Effects of Mode of Contraction on Neuromuscular Fatigue (DYN-AGING)
Primary Purpose
Volunteers
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mini Mental State Examination
6 Minutes Walk Test
Timed up and go
Isokinetic Body weight-based quadriceps intermittent fatigue test (BW-QIF Test)
Cycloergometer body weight-based quadriceps intermittent fatigue test (BW-QIF Test)
Isometric BW-QIF Test (Body weight-based quadriceps intermittent fatigue test)
Sponsored by
About this trial
This is an interventional other trial for Volunteers focused on measuring Aging, neuromuscular performance, central fatigue, peripheral fatigue, dynamic
Eligibility Criteria
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
Sites / Locations
- CHU de Saint-EtienneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Young people
Old people
Very old people
Arm Description
Men or Women under 35 years old
Men or Women between 60 and 80 years old
Men or Women over 80 years old
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Maximum Voluntary Contraction (%) - 18-35 years old 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.
Percentage of Maximum Voluntary Contraction (%) - 60-80 years old 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.
Percentage of Maximum Voluntary Contraction (%) - more than 80 years old 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.
Percentage of Maximum Voluntary Contraction (%) - more than 80 years old 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.
Percentage of Maximum Voluntary Contraction (%) - 60-80 years old 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.
Percentage of Maximum Voluntary Contraction (%) - 18-35 years old 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.
Percentage of Maximum Voluntary Contraction (%) - 18-35 years old 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.
Percentage of Maximum Voluntary Contraction (%) - 60-80 years old 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.
Percentage of Maximum Voluntary Contraction (%) - more than 80 years old 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.
Full Information
NCT ID
NCT04516538
First Posted
July 29, 2020
Last Updated
October 28, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT04516538
Brief Title
Effects of Mode of Contraction on Neuromuscular Fatigue
Acronym
DYN-AGING
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Volunteers
Keywords
Aging, neuromuscular performance, central fatigue, peripheral fatigue, dynamic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Young people
Arm Type
Experimental
Arm Description
Men or Women under 35 years old
Arm Title
Old people
Arm Type
Experimental
Arm Description
Men or Women between 60 and 80 years old
Arm Title
Very old people
Arm Type
Experimental
Arm Description
Men or Women over 80 years old
Intervention Type
Behavioral
Intervention Name(s)
Mini Mental State Examination
Intervention Description
test for evaluating a person's cognitive functions and memory capacity
Intervention Type
Diagnostic Test
Intervention Name(s)
6 Minutes Walk Test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Timed up and go
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Isokinetic Body weight-based quadriceps intermittent fatigue test (BW-QIF Test)
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Cycloergometer body weight-based quadriceps intermittent fatigue test (BW-QIF Test)
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Isometric BW-QIF Test (Body weight-based quadriceps intermittent fatigue test)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of Maximum Voluntary Contraction (%) - all participants
Description
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.
Time Frame
Immediately after pedalling on an ergocycle
Secondary Outcome Measure Information:
Title
Percentage of Maximum Voluntary Contraction (%) - 18-35 years old participants
Description
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.
Time Frame
Before and immediately after pedalling on an ergocycle
Title
Percentage of Maximum Voluntary Contraction (%) - 60-80 years old participants
Description
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.
Time Frame
Before and immediately after pedalling on an ergocycle
Title
Percentage of Maximum Voluntary Contraction (%) - more than 80 years old participants
Description
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.
Time Frame
Before and immediately after pedalling on an ergocycle
Title
Percentage of Maximum Voluntary Contraction (%) - more than 80 years old participants
Description
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.
Time Frame
Before and immediately after isometric contractions
Title
Percentage of Maximum Voluntary Contraction (%) - 60-80 years old participants
Description
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.
Time Frame
Before and immediately after isometric contractions
Title
Percentage of Maximum Voluntary Contraction (%) - 18-35 years old participants
Description
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.
Time Frame
Before and immediately after isometric contractions
Title
Percentage of Maximum Voluntary Contraction (%) - 18-35 years old participants
Description
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.
Time Frame
Before and immediately after concentric isokinetic contractions
Title
Percentage of Maximum Voluntary Contraction (%) - 60-80 years old participants
Description
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.
Time Frame
Before and immediately after concentric isokinetic contractions
Title
Percentage of Maximum Voluntary Contraction (%) - more than 80 years old participants
Description
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.
Time Frame
Before and immediately after concentric isokinetic contractions
Other Pre-specified Outcome Measures:
Title
Percentage of voluntary activation (%)
Description
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.
Time Frame
Before and immediately after concentric isokinetic contractions
Title
Percentage of voluntary activation (%)
Description
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.
Time Frame
Before and immediately after isometric contractions
Title
Percentage of voluntary activation (%)
Description
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.
Time Frame
Before and immediately after pedalling on an ergocycle
Title
Difference in amplitude of electric shock at rest (% of shock)
Description
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.
Time Frame
Before and immediately after pedalling on an ergocycle
Title
Difference in amplitude of electric shock at rest (% of shock)
Description
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.
Time Frame
Before and immediately after isometric contractions
Title
Difference in amplitude of electric shock at rest (% of shock)
Description
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.
Time Frame
Before and immediately after concentric isokinetic contractions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Léonard FEASSON, MD PhD
Phone
(0)4 77 12 03 83
Ext
+33
Email
Leonard.Feasson@univ-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Arnauld GARCIN, CRA
Phone
(0)4.77.12.02.86
Ext
+33
Email
arnauld.garcin@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Léonard FEASSON, MD PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Léonard FEASSON, MD PhD
First Name & Middle Initial & Last Name & Degree
Clément FOSCHIA, MD
First Name & Middle Initial & Last Name & Degree
Vianney ROZAND, MD
First Name & Middle Initial & Last Name & Degree
Marion RAVELOJAONA, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Mode of Contraction on Neuromuscular Fatigue
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