NCT06901219

Brief 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 reached ≥ 18, and the plasma lactate level differed from the baseline by ≥ 4mmol/L.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

March 16, 2025

Last Update Submit

March 27, 2025

Conditions

Keywords

Static BalanceAthletesDynamic BalanceLactate

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and immediately after the protocol

Study Arms (2)

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

Behavioral: Running Fatigue Protocol

Control

NO INTERVENTION

Will rest for 20 minutes

Interventions

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.

Fatigue protocol group

Eligibility Criteria

Age18 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male and aged between 18-24 years old,
  • physically active (i.e. exercised ≥ 3 times weekly during the past three months).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuwait University

Safat, 13060, Kuwait

Location

Related Publications (5)

  • 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.

    PMID: 22892412BACKGROUND
  • 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.

    PMID: 29304510BACKGROUND
  • 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.

    PMID: 23339207BACKGROUND
  • 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.

    PMID: 22629249BACKGROUND
  • Almutairi 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.

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 16, 2025

First Posted

March 28, 2025

Study Start

March 1, 2022

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations