FatigueNCT06901219
The Effect of Fatigue on Static and Dynamic Balance in Healthy Young Male Athletes
A study testing Running Fatigue Protocol in people with Fatigue, run by Kuwait University at 1 site in Kuwait.
Trial summary
Participants were randomized into control and experimental groups. They were examined on static and dynamic balance (pre- \& post-tests). Then, the experimental group went through a fatigue protocol, in which speed and incline increase one unit each minute passing, and stopped when rate of perceived exertion level… Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Running Fatigue Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Mar 2022to 15 May 2023
- 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 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and aged between 18-24 years old,
- physically active (i.e. exercised ≥ 3 times weekly during the past three months).
Who cannot join
- reported a minor injury in the past two months,
- major injury in the past 12 months, and/or underwent a major primary surgery in their lower limb.
Trial locations and contacts
1 site in 1 country.
About this study
Participants were randomized into control and experimental groups. They were examined on static and dynamic balance (pre- \& post-tests). Then, the experimental group went through a fatigue protocol, in which speed and incline increase one unit each minute passing, and stopped when rate of perceived exertion level reached ≥ 18, and the plasma lactate level differed from the baseline by ≥ 4mmol/L.
- Conditions
- Fatigue
- Being tested
- Running Fatigue Protocol
- Keywords
- Static Balance, Athletes, Dynamic Balance, Lactate
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Running Fatigue ProtocolBehavioural
The experimental group went through a fatigue protocol, in which speed and incline increase one unit each minute passing, and stopped when rate of perceived exertion level reached ≥ 18, and the plasma lactate level differed from the baseline by ≥ 4mmol/L.
| Study group | Role | What they receive |
|---|---|---|
| Fatigue protocol group | Experimental | The experimental group went through a fatigue protocol, in which speed and incline increase one unit each minute passing, and stopped when rate of perceived exertion level reached ≥ 18, and the plasma lactate level differed from the baseline by ≥ 4mmol/L Receives: Behavioral: Running Fatigue Protocol |
| Control | No intervention | Will rest for 20 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance
Dynamic postural balance was measured using Y-balance (YB). A test designed to examine the ability to maintain postural stability in dynamic conditions. In this test, participants would single-leg stand on a block (start with left) and were instructed to push another block with their other leg as far as they can without losing their balance (i.e. placing their leg on the ground), while having their hands on their hips. The free blocks are placed anteriorly and posterolaterally of the participant in both directions, creating a Y shape with the stable block on the intersection of these lines. Distance reached was recorded for each direction. The directions of the test were anterior, posteromedial, posterolateral (pushing on the contralateral side). Then, the participants were asked to switch their feet and preform the task again; six trials in total were recorded to minimize learning effect.
Measured: Baseline and immediately after the protocol
Static balance
Static balance (SB) testing was performed using virtual reality interactive gaming system (Wii balance board (WBB) [Nintendo, Kyoto, Japan]). The WBB contains four strain gauge-based load sensors, qualified to obtain center of pressure movement, which makes it valid and reliable to measure posture stability5. The participants were asked to perform stand quietly with their hand on their sides with both legs with equal weight-bearing and on a single-leg stance on the right leg, then on the left leg. All postures were performed under two conditions: open eyes and closed eyes.
Measured: Baseline and immediately after the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Mar 2022
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuwait University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anwar Amutairi, Kuwait University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901219
- Sponsor's protocol ID
- no. BE-17-14
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wikstrom EA. Validity and reliability of Nintendo Wii Fit balance scores. J Athl Train. 2012 May-Jun;47(3):306-13. doi: 10.4085/1062-6050-47.3.16.
PubMed 22892412Clark RA, Mentiplay BF, Pua YH, Bower KJ. Reliability and validity of the Wii Balance Board for assessment of standing balance: A systematic review. Gait Posture. 2018 Mar;61:40-54. doi: 10.1016/j.gaitpost.2017.12.022. Epub 2017 Dec 30.
PubMed 29304510Kluger BM, Krupp LB, Enoka RM. Fatigue and fatigability in neurologic illnesses: proposal for a unified taxonomy. Neurology. 2013 Jan 22;80(4):409-16. doi: 10.1212/WNL.0b013e31827f07be.
PubMed 23339207Bogdanis GC. Effects of physical activity and inactivity on muscle fatigue. Front Physiol. 2012 May 18;3:142. doi: 10.3389/fphys.2012.00142. eCollection 2012.
PubMed 22629249Almutairi AB, Alabdulwahab A, Alkhalidi M, Alnouri S, Alkatan M. The effect of fatigue on static and dynamic balance in healthy young male athletes: a randomized trial. BMC Sports Sci Med Rehabil. 2025 Oct 31;17(1):316. doi: 10.1186/s13102-025-01363-4.
