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Clinical Trials/NCT05343286
NCT05343286
Recruiting
N/A

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

Centre Hospitalier Universitaire de Nice1 site in 1 country900 target enrollmentApril 29, 2022
ConditionsElderly

Overview

Phase
N/A
Intervention
Not specified
Conditions
Elderly
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
900
Locations
1
Primary Endpoint
muscle power
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

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.

Detailed Description

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 Total duration of the study 5 years, duration of participation for a patient 3 months; inclusion period: 57 months Improvement of muscle failure in its broad definition (Strength, power, speed and lean mass) ) General data: description of characteristics with frequencies and percentage for categorical variables and with mean and standard deviation for quantitative variables. ii) Analysis of the primary endpoint: Machine Learning (or supervised classification) and signaling pathway prediction approaches for statistical analysis and data interpretation. iii) Analysis of secondary judgment criteria: approaches in Machine Learning (or supervised classification) and signaling pathway prediction for statistical analysis and interpretation of data with comparison of quantitative variables by Pearson correlation and categorical variables by t or chi 2 test depending on the case. Adapt and individualize physical activity support for healthy or frail elderly people

Registry
clinicaltrials.gov
Start Date
April 29, 2022
End Date
April 15, 2028
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

muscle power

Time Frame: before and after 12 week of physical activity program

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

Secondary Outcomes

  • 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)

Study Sites (1)

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