- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Lisboa, Portugal, 1300-125
- Escola Superior de Saúde da Cruz Vermelha Portuguesa - Lisboa
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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
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in perceived effort on the Borg category-ratio 10-point scale (CR 10)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: From baseline to end of activity, up to 15 minutes
|
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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Health Status
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Daniel López López, PhD, Universidade da Coruña
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ESSCVP_FIS01/2021
Plan for individuelle deltakerdata (IPD)
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