- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04516538
Effects of Mode of Contraction on Neuromuscular Fatigue (DYN-AGING)
Effects of Mode of Contraction on Neuromuscular Fatigue in Young People Aged 18 to 35, Aged 60 to 80 and Very Old People Aged Over 80
Study Overview
Status
Conditions
Intervention / Treatment
- Diagnostic test: 6 Minutes Walk Test
- Diagnostic test: Timed up and go
- Diagnostic 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)
- Behavioral: Mini Mental State Examination
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Léonard FEASSON, MD PhD
- Phone Number: +33 (0)4 77 12 03 83
- Email: Leonard.Feasson@univ-st-etienne.fr
Study Contact Backup
- Name: Arnauld GARCIN, CRA
- Phone Number: +33 (0)4.77.12.02.86
- Email: arnauld.garcin@chu-st-etienne.fr
Study Locations
-
-
-
Saint-Étienne, France
- Recruiting
- CHU de Saint-Etienne
-
Sub-Investigator:
- Vianney ROZAND, MD
-
Sub-Investigator:
- Clément FOSCHIA, MD
-
Principal Investigator:
- Léonard FEASSON, MD PhD
-
Sub-Investigator:
- Marion RAVELOJAONA, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Young people
Men or Women under 35 years old
|
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.
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.
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).
Diagnostic test: Cycloergometer body weight-based quadriceps intermittent fatigue test (BW-QIF Test)
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). 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). |
Experimental: Old people
Men or Women between 60 and 80 years old
|
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.
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.
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).
Diagnostic test: Cycloergometer body weight-based quadriceps intermittent fatigue test (BW-QIF Test)
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). 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). |
Experimental: Very old people
Men or Women over 80 years old
|
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.
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.
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).
Diagnostic test: Cycloergometer body weight-based quadriceps intermittent fatigue test (BW-QIF Test)
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). 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).
test for evaluating a person's cognitive functions and memory capacity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Maximum Voluntary Contraction (%) - all participants
Time Frame: Immediately after pedalling on an ergocycle
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Maximum Voluntary Contraction (%) - 18-35 years old participants
Time Frame: Before and immediately after pedalling on an ergocycle
|
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.
|
Before and immediately after pedalling on an ergocycle
|
Percentage of Maximum Voluntary Contraction (%) - 60-80 years old participants
Time Frame: Before and immediately after pedalling on an ergocycle
|
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.
|
Before and immediately after pedalling on an ergocycle
|
Percentage of Maximum Voluntary Contraction (%) - more than 80 years old participants
Time Frame: Before and immediately after pedalling on an ergocycle
|
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.
|
Before and immediately after pedalling on an ergocycle
|
Percentage of Maximum Voluntary Contraction (%) - more than 80 years old participants
Time Frame: Before and immediately after isometric contractions
|
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.
|
Before and immediately after isometric contractions
|
Percentage of Maximum Voluntary Contraction (%) - 60-80 years old participants
Time Frame: Before and immediately after isometric contractions
|
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.
|
Before and immediately after isometric contractions
|
Percentage of Maximum Voluntary Contraction (%) - 18-35 years old participants
Time Frame: Before and immediately after isometric contractions
|
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.
|
Before and immediately after isometric contractions
|
Percentage of Maximum Voluntary Contraction (%) - 18-35 years old participants
Time Frame: Before and immediately after concentric isokinetic contractions
|
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.
|
Before and immediately after concentric isokinetic contractions
|
Percentage of Maximum Voluntary Contraction (%) - 60-80 years old participants
Time Frame: Before and immediately after concentric isokinetic contractions
|
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.
|
Before and immediately after concentric isokinetic contractions
|
Percentage of Maximum Voluntary Contraction (%) - more than 80 years old participants
Time Frame: Before and immediately after concentric isokinetic contractions
|
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.
|
Before and immediately after concentric isokinetic contractions
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of voluntary activation (%)
Time Frame: Before and immediately after concentric isokinetic contractions
|
To compare voluntary Activation of the extensor muscles of the knee by peripheral nerve stimulation between 18-35 years old, 60-80 years old and more than 80 years old participants.
|
Before and immediately after concentric isokinetic contractions
|
Percentage of voluntary activation (%)
Time Frame: Before and immediately after isometric contractions
|
To compare voluntary Activation of the extensor muscles of the knee by peripheral nerve stimulation between 18-35 years old, 60-80 years old and more than 80 years old participants.
|
Before and immediately after isometric contractions
|
Percentage of voluntary activation (%)
Time Frame: Before and immediately after pedalling on an ergocycle
|
To compare voluntary Activation of the extensor muscles of the knee by peripheral nerve stimulation between 18-35 years old, 60-80 years old and more than 80 years old participants.
|
Before and immediately after pedalling on an ergocycle
|
Difference in amplitude of electric shock at rest (% of shock)
Time Frame: Before and immediately after pedalling on an ergocycle
|
To compare the amplitude of the electric shock at rest of the extensor muscles of the knee between 18-35 years old, 60-80 years old and more than 80 years old participants.
|
Before and immediately after pedalling on an ergocycle
|
Difference in amplitude of electric shock at rest (% of shock)
Time Frame: Before and immediately after isometric contractions
|
To compare the amplitude of the electric shock at rest of the extensor muscles of the knee between 18-35 years old, 60-80 years old and more than 80 years old participants.
|
Before and immediately after isometric contractions
|
Difference in amplitude of electric shock at rest (% of shock)
Time Frame: Before and immediately after concentric isokinetic contractions
|
To compare the amplitude of the electric shock at rest of the extensor muscles of the knee between 18-35 years old, 60-80 years old and more than 80 years old participants.
|
Before and immediately after concentric isokinetic contractions
|
Collaborators and Investigators
Investigators
- Principal Investigator: Léonard FEASSON, MD PhD, CHU Saint-Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19CH178
- 2020-A00016-33 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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