Device Evaluating the Muscular Functional Age

Healthy Volunteers Clinical Trial

— CHRONOS  

Official title:

Innovative Device for the Evaluation of the "Motor Functional Age": How Old is Your Muscle?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560648
• Other study ID #: K170916J
• Secondary ID: 2018-A00909-46
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: February 4, 2019

Study information

• Verified date: May 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Skeletal Muscle

Intervention

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

Locations

Country	Name	City	State
France	APHP - Charles Foix Hospital	Ivry-sur-Seine

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Sorbonne University, Université de Technologie de Compiegne

Country where clinical trial is conducted

France, 

References & Publications (1)

Imrani L, Boudaoud S, Lahaye C, Moreau C, Ghezal M, Ben Manaa S, Doulazmi M, Laforêt J, Marin F, Kinugawa K. High-density surface electromyography as biomarker of muscle aging. J Gerontol A Biol Sci Med Sci. 2022 Jul 25. pii: glac143. doi: 10.1093/gerona/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Primary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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	Day 0
Secondary	Bone mineral density (T-score)	Dual-energy x-ray absorptiometry (DEXA) is the imaging technique recommended for bone mineral density measure	Day 0
Secondary	Muscle echography		Day 0
Secondary	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.	Day 0
Secondary	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).	Day 0
Secondary	Time to perform 5 sit-to-stand	Time in seconds	Day 0
Secondary	Physical activity	Physical activity assessed objectively by actimetry during 1 week	Day 7
Secondary	Sleep-wake duration	Sleep-wake duration assessed objectively by actimetry during 1 week	Day 7
Secondary	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"	Day 0