Investigating the Inverted-U Relationship Between Cognitive Performance and Plasma Epinephrine

Healthy Young Adults Clinical Trial

Official title:

Investigating the Inverted-U Relationship Between Cognitive Performance and Plasma Epinephrine: A Registered Report of a Four-arm Crossover Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05407259
• Other study ID #: 202205HM003
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: National Taiwan Normal University
• Contact: Ting-Yu Lin, B.A.
• Phone: +886975211701
• Email: leo850922[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Young Adults

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan Normal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (before intervention) and 5 minutes after (post-task) intervention/control.
Primary	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.	Baseline (before intervention) and 20 minutes after (post-task) intervention/control.
Primary	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.	Baseline (before intervention) and 35 minutes after (post-task) intervention/control.
Primary	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.	Baseline (before intervention) and 50 minutes after (post-task) intervention/control.
Primary	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.	Baseline (before intervention) and 5 minutes after intervention/control.
Primary	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.	Baseline (before intervention) and 20 minutes after intervention/control.
Primary	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.	Baseline (before intervention) and 35 minutes after intervention/control.
Primary	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.	Baseline (before intervention) and 50 minutes after intervention/control.
Secondary	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.	Baseline and immediately after intervention/control.
Secondary	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.	Baseline and 15 minutes after intervention/control.
Secondary	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.	Baseline and 30 minutes after intervention/control.
Secondary	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.	Baseline and 45 minutes after intervention/control.
Secondary	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.	Baseline and 60 minutes after intervention/control.

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