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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04516538
Other study ID # 19CH178
Secondary ID 2020-A00016-33
Status Recruiting
Phase N/A
First received
Last updated
Start date April 13, 2021
Est. completion date October 21, 2024

Study information

Verified date October 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Léonard FEASSON, MD PhD
Phone (0)4 77 12 03 83
Email Leonard.Feasson@univ-st-etienne.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date October 21, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mini Mental State Examination
test for evaluating a person's cognitive functions and memory capacity
Diagnostic Test:
6 Minutes Walk 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.
Timed up and go
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.
Isokinetic 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 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).
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).
Isometric BW-QIF Test (Body weight-based quadriceps intermittent fatigue 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 isometric BW-QIF test blocks consist in 10 contractions (5-s contraction / 5-s rest).

Locations

Country Name City State
France CHU de Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of voluntary activation (%) 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
Other Percentage of voluntary activation (%) 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
Other Percentage of voluntary activation (%) 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
Other Difference in amplitude of electric shock at rest (% of shock) 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
Other Difference in amplitude of electric shock at rest (% of shock) 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
Other Difference in amplitude of electric shock at rest (% of shock) 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
Primary 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 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. Before and immediately after pedalling on an ergocycle
Secondary 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. Before and immediately after pedalling on an ergocycle
Secondary 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. Before and immediately after pedalling on an ergocycle
Secondary 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. Before and immediately after isometric contractions
Secondary 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. Before and immediately after isometric contractions
Secondary 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. Before and immediately after isometric contractions
Secondary 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. Before and immediately after concentric isokinetic contractions
Secondary 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. Before and immediately after concentric isokinetic contractions
Secondary 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. Before and immediately after concentric isokinetic contractions
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