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

Official title

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

Overview

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

Interventions

• Procedure blood sample
  blood sample before and after 12 weeks of physical activity
• Other physical assessement
  physical assessement before and after 12 weeks of physical activity * Standardized geriatric assessment (physician visit) * ICOPE Monitor Assessment * Sit-to-stand Test * Quantified Gait Analysis (QAM) * Bone densitometer measurement of body composition
• Behavioral psychometric assessment
  Psychometric questionnaires * Cognitive tests (MMSE) * The long questionnaire of personality traits: Big Five Inventory * Perceived health and subjective age * Age group identification * Attitudes towards aging: French version of the Attitudes Toward Own Aging scale * Physical self-perception: French version of the Physical Self-Perception Profile * MOTIVATION SCALE FOR PA FOR HEALTH PURPOSES: Motivation Scale for Physical Activity in a Health Context * Aging Stereotypes and Exercise Scale

Primary outcome measures

• muscle power [Time frame: before and after 12 week of physical activity program]

Secondary outcome measures (12)

• Different metabolomic signature (The amino acid composition) between the groups (APA, APAP, no physical activity) [Time frame: at day 0]
• Change in the amino acid composition (metabolomic signature) after 3 month of physical activity [Time frame: between Day 0 and Month 3]
• ICOPE Monitor Assessment [Time frame: before and after 12 week of physical activity program]
• Sit-to-stand Test [Time frame: before and after 12 week of physical activity program]
• Quantified Gait Analysis (QAM) [Time frame: before and after 12 week of physical activity program]
• Bone densitometer measurement of body composition [Time frame: before and after 12 week of physical activity program]
• Cognitive tests [Time frame: before and after 12 week of physical activity program]
• The long questionnaire of personality traits [Time frame: before and after 12 week of physical activity program]
• Perceived health (Score of the scale) [Time frame: before and after 12 week of physical activity program]
• Subjective age [Time frame: before and after 12 week of physical activity program]
• Age group identification (Years) [Time frame: before and after 12 week of physical activity program]
• Attitudes towards aging [Time frame: before and after 12 week of physical activity program]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

France · 1 center

• CHU de Nice — Nice

Identifiers

NCT: NCT05343286 · 21-PP-24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