- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05407259
Investigating the Inverted-U Relationship Between Cognitive Performance and Plasma Epinephrine
June 7, 2022 updated by: Ting-Yu Lin, National Taiwan Normal University
Investigating the Inverted-U Relationship Between Cognitive Performance and Plasma Epinephrine: A Registered Report of a Four-arm Crossover Randomized Controlled Trial
Abstract Although acute resistance exercise has been suggested to enhance inhibitory control, a critical component of executive function, the mechanism by which acute exercise influences inhibitory control is unclear and there are methodological limitations in previous empirical studies.
According to the locus coeruleus-norepinephrine (LC-NE) theory, the activity of the LC, the major releaser of NE in the brain, regulates inhibitory control.
Because there is reciprocal communication between circulating epinephrine and the LC.
Plasma epinephrine is chosen as the index of LC-NE activity.
However, only one study in acute exercise-inhibitory control measured the plasma epinephrine.
Therefore, this registered report aims to extend its findings by a four-arm crossover randomized controlled design with three different intensities, using free-weight, multiple-joint, and structural resistance exercises.
Moreover, most studies showed some methodological limitations such as failing to report the process of randomization, implementing a familiarization of resistance exercise before the maximal strength test, and publishing the protocol.
Without a transparent report on how the participants were allocated, the results were at risk of bias.
Without a familiarization of resistance exercise, the maximal muscle strength was likely to be underestimated.
Without publishing the protocol before data collection, these findings were threatened by undetected researchers' degrees of freedom such as HARKing (hypothesizing after the results are known), cherry picking, and p-hacking.
This registered report will address the limitations of previous studies by incorporating cognitive and resistance exercise familiarization, transparently reporting the randomization process, and submitting it as a registered report.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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: Ting-Yu Lin, B.A.
- Phone Number: +886975211701
- Email: leo850922@gmail.com
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 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- healthy young male aged 18-40 years;
- recreational resistance-trained (≥ 1 time/week for the previous 6 months);
- free from cardiovascular, cerebrovascular, and neurological disorders and other chronic diseases;
- free from any medical condition listed on the 2014 update of the Physical Activity Readiness Questionnaire (PAR-Q+);
- non-smoker; and
- normal or corrected-to-normal vision.
Exclusion Criteria:
- athlete trained in a competitive sports team or engaging in exercise for more than 20 hours/week;
- unable to perform any of the intervention exercises (barbell squat, press, and deadlift); or
- color blind
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: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control condition
During the control condition, participants will be asked to read a book related to exercise for approximately 40 minutes.
|
|
|
EXPERIMENTAL: Low-intensity barbell resistance exercise
Exercise: Barbell squat, barbell press, and barbell deadlift Number of sets: 3 Number of repetitions: 5 Intensity: 65% 1RM Training method: Circuit training (Squat set 1 ➔ Press set 1 ➔ Deadlift set 1 ➔ Squat set 2 ➔ Press set 2 ➔ Deadlift set 2 ➔ Squat set 3 ➔ Press set 3 ➔ Deadlift set 3) Rest interval between exercises and sets: ~3 minutes (Warm-up: 1 set of 5 repetitions for each exercise at 50% 1RM)
|
There will be four conditions (three exercises and one control) on visits 3-6.
For the three exercise conditions, all training parameters except intensity will be the same.
The sets in high, moderate, and low intensity correspond to the rate of perceived exertion (0-10 scale) 7-9, 5-6, and 3-4, respectively.
Therefore, the participants will perform 5 repetitions barbell squat, barbell press, and barbell deadlift with 8RM (78% 1RM), 11RM (72% 1RM), and 16RM (65% 1RM) for 3 sets
Other Names:
|
|
EXPERIMENTAL: Moderate-intensity barbell resistance exercise
Exercise: Barbell squat, barbell press, and barbell deadlift Number of sets: 3 Number of repetitions: 5 Intensity: 72% 1RM Training method: Circuit training (Squat set 1 ➔ Press set 1 ➔ Deadlift set 1 ➔ Squat set 2 ➔ Press set 2 ➔ Deadlift set 2 ➔ Squat set 3 ➔ Press set 3 ➔ Deadlift set 3) Rest interval between exercises and sets: ~3 minutes (Warm-up: 1 set of 5 repetitions for each exercise at 50% 1RM)
|
There will be four conditions (three exercises and one control) on visits 3-6.
