BioFaSt: Biological & Fonctional Signatures for Muscle Failures, Aged People & Personalized Physical Activity
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Main objective: To determine the effects of personalized physical activity management on the biological signatures of muscle failure.
Secondary objectives:
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Propose a support system through adapted and individualized physical activity, based on physical, biological and psycho-social indicators
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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.
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Analysis of the primary endpoint: Machine Learning (or supervised classification) and signaling pathway prediction approaches for statistical analysis and data interpretation.
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: APAP group: adapted and personalized physical activity 12 weeks of adapted and personalized physical activity |
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
|
| Active Comparator: APA group: adapted physical activity 12 weeks of generic physical activity |
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
|
| Sham Comparator: Control group: no physical activity no physical activity |
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
|
Outcome Measures
Primary Outcome Measures
- muscle power [before and after 12 week of physical activity program]
muscle power (Watt/Kg) assessed with the isokinetic ergometer.
Secondary Outcome Measures
- Different metabolomic signature (The amino acid composition) between the groups (APA, APAP, no physical activity) [at day 0]
Change in the amino acid composition (metabolomic signature) at Day 0 between the groups
- Change in the amino acid composition (metabolomic signature) after 3 month of physical activity [between Day 0 and Month 3]
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
- ICOPE Monitor Assessment [before and after 12 week of physical activity program]
Score of frailty. (Implementation of the Integrated Care of Older People, ICOPmonitor, 8 item, higher score means worse outcome)
- Sit-to-stand Test [before and after 12 week of physical activity program]
number of movement
- Quantified Gait Analysis (QAM) [before and after 12 week of physical activity program]
Gait velocity in m.s-1
- Bone densitometer measurement of body composition [before and after 12 week of physical activity program]
% of lean mass
- Cognitive tests [before and after 12 week of physical activity program]
Score Mini-Mental State Examination (MMSE, 0-30, higher score mean worse outcome)
- The long questionnaire of personality traits [before and after 12 week of physical activity program]
Score of Big Five Inventory, 0-44, higher score means worse outcome
- Perceived health (Score of the scale) [before and after 12 week of physical activity program]
Score of the scale, 0-6, higher score means better outcome
- Subjective age [before and after 12 week of physical activity program]
Subjective age in years
- Age group identification (Years) [before and after 12 week of physical activity program]
Age group identification in years
- Attitudes towards aging [before and after 12 week of physical activity program]
Score on the French version of the Attitudes Toward Own Aging scales, 0-7, higher score means better outcome
- Physical self-perception [before and after 12 week of physical activity program]
Score on the French version of the Physical Self-Perception Profile, 0-6, higher score means better outcome
- Motivation scale for physical activity for health purposes [before and after 12 week of physical activity program]
Score on the Motivation Scale for Physical Activity in a Health Context,0-30, higher score means better outcome
- Aging Stereotypes and Exercise Scale [before and after 12 week of physical activity program]
Score on the French Aging Stereotypes and Exercise Scale (ASES), 0-12, higher score means better outcome
- Improvement of muscle force [before and after 12 week of physical activity program]
Improvement of muscle force (N/Kg) assessed with the isokinetic ergometer.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age greater than or equal to 60 years
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Affiliated patient or beneficiary of a social security scheme
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Patient having signed a prior informed consent.
Exclusion criteria
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Neurocognitive disorder preventing the expression of informed consent
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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
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Presence of a physical or cognitive pathology preventing the performance of the adapted physical activity protocol over 3 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nice | Nice | France | 06000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nice
Investigators
- Principal Investigator: Olivier GUERIN, PU-PH, geriatric Department
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-PP-24