Clinical trial NCT04029935: The Effect of Physical Fatigue on Lower Limb Functional Performance Tests in a Healthy Population
Official title: The Influence of Acute Physical Fatigue on Functional Performance Tests of the Lower Limb in a Healthy Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Fatigue
Return to Sport
Injury Prevention
Functional Performance
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Single-leg hop test
timeFrame: Change in single-leg hop test for distance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
measure: Vertical jump test
timeFrame: Change in vertical jump height performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
measure: Y-balance test
timeFrame: Change in Y-balance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
measure: Balance-reaction time test
timeFrame: Change in balance and reaction time performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Secondary outcomes:
measure: Mental fatigue Visual Analogue Scale (M-VAS)
timeFrame: 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)
measure: Perception of effort (Session RPE)
timeFrame: Change in session RPE: at baseline (immediately after the first test battery), 15 min after baseline (immediately after the final test battery)
measure: Self-reported motivation
timeFrame: At baseline: prior to the first test battery
measure: Blood lactate
timeFrame: 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)
measure: Blood glucose
timeFrame: 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)
measure: Blood pressure
timeFrame: 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)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Vrije Universiteit Brussel
Study officials:
affiliation: Vrije Universiteit Brussel
name: Romain Meeusen, Professor
role: PRINCIPAL_INVESTIGATOR
References: