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Device Evaluating the Muscular Functional Age (CHRONOS)

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ClinicalTrials.gov Identifier: NCT03560648
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Université de Technologie de Compiegne
Sorbonne Université
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Skeletal Muscle Device: High definition surface electromyography combined with accelerometer Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Innovative Device for the Evaluation of the "Motor Functional Age": How Old is Your Muscle?
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Reference group
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.
Device: High definition surface electromyography combined with accelerometer
HD-sEMG and accelerometer data will be collected by Mobita 32® (TMSi) device.

Test group
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).
Device: High definition surface electromyography combined with accelerometer
HD-sEMG and accelerometer data will be collected by Mobita 32® (TMSi) device.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Skeletal Mass Muscle Index [ Time Frame: Day 0 ]
    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.

  2. Hand grip strength [ Time Frame: Day 0 ]
    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.

  3. Walking speed [ Time Frame: Day 0 ]
    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.

  4. Short Physical Performance Battery (SPPB) [ Time Frame: Day 0 ]
    A battery of tests combining walking speed on 4 meters, sit-to-stand test and tandem balance test giving a physical performance score

  5. Bone mineral density (T-score) [ Time Frame: Day 0 ]
    Dual-energy x-ray absorptiometry (DEXA) is the imaging technique recommended for bone mineral density measure

  6. Muscle echography [ Time Frame: Day 0 ]
  7. Walking distance in 6 minutes [ Time Frame: Day 0 ]
    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.

  8. International Physical Activity Questionnaire (IPAQ) score [ Time Frame: Day 0 ]
    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).

  9. Time to perform 5 sit-to-stand [ Time Frame: Day 0 ]
    Time in seconds

  10. Physical activity [ Time Frame: Day 7 ]
    Physical activity assessed objectively by actimetry during 1 week

  11. Sleep-wake duration [ Time Frame: Day 7 ]
    Sleep-wake duration assessed objectively by actimetry during 1 week

  12. Sarcopenia stage [ Time Frame: Day 0 ]
    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"



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560648


Contacts
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Contact: Kiyoka KINUGAWA, MD, PhD + 33 1 49 59 47 50 kiyoka.kinugawa@aphp.fr

Locations
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France
APHP - Charles Foix Hospital Recruiting
Ivry-sur-Seine, France, 94200
Contact: KINUGAWA Kiyoka, MD, PhD    +33 1 49 59 47 53    kiyoka.kinugawa@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Université de Technologie de Compiegne
Sorbonne Université
Investigators
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Principal Investigator: Kiyoka KINUGAWA, MD, PhD Charles Foix Hospital

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03560648     History of Changes
Other Study ID Numbers: K170916J
2018-A00909-46 ( Other Identifier: IDCRB )
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
muscle aging
sarcopenia
neuromuscular dysfunction