Healthy VolunteersCHRONOSNCT03560648
Device Evaluating the Muscular Functional Age
A study testing High definition surface electromyography combined with accelerometer in people with Healthy Volunteers and Skeletal Muscle, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The CHRONOS project aims to provide a device to detect earlier the motor decline, by developing a precise quantitative device measuring "Motor Functional Age" (MFA) of young, middle-aged and old people, thus preventing future functional motor loss for healthy aging. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Skeletal Muscle
- What is being tested?
- High definition surface electromyography combined with accelerometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2018to 4 Feb 2019
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main inclusion criteria
- walking without help
- physically active (IPAQ questionnaire: moderately or highly active) for "reference group" and sedentary (IPAQ questionnaire: low activity) for "test" group.
Main exclusion Criteria
- Body mass index <18.5 and >= 30 kg/m2
- Neurological, endocrinological, rheumatologic, myopathy, orthopedic and severe cardio-respiratory diseases
- Non smoking and non alcoholism,
- Taking medications interfering with muscle function
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Device for the Evaluation of the "Motor Functional Age": How Old is Your Muscle?
The CHRONOS project aims to provide a device to detect earlier the motor decline, by developing a precise quantitative device measuring "Motor Functional Age" (MFA) of young, middle-aged and old people, thus preventing future functional motor loss for healthy aging. The MFA might be different from the Chronological Age (CA), depending on lifestyle, physical activity, and medical condition. Thus, this device will permit monitoring, adaptation and new design of a variety of personalized therapies for healthy aging including physical exercise, medication and nutritional interventions to reduce the MFA toward or less than the CA. The device combines data processing software that estimates the MFA by assessing muscle aging using a non-invasive multichannel electromyographical technique coupled to accelerometry sensors for motion evaluation. These data will provide with a built-in clinical database of subjects from different age categories (25-75 years old).
Read the detailed description
Background:
Aging is accompanied by sarcopenia, defined by a loss in muscle mass (starting from the age of 25) and strength/function, leading to a decline in mobility. This functional motor decline is an increasing health problem with impairing functional independence and quality of life among seniors. Furthermore, a sedentary lifestyle reinforced by an abusive use of modern technology (videogames, transportation and communication) and poor dietary habits (often rich in sugar and fats and poor in high quality proteins) are more common in younger demographics than ever before. These unhealthy habits lead to premature muscle aging, sarcopenia and future functional motor loss.
Methods to easily and rapidly assess muscle quality in multiple clinical settings and with minimal patient burden are needed.
Moreover, an individual's CA, taken solely, is rarely a reliable index of an individual's ability to perform specific physical task. The proposed MFA concept is innovative since it precisely expresses the motor abilities through a sensitive screening of muscle activation using a recent HD-sEMG (High density-surface electromyogram) technique that is, by far, more robust, precise and representative than the classical single bipolar technique.
Aim and Objectives:
In the CHRONOS project, a device using HD-sEMG technology actually devoted to research actions only, even though CE-certified, will be designed by testing and combining data allowing one to assess the muscle activation efficiency and motion capacity (accelerometry sensors), as a function of CA.
- Main objective : attribute a MFA to define the normal muscle aging from HD-sEMG and accelerometer signals correlated to muscular parameters obtained from Dual Energy X-ray Absorptiometry (DEXA), handgrip strength and muscular echography. Data will be collected in " reference " individuals, healthy volunteers, aged 25 to 75 years old.
- Secondary objectives :
- to evaluate the capacity of MFA to detect early muscle aging in " tests " individuals, sedentary volunteers within the same age group (45-55 years old).
- study correlation between HD-sEMG/accelerometer signals and muscular parameters from DEXA, handgrip strength, physical performance by SPPB (Short Physical Performance battery), walking speed, walking distance in 6min, physical activity evaluated objectively by actimeter, and subjectively by IPAQ (International Physical Activity Questionnaire), muscle echography parameters, and nutritional data.
- Conditions
- Healthy Volunteers, Skeletal Muscle
- Being tested
- High definition surface electromyography combined with accelerometer
- Keywords
- muscle aging, sarcopenia, neuromuscular dysfunction
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High definition surface electromyography combined with accelerometerDevice
HD-sEMG and accelerometer data will be collected by Mobita 32® (TMSi) device.
| Study group | Role | What they receive |
|---|---|---|
| Reference group | Other | To define the normal muscle aging from HD-sEMG and accelerometer signals correlated to muscular parameters obtained from Dual Energy X-ray Absorptiometry (DEXA), handgrip strength and muscular echography. Data will be collected in healthy volunteers, aged 25 to 75 years old, physically active on IPAQ questionnaire. Receives: Device: High definition surface electromyography combined with accelerometer |
| Test group | Other | To evaluate the capacity of MFA to detect early muscle aging in " tests " individuals, sedentary volunteers within the same age group (45-55 years old). Receives: Device: High definition surface electromyography combined with accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor functional age determined by HD-sEMG (rectus femoris) during sit to stand
HD-sEMG data will be correlated to Skeletal Mass Muscle Index, handgrip strength and muscle echography data.
