- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04938791
Fatigue and Kinematics During Isometric Activity of the Upper Limbs in Young and Older Adults
Relationship Between Perceive Effort, Physiological and Kinematic Changes During Upper Limbs Isometric Activity and Its Relationship With the Socio-demographic Characteristics
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Lisboa, 포르투갈, 1300-125
- Escola Superior de Saúde da Cruz Vermelha Portuguesa - Lisboa
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy
- Minimum age of 18 years;
Exclusion Criteria:
- Unable to provide written consent
- History of heart, cardiovascular and / or respiratory disease,
- Known untreated hypertension, cardiomyopathy, or exercise intolerance
- Presence of cognitive or neurological disorders
- Neuromuscular or orthopaedic disorder that limits the movement of the upper limb to 90° flexion or the maintenance of that position
- BMI ≥ 40
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Isometric activity
All participants will be included in this arm
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Participants will do elevation of upper limbs and mantain a 90º degree flexion position in an unsupported way.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in perceived effort on the Borg category-ratio 10-point scale (CR 10)
기간: From baseline to end of activity, up to 15 minutes
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The perceived effort will be measured with Borg CR 10 scale.
Possible scores range from 0 (no exertion at all) to 10 (extremely strong).
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From baseline to end of activity, up to 15 minutes
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Change from Baseline in heart rate
기간: From baseline to end of activity, up to 15 minutes
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Heart rate (heart beatings per minute) measured before and during activity to track cardiovascular changes during activity.
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From baseline to end of activity, up to 15 minutes
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Change from Baseline in respiratory rate
기간: From baseline to end of activity, up to 15 minutes
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Respiratory rate (respiratory cycles per minute) measured before and during activity to track changes in respiratory function during activity.
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From baseline to end of activity, up to 15 minutes
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Change from Baseline in heart rate variability (HRV)
기간: From baseline to end of activity, up to 15 minutes
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Interval (in milliseconds) between consecutive heartbeats measured before and during activity to track changes in autonomic function during activity.
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From baseline to end of activity, up to 15 minutes
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Change from Baseline in electrodermal activity (EDA)
기간: From baseline to end of activity, up to 15 minutes
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Electrical conductance (in microsiemens -µS) between two points of the hand over time measured before and during activity to track changes in autonomic function during activity.
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From baseline to end of activity, up to 15 minutes
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Change from Baseline in muscle action potential amplitude through surface electromyography (sEMG)
기간: From baseline to end of activity, up to 15 minutes
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Muscle action potential amplitude (in millivolts - ms) in surface electromyographic signal measured before and during activity to track muscular fatigue signs.
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From baseline to end of activity, up to 15 minutes
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Change from Baseline in muscle action potential duration through surface electromyography (sEMG)
기간: From baseline to end of activity, up to 15 minutes
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Muscle action potential duration (in milliseconds - ms) in surface electromyographic signal measured before and during activity to track muscular fatigue signs.
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From baseline to end of activity, up to 15 minutes
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Change from Baseline in muscle action potential frequency through surface electromyography (sEMG)
기간: From baseline to end of activity, up to 15 minutes
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Muscle action potential frequency (in hertz - Hz) of surface electromyographic signal measured before and during activity to track muscular fatigue signs.
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From baseline to end of activity, up to 15 minutes
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Change from Baseline in respiratory pattern through inertial motion units (IMU) from baseline and during activity
기간: From baseline to end of activity, up to 15 minutes
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Angular range of motion (in degrees) of rib cage and abdominal wall during upper limb activity measured before and during activity to track changes in respiratory pattern during activity
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From baseline to end of activity, up to 15 minutes
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Change from Baseline in upper limb motion angular acceleration through inertial motion units (IMU) system
기간: From baseline to end of activity, up to 15 minutes
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Angular acceleration (in m/s^2) of the arm measured before and during activity to track small movements of upper limb during isometric activity
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From baseline to end of activity, up to 15 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Health Status
기간: Before isometric activity
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Health Status will be measured with Medical Outcomes Study (MOS) Short Form Health Survey 36 Item version 2 which measure health status of populations and individuals.
Possible scores range from 0 0 (worst health status) to 100 (best health status).
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Before isometric activity
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Physical activity level
기간: Before isometric activity
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Physical activity level will be measured using European Prospective Investigation into Cancer and Nutrition Physical Activity Questionnaire (EPIC-PAQ) that allows to estimate energy expenditure through self-report assessment of the intensity and average duration (per day, week and month) of physical activity performed by the participants in three distinct dimensions (professional, domestic and leisure). Participants are classified as ACTIVE if they perform: at least 150 minutes per week of moderate physical activity; OR at least 75 minutes per week of vigorous physical activity; OR at least 150 minutes per week of a combination of moderate-intensity activity. If they don't present any of the conditions described, they will be categorized as SEDENTARY. |
Before isometric activity
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공동 작업자 및 조사자
수사관
- 연구 책임자: Daniel López López, PhD, Universidade da Coruña
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 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. .