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Feasibility Study of a Neuromuscular Fatigue Test and Associated Hemodynamic Responses: Application in Healthy Volunteers for Use in Patients with Chemotherapy-treated Breast Cancer

Feasibility Study of a Neuromuscular Fatigue Test and Associated Hemodynamic Responses: Application in Healthy Volunteers for Use in Patients with Chemotherapy-treated Breast Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06775119
Acronym
PROTECT-08A
Enrollment
30
Registered
2025-01-14
Start date
2024-08-26
Completion date
2025-01-03
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Heart, Muscle

Brief 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. These three visits will be conducted at a minimum interval of 48 hours.

Interventions

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.

Sponsors

Institut de cancérologie Strasbourg Europe
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the progressive changes in the level of peripheral fatigue through the consecutive blocks.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.

Secondary

MeasureTime frameDescription
Correlation between peripheral fatigue and haemodynamic responsesCorrelation between variables measured at the end of each of the four exercise bouts, during the same visitCorrelation between the level of change in the amplitude of the potentiated quadriceps twitch and the level of change in haemodynamic parameters.
Validate the feasibility of the test on the following secondary parameter: reproducibility of the test2 to 7 days between sessions 2 and 3.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.
Validate the feasibility of the test on the following secondary parameter: absence of transient discomfortAll measurements will be taken at the end of each of the four exercise bouts, during the same visitLow 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.
Validate the feasibility of the test on the following secondary parameter: Tolerance to peripheral nerve stimulation using the self-reports of pain intensity scales.All measurements will be taken during the same visit, at the end of each of the four exercise boutsEvaluation 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026