Measured: Day 0
Motor functional age determined accelerometer signals during sit to stand
Accelerometer data will be correlated to Skeletal Mass Muscle Index, handgrip strength and muscle echography data.
Measured: Day 0
Secondary outcomes (12)
Skeletal Mass Muscle Index
Dual-energy x-ray absorptiometry (DEXA) is the imaging technique recommended for the diagnosis of sarcopenia. It gives minimal irradiation and gives an adequate estimate of the appendicular muscle mass (ALM). By dividing the ALM by the size in centimeters, we obtain the Skeletal Mass Muscle Index (SMI). SMI values below 2 standard deviations from the mean point towards sarcopenia.
Measured: Day 0
Hand grip strength
By placing a dynamometer in the patient's hand and asking him to apply maximum pressure to it, the muscular strength of the extremities of the limbs is estimated.
Measured: Day 0
Walking speed
Walking speed evaluates the muscular performance. The seated patient must walk a distance of 4 meters as quickly as possible without the help of a third party. It has been shown that there is a non-linear relationship between walking speed and muscle strength.
Measured: Day 0
Short Physical Performance Battery (SPPB)
A battery of tests combining walking speed on 4 meters, sit-to-stand test and tandem balance test giving a physical performance score
Measured: Day 0
Bone mineral density (T-score)
Dual-energy x-ray absorptiometry (DEXA) is the imaging technique recommended for bone mineral density measure
Measured: Day 0
Muscle echography
Measured: Day 0
Walking distance in 6 minutes
Walking speed and distance evaluates the muscular performance. The seated patient must walk during 6minutes as quickly as possible without the help of a third party.
Measured: Day 0
International Physical Activity Questionnaire (IPAQ) score
IPAQ assesses physical activity undertaken across a comprehensive set of domains including:a. leisure time physical activity; b. domestic and gardening (yard) activities; c. work-related physical activity; d. transport-related physical activity. Two types of scoring: continuous score (sum of MET-minutes/week, reflecting the intensity of physical activity) and categorical score (low/moderate/high level of physical activity) with criteria based on MET-minutes/week and type of reported physical activity (moderate, vigorous intensities).
Measured: Day 0
Time to perform 5 sit-to-stand
Time in seconds
Measured: Day 0
Physical activity
Physical activity assessed objectively by actimetry during 1 week
Measured: Day 7
Sleep-wake duration
Sleep-wake duration assessed objectively by actimetry during 1 week
Measured: Day 7
Sarcopenia stage
The sarcopenia stage will be assessed according to the European Working Group on Sarcopenia in Older People (EWGSOP) definition: "non sarcopenia", "pre-sarcopenia" and "sarcopenia"
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start10 Jul 2018
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Technologie de Compiegne, Sorbonne University
- Responsible party
- Sponsor
- Investigators
- Kiyoka KINUGAWA, MD, PhD, Principal investigator, Charles Foix Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560648
- Sponsor's protocol ID
- K170916J
- Other IDs
- 2018-A00909-46
- Acronym
- CHRONOS
- Status last verified
- May 2019
- First submitted
- 18 May 2018
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Imrani L, Boudaoud S, Lahaye C, Moreau C, Ghezal M, Ben Manaa S, Doulazmi M, Laforet J, Marin F, Kinugawa K. High-density Surface Electromyography as Biomarker of Muscle Aging. J Gerontol A Biol Sci Med Sci. 2023 Jan 26;78(1):25-33. doi: 10.1093/gerona/glac143.
PubMed 35876634
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Device for the Evaluation of the "Motor Functional Age": How Old is Your Muscle?
- ClinicalTrials.gov ID
- NCT03560648
- Acronym / sponsor ID
- CHRONOS / K170916J
- Conditions
- Healthy Volunteers, Skeletal Muscle
- Keywords
- muscle aging, sarcopenia, neuromuscular dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Université de Technologie de Compiegne, Sorbonne University
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 18 Jun 2018 (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.
The CHRONOS project aims to provide a device to detect earlier the motor decline, by developing a precise quantitative device measuring "Motor Functional Age" (MFA) of young, middle-aged and old people, thus preventing future functional motor loss for healthy aging. The MFA might be different from the Chronological Age (CA), depending on lifestyle, physical activity, and medical condition. Thus, this device will permit monitoring, adaptation and new design of a variety of personalized therapies for healthy aging including physical exercise, medication and nutritional interventions to reduce the MFA toward or less than the CA. The device combines data processing software that estimates the MFA by assessing muscle aging using a non-invasive multichannel electromyographical technique coupled to accelerometry sensors for motion evaluation. These data will provide with a built-in clinical database of subjects from different age categories (25-75 years old).
