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

NCT06775119 | Completed

• 1 other identifier: 2024-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Muscle; Heart

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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: reproducibility of the test

  2 to 7 days between sessions 2 and 3.

• 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

Study Arms (1)

Experimental protocol

EXPERIMENTAL

Other: Test of neuromuscular fatigue and associated hemodynamic responses

Interventions

Test of neuromuscular fatigue and associated hemodynamic responses OTHER

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.

Experimental protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, France

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roland SCHOTT, MD

  Institut de cancérologie Strasbourg Europe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: January 14, 2025
• Study Start: August 26, 2024
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

FR (1)