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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04938791
Other study ID # ESSCVP_FIS01/2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date February 28, 2022

Study information

Verified date March 2022
Source Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to understand the relationship between perceived effort and physiological and kinematic variables caused by isometric activity of the upper limbs, as well as its relationship with socio-demographic characteristics, level of activity and quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Isometric activity
Participants will do elevation of upper limbs and mantain a 90º degree flexion position in an unsupported way.

Locations

Country Name City State
Portugal Escola Superior de Saúde da Cruz Vermelha Portuguesa - Lisboa Lisboa

Sponsors (1)

Lead Sponsor Collaborator
Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in perceived effort on the Borg category-ratio 10-point scale (CR 10) The perceived effort will be measured with Borg CR 10 scale. Possible scores range from 0 (no exertion at all) to 10 (extremely strong). From baseline to end of activity, up to 15 minutes
Primary Change from Baseline in heart rate Heart rate (heart beatings per minute) measured before and during activity to track cardiovascular changes during activity. From baseline to end of activity, up to 15 minutes
Primary Change from Baseline in respiratory rate Respiratory rate (respiratory cycles per minute) measured before and during activity to track changes in respiratory function during activity. From baseline to end of activity, up to 15 minutes
Primary Change from Baseline in heart rate variability (HRV) Interval (in milliseconds) between consecutive heartbeats measured before and during activity to track changes in autonomic function during activity. From baseline to end of activity, up to 15 minutes
Primary Change from Baseline in electrodermal activity (EDA) 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. From baseline to end of activity, up to 15 minutes
Primary Change from Baseline in muscle action potential amplitude through surface electromyography (sEMG) Muscle action potential amplitude (in millivolts - ms) in surface electromyographic signal measured before and during activity to track muscular fatigue signs. From baseline to end of activity, up to 15 minutes
Primary Change from Baseline in muscle action potential duration through surface electromyography (sEMG) Muscle action potential duration (in milliseconds - ms) in surface electromyographic signal measured before and during activity to track muscular fatigue signs. From baseline to end of activity, up to 15 minutes
Primary Change from Baseline in muscle action potential frequency through surface electromyography (sEMG) Muscle action potential frequency (in hertz - Hz) of surface electromyographic signal measured before and during activity to track muscular fatigue signs. From baseline to end of activity, up to 15 minutes
Primary Change from Baseline in respiratory pattern through inertial motion units (IMU) from baseline and during activity 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 From baseline to end of activity, up to 15 minutes
Primary Change from Baseline in upper limb motion angular acceleration through inertial motion units (IMU) system Angular acceleration (in m/s^2) of the arm measured before and during activity to track small movements of upper limb during isometric activity From baseline to end of activity, up to 15 minutes
Secondary Health Status 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). Before isometric activity
Secondary Physical activity level 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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