ExerCube Training on Executive Functions in Young Athletes

October 21, 2020 updated by: Swiss Federal Institute of Technology

The Influence of a Ten-week ExerCube Training on Executive Functions as Well as on Training Motivation, Enjoyment and Mental Well-being in Young Athletes

Competitive game sports require the existence of several sport-specific skills. In particular, game sport athletes need a good set of skills in order to perform well on the field. Therefore, it is important for athletes, especially young athletes, not only perform their sport, but also perform variable trainings, which differently train/trigger sport-specific skills. One skill set that is important in competitive game sports are so-called executive functions. Executive functions are needed for action planning and adaptation to the individual environmental situation, e.g. inhibition, flexibility and divided attention. A form of training that is very promising in this respect is exergaming as nowadays coaches are using virtual reality simulations to create realistic training environments. An exergame that combines this cognitive stimulation with whole-body movements in a motivating training environment is the ExerCube. Until now, however, evidence is lacking how an additional holistic exergame training can influence executive functioning in young athletes. Therefore, this study aims to get preliminary insight into the effects of the ExerCube performance on the executive function in young athletes (primary objective). The participants will be allocated into either the intervention group (ExerCube training) or the control group (no additional ExerCube training). The intervention group will train 2 times per week for about 30 minutes over a time frame of 10 weeks. Additionally, to consider the effects of the training environment, the secondary objectives include training motivation, enjoyment and flow as well as mental well-being.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8093
        • Institute of Human Movement Sciences and Sport, ETH Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female and male
  • Age between 15 to 20 years
  • Young athletes (game sports)
  • Healthy (self-reported)
  • Able to provide written informed consent and understand instructions

Exclusion Criteria:

  • History of cardiovascular issue that would prevent training participation
  • Asthma (not controllable)
  • Musculosceletal injuries that would prevent training participation
  • Pain that would be reinforced by sportive activities
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ExerCube group
The ExerCube is an immersive fitness game setting that combines innovative soft- and hardware designs with state of-the-art training concepts. The ExerCube has three walls which serve as virtual reality projection screens and haptic interfaces. The ExerCube is a playful physical-cognitive exergame training. The user navigates a virtual environment/reality via whole body exercise. The video game navigates the user and triggers various cognitive functions. The used physical exercises are functionally and elicit the improvement of endurance and strength components. Via different monitoring systems (points and heart rate), the game adapts to the individual abilities and training level to tailor workout intensity. The ExerCube training consists of two sessions a week each session will last about 30 minutes of which 25 minutes will be pure playtime
Other: Exergame Training
An exergame combines exercise and gaming in a holistic approach.
No Intervention: Control group
The control group does not have any additional ExerCube training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FitLight
Time Frame: Before and after the intervention, within two weeks
FitLight Trainer™ (Sports Corp. Ontario, Canada) is a commercially available product and consists of eight LED powered lights controlled by a wireless connection via a tablet. The tablet is running on android version 4.2.2 and has in advance a FitLight Trainer™ software to interact with the lights. With this software, it is possible to generate new specific light sequences.The FitLight allow the testing of executive functions depending on the programmed sequences. The participants use whole-body movements of arms and legs to solve the programmes sequences. Before the participants execute the main test, they perform a pre-test to minimize the learning effect and to get familiar with the test environment
Before and after the intervention, within two weeks
Test for Attentional Performance
Time Frame: Before and after the intervention, within two weeks
Initially the TAP (D-TAP 2.3 VL, PSYTEST, Psychologische Testsysteme, Herzogenrath, Germany) was developed to assess attentional deficits in a cerebral impaired population. The participants perform a simple reaction task.The stimuli are presented on a screen of a personal computer. Before the participants execute the main test, they perform a pre-test to minimize the learning effect and to get familiar with the test environment.
Before and after the intervention, within two weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Situation Motivation Scale
Time Frame: Before and after the intervention, within two weeks

The Situation Motivation Scale was designed to assess the constructs of intrinsic motivation, identified regulation, external regulation and amotivation in field and laboratory settings.

- 16 items graded on a 7-point Likert scale, a higher score means a better outcome
Before and after the intervention, within two weeks
Flow Short Scale
Time Frame: Before and after the intervention, within two weeks

The first 10 items measure the components of Flow-Experience as first described by Mihaly Csikszentmihalyi 1975. The items 11 - 13 measure Worry someone may have in the situation the measurement is made.

- 13 items graded on a 7-point Likert scale, Item 1-10: a higher score means a better outcome, Item 11-13: a lower score means a better outcome
Before and after the intervention, within two weeks
Physical Activity Enjoyment Scale
Time Frame: Before and after the intervention, within two weeks

The Physical Activity Enjoyment Scale was developed to measure physical activity enjoyment using college-aged students. The scale is a reliable and valid measure of enjoyment in physical activity environments.

- 18 bipolar statements and a 7-point continuum, a higher score means a better outcome
Before and after the intervention, within two weeks
Warwick-Edinburgh Mental Well-being Scale
Time Frame: Before and after the intervention, within two weeks
This mental well-being scale is a valid measurement at a population and on an individual level. The questionnaire consists of 14 items and covers following aspects of mental health: positive affect (feelings of optimism, cheerfulness, and relaxation), satisfying interpersonal relationships, positive functioning (energy, clear thinking, self-acceptance, personal development, competence and autonomy). A minimum score of 14 and a maximum score of 70 can be achieved, whereas a score from 51 can be assumed normal. The higher the score is, the higher the level of mental well-being.
Before and after the intervention, within two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Federal Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EK 2019-N-161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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