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

Study 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

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

Conditions
-----------------
Elderly

Intervention / Treatment
-----------------
* Procedure: blood sample
* Other: physical assessement
* Behavioral: psychometric assessment


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APAP group: adapted and personalized physical activity<br>12 weeks of adapted and personalized physical activity | Procedure: blood sample<br>* blood sample before and after 12 weeks of physical activity<br>Other: physical assessement<br>* 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<br>Behavioral: psychometric assessment<br>* 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<br>|
| Active Comparator: APA group: adapted physical activity<br>12 weeks of generic physical activity | Procedure: blood sample<br>* blood sample before and after 12 weeks of physical activity<br>Other: physical assessement<br>* 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<br>Behavioral: psychometric assessment<br>* 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<br>|
| Sham Comparator: Control group: no physical activity<br>no physical activity | Procedure: blood sample<br>* blood sample before and after 12 weeks of physical activity<br>Other: physical assessement<br>* 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<br>Behavioral: psychometric assessment<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle power | muscle power (Watt/Kg) assessed with the isokinetic ergometer. | before and after 12 week of physical activity program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Different metabolomic signature (The amino acid composition) between the groups (APA, APAP, no physical activity) | Change in the amino acid composition (metabolomic signature) at Day 0 between the groups | at day 0 | 
| Change in the amino acid composition (metabolomic signature) after 3 month of physical activity | Change in the amino acid composition (metabolomic signature) after 3 month of physical activity for the APA and APAP groups compared to the no physical activity group | between Day 0 and Month 3 | 
| ICOPE Monitor Assessment | Score of frailty. (Implementation of the Integrated Care of Older People, ICOPmonitor, 8 item, higher score means worse outcome) | before and after 12 week of physical activity program | 
| Sit-to-stand Test | number of movement | before and after 12 week of physical activity program | 
| Quantified Gait Analysis (QAM) | Gait velocity in m.s-1 | before and after 12 week of physical activity program | 
| Bone densitometer measurement of body composition | % of lean mass | before and after 12 week of physical activity program | 
| Cognitive tests | Score Mini-Mental State Examination (MMSE, 0-30, higher score mean worse outcome) | before and after 12 week of physical activity program | 
| The long questionnaire of personality traits | Score of Big Five Inventory, 0-44, higher score means worse outcome | before and after 12 week of physical activity program | 
| Perceived health (Score of the scale) | Score of the scale, 0-6, higher score means better outcome | before and after 12 week of physical activity program | 
| Subjective age | Subjective age in years | before and after 12 week of physical activity program | 
| Age group identification (Years) | Age group identification in years | before and after 12 week of physical activity program | 
| Attitudes towards aging | Score on the French version of the Attitudes Toward Own Aging scales, 0-7, higher score means better outcome | before and after 12 week of physical activity program | 
| Physical self-perception | Score on the French version of the Physical Self-Perception Profile, 0-6, higher score means better outcome | before and after 12 week of physical activity program | 
| Motivation scale for physical activity for health purposes | Score on the Motivation Scale for Physical Activity in a Health Context,0-30, higher score means better outcome | before and after 12 week of physical activity program | 
| Aging Stereotypes and Exercise Scale | Score on the French Aging Stereotypes and Exercise Scale (ASES), 0-12, higher score means better outcome | before and after 12 week of physical activity program | 
| Improvement of muscle force | Improvement of muscle force (N/Kg) assessed with the isokinetic ergometer. | before and after 12 week of physical activity program |