- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Brussels, 벨기에, 1050
- Vrije Universiteit Brussel
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 제어 조건
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시간 일치 작업(페달을 밟지 않고 자전거에 앉기)
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실험적: 육체적 피로 상태
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30초 동안 최대 사이클링 노력(Wingate 수정됨)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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균형 반응 시간 테스트
기간: 균형 및 반응 시간 성능의 변화: 기준선에서 기준선 후 20분(지정된 개입 직후)
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균형 및 반응 시간 성능 참가자는 3가지 방향에서 최대한 빠르게 반응하면서 균형을 유지해야 합니다.
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균형 및 반응 시간 성능의 변화: 기준선에서 기준선 후 20분(지정된 개입 직후)
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Y-balance test
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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자기보고 동기
기간: 기준선에서: 첫 번째 테스트 배터리 이전
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Matthews 등의 자가 보고 동기 척도로 평가된 동기 부여의 주관적 척도. 4 = 최대한 동기부여됨].
각 구조에는 7개의 질문이 포함되어 있습니다.)
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기준선에서: 첫 번째 테스트 배터리 이전
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Mental fatigue Visual Analogue Scale (M-VAS)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Romain Meeusen, Professor, Vrije Universiteit Brussel
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 143201939780
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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