NCT04516538

Brief Summary

Aging is associated with multiple deteriorations of the neuromuscular system. Given the increase in life expectancy, the investigators can now distinguish old adults (\>60 years old) who conserve their neuromuscular capacities with regular physical activity and very old adults (\>80 years old) who suffer from an inexorable decline, even if the number of octogenarians and their quality of life are progressively increasing. However, the most part of the literature on fatigue and neuromuscular capacity with aging focused on isometric tasks. The results showed a significant decrease in maximal force production capacity and a greater resistance to fatigue for old people compared to the young population. When fatigue is induced trough dynamic contractions, greater fatigability was observed in old adults compared to young adults. Investigations performed on the population aged over 80 years old are rare, showing greater fatigability in octogenarians than old men (aged 60-80 years old) during isometric tasks. The knowledge about the effects of dynamic contractions in this population are limited, and performed uniquely in single leg isokinetic mode. Evaluations that require the use of both legs and higher muscle mass involved in the task (cycloergometer) are needed. Understanding neuromuscular fatigue and fatigability across different exercise modalities is necessary to set adapted physical activity programs aimed to maintain autonomy in older individuals.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

April 13, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2022

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

July 29, 2020

Last Update Submit

October 24, 2024

Conditions

Keywords

Agingneuromuscular performancecentral fatigueperipheral fatiguedynamic

Outcome Measures

Primary Outcomes (1)

  • Percentage of Maximum Voluntary Contraction (%) - all participants

    The measurement of the maximum voluntary contraction is carried out at rest with the instruction to contract the extensor muscles of the knee as hard as possible by pushing against a fixed pedal. This force is measured by an isokinetic ergometer.

    Immediately after pedalling on an ergocycle

Secondary Outcomes (9)

  • Percentage of Maximum Voluntary Contraction (%) - 18-35 years old participants

    Before and immediately after pedalling on an ergocycle

  • Percentage of Maximum Voluntary Contraction (%) - 60-80 years old participants

    Before and immediately after pedalling on an ergocycle

  • Percentage of Maximum Voluntary Contraction (%) - more than 80 years old participants

    Before and immediately after pedalling on an ergocycle

  • Percentage of Maximum Voluntary Contraction (%) - more than 80 years old participants

    Before and immediately after isometric contractions

  • Percentage of Maximum Voluntary Contraction (%) - 60-80 years old participants

    Before and immediately after isometric contractions

  • +4 more secondary outcomes

Other Outcomes (6)

  • Percentage of voluntary activation (%)

    Before and immediately after concentric isokinetic contractions

  • Percentage of voluntary activation (%)

    Before and immediately after isometric contractions

  • Percentage of voluntary activation (%)

    Before and immediately after pedalling on an ergocycle

  • +3 more other outcomes

Study Arms (3)

Young people

EXPERIMENTAL

Men or Women under 35 years old

Diagnostic Test: 6 Minutes Walk TestDiagnostic Test: Timed up and goDiagnostic Test: Isokinetic Body weight-based quadriceps intermittent fatigue test (BW-QIF Test)Diagnostic Test: Cycloergometer body weight-based quadriceps intermittent fatigue test (BW-QIF Test)Diagnostic Test: Isometric BW-QIF Test (Body weight-based quadriceps intermittent fatigue test)

Old people

EXPERIMENTAL

Men or Women between 60 and 80 years old

Diagnostic Test: 6 Minutes Walk TestDiagnostic Test: Timed up and goDiagnostic Test: Isokinetic Body weight-based quadriceps intermittent fatigue test (BW-QIF Test)Diagnostic Test: Cycloergometer body weight-based quadriceps intermittent fatigue test (BW-QIF Test)Diagnostic Test: Isometric BW-QIF Test (Body weight-based quadriceps intermittent fatigue test)

Very old people

EXPERIMENTAL

Men or Women over 80 years old

Behavioral: Mini Mental State ExaminationDiagnostic Test: 6 Minutes Walk TestDiagnostic Test: Timed up and goDiagnostic Test: Isokinetic Body weight-based quadriceps intermittent fatigue test (BW-QIF Test)Diagnostic Test: Cycloergometer body weight-based quadriceps intermittent fatigue test (BW-QIF Test)Diagnostic Test: Isometric BW-QIF Test (Body weight-based quadriceps intermittent fatigue test)

Interventions

test for evaluating a person's cognitive functions and memory capacity

Very old people
6 Minutes Walk TestDIAGNOSTIC_TEST

a standardized test of an individual's functional ability that involves walking the greatest distance a person can walk in six minutes. This walking may be limited by shortness of breath or fatigability.

