HealthyNCT06405022
Does Sport Specific Brain Endurance Training Enhance Physical and Cognitive Performance in Elite Orienteering Athletes?
A study testing Brain Endurance Training in people with Healthy, run by Department of Public Health, Denmark at 1 site in Denmark.
Trial summary
The purpose of the study is to measure the effects of a 6 week sport specific BET intervention on physical and cognitive performance parameters in elite orienteering athletes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- Brain Endurance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Danish National Team Elite Orienteering Runners
Who cannot join
- Consent withdrawal
- Injury
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to measure the effects of a 6 week sport specific BET intervention on physical and cognitive performance parameters in elite orienteering athletes.
Read the detailed description
The purpose of the study is to measure the effects of a 6 week sport specific BET intervention on physical and cognitive performance parameters in elite orienteering athletes.
The study is constructed as a cross-over design, where participants function as their own control condition. The control condition (the first period) and the intervention (the latter period) consists of a 6 week training period, both leading up to a prioritized international competition. In the control condition participants will train normally leading up to the European Championships. During the intervention period participants will implement 3 sessions per week of a specially designed brain endurance program, leading up to the World Championships. To investigate the effect on all endpoints, physical and cognitive tests are conducted before and after the training periods.
- Conditions
- Healthy
- Being tested
- Brain Endurance Training, Control
- Keywords
- Elite Athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Endurance TrainingOther
Six week period with three weekly blocks with a 20 min brain endurance training program following a regular HIT session. Before the HIT session questionnaires are completed to measure the motivation for the HIT session and the current state of mood. In between the HIT session and the RCA session, questionnaires are completed to measure the experienced workload of the HIT session, the current state of mood, and the motivation for following the RCA session. Immediately after the RCA session, questionnaires are completed to measure the experienced workload of the RCA session and the current state of mood.
ControlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Control (CON) | Active comparator | The control condition entails a six-week period. The participant will complete three regular high intensity training per week followed by 20 min of rest Receives: Other: Control |
| Brain Endurance Training (BET) | Experimental | The intervention period also entails a 6 week period but with three weekly blocks with a 20 min brain endurance training program following a regular high intensity training session. Receives: Other: Brain Endurance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 5000 m run performance (time)
Self Paced endurance test (physical test part 1) To measure maximal self-paced endurance performance, a track and field test will be performed. This test is completed on a standard athletic track measuring 400m.
Measured: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Change in Cognitive performance #1 (score)
Change in Inhibition task performance (cognitive test part 1a) This cognitive test consists of the Stroop colour-word task. Participants perform this task on a computer whilst sitting in a quiet and dim lit room. Four words (yellow, blue, green, red) are serially presented on the screen until the participant validates an answer which is followed by a 1,500 ms interval.
Measured: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Change in Cognitive performance #2 (score)
Route Choice Assessment program (RCA) (cognitive test part 1b) Participants perform the RCA on a computer whilst sitting comfortably in a quiet and dim lit room. The RCA program is a specially designed computer program. The program contains approximately 1500 different orienteering legs.
Measured: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Secondary outcomes (4)
1000 m submaximal running performance
Lactate levels during a submaximal 1000 m run is measured to assess physiological stress during the submax test.
Measured: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Mood change
The Brunel Mood Scale (BRUMS) is used to assess mood. This questionnaire, which is based on the Profile of Mood States, contains 24 items (e.g., angry, uncertain, miserable, tired, nervous, energetic) divided into six respective subscales: anger, confusion, depression, fatigue, tension, and vigor. The items are answered on a 5-point Likert scale (0 not at all, 1 a little, 2 moderately, 3 quite a bit, 4 extremely), and each subscale, with four relevant items, can achieve a raw score in the range of 0 to 16 with a higher number indicating a stronger expression. Because of the particular interest in mental fatigue in the present study, we specify that an alteration in the subscales for fatigue and vigor is an indication of mental fatigue.
Measured: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Subjective workload change
The National Aeronautics and Space Administration Task Load Index (NASA-TLX) rating scale is used to assess subjective workload. The NASA-TLX is composed of six subscales: mental demand (How much mental and perceptual activity was required?), physical demand (How much physical activity was required?), temporal demand (How much time pressure did you feel due to the rate or pace at which the task occurred?), performance (How much successful do you think you were in accomplishing the goals of the task set by the experimenter?), effort (How hard did you have to work to accomplish your level of performance?) and frustration (How much irritating or annoying did you perceive the task?). The participants scores on each of the items on a scale divided into 20 equal intervals anchored by a bipolar descriptor (e.g. high/low). This score is multiplied by 5, resulting in a final score between 0 and 100 for each of the subscales with a higher number indicating a higher workload.
