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

Institut de cancérologie Strasbourg Europe1 site in 1 country30 target enrollmentAugust 26, 2024

ConditionsFatigue Muscle Heart

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fatigue
Sponsor: Institut de cancérologie Strasbourg Europe
Enrollment: 30
Locations: 1
Primary Endpoint: Evaluation of the progressive changes in the level of peripheral fatigue through the consecutive blocks.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 26, 2024

End Date

January 3, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Institut de cancérologie Strasbourg Europe

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Validate the feasibility of the test on the following secondary parameter: reproducibility of the test(2 to 7 days 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)
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)
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)