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临床试验/NCT03560648
NCT03560648已完成不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2018年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Motor functional age determined by HD-sEMG (rectus femoris) during sit to stand

研究概览

简要总结

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).

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: High definition surface electromyography combined with accelerometer (Device)

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).

干预措施: High definition surface electromyography combined with accelerometer (Device)

结局指标

主要结局

Motor functional age determined by HD-sEMG (rectus femoris) during sit to stand

时间窗: Day 0

HD-sEMG data will be correlated to Skeletal Mass Muscle Index, handgrip strength and muscle echography data.

Motor functional age determined accelerometer signals during sit to stand

时间窗: Day 0

Accelerometer data will be correlated to Skeletal Mass Muscle Index, handgrip strength and muscle echography data.

次要结局

  • Sleep-wake duration(Day 7)
  • Walking speed(Day 0)
  • Walking distance in 6 minutes(Day 0)
  • Skeletal Mass Muscle Index(Day 0)
  • Bone mineral density (T-score)(Day 0)
  • Time to perform 5 sit-to-stand(Day 0)
  • Hand grip strength(Day 0)
  • Muscle echography(Day 0)
  • International Physical Activity Questionnaire (IPAQ) score(Day 0)
  • Short Physical Performance Battery (SPPB)(Day 0)
  • Physical activity(Day 7)
  • Sarcopenia stage(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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