- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Lisboa, Portogallo, 1300-125
- Escola Superior de Saúde da Cruz Vermelha Portuguesa - Lisboa
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from Baseline in perceived effort on the Borg category-ratio 10-point scale (CR 10)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Health Status
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Direttore dello studio: Daniel López López, PhD, Universidade da Coruña
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ESSCVP_FIS01/2021
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .