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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05452460
Other study ID # PACNL_JT_MF_Intervention
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 17, 2022
Est. completion date January 10, 2023

Study information

Verified date July 2022
Source National Taiwan Normal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date January 10, 2023
Est. primary completion date January 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: 1. Regular sports training at least 4 hours weekly 2. Normal or corrected-to-normal vision 3. Right-handed Exclusion Criteria: 1. Physical limitation or injury in lower limbs before and during the study 2. Diagnosed or self-reported neurological disorders (e.g., epilepsy) 3. Diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia) 4. Major previous experience with mindfulness training

Study Design


Intervention

Behavioral:
Mindfulness intervention
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.

Locations

Country Name City State
Taiwan Department of Physical Education and Sport Sciences, National Taiwan Normal University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inhibitory control 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 and accuracy in Flanker task will be calculated as inhibitory control performance. 20 minutes
Primary Endurance performance The graded exercise test (GXT) on treadmill (h/p/cosmos pulsar 3p, Germany) will be used to assess participant's endurance performance (i.e., VO2max and exhaustion time). 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 grade of 10% and increases speed and grade every 3 min until participants are voluntarily exhausted. Maximum oxygen consumption (VO2max) and time to exhaustion (TTE) will be recorded from test results. 30 minutes
Primary ERP The neuroelectrical activities during the cognitive tasks (i.e., Stroop task, Flanker task) will be recorded and analyzed using the Neuroscan system. Changes in the neuroelectrical activities from baseline to end of the intervention (i.e., week 8) will be examined in each conditions (i.e., mental fatigue condition & control condition). 60 minutes
Secondary Subjective mental fatigue Both in the baseline and post-intervention, the visual analog scale for mental fatigue (VAS-MF) will be used to assess changes in subjective mental fatigue before and after two separate experimental conditions, including mental fatigue condition (i.e., 30-min of incongruent version Stroop task) and control condition (i.e., 30-min of congruent version Stroop task). 30 second
Secondary Objective mental fatigue Both in the baseline and post-intervention, participants will complete either a 30-min incongruent version Stroop task or 30-min congruent version Stroop task, the reaction time and accuracy in both Stroop tasks will be calculated as an index of objective mental fatigue. 30 minutes
Secondary Dispositional mindfulness The changes in dispositional mindfulness will be assessed using the 16-items (5-Likert scale) athlete mindfulness questionnaire (AMQ). Higher mean scores indicates a higher levels of dispositional mindfulness. Changes in mindfulness scores from baseline to end of intervention will be examined. 5 minutes each at baseline an at post-intervention
Secondary Mood state The change in mood state before and after manipulation conditions will be assessed using the Brunel mood scale-Chinese (BRUMS-C), which contains 23 items and divided into six respective sub-scales such as anger, confusion, depression, fatigue, tension, and vigour. 5 minutes
Secondary 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. every 2.5 minutes during graded exercise test
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