Detailed description
Background:
Aging is accompanied by sarcopenia, defined by a loss in muscle mass (starting from the age of 25) and strength/function, leading to a decline in mobility. This functional motor decline is an increasing health problem with impairing functional independence and quality of life among seniors. Furthermore, a sedentary lifestyle reinforced by an abusive use of modern technology (videogames, transportation and communication) and poor dietary habits (often rich in sugar and fats and poor in high quality proteins) are more common in younger demographics than ever before. These unhealthy habits lead to premature muscle aging, sarcopenia and future functional motor loss.
Methods to easily and rapidly assess muscle quality in multiple clinical settings and with minimal patient burden are needed.
Moreover, an individual's CA, taken solely, is rarely a reliable index of an individual's ability to perform specific physical task. The proposed MFA concept is innovative since it precisely expresses the motor abilities through a sensitive screening of muscle activation using a recent HD-sEMG (High density-surface electromyogram) technique that is, by far, more robust, precise and representative than the classical single bipolar technique.
Aim and Objectives:
In the CHRONOS project, a device using HD-sEMG technology actually devoted to research actions only, even though CE-certified, will be designed by testing and combining data allowing one to assess the muscle activation efficiency and motion capacity (accelerometry sensors), as a function of CA.
- Main objective : attribute a MFA to define the normal muscle aging from HD-sEMG and accelerometer signals correlated to muscular parameters obtained from Dual Energy X-ray Absorptiometry (DEXA), handgrip strength and muscular echography. Data will be collected in " reference " individuals, healthy volunteers, aged 25 to 75 years old.
- Secondary objectives :
- to evaluate the capacity of MFA to detect early muscle aging in " tests " individuals, sedentary volunteers within the same age group (45-55 years old).
- study correlation between HD-sEMG/accelerometer signals and muscular parameters from DEXA, handgrip strength, physical performance by SPPB (Short Physical Performance battery), walking speed, walking distance in 6min, physical activity evaluated objectively by actimeter, and subjectively by IPAQ (International Physical Activity Questionnaire), muscle echography parameters, and nutritional data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference group | Other | Device: High definition surface electromyography combined with accelerometerTo define the normal muscle aging from HD-sEMG and accelerometer signals correlated to muscular parameters obtained from Dual Energy X-ray Absorptiometry (DEXA), handgrip strength and muscular echography. Data will be collected in healthy volunteers, aged 25 to 75 years old, physically active on IPAQ questionnaire. |
| Test group | Other | Device: High definition surface electromyography combined with accelerometerTo evaluate the capacity of MFA to detect early muscle aging in " tests " individuals, sedentary volunteers within the same age group (45-55 years old). |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| High definition surface electromyography combined with accelerometerHD-sEMG and accelerometer data will be collected by Mobita 32® (TMSi) device. | Device | Reference group, Test group |
Primary outcome
Motor functional age determined by HD-sEMG (rectus femoris) during sit to stand
Time frame: Day 0
HD-sEMG data will be correlated to Skeletal Mass Muscle Index, handgrip strength and muscle echography data.
Motor functional age determined accelerometer signals during sit to stand
Time frame: Day 0
Accelerometer data will be correlated to Skeletal Mass Muscle Index, handgrip strength and muscle echography data.
12 secondary outcomes
Skeletal Mass Muscle Index
Time frame: Day 0
Hand grip strength
Time frame: Day 0
Walking speed
Time frame: Day 0
Short Physical Performance Battery (SPPB)
Time frame: Day 0
Bone mineral density (T-score)
Time frame: Day 0
Muscle echography
Time frame: Day 0
Walking distance in 6 minutes
Time frame: Day 0
International Physical Activity Questionnaire (IPAQ) score
Time frame: Day 0
Time to perform 5 sit-to-stand
Time frame: Day 0
Physical activity
Time frame: Day 7
Sleep-wake duration
Time frame: Day 7
Sarcopenia stage
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Results publication: PubMed 35876634Imrani L, Boudaoud S, Lahaye C, Moreau C, Ghezal M, Ben Manaa S, Doulazmi M, Laforet J, Marin F, Kinugawa K. High-density Surface Electromyography as Biomarker of Muscle Aging. J Gerontol A Biol Sci Med Sci. 2023 Jan 26;78(1):25-33. doi: 10.1093/gerona/glac143.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingPhase 1
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
Healthy
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.
Kiyoka KINUGAWA, MD, PhD principal investigator
Charles Foix Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High definition surface electromyography combined with accelerometer in people with Healthy Volunteers and Skeletal Muscle, run by Assistance Publique - Hôpitaux de Paris 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?
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: finished, as of the sponsor's last update on 1 Sep 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Motor functional age determined by HD-sEMG (rectus femoris) during sit to stand (time frame: Day 0). The study lists 2 primary outcomes in all. 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 NCT03560648, which also lists 1 linked publication.
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 1 Sep 2022.