AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

France1 site

  • APHP - Charles Foix Hospital

    Ivry-sur-Seine, 94200

Other trials in France

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 :
  1. 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).
  2. 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.
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 groups in NCT03560648
Study groupRoleWhat they receive
Reference groupOtherTo 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 groupOtherTo 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.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. Bone mineral density (T-score)

    Dual-energy x-ray absorptiometry (DEXA) is the imaging technique recommended for bone mineral density measure

    Measured: Day 0

  6. Muscle echography

    Measured: Day 0

  7. 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

  8. 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

  9. Time to perform 5 sit-to-stand

    Time in seconds

    Measured: Day 0

  10. Physical activity

    Physical activity assessed objectively by actimetry during 1 week

    Measured: Day 7

  11. Sleep-wake duration

    Sleep-wake duration assessed objectively by actimetry during 1 week

    Measured: Day 7

  12. 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.

  1. First posted18 Jun 2018
  2. Study start10 Jul 2018
  3. Primary completion4 Feb 2019
  4. Study completion4 Feb 2019

Resources

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)
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

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in