NCT03560648

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2019

Completed
Last Updated

September 1, 2022

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

May 18, 2018

Last Update Submit

August 29, 2022

Conditions

Healthy VolunteersSkeletal Muscle

Keywords

muscle agingsarcopenianeuromuscular dysfunction

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (12)

  • Skeletal Mass Muscle Index

    Day 0

  • Hand grip strength

    Day 0

  • Walking speed

    Day 0

  • Short Physical Performance Battery (SPPB)

    Day 0

  • Bone mineral density (T-score)

    Day 0

  • +7 more secondary outcomes

Study Arms (2)

Reference group

OTHER

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

Test group

OTHER

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

Interventions

High definition surface electromyography combined with accelerometerDEVICE

HD-sEMG and accelerometer data will be collected by Mobita 32® (TMSi) device.

Reference groupTest group

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • walking without help
  • physically active (IPAQ questionnaire: moderately or highly active) for "reference group" and sedentary (IPAQ questionnaire: low activity) for "test" group.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP - Charles Foix Hospital

Ivry-sur-Seine, 94200, France

Location

Related Publications (1)

  • 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.

    PMID: 35876634RESULT

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Kiyoka KINUGAWA, MD, PhD

    Charles Foix Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2018

First Posted

June 18, 2018

Study Start

July 10, 2018

Primary Completion

February 4, 2019

Study Completion

February 4, 2019

Last Updated

September 1, 2022

Record last verified: 2019-05

Locations

FR(1)