Trials / Recruiting
RecruitingNCT05343286
Biological & Fonctional Signatures for Muscle Failures, Aged People & Personalized Physical Activity
Biological & Fonctional Signatures for Muscle Failures, Aged People & Personalized Physical Activity : BioFaSt MAPPA
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- Sponsor
- Centre Hospitalier Universitaire de Nice · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-04-29
- Primary completion
- 2027-04-15
- Completion
- 2028-04-15
- First posted
- 2022-04-25
- Last updated
- 2025-12-03
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05343286. Inclusion in this directory is not an endorsement.