NCT05466136

Brief Summary

This study investigated whether trait mindfulness in athletes is associated with impairments in neurocognitive function and endurance performance resulting from mental fatigue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

March 16, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

July 6, 2022

Results QC Date

January 19, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

MindfulnessAthletesMental fatigueInhibitory controlEndurance performance

Outcome Measures

Primary Outcomes (5)

  • Inhibitory Control: Reaction Time

    Inhibitory control will be evaluated by a Flanker task in terms of reaction time in this study, and the types of trials are the congruent (i.e., \> \> \> \> \>) and incongruent (i.e., \< \< \> \< \<). In the Flanker task, participants were presented with five arrows and instructed to respond as quickly and accurately as possible to the direction where the middle arrow is pointing (i.e., left or right).

    From enrollment to the end of second intervention at 1 week. During Flanker task, up to 15 minutes.

  • Inhibitory Control: Accuracy

    Inhibitory control will be evaluated by a Flanker task in terms of accuracy in this study, and the types of trials are the congruent (i.e., \> \> \> \> \>) and incongruent (i.e., \< \< \> \< \<). In the Flanker task, participants were presented with five arrows and instructed to respond as quickly and accurately as possible to the direction where the middle arrow is pointing (i.e., left or right).

    From enrollment to the end of second intervention at 1 week. During Flanker task, up to 15 minutes.

  • Endurance Performance: Time to Exhaustion

    The endurance performance in terms of time to exhaustion (TTE) will be assessed by graded exercise test (GXT) with Bruce protocol on treadmill (h/p/cosmos pulsar 3p, Germany). The initial speed and grade of the GXT will be set at 2.74 km/hr with grade of 10% and increase speed and grade every 3 min until participants are volitionally exhausted.

    From enrollment to the end of second intervention at 1 week. During graded exercise test, up to 30 minutes

  • Endurance Performance: Maximum Oxygen Consumption

    The maximal oxygen consumption (VO2max) throughout the whole GXT will be recorded by a computerized indirect calorimetry system (SensorMedics Vmax 29C, USA), and until the participants reached volitional exhaustion. The VO2max in the study will be defined as the highest 30-s average value of VO2 measured during GXT.

    From enrollment to the end of second intervention at 1 week. During graded exercise test, up to 30 minutes.

  • Changes in Neuroelectrical Activities

    Neuroelectrical activity during the Flanker task was recorded using electroencephalography (EEG) with continuous data acquisition throughout task performance. Changes in neuroelectrical activity were operationalized as differences in event-related potential (ERP) amplitudes during the Flanker task (e.g., N2 and P3 components). The mean amplitudes of the N2 and P3 were quantified within predefined time windows of 250-350 ms and 350-550 ms, respectively, following stimulus onset.

    From enrollment to the end of second intervention at 1 week. During Flanker task, up to 15 minutes.

Secondary Outcomes (5)

  • Subjective Mental Fatigue

    Three standardized time points within each experimental session at baseline and post-intervention: T0 (before the Stroop task), T1 (after the Stroop task), and T2 (after the Flanker task).

  • Objective Mental Fatigue: Reaction Time in Stroop Task

    From enrollment to the end of second intervention at 1 week. During Stroop task, up to 30 minutes.

  • Objective Mental Fatigue: Accuracy in Stroop Task

    From enrollment to the end of second intervention at 1 week. During Stroop task, up to 30 minutes.

  • Mood State

    Two standardized time points within each experimental session at baseline and post-intervention: T0 (before the Stroop task) and T1 (after the Stroop task).

  • Motivation

    From enrollment to the end of second intervention at 1 week. Immediately after completing Flanker task and GXT.

Study Arms (2)

Mental Fatigue Condition, Then Control Condition

EXPERIMENTAL

Performing a completed incongruent version of Stroop task for 30min in mental fatigue condition. Then performing a completed congruent version of Stroop task for 30min in control condition.

Behavioral: Mental fatigue condition

Control Condition, Then Mental Fatigue Condition

EXPERIMENTAL

Performing a completed congruent version of Stroop task for 30min in Control condition. Then performing a completed incongruent version of Stroop task for 30min in mental fatigue condition.

Behavioral: Control condition

Interventions

Similar to mental fatigue conditions, the modified Stroop task with complete congruent trials will be used, The Stroop task also included four colored words presented in traditional Chinese (i.e., red, green, blue, and yellow), but the color of the word will paint consistent with the semantic meaning of the word (e.g., red word printed in red) in order to set up the match condition of relative less cognitive demanding for participants. Same with the mental fatigue condition, the task consisted of five 6-minute blocks and 1080 congruent trials for each block. The total duration will be 30-min.

Control Condition, Then Mental Fatigue Condition

In mental fatigue condition, the mental fatigue manipulation will use a modified Stroop task with complete incongruent trials, which is wildly used to induce a mentally fatigued state in previous studies. The Stroop task included four colored words presented in traditional Chinese (i.e., red, green, blue, and yellow), the color of the word will paint inconsistent with the semantic meaning of the word (e.g., red word printed in green). The task consisted of five 6-minute blocks and 1080 incongruent trials for each block. The total duration will be 30-min.

Mental Fatigue Condition, Then Control Condition

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Regular sports training at least 4 hours weekly
  • Normal or corrected-to-normal vision
  • Right-handed

You may not qualify if:

  • Physical limitation or injury in lower limbs before and during the study
  • Diagnosed or self-reported neurological disorders (e.g., epilepsy)
  • Diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education and Sport Sciences, National Taiwan Normal University

Taipei, 106, Taiwan

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Yu-Kai Chang
Organization
Department of Physical Education and Sports Sciences, National Taiwan Normal University

Study Officials

  • Yu-Kai Chang, Ph.D

    Department of Physical Education and Sport Sciences, National Taiwan Normal University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: The participants will visit the lab on two counterbalanced order occasions to complete either an incongruent version Stroop task (mental fatigue condition, MF) or a congruent version Stroop task (control condition, CON) for 30 minutes to induce the mental fatigue state.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 20, 2022

Study Start

April 20, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

March 16, 2026

Results First Posted

March 16, 2026

Record last verified: 2026-03

Locations