- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06901219
The Effect of Fatigue on Static and Dynamic Balance in Healthy Young Male Athletes
March 27, 2025 updated by: Dr. Anwar Amutairi, Kuwait University
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 Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- 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
-
-
-
Safat, Kuwait, 13060
- Kuwait University
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- male and aged between 18-24 years old,
- physically active (i.e. exercised ≥ 3 times weekly during the past three months).
Exclusion Criteria:
- 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.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fatigue protocol group
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
|
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.
|
|
No Intervention: Control
Will rest for 20 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and immediately after the protocol
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|
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.
|
Baseline and immediately after the protocol
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kluger 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.
- Clark 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.
- 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.
- Bogdanis 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.
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)
March 1, 2022
Primary Completion (Actual)
May 15, 2023
Study Completion (Actual)
May 15, 2023
Study Registration Dates
First Submitted
March 16, 2025
First Submitted That Met QC Criteria
March 27, 2025
First Posted (Actual)
March 28, 2025
Study Record Updates
Last Update Posted (Actual)
March 28, 2025
Last Update Submitted That Met QC Criteria
March 27, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- no. BE-17-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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