- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04029935
The Effect of Physical Fatigue on Lower Limb Functional Performance Tests in a Healthy Population
The Influence of Acute Physical Fatigue on Functional Performance Tests of the Lower Limb in a Healthy Population
The main objective of this project is:
1. To assess the influence of physical fatigue on a return-to-play test battery in a healthy population. In a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population).
The researchers will use a randomized, placebo controlled, counter-balanced, cross-over design. Twenty healthy subjects will visit the lab 3 times. On the first visit (familiarisation trial), the investigators will collect the participants' characteristics. The participants will also be familiarized to the procedures and materials of the experiment during this first visit. The second and third visit contain the experimental setup and will proceed as follows: first, the participants will fill in a pre-test checklist, a mental fatigue scale (M-VAS) and motivation scale. In the mean time a little blood will be collected from the ear lobe to determine lactate and glucose levels; also, blood pressure will be checked. Next, the subjects will carry out a functional test battery (hop test, vertical jump test, Y-balance test, and a balance reaction-time test). Session rate of perceived exertion (SRPE) is measured to indicate how fatigued the participants feel due to the test battery; also, M-VAS is collected once more, as well blood lactate, glucose and blood pressure. These measures are followed by either a physical fatigue inducing task (Modified 30 seconds Wingate protocol) or time-matched control task (sitting on the bike without pedalling). Afterwards, researchers will collect blood lactate, glucose and blood pressure two times more; participants have to fill in M-VAS (2x), perform the same test battery, and fill in the SRPE scale one more time.
Heart frequency will be measured continuously during the trials.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1050
- Vrije Universiteit Brussel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy (No neurological/cardiorespiratory/psychological/musculoskeletal disorders)
- Male and female
- No medication
- Non-smoker
- Between 18 and 35 years old
Exclusion Criteria:
- Back and/or lower extremity injuries during the past 6 months
- Bone/joint abnormalities
- Dizziness, history of loss of consciousness, any inner ear disorders
- Nervous system disorders or dysfunctions
- Uncorrected eye disorders/dysfunctions
- Illness
- Use of medication or any kind of drugs
- Use of alcohol, caffeine and heavy efforts 24 hours before each trial
- Not eating the same meal the night before and the morning of each experimental trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control Condition
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time-matched task (sitting on the bike without pedalling)
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Experimental: Physical Fatigue Condition
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Maximal cycling effort for 30s (Wingate modified)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Single-leg hop test
Time Frame: Change in single-leg hop test for distance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Single-leg hop test for distance performance
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Change in single-leg hop test for distance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Vertical jump test
Time Frame: Change in vertical jump height performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Vertical jump height performance
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Change in vertical jump height performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Y-balance test
Time Frame: Change in Y-balance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Balance and reach performance; participants have to maintain their balance while reaching as far as possible along 3 different directions.
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Change in Y-balance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Balance-reaction time test
Time Frame: Change in balance and reaction time performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Balance and reaction time performance; participants have to maintain their balance while reacting as fast as possible in 3 different directions.
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Change in balance and reaction time performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental fatigue Visual Analogue Scale (M-VAS)
Time Frame: Change in M-VAS: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
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Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
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Change in M-VAS: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
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Perception of effort (Session RPE)
Time Frame: Change in session RPE: at baseline (immediately after the first test battery), 15 min after baseline (immediately after the final test battery)
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Subjective measure of effort after completion of the test battery (scale from 0 to 10; 0 = very very easy; 10 = maximal effort)
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Change in session RPE: at baseline (immediately after the first test battery), 15 min after baseline (immediately after the final test battery)
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Self-reported motivation
Time Frame: At baseline: prior to the first test battery
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Subjective measure of motivation assessed with the self-reported Motivation scale of Matthews et al.. (the questionnaire measures 2 constructs: intrinsic motivation and task succes motivation;the questionnaire comprises 14 questions scored from 0 to 4 [0 = not all motivated, while 4 = maximally motivated].
Each construct contains 7 questions).
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At baseline: prior to the first test battery
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Blood lactate
Time Frame: Change in blood lactate: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
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Capillary blood will be collected at the ear lobe for the determination of blood lactate (determined enzymatically)
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Change in blood lactate: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
|
Blood glucose
Time Frame: Change in blood glucose: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
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Capillary blood will be collected at the ear lobe for the determination of blood glucose concentration
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Change in blood glucose: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
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Blood pressure
Time Frame: Change in blood pressure: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
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Objective measure of blood pressure via eletronic blood pressure measuring device
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Change in blood pressure: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Romain Meeusen, Professor, Vrije Universiteit Brussel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 143201939779
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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