Feasibility Study of a Neuromuscular Fatigue Test and Associated Hemodynamic Responses: Application in Healthy Volunteers for Use in Patients with Chemotherapy-treated Breast Cancer (PROTECT-08A)

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 Overview

• Status: Completed
• Conditions: Fatigue; Heart; Muscle
• Intervention / Treatment: Other: Test of neuromuscular fatigue and associated hemodynamic responses

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France
    • Institut de cancérologie Strasbourg Europe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental protocol

Other: Test of neuromuscular fatigue and associated hemodynamic responses; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	All measurements will be taken at the end of each of the four exercise bouts, during the same visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	All measurements will be taken during the same visit, at the end of each of the four exercise bouts

Collaborators and Investigators

• Sponsor: Institut de cancérologie Strasbourg Europe
• Investigators: Principal Investigator: Roland SCHOTT, MD, Institut de cancérologie Strasbourg Europe

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Actual): January 3, 2025
• Study Completion (Actual): January 3, 2025

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 2024-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No