FatigueNCT06458166
Associations Between Low Frequency Fatigue, Jump Height and Perceptual Measures of Muscle Soreness, Fatigue and Recovery
An observational study of Fatigue and Physical Exercise, run by University of Maia at 1 site in Portugal.
Trial summary
Over the recent years, the increased competitive demands in elite competitive athletes has sparked a heightened interest in monitoring fatigue. Given the nature of the soccer game, athletes may experience low-frequency fatigue. Until recently, this assessment was restricted to in-lab. Read more about this study
- Who is it for?
- Ages 16 to 21 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Physical Exercise
- What is being tested?
- Assessment of low frequency fatigue using low frequency eletrical stimulation
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jul 2024to 30 Sep 2024
- Phase
- Observational
- 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 16 to 21 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Players at the highest division of the portuguese national championships in their respective age group.
Who may be able to join
- Elite level youth soccer players, competing in the highest portuguese division
Who cannot join
- Older adults
- none elite soccer player
- Play less than 70 minutes of match
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
University of Maia
Maia, Porto District
Filipe Maia, 914957798, fm.filipemaia@gmail.com
About this study
Official title: Associations Between Low Frequency Fatigue, Jump Height and Perceptual Measures of Muscle Soreness, Fatigue and Recovery in Youth Elite Soccer Players
Over the recent years, the increased competitive demands in elite competitive athletes has sparked a heightened interest in monitoring fatigue. Given the nature of the soccer game, athletes may experience low-frequency fatigue. Until recently, this assessment was restricted to in-lab. However, the emergence of new instruments aiming to allow low-frequency assessment to be carried out on a daily basis, in the context of professional teams. This study aimed to analyze the recovery of low-frequency fatigue, jump height and perceptual responses following competition and investigate possible associations between the objective and subjective parameters.
- Conditions
- Fatigue, Physical Exercise
- Being tested
- Assessment of low frequency fatigue using low frequency eletrical stimulation
- Keywords
- sports, soccer, low frequency fatigue
- Medical subject headings
- Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of low frequency fatigue using low frequency eletrical stimulationOther
Pre-programmed muscle electrical stimuli will be applied via Myocene® software using 3 electrodes: 1 cathode (5 x 10 cm) placed transversely over the proximal quadriceps femoris, and 2 anodes (5 x 5 cm) over the distal vastus medialis and vastus lateralis. Sixteen sets of stimuli will be administered with 5 seconds between sets. Each set consists of a single pulse, a train of 5 stimuli at 20 Hz, and a train of 18 stimuli at 120 Hz, with 1-second intervals between. The stimulation intensity starts at 25 mA and increases by 1 mA per set, reaching 40 mA in the final set. The Myocene® software calculates the ratio of low- to high-frequency evoked forces within each set. The outcome (Powerdex) is the median value of these 16 ratios for each leg. This evaluation will be conducted on both legs, taking 2 minutes per leg.
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Low frequency fatigue measured using Myocene (eletrical stimulus and force measurement)
Assessment using myocene. Muscles are stimulated with low-frequency electrical pulses. The response of the muscle (force or torque) output, is recorded. A decrease in force output compared to baseline levels indicates fatigue.
Measured: 2 hours before the match; 30 minutes following the match, 24 hours following the match; 48 hours following the match
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion21 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filipe Silvano Pinto Maia, University of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458166
- Sponsor's protocol ID
- ST_S_
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Low Frequency Fatigue, Jump Height and Perceptual Measures of Muscle Soreness, Fatigue and Recovery in Youth Elite Soccer Players
- ClinicalTrials.gov ID
- NCT06458166
- Acronym / sponsor ID
- ST_S_
- Conditions
- Fatigue, Physical Exercise
- Keywords
- sports, soccer, low frequency fatigue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MaiaUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 21 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 13 Jun 2024 (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.
Over the recent years, the increased competitive demands in elite competitive athletes has sparked a heightened interest in monitoring fatigue. Given the nature of the soccer game, athletes may experience low-frequency fatigue. Until recently, this assessment was restricted to in-lab. However, the emergence of new instruments aiming to allow low-frequency assessment to be carried out on a daily basis, in the context of professional teams. This study aimed to analyze the recovery of low-frequency fatigue, jump height and perceptual responses following competition and investigate possible associations between the objective and subjective parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 21 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Players at the highest division of the portuguese national championships in their respective age group.
Key inclusion criteria (1 listed)
- Elite level youth soccer players, competing in the highest portuguese division
Key exclusion criteria (3 listed)
- Older adults
- none elite soccer player
- Play less than 70 minutes of match
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 |
|---|---|---|
| Assessment of low frequency fatigue using low frequency eletrical stimulationPre-programmed muscle electrical stimuli will be applied via Myocene® software using 3 electrodes: 1 cathode (5 x 10 cm) placed transversely over the proximal quadriceps femoris, and 2 anodes (5 x 5 cm) over the distal vastus medialis and vastus lateralis. Sixteen sets of stimuli will be administered with 5 seconds between sets. Each set consists of a single pulse, a train of 5 stimuli at 20 Hz, and a train of 18 stimuli at 120 Hz, with 1-second intervals between. The stimulation intensity starts at 25 mA and increases by 1 mA per set, reaching 40 mA in the final set. The Myocene® software calculates the ratio of low- to high-frequency evoked forces within each set. The outcome (Powerdex) is the median value of these 16 ratios for each leg. This evaluation will be conducted on both legs, taking 2 minutes per leg. | Other | – |
Primary outcome
Differences in Low frequency fatigue measured using Myocene (eletrical stimulus and force measurement)
Time frame: 2 hours before the match; 30 minutes following the match, 24 hours following the match; 48 hours following the match
Assessment using myocene. Muscles are stimulated with low-frequency electrical pulses. The response of the muscle (force or torque) output, is recorded. A decrease in force output compared to baseline levels indicates fatigue.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Physical Exercise, run by University of Maia 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filipe Maia (22 986 6000, FMAIA.dcd@umaia.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Low frequency fatigue measured using Myocene (eletrical stimulus and force measurement) (time frame: 2 hours before the match; 30 minutes following the match, 24 hours following the match; 48 hours following the match). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2024.