FatiguePROTECT-08ANCT06775119
Feasibility Study of a Neuromuscular Fatigue Test and Associated Hemodynamic Responses: Application in Healthy Volunteers for Use in Patients with Chemotherapy-treated Breast Cancer
A study testing Test of neuromuscular fatigue and associated hemodynamic responses in people with Fatigue and Muscle, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
This cross-sectional and single-center study aims to progressively induce an increase in peripheral fatigue during successive efforts in healthy subjects. Participants will undergo three evaluations, each lasting one and half hours, to validate the test and assess its reproducibility. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Test of neuromuscular fatigue and associated hemodynamic responses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2024to 3 Jan 2025
- 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
- Man or woman
- Informed consent
- Age ≥ 18 years old
- Affiliation to a social security system
- Able to speak, read and understand French
- Practice physical activity 1 to 5 times per week, without reaching a level of intense training or high-level performance.
Who cannot join
- History of cancer
- Any known chronic pathology
- Protected minor or adult
- Psychiatric, musculoskeletal or neurological problems
- Implantation of a pacemaker
- Pregnant woman
- Presenting at least one contraindication to the use of transient blood flow occlusion
Trial locations and contacts
1 site in 1 country.
About this study
This cross-sectional and single-center study aims to progressively induce an increase in peripheral fatigue during successive efforts in healthy subjects. Participants will undergo three evaluations, each lasting one and half hours, to validate the test and assess its reproducibility. These three visits will be conducted at a minimum interval of 48 hours.
- Being tested
- Test of neuromuscular fatigue and associated hemodynamic responses
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of neuromuscular fatigue and associated hemodynamic responsesOther
Baseline measurements of neuromuscular function and hemodynamic responses will be done. Investigators will then assess the mechanoreflex activation using the experimental technique of passive leg movement (PLM).
Following the PLM and the neuromuscular function baseline assessments, participants will perform four consecutive blocks, each consisting of a fatigue task followed by post-exercise circulatory occlusion (PECO). Neuromuscular function, assessed through maximal voluntary contraction (MVC) and quadriceps twitch techniques, will be measured before the fatigue task and after PECO in each block. Participants will perform 2-minutes isometric quadriceps sustained contraction at 20% MVC to induce exercise-induced neuromuscular fatigue. Hemodynamic responses will be measured during the PECO to isolate to the metaboreflex by inflating a cuff over the right thigh for a 2 minutes duration. After the PECO, the thigh cuff will be deflated, and neuromuscular function will be reassessed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental protocol | Experimental | Not described Receives: Other: Test of neuromuscular fatigue and associated hemodynamic responses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the progressive changes in the level of peripheral fatigue through the consecutive blocks.
Significant changes in the level of peripheral fatigue during successive efforts as measured by the non invasive technique of nervous stimulation of the motor nerve.
Measured: All measurements will be taken at the end of each of the four exercise bouts, during the same visit.
Secondary outcomes (4)
Correlation between peripheral fatigue and haemodynamic responses
Correlation between the level of change in the amplitude of the potentiated quadriceps twitch and the level of change in haemodynamic parameters.
Measured: Correlation between variables measured at the end of each of the four exercise bouts, during the same visit
Validate the feasibility of the test on the following secondary parameter: reproducibility of the test
Reproducibility of the test due to the absence of significant difference in the exercise-induced peripheral fatigue levels (percentage change from baseline) and mean arterial pressure (mmHg) between sessions 2 and 3.
Measured: 2 to 7 days between sessions 2 and 3.
Validate the feasibility of the test on the following secondary parameter: absence of transient discomfort
Low rating of the level of discomfort assessed by a 10 cm visual analog scale after each effort. The participant will be asked to grade between 0 and 10 the level of discomfort felt in the thighs.
Measured: All measurements will be taken at the end of each of the four exercise bouts, during the same visit
Validate the feasibility of the test on the following secondary parameter: Tolerance to peripheral nerve stimulation using the self-reports of pain intensity scales.
Evaluation of the subject's response to various levels of peripheral nerve stimulation intensity, starting with very low intensities, while recording any sensations of discomfort reported by the subject using the self-reports of pain intensity scales (10 cm visual analog scale).