For the three exercise conditions, all training parameters except intensity will be the same.
The sets in high, moderate, and low intensity correspond to the rate of perceived exertion (0-10 scale) 7-9, 5-6, and 3-4, respectively.
Therefore, the participants will perform 5 repetitions barbell squat, barbell press, and barbell deadlift with 8RM (78% 1RM), 11RM (72% 1RM), and 16RM (65% 1RM) for 3 sets
Other Names:
|
|
EXPERIMENTAL: High-intensity barbell resistance exercise
Exercise: Barbell squat, barbell press, and barbell deadlift Number of sets: 3 Number of repetitions: 5 Intensity: 78% 1RM Training method: Circuit training (Squat set 1 ➔ Press set 1 ➔ Deadlift set 1 ➔ Squat set 2 ➔ Press set 2 ➔ Deadlift set 2 ➔ Squat set 3 ➔ Press set 3 ➔ Deadlift set 3) Rest interval between exercises and sets: ~3 minutes (Warm-up: 1 set of 5 repetitions for each exercise at 50% 1RM)
|
There will be four conditions (three exercises and one control) on visits 3-6.
For the three exercise conditions, all training parameters except intensity will be the same.
The sets in high, moderate, and low intensity correspond to the rate of perceived exertion (0-10 scale) 7-9, 5-6, and 3-4, respectively.
Therefore, the participants will perform 5 repetitions barbell squat, barbell press, and barbell deadlift with 8RM (78% 1RM), 11RM (72% 1RM), and 16RM (65% 1RM) for 3 sets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inhibitory control (change between baseline and 5 minutes after intervention/control)
Time Frame: Baseline (before intervention) and 5 minutes after (post-task) intervention/control.
|
The Inhibitory control (Stroop interference score) will be the mean incongruent reaction time minus the mean congruent reaction time.
Lower scores mean a better outcome.
|
Baseline (before intervention) and 5 minutes after (post-task) intervention/control.
|
|
Inhibitory control (change between baseline and 20 minutes after intervention/control)
Time Frame: Baseline (before intervention) and 20 minutes after (post-task) intervention/control.
|
The Inhibitory control (Stroop interference score) will be the mean incongruent reaction time minus the mean congruent reaction time.
Lower scores mean a better outcome.
|
Baseline (before intervention) and 20 minutes after (post-task) intervention/control.
|
|
Inhibitory control (change between baseline and 35 minutes after intervention/control)
Time Frame: Baseline (before intervention) and 35 minutes after (post-task) intervention/control.
|
The Inhibitory control (Stroop interference score) will be the mean incongruent reaction time minus the mean congruent reaction time.
Lower scores mean a better outcome.
|
Baseline (before intervention) and 35 minutes after (post-task) intervention/control.
|
|
Inhibitory control (change between baseline and 50 minutes after intervention/control)
Time Frame: Baseline (before intervention) and 50 minutes after (post-task) intervention/control.
|
The Inhibitory control (Stroop interference score) will be the mean incongruent reaction time minus the mean congruent reaction time.
Lower scores mean a better outcome.
|
Baseline (before intervention) and 50 minutes after (post-task) intervention/control.
|
|
Information processing speed (change between baseline and 5 minutes after intervention/control)
Time Frame: Baseline (before intervention) and 5 minutes after intervention/control.
|
The Information processing speed will be the mean simple reaction time.
Lower scores mean a better outcome.
|
Baseline (before intervention) and 5 minutes after intervention/control.
|
|
Information processing speed (change between baseline and 20 minutes after intervention/control)
Time Frame: Baseline (before intervention) and 20 minutes after intervention/control.
|
The Information processing speed will be the mean simple reaction time.
Lower scores mean a better outcome.
|
Baseline (before intervention) and 20 minutes after intervention/control.
|
|
Information processing speed (change between baseline and 35 minutes after intervention/control)
Time Frame: Baseline (before intervention) and 35 minutes after intervention/control.
|
The Information processing speed will be the mean simple reaction time.