Old peopleVery old peopleYoung people
Timed up and goDIAGNOSTIC_TEST

A simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time it takes for a person to get up from a chair, walk three metres, turn around, walk to the chair and sit down.

Old peopleVery old peopleYoung people

The BW-QIF test is an interval incremental contraction test including blocks of discontinuous 100-s effort. Neuromuscular evaluation of the knee extensors between blocks (duration 25 s) includes one maximal voluntary contraction, one contraction at the 60% of the actual maximal force and at the 80% of the actual maximal force. During each contraction, transcranial magnetic stimulation over the motor cortex will be delivered to assess corticospinal voluntary activation (central fatigue). Single-twitch electrical stimulations will be delivered on the femoral nerve during the maximal voluntary contraction and at rest to evaluate peripheral fatigue. The isokinetic BW-QIF test blocks consist in 100 contractions at 120° deg.s-1 and 60° of range of motion (0.5-s contraction /0.5-s rest).

Old peopleVery old peopleYoung people

The BW-QIF test is an interval incremental contraction test including blocks of discontinuous 100-s effort. Neuromuscular evaluation of the knee extensors between blocks (duration 25 s) includes one maximal voluntary contraction, one contraction at the 60% of the actual maximal force and at the 80% of the actual maximal force. During each contraction, transcranial magnetic stimulation over the motor cortex will be delivered to assess corticospinal voluntary activation (central fatigue). Single-twitch electrical stimulations will be delivered on the femoral nerve during the maximal voluntary contraction and at rest to evaluate peripheral fatigue. The BW-QIF test blocks on the cycloergometer consist in 100 s of cycling at 60 Revolution Per Minute (RPM).

Old peopleVery old peopleYoung people

The BW-QIF test is an interval incremental contraction test including blocks of discontinuous 100-s effort. Neuromuscular evaluation of the knee extensors between blocks (duration 25 s) includes one maximal voluntary contraction, one contraction at the 60% of the actual maximal force and at the 80% of the actual maximal force. During each contraction, transcranial magnetic stimulation over the motor cortex will be delivered to assess corticospinal voluntary activation (central fatigue). Single-twitch electrical stimulations will be delivered on the femoral nerve during the maximal voluntary contraction and at rest to evaluate peripheral fatigue. The isometric BW-QIF test blocks consist in 10 contractions (5-s contraction / 5-s rest).

Old peopleVery old peopleYoung people

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Belong to a defined age group: young (18 to 35 years old inclusive), old (60 to 80 years old inclusive) and very old (81 to 95 years old inclusive),
  • Signed written consent form
  • Being affiliated to social security

You may not qualify if:

  • Pathology or surgery resulting in a locomotor disorder, within 6 months prior to the study,
  • Chronic neurological, motor or psychological pathologies
  • Use of neuro-active substances likely to alter cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) for the duration of the study.
  • Contraindication to magnetic stimulation:
  • Cardiac or respiratory insufficiency.
  • Cardiac pacemaker.
  • Cardiac valve wear and serious cardiovascular diseases.
  • Presence of prosthetic material or ferromagnetic foreign bodies in the head.
  • Presence of cochlear implants or ocular prosthetic material.
  • History of neurosurgical interventions.
  • Neurological diseases that may affect brain structures and cognitive abilities (e.g., intracranial tumour, multiple sclerosis, history of stroke or traumatic brain injury).
  • History of comitiality, contralateral knee pathology or pathology of the musculoskeletal system.
  • Mini Mental State Examination \< 20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, France

Location

Related Publications (2)

  • Luneau E, Rozand V, Rimaud D, Foschia C, Millet GY. Walking Economy and Preferred Speed in Old and Very Old Men. Med Sci Sports Exerc. 2025 Feb 1;57(2):400-412. doi: 10.1249/MSS.0000000000003565. Epub 2024 Sep 17.

  • Varesco G, Luneau E, Millet GY, Feasson L, Lapole T, Rozand V. Age-Related Differences between Old and Very Old Men in Performance and Fatigability Are Evident after Cycling but Not Isometric or Concentric Single-Limb Tasks. Med Sci Sports Exerc. 2023 Sep 1;55(9):1641-1650. doi: 10.1249/MSS.0000000000003181. Epub 2023 Apr 4.

MeSH Terms

Interventions

Mental Status and Dementia TestsWalk Test

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesExercise TestHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Léonard FEASSON, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 18, 2020

Study Start

April 13, 2021

Primary Completion

May 9, 2022

Study Completion

June 3, 2022

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations