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Fatigue and Kinematics During Isometric Activity of the Upper Limbs in Young and Older Adults

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ClinicalTrials.gov Identifier: NCT04938791
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Helena Silva, Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa

Brief 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.

Condition or disease Intervention/treatment Phase
Fatigue Other: Isometric activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Relationship Between Perceive Effort, Physiological and Kinematic Changes During Upper Limbs Isometric Activity and Its Relationship With the Socio-demographic Characteristics
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Isometric activity
All participants will be included in this arm
Other: Isometric activity
Participants will do elevation of upper limbs and mantain a 90º degree flexion position in an unsupported way.
Other Name: Isometric task




Primary Outcome Measures :
  1. 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 ]
    The perceived effort will be measured with Borg CR 10 scale. Possible scores range from 0 (no exertion at all) to 10 (extremely strong).

  2. Change from Baseline in heart rate [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Heart rate (heart beatings per minute) measured before and during activity to track cardiovascular changes during activity.

  3. Change from Baseline in respiratory rate [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Respiratory rate (respiratory cycles per minute) measured before and during activity to track changes in respiratory function during activity.

  4. Change from Baseline in heart rate variability (HRV) [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Interval (in milliseconds) between consecutive heartbeats measured before and during activity to track changes in autonomic function during activity.

  5. Change from Baseline in electrodermal activity (EDA) [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    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.

  6. Change from Baseline in muscle action potential amplitude through surface electromyography (sEMG) [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Muscle action potential amplitude (in millivolts - ms) in surface electromyographic signal measured before and during activity to track muscular fatigue signs.

  7. Change from Baseline in muscle action potential duration through surface electromyography (sEMG) [ Time Frame: From baseline to end of activity, up to 15 minutes ]
    Muscle action potential duration (in milliseconds - ms) in surface electromyographic signal measured before and during activity to track muscular fatigue signs.

  8. Change from Baseline in muscle action potential frequency through surface electromyography (sEMG) [ Time Frame: 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.

  9. 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 ]
    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

  10. 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 ]
    Angular acceleration (in m/s^2) of the arm measured before and during activity to track small movements of upper limb during isometric activity


Secondary Outcome Measures :
  1. Health Status [ Time Frame: Before isometric activity ]
    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).

  2. Physical activity level [ Time Frame: Before isometric activity ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04938791


Contacts
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Contact: Helena Silva Migueis, MSc 917988595 hsilva@esscvp.eu

Locations
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Portugal
Escola Superior de Saúde da Cruz Vermelha Portuguesa - Lisboa Recruiting
Lisboa, Portugal, 1300-125
Contact: Helena Silva Migueis, MSc    +351917988595    hsilva@esscvp.eu   
Sponsors and Collaborators
Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa
Investigators
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Study Director: Daniel López López, PhD Universidade da Coruña
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Responsible Party: Helena Silva, Associate Senior Professor, Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa
ClinicalTrials.gov Identifier: NCT04938791    
Other Study ID Numbers: ESSCVP_FIS01/2021
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helena Silva, Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa:
Respiration
Perceived
Kinematics
Performance
Additional relevant MeSH terms:
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Fatigue