Fatigue IntensityNCT06913036
Myocene Sensivity to Cycling Intensities
A study testing Low-frequency fatigue - Myocene in people with Fatigue Intensity, run by University of Maia.
Trial summary
This study aims to address this gap by assessing LFF following different efforts in cycling, aiming to identify a pattern. Also, we expect that this study helps to clarify to which efforts (prolonged vs short) are more likely to trigger substantial changes in LFF responses. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue Intensity
- What is being tested?
- Low-frequency fatigue - Myocene
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Road cyclists
Who cannot join
- Injured or recently injured participants
About this study
Official title: Muscular Response to Short vs. Prolonged Cycling: A Crossover Trial on Low-Frequency Fatigue Sensitivity
This study aims to address this gap by assessing LFF following different efforts in cycling, aiming to identify a pattern. Also, we expect that this study helps to clarify to which efforts (prolonged vs short) are more likely to trigger substantial changes in LFF responses.
- Conditions
- Fatigue Intensity
- Being tested
- Low-frequency fatigue - Myocene
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-frequency fatigue - MyoceneDevice
Low frequency fatigue will be measured using Myocene
| Study group | Role | What they receive |
|---|---|---|
| 4 minutes all-out | Experimental | 4 minute time trial all-out Receives: Device: Low-frequency fatigue - Myocene |
| 30 minute all-out | Experimental | 30 minute cycling all-out Receives: Device: Low-frequency fatigue - Myocene |
What is being measured
The primary outcome is the main question the study is designed to answer.
low-frequency fatigue
Low-frequency fatigue assessed using Myocene software, which computes the median value of the ratio between high and low frequency stimulations
Measured: Baseline, 30 minutes post, 24 hours post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue IntensityStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT06913036
- Sponsor's protocol ID
- Myo_sens_001
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2025
- Last updated
- 6 Apr 2025
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscular Response to Short vs. Prolonged Cycling: A Crossover Trial on Low-Frequency Fatigue Sensitivity
- ClinicalTrials.gov ID
- NCT06913036
- Acronym / sponsor ID
- Myo_sens_001
- Conditions
- Fatigue Intensity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MaiaUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 6 Apr 2025 (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.
This study aims to address this gap by assessing LFF following different efforts in cycling, aiming to identify a pattern. Also, we expect that this study helps to clarify to which efforts (prolonged vs short) are more likely to trigger substantial changes in LFF responses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 minutes all-out | Experimental | Device: Low-frequency fatigue - Myocene4 minute time trial all-out |
| 30 minute all-out | Experimental | Device: Low-frequency fatigue - Myocene30 minute cycling all-out |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Road cyclists
Key exclusion criteria (1 listed)
- Injured or recently injured participants
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 |
|---|---|---|
| Low-frequency fatigue - MyoceneLow frequency fatigue will be measured using Myocene | Device | 30 minute all-out, 4 minutes all-out |
Primary outcome
low-frequency fatigue
Time frame: Baseline, 30 minutes post, 24 hours post
Low-frequency fatigue assessed using Myocene software, which computes the median value of the ratio between high and low frequency stimulations
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low-frequency fatigue - Myocene in people with Fatigue Intensity, run by University of Maia.
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 1 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: opening soon, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
low-frequency fatigue (time frame: Baseline, 30 minutes post, 24 hours post). 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 6 Apr 2025.