- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03560648
Device Evaluating the Muscular Functional Age (CHRONOS)
Innovative Device for the Evaluation of the "Motor Functional Age": How Old is Your Muscle?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ivry-sur-Seine, France, 94200
- APHP - Charles Foix Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 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.
|
HD-sEMG and accelerometer data will be collected by Mobita 32® (TMSi) device.
|
OTHER: 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).
|
HD-sEMG and accelerometer data will be collected by Mobita 32® (TMSi) device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 0
|
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.
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 0
|
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.
|
Day 0
|
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.
|
Day 0
|
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
|
Day 0
|
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
|
Day 0
|
Muscle echography
Time Frame: Day 0
|
Day 0
|
|
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.
|
Day 0
|
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).
|
Day 0
|
Time to perform 5 sit-to-stand
Time Frame: Day 0
|
Time in seconds
|
Day 0
|
Physical activity
Time Frame: Day 7
|
Physical activity assessed objectively by actimetry during 1 week
|
Day 7
|
Sleep-wake duration
Time Frame: Day 7
|
Sleep-wake duration assessed objectively by actimetry during 1 week
|
Day 7
|
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"
|
Day 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kiyoka KINUGAWA, MD, PhD, Charles Foix Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- K170916J
- 2018-A00909-46 (OTHER: IDCRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on High definition surface electromyography combined with accelerometer
-
Assistance Publique - Hôpitaux de ParisUniversité de Technologie de CompiegneCompletedHip Fracture, Post Surgery Recovery, Muscle ResilienceFrance
-
King's College Hospital NHS TrustCompletedMotor Neuron Disease | Benign Fasciculation-Cramp SyndromeUnited Kingdom
-
Shanghai Mental Health CenterRecruitingObsessive-Compulsive DisorderChina
-
University of Dublin, Trinity CollegeMotor Neurone Disease Association, UK; Irish Research Council, IE; Research Motor... and other collaboratorsRecruitingALS (Amyotrophic Lateral Sclerosis) | Postpoliomyelitis Syndrome | Spinal Muscular AtrophyIreland
-
Robert Jones and Agnes Hunt Orthopaedic and District...University of Liverpool; University of Aberdeen; Bournemouth University; Keele...RecruitingShoulder Injuries | Pediatric ALL | Musculoskeletal Injury | Instability, Joint | Dislocation, ShoulderUnited Kingdom
-
University of LiverpoolBournemouth University; Robert Jones and Agnes Hunt Orthopaedic and District... and other collaboratorsRecruitingNeuromuscular Diseases | Shoulder Injuries | Shoulder Pain | Upper Extremity Problem | Facio-Scapulo-Humeral DystrophyUnited Kingdom
-
Instituto Ecuatoriano de Enfermedades DigestivasCompletedGastritis | Helicobacter Pylori Infection | Intestinal Metaplasia | Gastritis, AtrophicEcuador
-
Radboud University Medical CenterSolve FSHDRecruitingMuscular Dystrophy, FacioscapulohumeralNetherlands
-
Shandong UniversityUnknownGastric Intestinal MetaplasiaChina
-
Istituto Clinico HumanitasRecruiting