VolunteersDYN-AGINGNCT04516538
Effects of Mode of Contraction on Neuromuscular Fatigue
A study testing Mini Mental State Examination, 6 Minutes Walk Test and Timed up and go in people with Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volunteers
- What is being tested?
- Mini Mental State Examination, 6 Minutes Walk Test and Timed up and go
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2021to 3 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Volunteers
- Being tested
- 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)
- Keywords
- Aging, neuromuscular performance, central fatigue, peripheral fatigue, dynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Mental State ExaminationBehavioural
test for evaluating a person's cognitive functions and memory capacity
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.
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.
Isokinetic Body weight-based quadriceps intermittent fatigue test (BW-QIF Test)Diagnostic 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)Diagnostic 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)Diagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Young people | Experimental | Men or Women under 35 years old Receives: 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) |
| Old people | Experimental | Men or Women between 60 and 80 years old Receives: 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) |
| Very old people | Experimental | Men or Women over 80 years old Receives: Behavioral: Mini Mental State Examination; 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after pedalling on an ergocycle
Secondary outcomes (9)
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.
Measured: Before and immediately after pedalling on an ergocycle
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.
Measured: Before and immediately after pedalling on an ergocycle
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.
Measured: Before and immediately after pedalling on an ergocycle
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.
Measured: Before and immediately after isometric contractions
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.
Measured: Before and immediately after isometric contractions
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.
Measured: Before and immediately after isometric contractions
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.
Measured: Before and immediately after concentric isokinetic contractions
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.
Measured: Before and immediately after concentric isokinetic contractions
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.
Measured: Before and immediately after concentric isokinetic contractions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start13 Apr 2021
- Primary completion9 May 2022
- Study completion3 Jun 2022
Why it stopped: Lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VolunteersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Léonard FEASSON, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516538
- Sponsor's protocol ID
- 19CH178
- Other IDs
- 2020-A00016-33
- Acronym
- DYN-AGING
- Status last verified
- Oct 2024
- First submitted
- 29 Jul 2020
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39285590Varesco 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.
PubMed 37580874
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04516538
- Acronym / sponsor ID
- DYN-AGING / 19CH178
- Conditions
- Volunteers
- Keywords
- Aging, neuromuscular performance, central fatigue, peripheral fatigue, dynamic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young people | Experimental | 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)Men or Women under 35 years old |
| Old people | Experimental | 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)Men or Women between 60 and 80 years old |
| Very old people | Experimental | Behavioral: Mini Mental State Examination, 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)Men or Women over 80 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini Mental State Examinationtest for evaluating a person's cognitive functions and memory capacity | Behavioural | Very old people |
| 6 Minutes Walk Testa 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. | Diagnostic test | Old people, Very old people, Young people |
| Timed up and goA 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. | Diagnostic test | Old people, Very old people, Young people |
| 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). | Diagnostic test | Old people, Very old people, Young people |
| 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). | Diagnostic test | Old people, Very old people, Young people |
| 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). | Diagnostic test | Old people, Very old people, Young people |
Primary outcome
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.
9 secondary outcomes
Percentage of Maximum Voluntary Contraction (%) - 18-35 years old participants
Time frame: 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
Percentage of Maximum Voluntary Contraction (%) - more than 80 years old participants
Time frame: 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
Percentage of Maximum Voluntary Contraction (%) - 60-80 years old participants
Time frame: Before and immediately after isometric contractions
Percentage of Maximum Voluntary Contraction (%) - 18-35 years old participants
Time frame: 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
Percentage of Maximum Voluntary Contraction (%) - 60-80 years old participants
Time frame: 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
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 39285590Luneau 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.
- Derived from this study: PubMed 37580874Varesco 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Léonard FEASSON, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini Mental State Examination, 6 Minutes Walk Test and Timed up and go in people with Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Maximum Voluntary Contraction (%) - all participants (time frame: Immediately after pedalling on an ergocycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04516538, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.