NCT04938791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

June 4, 2021

Last Update Submit

March 30, 2022

Conditions

Keywords

RespirationPerceivedKinematicsPerformance

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Health Status

    Before isometric activity

  • Physical activity level

    Before isometric activity

Study Arms (1)

Isometric activity

EXPERIMENTAL

All participants will be included in this arm

Other: Isometric activity

Interventions

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

Also known as: Isometric task
Isometric activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Minimum age of 18 years;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Saúde da Cruz Vermelha Portuguesa - Lisboa

Lisbon, 1300-125, Portugal

Location

Related Publications (1)

  • Silva-Migueis H, Martinez-Jimenez EM, Casado-Hernandez I, Dias A, Monteiro AJ, Martins RB, Bernardes JM, Lopez-Lopez D, Gomez-Salgado J. Assessment and indicators of kinematic behavior and perceived fatigability. Rev Assoc Med Bras (1992). 2024 Feb 26;70(2):e20230924. doi: 10.1590/1806-9282.20230924. eCollection 2024.

MeSH Terms

Conditions

FatigueRespiratory Aspiration

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Study Officials

  • Daniel López López, PhD

    Universidade da Coruña

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Senior Professor

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 24, 2021

Study Start

October 1, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations