- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lisboa, Portugal, 1300-125
- Escola Superior de Saúde da Cruz Vermelha Portuguesa - Lisboa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in perceived effort on the Borg category-ratio 10-point scale (CR 10)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Status
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Investigators
- Study Director: Daniel López López, PhD, Universidade da Coruña
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESSCVP_FIS01/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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