants will be made both at baseline and following the acute exercise.
HIIT exercise lasting 23 minutes will be performed on the bicycle ergometer. Participants will make 3 visits to the laboratory. First session: Cardiorespiratory fitness assessment, all questionnaires. Second session: TMS analyses, cognitive assessments, HIIT, myokine assessments Third session: TMS analyses, cognitive assessments, control (watching a nature documentary).
The second and third sessions will be performed by cross-over design. Data analysis will be performed with two-way repeated ANOVA to determine the effect of within-group factors (control and HIIT) and time (PRE and POST) on corticospinal excitability and other parameters. When the effect size was calculated as ɳp2 >0.26, the sample size was calculated a priori as n = 22. Considering possible data losses, the number of participants was determined as 28.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: ExerciseThe exercise group performs acute high-intensity interval training. |
| Control group | No intervention | –The Control group includes the same participants. In this session, they do not exercise, and they watch a nature documentary. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being right-handed
- Aged between 20 and 30 years
- Being sedentary
Key exclusion criteria (2 listed)
- having intracranial implants
- history of psychiatric or neurological disease, seizure, any serious medical condition or pregnancy
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 |
|---|---|---|
| ExerciseExercise includes acute high-intensity interval training. | Behavioural | Exercise group |
Primary outcome
Resting motor threshold
Time frame: Change from Baseline resting motor threshold immediately following acute exercise
The amount of transcranial magnetic stimulation machine output necessary to produce a motor-evoked potential that exceeds a defined peak-to-peak amplitude. Lower scores mean a better outcome.
Short interval intracortical inhibition
Time frame: Change from Baseline short interval intracortical inhibition immediately following acute exercise
The relative amplitude reduction of motor evoked potentials by subthreshold conditioning stimuli.
Input output curve
Time frame: Change from Baseline input output curve immediately following acute exercise
The input-output curve is a sigmoid-shaped relation between the MEP amplitude at incremented TMS intensities. Higher scores mean a better outcome.
Working memory
Time frame: Change from Baseline working memory score immediately following acute exercise
The small amount of information that can be held in mind and used in the execution of cognitive tasks. Higher scores mean a better outcome.
Serum BDNF
Time frame: Change from Baseline serum BDNF immediately following acute exercise
Serum level of BDNF. Higher scores mean a better outcome.
Mental rotation
Time frame: Change from Baseline mental rotation score immediately following acute exercise
The ability to transform a mental representation of an object so as to accurately predict how the object would look from a different angle. Higher scores mean a better outcome.
Serum Cathepsin B
Time frame: Change from Baseline serum Cathepsin B immediately following acute exercise
Serum level of Cathepsin B. Higher scores mean a better outcome.
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 5 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 5 Aug 2024. 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 Turkey (Türkiye). 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?
Resting motor threshold (time frame: Change from Baseline resting motor threshold immediately following acute exercise). The study lists 7 primary outcomes in all. 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 5 Aug 2024.