跳至主要内容
临床试验/NCT05343286
NCT05343286招募中不适用

Biological & Fonctional Signatures for Muscle Failures, Aged People & Personalized Physical Activity : BioFaSt MAPPA

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2022年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
2
主要终点
muscle power

研究概览

简要总结

Physical activity is one of the most effective therapeutic interventions for frailty, sarcopenia or dynapenia. The benefits of physical activity processes are already widely documented. Typically, researchers want to understand the average response to an intervention to determine its overall effectiveness. However, sports trainers have understood it for a long time, the response of an athlete or a patient to training is very variable and the standard deviations present in all the scientific studies on the subject confirm it. There is therefore inter-individual variation in the response to exercise, with some subjects showing much greater improvements than others. Thus, one can wonder if this "non-response" following training is specific to the training modality. The effects of physical exercise on the body depend mainly on its type, intensity and duration. Thus, from a practical point of view, the most important perspective is the prediction and, ultimately, the individual optimization of management through physical activity.

详细描述

Main objective: To determine the effects of personalized physical activity management on the biological signatures of muscle failure.

Secondary objectives:

  • Propose a support system through adapted and individualized physical activity, based on physical, biological and psycho-social indicators
  • Identify the biological signatures (metabolomics, epigenetic) of muscle failure in the elderly.

Phenotype responders and non-responders in training

900 seniors (300 per group) APAP group: adapted and personalized physical activity APA group: adapted physical activity Control group: no physical activity

研究设计

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

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 60 years
  • Affiliated patient or beneficiary of a social security scheme
  • Patient having signed a prior informed consent.
  • Exclusion criteria
  • Neurocognitive disorder preventing the expression of informed consent
  • Patients protected by law under guardianship or curatorship, or who cannot participate in a clinical study under Article L. 1121-16 of the French Public Health Code
  • Presence of a physical or cognitive pathology preventing the performance of the adapted physical activity protocol over 3 months.

排除标准

  • 未提供

结局指标

主要结局

muscle power

时间窗: before and after 12 week of physical activity program

muscle power (Watt/Kg) assessed with the isokinetic ergometer.

次要结局

  • Sit-to-stand Test(before and after 12 week of physical activity program)
  • Quantified Gait Analysis (QAM)(before and after 12 week of physical activity program)
  • Physical self-perception(before and after 12 week of physical activity program)
  • Change in the amino acid composition (metabolomic signature) after 3 month of physical activity(between Day 0 and Month 3)
  • Different metabolomic signature (The amino acid composition) between the groups (APA, APAP, no physical activity)(at day 0)
  • ICOPE Monitor Assessment(before and after 12 week of physical activity program)
  • Cognitive tests(before and after 12 week of physical activity program)
  • The long questionnaire of personality traits(before and after 12 week of physical activity program)
  • Perceived health (Score of the scale)(before and after 12 week of physical activity program)
  • Subjective age(before and after 12 week of physical activity program)
  • Motivation scale for physical activity for health purposes(before and after 12 week of physical activity program)
  • Aging Stereotypes and Exercise Scale(before and after 12 week of physical activity program)
  • Age group identification (Years)(before and after 12 week of physical activity program)
  • Bone densitometer measurement of body composition(before and after 12 week of physical activity program)
  • Attitudes towards aging(before and after 12 week of physical activity program)
  • Improvement of muscle force(before and after 12 week of physical activity program)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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