Clinical trial NCT03560648: Device Evaluating the Muscular Functional Age
Official title: Innovative Device for the Evaluation of the "Motor Functional Age": How Old is Your Muscle?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Skeletal Muscle
Keywords: muscle aging
sarcopenia
neuromuscular dysfunction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Université de Technologie de Compiegne
name: Sorbonne University
First posted: 2018-06-18
Enrollment: 91
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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.

Eligibility 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

Primary outcomes:
measure: Motor functional age determined by HD-sEMG (rectus femoris) during sit to stand
timeFrame: Day 0
measure: Motor functional age determined accelerometer signals during sit to stand
timeFrame: Day 0
Secondary outcomes:
measure: Skeletal Mass Muscle Index
timeFrame: Day 0
measure: Hand grip strength
timeFrame: Day 0
measure: Walking speed
timeFrame: Day 0
measure: Short Physical Performance Battery (SPPB)
timeFrame: Day 0
measure: Bone mineral density (T-score)
timeFrame: Day 0
measure: Muscle echography
timeFrame: Day 0
measure: Walking distance in 6 minutes
timeFrame: Day 0
measure: International Physical Activity Questionnaire (IPAQ) score
timeFrame: Day 0
measure: Time to perform 5 sit-to-stand
timeFrame: Day 0
measure: Physical activity
timeFrame: Day 7
measure: Sleep-wake duration
timeFrame: Day 7
measure: Sarcopenia stage
timeFrame: Day 0
Other outcomes:
Locations:
city: Ivry-sur-Seine
country: France
facility: APHP - Charles Foix Hospital
Study officials:
affiliation: Charles Foix Hospital
name: Kiyoka KINUGAWA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.