- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Lisboa, Portugalia, 1300-125
- Escola Superior de Saúde da Cruz Vermelha Portuguesa - Lisboa
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from Baseline in perceived effort on the Borg category-ratio 10-point scale (CR 10)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Health Status
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Śledczy
- Dyrektor Studium: Daniel López López, PhD, Universidade da Coruña
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ESSCVP_FIS01/2021
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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