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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. healthy young male aged 18-40 years;
  2. recreational resistance-trained (≥ 1 time/week for the previous 6 months);
  3. free from cardiovascular, cerebrovascular, and neurological disorders and other chronic diseases;
  4. free from any medical condition listed on the 2014 update of the Physical Activity Readiness Questionnaire (PAR-Q+);
  5. non-smoker; and
  6. normal or corrected-to-normal vision.

Exclusion Criteria:

  1. athlete trained in a competitive sports team or engaging in exercise for more than 20 hours/week;
  2. unable to perform any of the intervention exercises (barbell squat, press, and deadlift); or
  3. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Behavioral: Resistance exercise
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:
  • Resistance training
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)
Behavioral: Resistance exercise
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:
  • Resistance training
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)
Behavioral: Resistance exercise
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:
  • Resistance training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan Normal University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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