NCT03049241

Brief Summary

Potential factors involved in neuromuscular fatigue were classified into two categories: 1) central factors involving the central nervous system and neural pathways, and 2) peripheral factors occurring within the muscle beyond the neuromuscular junction. In adults, it has been shown that peripheral factors contribute to a large part of the fatigue induced by repeated maximal contractions. However in children, central factors could account for the development of fatigue to a greater extent. Force-generating capacity and musculotendinous stiffness could be two of the discriminatory factors accounting for the differences in the neuromuscular fatigue between children and adults. Force production capacity and musculotendinous stiffness vary as function of muscle length. Naturally, they could differ depending on the muscle groups studied. The main aim of the present protocol is to compare the effect of knee extensors and ankle plantarflexors length on the development and aetiology of neuromuscular fatigue, in children and adults. The investigators formulated the hypotheses that at short muscle length force and low musculotendinous stiffness, differences in force between children and adults would be reduced. Thus neuromuscular fatigue development and aetiology would be similar between both groups. The results of the present protocol will allow to better understanding of the aetiology of neuromuscular fatigue in children and help improving training or rehabilitation programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

February 3, 2017

Last Update Submit

November 27, 2017

Conditions

Neuromuscular Fatigue

Keywords

ChildrenNeuromuscular fatigueMuscle groupMagnetic Nerve stimulationMuscle lengthStiffnessprepubertal childrenadults

Outcome Measures

Primary Outcomes (2)

  • Maximal torque of knee extensors

    once a week during six weeks.

  • ankle plantar flexors joint (in N.m) measured with a dynamometer.

    once a week during six weeks.

Secondary Outcomes (10)

  • Doublet torque amplitude (100Hz, in N.m) evoked using magnetic nerve stimulation at rest

    once a week during six weeks.

  • Muscular tissue oxygenation (in μmol.L-1) measured at skin surface by Near-infrared spectroscopy.

    once a week during six weeks

  • Compound muscle action potential amplitude (i.e. M-wave ; in mV) evoked by supramaximal magnetic nerve stimulation and measured by surface Electromyography (EMG).

    once a week during six weeks

  • High frequency doublet (100Hz)/low frequency doublet (10Hz) ratio

    once a week during six weeks

  • fascicule length (mm) measured by B-mode real time ultrasound scanner.

    once a week during six weeks

  • +5 more secondary outcomes

Study Arms (2)

knee extensors

Other: neuromuscular fatigue

ankle plantar

Other: neuromuscular fatigue

Interventions

neuromuscular fatigueOTHER

The main aim of the present protocol is to compare the effect of knee extensors and ankle plantarflexors length on the development and aetiology of neuromuscular fatigue, in children and adults

ankle plantarknee extensors

Eligibility Criteria

Age8 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

prepubertal boys and adults

You may qualify if:

  • Boys aged 8 to 11 years old, Tanner stages 1 to 3
  • Male aged 18 to 35 years old
  • Non-smoker
  • Moderate physical activity level (\< 4h/week)
  • Covered by a social health insurance
  • Consent form signed by participants and/or legal guardians.

You may not qualify if:

  • Competitive training
  • Cardiac or pulmonary diseases
  • Epileptic seizures past history
  • Magnetic field contraindication (including cardiac valve, pacemaker, prosthesis material, ferro-magnetic foreign body, cochlear implant and ocular prosthesis material.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

  • Martine DUCLOS

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 10, 2017

Study Start

February 13, 2017

Primary Completion

November 20, 2017

Study Completion

November 20, 2017

Last Updated

November 28, 2017

Record last verified: 2017-11

Locations

FR(1)