Clinical trial · Interventional
Feasibility Study of a Neuromuscular Fatigue Test and Associated Hemodynamic Responses: Application in Healthy Volunteers for Use in Patients with Chemotherapy-treated Breast Cancer
NCT06775119CI-TRIAL-00084660PROTECT-08AcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Heart | — | UNRESOLVED | — |
| Muscle | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Test of neuromuscular fatigue and associated hemodynamic responses | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental protocol
- interventionNames
- Other: Test of neuromuscular fatigue and associated hemodynamic responses
Primary outcomes (1)
- measure
- Evaluation of the progressive changes in the level of peripheral fatigue through the consecutive blocks.
- timeFrame
- All measurements will be taken at the end of each of the four exercise bouts, during the same visit.
- description
- 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.
Secondary outcomes (4)
- measure
- Correlation between peripheral fatigue and haemodynamic responses
- timeFrame
- Correlation between variables measured at the end of each of the four exercise bouts, during the same visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDKouzkouz 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. PMID 42666013