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Mindfulness TrainingNCT05452460

Mindfulness Training, Mental Fatigue, Endurance Performance and Neurocognitive Functions

A study testing Mindfulness intervention in people with Mindfulness Training and Neurocognitive Function, run by National Taiwan Normal University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
What is being tested?
Mindfulness intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteTaiwan
Study dates
17 Feb 2022to 10 Jan 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Department of Physical Education and Sport Sciences, National Taiwan Normal University

    Taipei, 106

Other trials in Taiwan

About this study

Official title: Effect of Mindfulness Training on Mental Fatigue-Related Impairments of Endurance Performance and Inhibitory Control in Athletes: An Event-Related Potential Study

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.

Read the detailed description

Accumulating research indicates that mental fatigue induced by prolonged cognitive tasks would impair neurocognitive functions and sports performance. Additionally, recent studies demonstrate that inhibitory control and endurance performance are significantly susceptible to detrimental effects of mental fatigue. On the other hand, mindfulness training (MT) has been widely been used to enhance cognitive functions and sports performance in neurocognitive and sports research, which has been considered a promising approach for attenuating mental fatigue and counteracting the detrimental effect of mental fatigue. However, the effect of MT on inhibitory control, endurance performance, and underlying mechanisms in mentally fatigued athletes remain unclear.

Therefore, 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.

Specifically, the targeted primary outcomes are neurocognitive functions (i.e., reaction time, accuracy and ERPs in Flanker task) and endurance performance (i.e., VO2max \& time to exhaustion); The secondary outcomes are changes in dispositional mindfulness, subjective (i.e., scores in visual analog scale)/objective (i.e., reaction time, accuracy in Stroop task) mental fatigue, motivation in tasks, and changes in mood state (i.e., BRUMS-C).

Being tested
Mindfulness intervention
Keywords
Mindfulness Training, Mental Fatigue, Inhibitory Control, Endurance Performance, ERP
Medical subject headings
Mental Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness interventionBehavioural

    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.

Study groups in NCT05452460
Study groupRoleWhat they receive
Mindfulness training groupExperimentalParticipants in the mindfulness training (MT) group will engage in a 60-min session of mindfulness program per week for 8 weeks.
Receives: Behavioral: Mindfulness intervention
Waitlist control groupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

Secondary outcomes (10)
  1. Subjective Mental Fatigue

    Both in the baseline and post-intervention, the visual analog scale for mental fatigue (VAS-MF) was used to assess changes in subjective mental fatigue before and after experimental manipulation. The scale ranges from 0 (not at all mentally fatigued) to 100 (extremely mentally fatigued).

    Measured: 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)

  2. Objective Mental Fatigue

    Both at baseline and post-intervention, participants completed either a 30-min 100% incongruent version Stroop task (i.e., mental fatigue condition) or a 30-min 100% congruent version Stroop task (i.e., control condition). In the Stroop task, accuracy (ACC) was calculated as an index of objective mental fatigue. It is expressed as a percentage, determined by dividing the number of correct responses by the total number of responses.

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

  3. Dispositional Mindfulness

    The change in dispositional mindfulness was assessed using the 16-item (5-Likert scale) athlete mindfulness questionnaire (AMQ). The mean score range is between 1-5. Higher mean scores indicate a higher level of dispositional mindfulness.

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

  4. Mood State: Anger

    Mood state change was determined by the difference in scores on the Brunel Mood Scale-Chinese (BRUMS-C) between before and after manipulation. The BRUMS-C contains 23 item (5-Likert scale) and is divided into six sub-scales: anger, confusion, depression, fatigue, tension, and vigour. The mean score range is between 0-4. Higher mean scores indicate a higher anger mood.

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

  5. Mood State: Confusion

    Mood state change was determined by the difference in scores on the Brunel Mood Scale-Chinese (BRUMS-C) between before and after manipulation. The BRUMS-C contains 23 item (5-Likert scale) and is divided into six sub-scales: anger, confusion, depression, fatigue, tension, and vigour. The mean score range is between 0-4. Higher mean scores indicate a higher confusion mood.

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

  6. Mood State: Depression

    Mood state change was determined by the difference in scores on the Brunel Mood Scale-Chinese (BRUMS-C) between before and after manipulation. The BRUMS-C contains 23 item (5-Likert scale) and is divided into six sub-scales: anger, confusion, depression, fatigue, tension, and vigour. The mean score range is between 0-4. Higher mean scores indicate a higher depression mood.

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

  7. Mood State: Fatigue

    Mood state change was determined by the difference in scores on the Brunel Mood Scale-Chinese (BRUMS-C) between before and after manipulation. The BRUMS-C contains 23 item (5-Likert scale) and is divided into six sub-scales: anger, confusion, depression, fatigue, tension, and vigour. The mean score range is between 0-4. Higher mean scores indicate a higher fatigue mood.

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

  8. Mood State: Tension

    Mood state change was determined by the difference in scores on the Brunel Mood Scale-Chinese (BRUMS-C) between before and after manipulation. The BRUMS-C contains 23 item (5-Likert scale) and is divided into six sub-scales: anger, confusion, depression, fatigue, tension, and vigour. The mean score range is between 0-4. Higher mean scores indicate a higher tension mood.

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

  9. Mood State: Vigour

    Mood state change was determined by the difference in scores on the Brunel Mood Scale-Chinese (BRUMS-C) between before and after manipulation. The BRUMS-C contains 23 item (5-Likert scale) and is divided into six sub-scales: anger, confusion, depression, fatigue, tension, and vigour. The mean score range is between 0-4. Higher mean scores indicate a higher vigor mood.

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

  10. Perception of Effort

    During the graded exercise test, the perception of effort will be asked at beginning and every 2.5-min using Borg 6 to 20 scale, until the participant comes to voluntary exhaustion.

    Measured: every 2.5 minutes during graded exercise test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start17 Feb 2022
  3. Primary completion10 Jan 2023
  4. Study completion10 Jan 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05452460
Sponsor's protocol ID
PACNL_JT_MF_Intervention
Status last verified
Dec 2024
First submitted
6 Jul 2022
Last updated
30 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness intervention in people with Mindfulness Training and Neurocognitive Function, run by National Taiwan Normal University at 1 site in Taiwan.

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inhibitory Control: Reaction Time (time frame: After 30-minute mental fatigue and control conditions at pre-test and post-test (8 weeks)). The study lists 6 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 30 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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