NCT05452460

Brief Summary

Mental fatigue has been suggested that would impair neurocognitive functions and sports performance. On the other hand, mindfulness training (MT) seems to as a promising approach to attenuate mental fatigue and counteract its detrimental effect on cognitive functions and sports performance. The purpose of the present study is to examine the effect of MT on behavioral and neuroelectric indices of inhibitory control, and endurance performance in mentally fatigued athletes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

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

February 17, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 30, 2025

Completed
Last Updated

January 30, 2025

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

July 6, 2022

Results QC Date

December 20, 2023

Last Update Submit

December 26, 2024

Conditions

Keywords

Mindfulness TrainingMental FatigueInhibitory ControlEndurance PerformanceERP

Outcome Measures

Primary Outcomes (6)

  • Inhibitory Control: Reaction Time

    Followed by the manipulation conditions, inhibitory control will be evaluated by a Flanker task (i.e., either mental fatigue condition or control condition). In the Flanker task, participants will be presented with five arrows and will be instructed to respond as quickly and accurately as possible to the direction where the middle arrow is pointing (i.e., left or right). Types of trials are the congruent (i.e., \> \> \> \> \>) and incongruent (i.e., \< \< \> \< \<). The reaction time (RT) and accuracy (ACC) of the incongruent trials were calculated as inhibitory control performance, and the difference between conditions was further calculated to represent a mental fatigue-related impairment of inhibitory control in pre-test and post-test.

    After 30-minute mental fatigue and control conditions at pre-test and post-test (8 weeks)

  • Inhibitory Control: Accuracy

    Followed by the manipulation conditions, inhibitory control will be evaluated by a Flanker task (i.e., either mental fatigue condition or control condition). In the Flanker task, participants will be presented with five arrows and will be instructed to respond as quickly and accurately as possible to the direction where the middle arrow is pointing (i.e., left or right). Types of trials are the congruent (i.e., \> \> \> \> \>) and incongruent (i.e., \< \< \> \< \<). The reaction time (RT) and accuracy (ACC) of the incongruent trials were calculated as inhibitory control performance, and the difference between conditions was further calculated to represent a mental fatigue-related impairment of inhibitory control in pre-test and post-test.

    After 30-minute mental fatigue and control conditions at pre-test and post-test (8 weeks)

  • ERP: N2

    The neuroelectrical activities (i.e., N2, P3) during the Flanker task were recorded and analyzed using the Neuroscan system. The difference in neuroelectrical activities between conditions (i.e., mental fatigue condition \& control condition) were calculated as mental fatigue-related impairment in neuroelectrical markers of inhibitory control.

    After 30-minute mental fatigue and control conditions at pre-test and post-test (8 weeks)

  • ERP: P3

    The neuroelectrical activities (i.e., N2, P3) during the Flanker task were recorded and analyzed using the Neuroscan system. The difference in neuroelectrical activities between conditions (i.e., mental fatigue condition \& control condition) were calculated as mental fatigue-related impairment in neuroelectrical markers of inhibitory control.

    After 30-minute mental fatigue and control conditions at pre-test and post-test (8 weeks)

  • Endurance Performance: Time to Exhaustion

    The graded exercise test (GXT) on treadmill was used to assess participant's endurance performance. Bruce protocol will be adopted in the test. The initial speed and grade of the GXT will be set at 2.74 km/hr with a grade of 10% and increase speed and grade every 3 min until participants are voluntarily exhausted. The time to exhaustion (TTE) was recorded as the endurance performance. The difference in TTE between conditions was further calculated (i.e., control condition minus mental fatigue condition) for both the pre-test and post-test.

    After 30-minute mental fatigue and control conditions at pre-test and post-test (8 weeks)

  • Endurance Performance: VO2max

    The graded exercise test (GXT) on treadmill was used to assess participant's endurance performance. Bruce protocol will be adopted in the test. The initial speed and grade of the GXT will be set at 2.74 km/hr with a grade of 10% and increase speed and grade every 3 min until participants are voluntarily exhausted. The maximum oxygen consumption (VO2 max) was recorded as the endurance performance. The difference in VO2max between conditions was further calculated (i.e., control condition minus mental fatigue condition) for both the pre-test and post-test.

    After 30-minute mental fatigue and control conditions at pre-test and post-test (8 weeks)

Secondary Outcomes (10)

  • Subjective Mental Fatigue

    Before, after 30-minute Stroop task and after Flanker task in the mental fatigue and control condition at pre-test and post-test (8 weeks)

  • Objective Mental Fatigue

    Post 30-minute mental fatigue and control condition at pre-test and post-test (8 weeks)

  • Dispositional Mindfulness

    Baseline (pre-test) and 8 weeks (post-test)

  • Mood State: Anger

    Before, after 30-minute Stroop task in the mental fatigue and control condition at pre-test and post-test (8 weeks)

  • Mood State: Confusion

    Before, after 30-minute Stroop task in the mental fatigue and control condition at pre-test and post-test (8 weeks)

  • +5 more secondary outcomes

Study Arms (2)

Mindfulness training group

EXPERIMENTAL

Participants in the mindfulness training (MT) group will engage in a 60-min session of mindfulness program per week for 8 weeks.

Behavioral: Mindfulness intervention

Waitlist control group

NO INTERVENTION

Participants in the waitlist control group will be required to maintain regular life and routine training. Once the participants in control group finished the whole experiment, they will be invited to participate in the MBPP program for eight weeks.

Interventions

The mindfulness program called "Mindfulness-based peak performance (MBPP)" will be used in this study. MBPP is a program that consists of eight 60-min training, and a 60-min session weekly for 8-weeks. The MBPP program will include (1) 5 minutes of will start with a brief recap of the preceding session and homework discussion, (2) after which the 5 minutes of a brief story about performance aimed at inducing the learning motivation of the participants; (3) Followed by 20 minutes of a theoretical lecture introducing a new topic and then (4) 25 minutes of mindfulness exercise. (5) Finally, how to apply the mindfulness skills to sports context will be discussed at the end of each session for 5 minutes.

Mindfulness training group

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)
  • Major previous experience with mindfulness training

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 Sport Sciences, National Taiwan Normal University

Study Officials

  • Yu-Kai Chang, PhD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 11, 2022

Study Start

February 17, 2022

Primary Completion

January 10, 2023

Study Completion

January 10, 2023

Last Updated

January 30, 2025

Results First Posted

January 30, 2025

Record last verified: 2024-12

Locations