Healthy Young AdultsNCT05407259
Investigating the Inverted-U Relationship Between Cognitive Performance and Plasma Epinephrine
A study testing Resistance exercise in people with Healthy Young Adults, run by National Taiwan Normal University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 31 Dec 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Healthy Young Adults
- Being tested
- Resistance exercise
- Keywords
- Resistance Training, Kinesiology, Applied, Cognitive Neuroscience, Psychology, Sports, Cognitive Psychology, Psychophysiology, Exercise, Circuit-Based Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseBehavioural
Also called Resistance training
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
| Study group | Role | What they receive |
|---|---|---|
| Control condition | No intervention | During the control condition, participants will be asked to read a book related to exercise for approximately 40 minutes. |
| Low-intensity barbell resistance exercise | Experimental | 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) Receives: Behavioral: Resistance exercise |
| Moderate-intensity barbell resistance exercise | Experimental | 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) Receives: Behavioral: Resistance exercise |
| High-intensity barbell resistance exercise | Experimental | 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) Receives: Behavioral: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibitory control (change between baseline and 5 minutes after 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.
Measured: Baseline (before intervention) and 5 minutes after (post-task) intervention/control.
Inhibitory control (change between baseline and 20 minutes after 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.
Measured: Baseline (before intervention) and 20 minutes after (post-task) intervention/control.
Inhibitory control (change between baseline and 35 minutes after 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.
Measured: Baseline (before intervention) and 35 minutes after (post-task) intervention/control.
Inhibitory control (change between baseline and 50 minutes after 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.
Measured: Baseline (before intervention) and 50 minutes after (post-task) intervention/control.
Information processing speed (change between baseline and 5 minutes after intervention/control)
The Information processing speed will be the mean simple reaction time. Lower scores mean a better outcome.
Measured: Baseline (before intervention) and 5 minutes after intervention/control.
Information processing speed (change between baseline and 20 minutes after intervention/control)
The Information processing speed will be the mean simple reaction time. Lower scores mean a better outcome.
Measured: Baseline (before intervention) and 20 minutes after intervention/control.
Information processing speed (change between baseline and 35 minutes after intervention/control)
The Information processing speed will be the mean simple reaction time. Lower scores mean a better outcome.
Measured: Baseline (before intervention) and 35 minutes after intervention/control.
Information processing speed (change between baseline and 50 minutes after intervention/control)
The Information processing speed will be the mean simple reaction time. Lower scores mean a better outcome.
Measured: Baseline (before intervention) and 50 minutes after intervention/control.
Secondary outcomes (5)
Epinephrine (change between baseline and immediately after intervention/control)
Plasma epinephrine concentrations will be measured in duplicate using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
Measured: Baseline and immediately after intervention/control.
Epinephrine (change between 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.
Measured: Baseline and 15 minutes after intervention/control.
Epinephrine (change between 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.
Measured: Baseline and 30 minutes after intervention/control.
Epinephrine (change between 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.
Measured: Baseline and 45 minutes after intervention/control.
Epinephrine (change between 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.
Measured: Baseline and 60 minutes after intervention/control.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jun 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young AdultsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting-Yu Lin, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407259
- Sponsor's protocol ID
- 202205HM003
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will publish the raw data online when we submit the resulting manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Inverted-U Relationship Between Cognitive Performance and Plasma Epinephrine: A Registered Report of a Four-arm Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05407259
- Acronym / sponsor ID
- 202205HM003
- Conditions
- Healthy Young Adults
- Keywords
- Resistance Training, Kinesiology, Applied, Cognitive Neuroscience, Psychology, Sports, Cognitive Psychology, Psychophysiology, Exercise, Circuit-Based Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Jun 2022 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control condition | No intervention | –During the control condition, participants will be asked to read a book related to exercise for approximately 40 minutes. |
| Low-intensity barbell resistance exercise | Experimental | Behavioral: Resistance exerciseExercise: 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) |
| Moderate-intensity barbell resistance exercise | Experimental | Behavioral: Resistance exerciseExercise: 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) |
| High-intensity barbell resistance exercise | Experimental | Behavioral: Resistance exerciseExercise: 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) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Resistance exerciseAlso: Resistance trainingThere 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 | Behavioural | High-intensity barbell resistance exercise, Low-intensity barbell resistance exercise, Moderate-intensity barbell resistance exercise |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Epinephrine (change between baseline and immediately after intervention/control)
Time frame: 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.
Epinephrine (change between baseline and 30 minutes after intervention/control)
Time frame: 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.
Epinephrine (change between baseline and 60 minutes after intervention/control)
Time frame: Baseline and 60 minutes after intervention/control.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will publish the raw data online when we submit the resulting manuscript.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise in people with Healthy Young Adults, run by National Taiwan Normal University.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting-Yu Lin, B.A. (+886975211701, leo850922@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 8 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 9 Jun 2022.