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

Not Applicable

Completed

• Conditions: Fatigue; Muscle; Heart

• Registration Number: NCT06775119
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-12
• Study Start: 2024-08-26
• Status Verified: 2025-01
• Primary Completion: 2025-01-03
• Study Completion: 2025-01-03
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Validate the feasibility of the test on the following secondary parameter: reproducibility of the test	2 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.
Correlation between peripheral fatigue and haemodynamic responses	Correlation between variables measured at the end of each of the four exercise bouts, during the same visit	Correlation 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: absence of transient discomfort	All measurements will be taken at the end of each of the four exercise bouts, during the same visit	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.
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 bouts	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).

Trial Locations

Locations (1)

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France