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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Brussels、ベルギー、1050
- Vrije Universiteit Brussel
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：制御条件
|
時間に合わせたタスク（ペダルを踏まずに自転車に座る）
|
|
実験的：肉体的な疲労状態
|
30 秒間の最大サイクリング努力 (Wingate 修正)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
平衡反応時間試験
時間枠：バランスと反応時間のパフォーマンスの変化: ベースラインからおよびベースラインから 20 分後 (割り当てられた介入の直後)
|
バランスと反応時間のパフォーマンス。参加者はバランスを維持しながら、3 つの異なる方向にできるだけ早く反応する必要があります。
|
バランスと反応時間のパフォーマンスの変化: ベースラインからおよびベースラインから 20 分後 (割り当てられた介入の直後)
|
|
Y-balance test
時間枠：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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
自己申告による志望動機
時間枠：ベースライン時: 最初のテストバッテリーの前
|
Matthews らの自己申告のモチベーション スケールで評価されたモチベーションの主観的な尺度。 (アンケートでは、内発的モチベーションとタスク成功モチベーションの 2 つの構成要素が測定されます。アンケートは、0 から 4 までのスコアが付いた 14 の質問で構成されています [0 = 全員がモチベーションを持っているわけではありません、一方、 4 = 最大限のモチベーションがある]。
各構成には 7 つの質問が含まれています)。
|
ベースライン時: 最初のテストバッテリーの前
|
|
Mental fatigue Visual Analogue Scale (M-VAS)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
捜査官
- 主任研究者：Romain Meeusen, Professor、Vrije Universiteit Brussel
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 143201939780
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。