Measured: All measurements will be taken during the same visit, at the end of each of the four exercise bouts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start26 Aug 2024
- Primary completion3 Jan 2025
- Study completion3 Jan 2025
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland SCHOTT, MD, Principal investigator, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775119
- Sponsor's protocol ID
- 2024-002
- Acronym
- PROTECT-08A
- Status last verified
- Jan 2025
- First submitted
- 12 Aug 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kouzkouz N, Mallard J, Hucteau E, Schott R, Pivot X, Ducrocq GP, Hureau TJ. Innovative Dose-Response Assessment of the Metaboreflex With Indirect Control of Intramuscular Metabolic Perturbation in Humans. Acta Physiol (Oxf). 2026 Oct;242(10):e70303. doi: 10.1111/apha.70303.
PubMed 42666013
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Neuromuscular Fatigue Test and Associated Hemodynamic Responses: Application in Healthy Volunteers for Use in Patients with Chemotherapy-treated Breast Cancer
- ClinicalTrials.gov ID
- NCT06775119
- Acronym / sponsor ID
- PROTECT-08A / 2024-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 14 Jan 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 cross-sectional and single-center study aims to progressively induce an increase in peripheral fatigue during successive efforts in healthy subjects. Participants will undergo three evaluations, each lasting one and half hours, to validate the test and assess its reproducibility. These three visits will be conducted at a minimum interval of 48 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental protocol | Experimental | Other: Test of neuromuscular fatigue and associated hemodynamic responses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman
- Informed consent
- Age ≥ 18 years old
- Affiliation to a social security system
- Able to speak, read and understand French
Key exclusion criteria (7 listed)
- History of cancer
- Any known chronic pathology
- Protected minor or adult
- Psychiatric, musculoskeletal or neurological problems
- Implantation of a pacemaker
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 |
|---|---|---|
| Test of neuromuscular fatigue and associated hemodynamic responsesBaseline measurements of neuromuscular function and hemodynamic responses will be done. Investigators will then assess the mechanoreflex activation using the experimental technique of passive leg movement (PLM). Following the PLM and the neuromuscular function baseline assessments, participants will perform four consecutive blocks, each consisting of a fatigue task followed by post-exercise circulatory occlusion (PECO). Neuromuscular function, assessed through maximal voluntary contraction (MVC) and quadriceps twitch techniques, will be measured before the fatigue task and after PECO in each block. Participants will perform 2-minutes isometric quadriceps sustained contraction at 20% MVC to induce exercise-induced neuromuscular fatigue. Hemodynamic responses will be measured during the PECO to isolate to the metaboreflex by inflating a cuff over the right thigh for a 2 minutes duration. After the PECO, the thigh cuff will be deflated, and neuromuscular function will be reassessed. | Other | Experimental protocol |
Primary outcome
Evaluation of the progressive changes in the level of peripheral fatigue through the consecutive blocks.
Time frame: All measurements will be taken at the end of each of the four exercise bouts, during the same visit.
Significant changes in the level of peripheral fatigue during successive efforts as measured by the non invasive technique of nervous stimulation of the motor nerve.
4 secondary outcomes
Correlation between peripheral fatigue and haemodynamic responses
Time frame: Correlation between variables measured at the end of each of the four exercise bouts, during the same visit
Validate the feasibility of the test on the following secondary parameter: reproducibility of the test
Time frame: 2 to 7 days between sessions 2 and 3.
Validate the feasibility of the test on the following secondary parameter: absence of transient discomfort
Time frame: All measurements will be taken at the end of each of the four exercise bouts, during the same visit
Validate the feasibility of the test on the following secondary parameter: Tolerance to peripheral nerve stimulation using the self-reports of pain intensity scales.
Time frame: All measurements will be taken during the same visit, at the end of each of the four exercise bouts
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 14 Jan 2025.
- Derived from this study: PubMed 42666013Kouzkouz N, Mallard J, Hucteau E, Schott R, Pivot X, Ducrocq GP, Hureau TJ. Innovative Dose-Response Assessment of the Metaboreflex With Indirect Control of Intramuscular Metabolic Perturbation in Humans. Acta Physiol (Oxf). 2026 Oct;242(10):e70303. doi: 10.1111/apha.70303.
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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.
Roland SCHOTT, MD principal investigator
Institut de cancérologie Strasbourg Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test of neuromuscular fatigue and associated hemodynamic responses in people with Fatigue and Muscle, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
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 6 inclusion and 7 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 14 Jan 2025. 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 France. 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?
Evaluation of the progressive changes in the level of peripheral fatigue through the consecutive blocks. (time frame: All measurements will be taken at the end of each of the four exercise bouts, during the same visit.). 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 NCT06775119, 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 14 Jan 2025.