Lower scores mean a better outcome.
|
Baseline (before intervention) and 35 minutes after intervention/control.
|
|
Information processing speed (change between baseline and 50 minutes after intervention/control)
Time Frame: Baseline (before intervention) and 50 minutes after intervention/control.
|
The Information processing speed will be the mean simple reaction time.
Lower scores mean a better outcome.
|
Baseline (before intervention) and 50 minutes after intervention/control.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Epinephrine (change between baseline and immediately after intervention/control)
Time Frame: Baseline and immediately after intervention/control.
|
Plasma epinephrine concentrations will be measured in duplicate using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
|
Baseline and immediately after intervention/control.
|
|
Epinephrine (change between baseline and 15 minutes after intervention/control)
Time Frame: Baseline and 15 minutes after intervention/control.
|
Plasma epinephrine concentrations will be measured in duplicate using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
|
Baseline and 15 minutes after intervention/control.
|
|
Epinephrine (change between baseline and 30 minutes after intervention/control)
Time Frame: Baseline and 30 minutes after intervention/control.
|
Plasma epinephrine concentrations will be measured in duplicate using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
|
Baseline and 30 minutes after intervention/control.
|
|
Epinephrine (change between baseline and 45 minutes after intervention/control)
Time Frame: Baseline and 45 minutes after intervention/control.
|
Plasma epinephrine concentrations will be measured in duplicate using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
|
Baseline and 45 minutes after intervention/control.
|
|
Epinephrine (change between baseline and 60 minutes after intervention/control)
Time Frame: Baseline and 60 minutes after intervention/control.
|
Plasma epinephrine concentrations will be measured in duplicate using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
|
Baseline and 60 minutes after intervention/control.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 (ANTICIPATED)
June 1, 2022
Primary Completion (ANTICIPATED)
September 30, 2023
Study Completion (ANTICIPATED)
December 31, 2023
Study Registration Dates
First Submitted
May 26, 2022
First Submitted That Met QC Criteria
June 1, 2022
First Posted (ACTUAL)
June 7, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 9, 2022
Last Update Submitted That Met QC Criteria
June 7, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202205HM003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We will publish the raw data online when we submit the resulting manuscript.
IPD Sharing Time Frame
The study protocol is available on Open Science Framework (https://osf.io/4fkpc/).
The raw data will be published after the trial is completed. (No time limitation imposed)
IPD Sharing Access Criteria
No limitation.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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.
Clinical Trials on Healthy Young Adults
-
Aix Marseille UniversitéNot yet recruitingHealthy Young Adults | Healthy Older AdultsFrance
-
Essilor InternationalNot yet recruiting
-
The Hong Kong Polytechnic UniversityRecruitingYoung Healthy AdultsHong Kong
-
Escola Superior de Tecnologia da Saúde do PortoNot yet recruitingHealthy Young AdultsPortugal
-
European University Miguel de CervantesCompletedHealthy Young AdultsSpain
-
Poznan University of Physical EducationCompletedHealthy Young AdultsPoland
-
Riphah International UniversityCompletedHealthy Young AdultsPakistan
-
Georgia Institute of TechnologyNational Institute of Neurological Disorders and Stroke (NINDS)CompletedHealthy Young AdultsUnited States
-
Touro University NevadaCompleted
-
Charite University, Berlin, GermanyCompleted
Clinical Trials on Resistance exercise
-
Princess Nourah Bint Abdulrahman UniversityKırıkkale UniversityCompleted
-
Universidade Federal de PernambucoUnknownChikungunya FeverBrazil
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)TerminatedChildhood ObesityUnited States
-
National Taiwan Normal UniversityRecruitingResistance Exercise | Energy Expenditure | Energy Balance | Males and FemalesTaiwan
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI); Harvard School of Public... and other collaboratorsRecruitingCardiovascular RiskUnited States
-
University of ValenciaRecruitingRotator Cuff Related Shoulder PainSpain
-
Riphah International UniversityCompletedChronic Obstructive Pulmonary DiseasePakistan
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension | Healthy
-
Iowa State UniversityCompletedCardiovascular Risk Factor
-
Björn AlknerKarolinska Institutet; The Swedish Research Council; Umeå University; Linkoeping... and other collaboratorsCompletedMagnetic Resonance Imaging | Resistance Exercise | Skeletal Muscle | Children, Adult | EMG | Muscle Hypertrophy | Growth Plate Early ClosingSweden