FatigueNCT04938791
Fatigue and Kinematics During Isometric Activity of the Upper Limbs in Young and Older Adults
A study testing Isometric activity in people with Fatigue, run by Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Isometric activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Minimum age of 18 years;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde da Cruz Vermelha Portuguesa - Lisboa
Lisbon, 1300-125
About this study
Official title: Relationship Between Perceive Effort, Physiological and Kinematic Changes During Upper Limbs Isometric Activity and Its Relationship With the Socio-demographic Characteristics
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.
- Conditions
- Fatigue
- Being tested
- Isometric activity
- Keywords
- Respiration, Perceived, Kinematics, Performance
- Medical subject headings
- Fatigue, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric activityOther
Also called Isometric task
Participants will do elevation of upper limbs and mantain a 90º degree flexion position in an unsupported way.
| Study group | Role | What they receive |
|---|---|---|
| Isometric activity | Experimental | All participants will be included in this arm Receives: Other: Isometric activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: From baseline to end of activity, up to 15 minutes
Secondary outcomes (2)
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).
Measured: Before isometric activity
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.
Measured: Before isometric activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Oct 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Silva, Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa
- Investigators
- Daniel López López, PhD, Study director, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938791
- Sponsor's protocol ID
- ESSCVP_FIS01/2021
- Status last verified
- Mar 2022
- First submitted
- 4 Jun 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38422320
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Perceive Effort, Physiological and Kinematic Changes During Upper Limbs Isometric Activity and Its Relationship With the Socio-demographic Characteristics
- ClinicalTrials.gov ID
- NCT04938791
- Acronym / sponsor ID
- ESSCVP_FIS01/2021
- Conditions
- Fatigue
- Keywords
- Respiration, Perceived, Kinematics, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Escola Superior de Saude da Cruz Vermelha Portuguesa - LisboaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isometric activity | Experimental | Other: Isometric activityAll participants will be included in this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy
- Minimum age of 18 years;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric activityAlso: Isometric taskParticipants will do elevation of upper limbs and mantain a 90º degree flexion position in an unsupported way. | Other | Isometric activity |
Primary outcome
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).
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.
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.
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.
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.
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.
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.
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.
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
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
2 secondary outcomes
Health Status
Time frame: Before isometric activity
Physical activity level
Time frame: Before isometric activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 38422320Silva-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel López López, PhD study director
Universidade da Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric activity in people with Fatigue, run by Escola Superior de Saude da Cruz Vermelha Portuguesa - Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04938791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.