Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05689606 |
Other study ID # |
12091985 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 7, 2022 |
Est. completion date |
April 1, 2023 |
Study information
Verified date |
January 2023 |
Source |
Ankara City Hospital Bilkent |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 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.
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.