Measured: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Motivation change
Motivation is measured using the visual analogue scale (VAS) with 1 item (How motivated do you feel for the upcoming task?) The VAS scale consists of a 100-mm line anchored by a bipolar descriptor (not at all / a lot), on which participants mark their answer. Participants are instructed to answer VAS regarding their feeling of motivation for the upcoming task. The mark is transferred to a final score between 0 and 100 corresponding to the actual physical placement of the mark on the scale. A higher number indicating a high amount of motivation.
Measured: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Mar 2021
- Primary completion1 Aug 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The study is constructed as a cross-over design (Fig. 1), where participants function as their own control condition. The control condition (the first period) and the intervention (the latter period) consists of a 6 week training period, both leading up to a prioritized international competition
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Public Health, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Team Denmark
- Responsible party
- Principal investigator, Simon Lønbro, Department of Public Health, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405022
- Sponsor's protocol ID
- BET in orienteering
- Status last verified
- May 2024
- First submitted
- 16 Mar 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sport Specific Brain Endurance Training Enhance Physical and Cognitive Performance in Elite Orienteering Athletes?
- ClinicalTrials.gov ID
- NCT06405022
- Acronym / sponsor ID
- BET in orienteering
- Conditions
- Healthy
- Keywords
- Elite Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Department of Public Health, DenmarkUniversity, hospital or other
- Collaborators
- Team Denmark
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to measure the effects of a 6 week sport specific BET intervention on physical and cognitive performance parameters in elite orienteering athletes.
Detailed description
The purpose of the study is to measure the effects of a 6 week sport specific BET intervention on physical and cognitive performance parameters in elite orienteering athletes.
The study is constructed as a cross-over design, where participants function as their own control condition. The control condition (the first period) and the intervention (the latter period) consists of a 6 week training period, both leading up to a prioritized international competition. In the control condition participants will train normally leading up to the European Championships. During the intervention period participants will implement 3 sessions per week of a specially designed brain endurance program, leading up to the World Championships. To investigate the effect on all endpoints, physical and cognitive tests are conducted before and after the training periods.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is constructed as a cross-over design (Fig. 1), where participants function as their own control condition. The control condition (the first period) and the intervention (the latter period) consists of a 6 week training period, both leading up to a prioritized international competition
| Arm | Type | Receives |
|---|---|---|
| Control (CON) | Active comparator | Other: ControlThe control condition entails a six-week period. The participant will complete three regular high intensity training per week followed by 20 min of rest |
| Brain Endurance Training (BET) | Experimental | Other: Brain Endurance TrainingThe intervention period also entails a 6 week period but with three weekly blocks with a 20 min brain endurance training program following a regular high intensity training session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Danish National Team Elite Orienteering Runners
Key exclusion criteria (2 listed)
- Consent withdrawal
- Injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Endurance TrainingSix week period with three weekly blocks with a 20 min brain endurance training program following a regular HIT session. Before the HIT session questionnaires are completed to measure the motivation for the HIT session and the current state of mood. In between the HIT session and the RCA session, questionnaires are completed to measure the experienced workload of the HIT session, the current state of mood, and the motivation for following the RCA session. Immediately after the RCA session, questionnaires are completed to measure the experienced workload of the RCA session and the current state of mood. | Other | Brain Endurance Training (BET) |
| ControlNo intervention | Other | Control (CON) |
Primary outcome
Change in 5000 m run performance (time)
Time frame: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Self Paced endurance test (physical test part 1) To measure maximal self-paced endurance performance, a track and field test will be performed. This test is completed on a standard athletic track measuring 400m.
Change in Cognitive performance #1 (score)
Time frame: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Change in Inhibition task performance (cognitive test part 1a) This cognitive test consists of the Stroop colour-word task. Participants perform this task on a computer whilst sitting in a quiet and dim lit room. Four words (yellow, blue, green, red) are serially presented on the screen until the participant validates an answer which is followed by a 1,500 ms interval.
Change in Cognitive performance #2 (score)
Time frame: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Route Choice Assessment program (RCA) (cognitive test part 1b) Participants perform the RCA on a computer whilst sitting comfortably in a quiet and dim lit room. The RCA program is a specially designed computer program. The program contains approximately 1500 different orienteering legs.
4 secondary outcomes
1000 m submaximal running performance
Time frame: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Mood change
Time frame: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Subjective workload change
Time frame: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Motivation change
Time frame: At baseline, after 6 (after CON) and after 12 (after BET) weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Endurance Training in people with Healthy, run by Department of Public Health, Denmark at 1 site in Denmark.
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 1 inclusion and 2 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 8 May 2024. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in 5000 m run performance (time) (time frame: At baseline, after 6 (after CON) and after 12 (after BET) weeks). The study lists 3 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 8 May 2024.