PubMed 41174785
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fatigue on Static and Dynamic Balance in Healthy Young Male Athletes
- ClinicalTrials.gov ID
- NCT06901219
- Acronym / sponsor ID
- no. BE-17-14
- Conditions
- Fatigue
- Keywords
- Static Balance, Athletes, Dynamic Balance, Lactate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kuwait UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 28 Mar 2025 (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.
Participants were randomized into control and experimental groups. They were examined on static and dynamic balance (pre- \& post-tests). Then, the experimental group went through a fatigue protocol, in which speed and incline increase one unit each minute passing, and stopped when rate of perceived exertion level reached ≥ 18, and the plasma lactate level differed from the baseline by ≥ 4mmol/L.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatigue protocol group | Experimental | Behavioral: Running Fatigue ProtocolThe experimental group went through a fatigue protocol, in which speed and incline increase one unit each minute passing, and stopped when rate of perceived exertion level reached ≥ 18, and the plasma lactate level differed from the baseline by ≥ 4mmol/L |
| Control | No intervention | –Will rest for 20 minutes |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male and aged between 18-24 years old,
- physically active (i.e. exercised ≥ 3 times weekly during the past three months).
Key exclusion criteria (2 listed)
- reported a minor injury in the past two months,
- major injury in the past 12 months, and/or underwent a major primary surgery in their lower limb.
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 |
|---|---|---|
| Running Fatigue ProtocolThe experimental group went through a fatigue protocol, in which speed and incline increase one unit each minute passing, and stopped when rate of perceived exertion level reached ≥ 18, and the plasma lactate level differed from the baseline by ≥ 4mmol/L. | Behavioural | Fatigue protocol group |
Primary outcome
Dynamic Balance
Time frame: Baseline and immediately after the protocol
Dynamic postural balance was measured using Y-balance (YB). A test designed to examine the ability to maintain postural stability in dynamic conditions. In this test, participants would single-leg stand on a block (start with left) and were instructed to push another block with their other leg as far as they can without losing their balance (i.e. placing their leg on the ground), while having their hands on their hips. The free blocks are placed anteriorly and posterolaterally of the participant in both directions, creating a Y shape with the stable block on the intersection of these lines. Distance reached was recorded for each direction. The directions of the test were anterior, posteromedial, posterolateral (pushing on the contralateral side). Then, the participants were asked to switch their feet and preform the task again; six trials in total were recorded to minimize learning effect.
Static balance
Time frame: Baseline and immediately after the protocol
Static balance (SB) testing was performed using virtual reality interactive gaming system (Wii balance board (WBB) [Nintendo, Kyoto, Japan]). The WBB contains four strain gauge-based load sensors, qualified to obtain center of pressure movement, which makes it valid and reliable to measure posture stability5. The participants were asked to perform stand quietly with their hand on their sides with both legs with equal weight-bearing and on a single-leg stance on the right leg, then on the left leg. All postures were performed under two conditions: open eyes and closed eyes.
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 28 Mar 2025.
- Background: PubMed 22892412Wikstrom EA. Validity and reliability of Nintendo Wii Fit balance scores. J Athl Train. 2012 May-Jun;47(3):306-13. doi: 10.4085/1062-6050-47.3.16.
- Background: PubMed 29304510Clark RA, Mentiplay BF, Pua YH, Bower KJ. Reliability and validity of the Wii Balance Board for assessment of standing balance: A systematic review. Gait Posture. 2018 Mar;61:40-54. doi: 10.1016/j.gaitpost.2017.12.022. Epub 2017 Dec 30.
- Background: PubMed 23339207Kluger BM, Krupp LB, Enoka RM. Fatigue and fatigability in neurologic illnesses: proposal for a unified taxonomy. Neurology. 2013 Jan 22;80(4):409-16. doi: 10.1212/WNL.0b013e31827f07be.
- Background: PubMed 22629249Bogdanis GC. Effects of physical activity and inactivity on muscle fatigue. Front Physiol. 2012 May 18;3:142. doi: 10.3389/fphys.2012.00142. eCollection 2012.
- Derived from this study: PubMed 41174785Almutairi AB, Alabdulwahab A, Alkhalidi M, Alnouri S, Alkatan M. The effect of fatigue on static and dynamic balance in healthy young male athletes: a randomized trial. BMC Sports Sci Med Rehabil. 2025 Oct 31;17(1):316. doi: 10.1186/s13102-025-01363-4.
- Individual participant dataSharing planned: No
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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 Running Fatigue Protocol in people with Fatigue, run by Kuwait University at 1 site in Kuwait.
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 2 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 28 Mar 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 Kuwait. 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?
Dynamic Balance (time frame: Baseline and immediately after the protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06901219, which also lists 5 linked publications.
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 28 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.