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

Primary Purpose

Fatigue

Status

Completed

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Isometric activity

About this trial

This is an interventional basic science trial for Fatigue focused on measuring Respiration, Perceived, Kinematics, Performance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Escola Superior de Saúde da Cruz Vermelha Portuguesa - Lisboa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Isometric activity

Arm Description

All participants will be included in this arm

Outcomes

Primary Outcome Measures

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).

Change from Baseline in heart rate

Heart rate (heart beatings per minute) measured before and during activity to track cardiovascular changes during activity.

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.

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.

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.

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.

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.

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.

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

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

Secondary Outcome Measures

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).

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.

Full Information

NCT ID

NCT04938791

First Posted

June 4, 2021

Last Updated

March 30, 2022

Sponsor

Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa

1. Study Identification

Unique Protocol Identification Number

NCT04938791

Brief Title

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

Official Title

Relationship Between Perceive Effort, Physiological and Kinematic Changes During Upper Limbs Isometric Activity and Its Relationship With the Socio-demographic Characteristics

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

February 28, 2022 (Actual)

Study Completion Date

February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue

Keywords

Respiration, Perceived, Kinematics, Performance

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Isometric activity

Arm Type

Experimental

Arm Description

All participants will be included in this arm

Intervention Type

Other

Intervention Name(s)

Isometric activity

Other Intervention Name(s)

Isometric task

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Baseline in perceived effort on the Borg category-ratio 10-point scale (CR 10)

Description

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

Time Frame