- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04030390
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Brussels, Belgia, 1050
- Vrije Universiteit Brussel
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Kontrolltilstand
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tidstilpasset oppgave (sitte på sykkelen uten å tråkke)
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Eksperimentell: Fysisk utmattelsestilstand
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Maksimal sykkelinnsats i 30-årene (Wingate modifisert)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Test av balanse-reaksjonstid
Tidsramme: Endring i balanse og reaksjonstid ytelse: fra baseline og 20 minutter etter baseline (umiddelbart etter de tildelte intervensjonene)
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Balanse og reaksjonstid ytelse; Deltakerne må opprettholde balansen mens de reagerer så raskt som mulig i 3 forskjellige retninger.
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Endring i balanse og reaksjonstid ytelse: fra baseline og 20 minutter etter baseline (umiddelbart etter de tildelte intervensjonene)
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Y-balance test
Tidsramme: 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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EEG power spectrum analysis
Tidsramme: Change in EEG power spectrum: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Brain activity during the Y-balance test and balance-reaction time test will be registered at baseline and immediately after the assigned interventions.
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Change in EEG power spectrum: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Selvrapportert motivasjon
Tidsramme: Ved baseline: før det første testbatteriet
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Subjektivt mål på motivasjon vurdert med den selvrapporterte Motivasjonsskalaen til Matthews et al.. (spørreskjemaet måler 2 konstruksjoner: indre motivasjon og oppgavesuksessmotivasjon; spørreskjemaet består av 14 spørsmål scoret fra 0 til 4 [0 = ikke alle motiverte, mens 4 = maksimalt motivert].
Hver konstruksjon inneholder 7 spørsmål).
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Ved baseline: før det første testbatteriet
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Mental fatigue Visual Analogue Scale (M-VAS)
Tidsramme: 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)
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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 two balance tests), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final 2 balance tests)
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Perception of effort (Session RPE)
Tidsramme: 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)
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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 two balance tests), and 15 min after baseline (immediately after the final 2 balance tests)
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Blood lactate
Tidsramme: 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
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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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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
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Blood glucose
Tidsramme: 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)
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Capillary blood will be collected at the ear lobe for the determination of blood glucose concentration
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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)
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Blood pressure
Tidsramme: 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)
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Objective measure of blood pressure via eletronic blood pressure measuring device
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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)
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Romain Meeusen, Professor, Vrije Universiteit Brussel
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 143201939780
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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