The Effect of Physical Fatigue on Different Balance Tests and Brain Activity in a Healthy Population
The Influence of Acute Physical Fatigue on Different Balance Tests and Brain Activity During These Balance Tests in a Healthy Population
The main objective of this project is:
1. To assess the influence of physical fatigue on brain functioning during a balance and reaction time task 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 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 Y-balance test and balance reaction time test, and fill in the SRPE scale one more time. Heart frequency and EEG will be measured continuously during the trials.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Brussels, Belgique, 1050
- Vrije Universiteit Brussel
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Condition de contrôle
|
tâche chronométrée (assis sur le vélo sans pédaler)
|
|
Expérimental: État de fatigue physique
|
Effort cycliste maximal pendant 30 secondes (Wingate modifié)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Test de temps de réaction d'équilibre
Délai: Modification de la performance de l'équilibre et du temps de réaction : depuis la ligne de base et 20 minutes après la ligne de base (immédiatement après les interventions assignées)
|
Performances d'équilibre et de temps de réaction ; les participants doivent maintenir leur équilibre tout en réagissant le plus rapidement possible dans 3 directions différentes.
|
Modification de la performance de l'équilibre et du temps de réaction : depuis la ligne de base et 20 minutes après la ligne de base (immédiatement après les interventions assignées)
|
|
Y-balance test
Délai: Change in Y-balance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
|
Balance and reach performance; participants have to maintain their balance while reaching as far as possible along 3 different directions
|
Change in Y-balance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
|
|
EEG power spectrum analysis
Délai: Change in EEG power spectrum: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
|
Brain activity during the Y-balance test and balance-reaction time test will be registered at baseline and immediately after the assigned interventions.
|
Change in EEG power spectrum: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Motivation autodéclarée
Délai: Au départ : avant la première batterie de tests
|
Mesure subjective de la motivation évaluée avec l'échelle de motivation auto-déclarée de Matthews et al. 4 = motivé au maximum].
Chaque construction contient 7 questions).
|
Au départ : avant la première batterie de tests
|
|
Mental fatigue Visual Analogue Scale (M-VAS)
Délai: Change in M-VAS: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final 2 balance tests)
|
Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
|
Change in M-VAS: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final 2 balance tests)
|
|
Perception of effort (Session RPE)
Délai: Change in session RPE: at baseline (immediately after the first two balance tests), and 15 min after baseline (immediately after the final 2 balance tests)
|
Subjective measure of effort after completion of the test battery (scale from 0 to 10; 0 = very very easy; 10 = maximal effort)
|
Change in session RPE: at baseline (immediately after the first two balance tests), and 15 min after baseline (immediately after the final 2 balance tests)
|
|
Blood lactate
Délai: Blood lactate changes: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests
|
Capillary blood will be collected at the ear lobe for the determination of blood lactate (determined enzymatically)
|
Blood lactate changes: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests
|
|
Blood glucose
Délai: Blood glucose changes: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests)
|
Capillary blood will be collected at the ear lobe for the determination of blood glucose concentration
|
Blood glucose changes: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests)
|
|
Blood pressure
Délai: Blood pressure change: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests)
|
Objective measure of blood pressure via eletronic blood pressure measuring device
|
Blood pressure change: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Romain Meeusen, Professor, Vrije Universiteit Brussel
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 143201939780
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .